The persistent notion that multiple sclerosis (MS) is predominantly a White patient’s disease has been challenged by scientific data and our clinical experience in the field. Recent research has shown a higher risk of MS in non-White populations than originally thought. This may be surprising, but new data are influencing the way we now approach MS in under-represented minorities, bringing this topic to the forefront of scientific interest.

     The early conviction that “there is no MS in minorities” led to underdiagnosis and misdiagnosis of MS in those patients, which in turn deepened these patients’ distrust of physicians and reluctance to seek further medical care, very often delivered by non-minority providers. Inequities in social determinants of health, low health literacy, and lack of private insurance, along with structural racism in healthcare, has further hindered active engagement with an already marginalized patient population in their MS care. This lack of engagement and lack of minorities in scientific research has proved to be unfavorable for MS research as well, creating large and persistent knowledge gaps in understanding MS course, severity, and response to treatment specific to this group. A 2014 PubMed search found 52,000 publications on MS in English, but in only 136 of those were minority patients with MS (Black or Hispanic/Latino) the primary research focus. In 2019, the same search indicated that the subsequent 5 years produced only 30 more articles focusing solely on minority patients.

      Research participation of underrepresented minorities is another area where we, as a field, continue to fail these patients. A review of participant enrollment in MS clinical trials that took place between 1993 and 2006 showed a significant decrease in the percentage of enrolled Black patients (from 7% to about 4%). This trend did not improve by the DEFINE treatment trial (2012), in which only 2% of enrolled patients were Black. Of the 1246 participants in the 2019 SUNBEAM MS study, only 2 were Black. Low numbers of minority patients in trials prevent us from drawing any reasonable conclusion as to the efficacy of disease-modifying agents in those patients and make the goal of personalized medicine for this group impossible.

        The results of the research conducted on these groups are compelling and should be prompting further work. Not only do Black patients have a higher risk of MS, but there is also now convincing evidence that MS in minorities is more severe overall, causing early progression of disability and necessitating assistive gait devices such as a cane or wheelchair. Minority patients tend to have more extensive involvement of spinal cord and infra-tentorial brain structures during the disease, which could explain the increased likelihood of more severe disease and earlier disability. Minority patients were admitted to nursing homes at a younger age, with greater physical and cognitive impairment than nonminority patients. A study looking at MS mortality between 1999 and 2015 found that Black males with MS had the highest mortality rate before age 45, and Black females before age 53. MS mortality increased with age but peaked at age 55 to 64 for Black patients and 65 to 74 for White patients. Underrepresented minorities are also less likely to use community resources, case management, medical equipment, and home nursing services. When looking at other measures of disease impact on these patients, studies evaluating magnetic resonance imaging (MRI) data showed higher lesion volume in Black patients with MS, as well as a higher degree of brain demyelination and atrophy when compared with White patients. 

         Treatment strategies currently used for underrepresented minority patients, as well as estimations of medication efficacy, treatment responses, and adverse-event profiles are largely driven by data from clinical trials with only minimal representation of those patients. How can we propose a patient-tailored and individualized treatment plan without these crucial data? Given that, to this day, not a single trial has focused solely on underrepresented minorities, we are left with either post hoc exploratory subgroup analyses of existing trials or pragmatic, observational, and very often retrospective studies using chart analysis. Notwithstanding the methodological flaws of either approach, prior studies did suggest worse response to platform therapies in Black patients, but equal response to high-efficacy therapies when compared with White patients. 

       Definitive biological underpinnings of disparities in disease severity have not been identified. In recent years, the field of health outcomes research has suggested we move away from considering racial categories as biologically distinct and instead focus on long-overlooked sociodemographic and modifiable lifestyle

factors. The role of diet, exercise, body mass index, smoking, and vascular comorbidities as risk factors associated with worse MS outcomes has been previously shown; however, these factors have not been rigorously assessed in underrepresented populations with MS. Recent studies focused on uncovering what drives the differences in MS severity in underrepresented populations disagree on the role biological differences, socioeconomic disparities, and structural racism in both healthcare settings and society play in answering this question. While it is plausible that a combination of these factors might explain our observations, more research on larger, underserved patient populations and better-defined measures of socioeconomic differences are needed to answer this complex question. 

         The path of recognizing and correcting our mistakes is not simple but must be done, and our underrepresented minority patients depend on our swift action. There are many places where we as a field of experts can and must do better—in communities, healthcare systems, and society in general. 

       Increasing community health literacy around MS, rebuilding trust, and addressing structural racism on every level is important. Outreach and educational programs that include in-person meetings and leverage social media platforms can help empower patients and their families—and hopefully increase trust in healthcare providers. Devising targeted interventions focusing on modifiable factors of a healthy lifestyle such as diet and exercise can increase community engagement and strengthen the support system for our patients. Increasing diversity in our own field of physicians, nurses, and other healthcare providers can also aid in strengthening mutual relationships. 

         Improving access to comprehensive MS care for underrepresented minorities who very often also lack robust insurance coverage is paramount. Recipients of comprehensive care are more likely to participate in research, as these patients receive more well-rounded care and have a lower risk of mismanaged comorbidities. Their involvement in the treatment plan is higher, which also improves compliance with treatment. Patients in comprehensive care centers are more likely to receive newer treatment agents with better efficacy without hindrance of monitoring barriers, and they are likely to benefit from treatment strategies using newly approved agents soon after US Food and Drug Administration approval. 

          Increasing research participation and, ideally, conducting a clinical trial devoted solely to studying MS in underrepresented minorities is something for which we should actively strive. Identifying the main factors prohibiting enrollment and retention of a high number of minority participants in trials is critical to success. Multiple deterrents in day-to-day life, very often directly connected to economic hardship and racism, pose a very real threat to equitable trial participation. To even consider a successful trial for underrepresented minorities, we must do better in devising strategies and accommodations to help overcome those barriers. 

         The underserved minorities with MS deserve and need our attention and focus. These patients have largely been neglected and forgotten, but now are emerging at the forefront of our attention—where they belong. 

The persistent notion that multiple sclerosis (MS) is predominantly a White patient’s disease has been challenged by scientific data and our clinical experience in the field. Recent research has shown a higher risk of MS in non-White populations than originally thought. This may be surprising, but new data are influencing the way we now approach MS in under-represented minorities, bringing this topic to the forefront of scientific interest.

     The early conviction that “there is no MS in minorities” led to underdiagnosis and misdiagnosis of MS in those patients, which in turn deepened these patients’ distrust of physicians and reluctance to seek further medical care, very often delivered by non-minority providers. Inequities in social determinants of health, low health literacy, and lack of private insurance, along with structural racism in healthcare, has further hindered active engagement with an already marginalized patient population in their MS care. This lack of engagement and lack of minorities in scientific research has proved to be unfavorable for MS research as well, creating large and persistent knowledge gaps in understanding MS course, severity, and response to treatment specific to this group. A 2014 PubMed search found 52,000 publications on MS in English, but in only 136 of those were minority patients with MS (Black or Hispanic/Latino) the primary research focus. In 2019, the same search indicated that the subsequent 5 years produced only 30 more articles focusing solely on minority patients.

      Research participation of underrepresented minorities is another area where we, as a field, continue to fail these patients. A review of participant enrollment in MS clinical trials that took place between 1993 and 2006 showed a significant decrease in the percentage of enrolled Black patients (from 7% to about 4%). This trend did not improve by the DEFINE treatment trial (2012), in which only 2% of enrolled patients were Black. Of the 1246 participants in the 2019 SUNBEAM MS study, only 2 were Black. Low numbers of minority patients in trials prevent us from drawing any reasonable conclusion as to the efficacy of disease-modifying agents in those patients and make the goal of personalized medicine for this group impossible.

        The results of the research conducted on these groups are compelling and should be prompting further work. Not only do Black patients have a higher risk of MS, but there is also now convincing evidence that MS in minorities is more severe overall, causing early progression of disability and necessitating assistive gait devices such as a cane or wheelchair. Minority patients tend to have more extensive involvement of spinal cord and infra-tentorial brain structures during the disease, which could explain the increased likelihood of more severe disease and earlier disability. Minority patients were admitted to nursing homes at a younger age, with greater physical and cognitive impairment than nonminority patients. A study looking at MS mortality between 1999 and 2015 found that Black males with MS had the highest mortality rate before age 45, and Black females before age 53. MS mortality increased with age but peaked at age 55 to 64 for Black patients and 65 to 74 for White patients. Underrepresented minorities are also less likely to use community resources, case management, medical equipment, and home nursing services. When looking at other measures of disease impact on these patients, studies evaluating magnetic resonance imaging (MRI) data showed higher lesion volume in Black patients with MS, as well as a higher degree of brain demyelination and atrophy when compared with White patients. 

         Treatment strategies currently used for underrepresented minority patients, as well as estimations of medication efficacy, treatment responses, and adverse-event profiles are largely driven by data from clinical trials with only minimal representation of those patients. How can we propose a patient-tailored and individualized treatment plan without these crucial data? Given that, to this day, not a single trial has focused solely on underrepresented minorities, we are left with either post hoc exploratory subgroup analyses of existing trials or pragmatic, observational, and very often retrospective studies using chart analysis. Notwithstanding the methodological flaws of either approach, prior studies did suggest worse response to platform therapies in Black patients, but equal response to high-efficacy therapies when compared with White patients. 

       Definitive biological underpinnings of disparities in disease severity have not been identified. In recent years, the field of health outcomes research has suggested we move away from considering racial categories as biologically distinct and instead focus on long-overlooked sociodemographic and modifiable lifestyle

factors. The role of diet, exercise, body mass index, smoking, and vascular comorbidities as risk factors associated with worse MS outcomes has been previously shown; however, these factors have not been rigorously assessed in underrepresented populations with MS. Recent studies focused on uncovering what drives the differences in MS severity in underrepresented populations disagree on the role biological differences, socioeconomic disparities, and structural racism in both healthcare settings and society play in answering this question. While it is plausible that a combination of these factors might explain our observations, more research on larger, underserved patient populations and better-defined measures of socioeconomic differences are needed to answer this complex question. 

         The path of recognizing and correcting our mistakes is not simple but must be done, and our underrepresented minority patients depend on our swift action. There are many places where we as a field of experts can and must do better—in communities, healthcare systems, and society in general. 

       Increasing community health literacy around MS, rebuilding trust, and addressing structural racism on every level is important. Outreach and educational programs that include in-person meetings and leverage social media platforms can help empower patients and their families—and hopefully increase trust in healthcare providers. Devising targeted interventions focusing on modifiable factors of a healthy lifestyle such as diet and exercise can increase community engagement and strengthen the support system for our patients. Increasing diversity in our own field of physicians, nurses, and other healthcare providers can also aid in strengthening mutual relationships. 

         Improving access to comprehensive MS care for underrepresented minorities who very often also lack robust insurance coverage is paramount. Recipients of comprehensive care are more likely to participate in research, as these patients receive more well-rounded care and have a lower risk of mismanaged comorbidities. Their involvement in the treatment plan is higher, which also improves compliance with treatment. Patients in comprehensive care centers are more likely to receive newer treatment agents with better efficacy without hindrance of monitoring barriers, and they are likely to benefit from treatment strategies using newly approved agents soon after US Food and Drug Administration approval. 

          Increasing research participation and, ideally, conducting a clinical trial devoted solely to studying MS in underrepresented minorities is something for which we should actively strive. Identifying the main factors prohibiting enrollment and retention of a high number of minority participants in trials is critical to success. Multiple deterrents in day-to-day life, very often directly connected to economic hardship and racism, pose a very real threat to equitable trial participation. To even consider a successful trial for underrepresented minorities, we must do better in devising strategies and accommodations to help overcome those barriers. 

         The underserved minorities with MS deserve and need our attention and focus. These patients have largely been neglected and forgotten, but now are emerging at the forefront of our attention—where they belong. 

The persistent notion that multiple sclerosis (MS) is predominantly a White patient’s disease has been challenged by scientific data and our clinical experience in the field. Recent research has shown a higher risk of MS in non-White populations than originally thought. This may be surprising, but new data are influencing the way we now approach MS in under-represented minorities, bringing this topic to the forefront of scientific interest.

     The early conviction that “there is no MS in minorities” led to underdiagnosis and misdiagnosis of MS in those patients, which in turn deepened these patients’ distrust of physicians and reluctance to seek further medical care, very often delivered by non-minority providers. Inequities in social determinants of health, low health literacy, and lack of private insurance, along with structural racism in healthcare, has further hindered active engagement with an already marginalized patient population in their MS care. This lack of engagement and lack of minorities in scientific research has proved to be unfavorable for MS research as well, creating large and persistent knowledge gaps in understanding MS course, severity, and response to treatment specific to this group. A 2014 PubMed search found 52,000 publications on MS in English, but in only 136 of those were minority patients with MS (Black or Hispanic/Latino) the primary research focus. In 2019, the same search indicated that the subsequent 5 years produced only 30 more articles focusing solely on minority patients.

      Research participation of underrepresented minorities is another area where we, as a field, continue to fail these patients. A review of participant enrollment in MS clinical trials that took place between 1993 and 2006 showed a significant decrease in the percentage of enrolled Black patients (from 7% to about 4%). This trend did not improve by the DEFINE treatment trial (2012), in which only 2% of enrolled patients were Black. Of the 1246 participants in the 2019 SUNBEAM MS study, only 2 were Black. Low numbers of minority patients in trials prevent us from drawing any reasonable conclusion as to the efficacy of disease-modifying agents in those patients and make the goal of personalized medicine for this group impossible.

        The results of the research conducted on these groups are compelling and should be prompting further work. Not only do Black patients have a higher risk of MS, but there is also now convincing evidence that MS in minorities is more severe overall, causing early progression of disability and necessitating assistive gait devices such as a cane or wheelchair. Minority patients tend to have more extensive involvement of spinal cord and infra-tentorial brain structures during the disease, which could explain the increased likelihood of more severe disease and earlier disability. Minority patients were admitted to nursing homes at a younger age, with greater physical and cognitive impairment than nonminority patients. A study looking at MS mortality between 1999 and 2015 found that Black males with MS had the highest mortality rate before age 45, and Black females before age 53. MS mortality increased with age but peaked at age 55 to 64 for Black patients and 65 to 74 for White patients. Underrepresented minorities are also less likely to use community resources, case management, medical equipment, and home nursing services. When looking at other measures of disease impact on these patients, studies evaluating magnetic resonance imaging (MRI) data showed higher lesion volume in Black patients with MS, as well as a higher degree of brain demyelination and atrophy when compared with White patients. 

         Treatment strategies currently used for underrepresented minority patients, as well as estimations of medication efficacy, treatment responses, and adverse-event profiles are largely driven by data from clinical trials with only minimal representation of those patients. How can we propose a patient-tailored and individualized treatment plan without these crucial data? Given that, to this day, not a single trial has focused solely on underrepresented minorities, we are left with either post hoc exploratory subgroup analyses of existing trials or pragmatic, observational, and very often retrospective studies using chart analysis. Notwithstanding the methodological flaws of either approach, prior studies did suggest worse response to platform therapies in Black patients, but equal response to high-efficacy therapies when compared with White patients. 

       Definitive biological underpinnings of disparities in disease severity have not been identified. In recent years, the field of health outcomes research has suggested we move away from considering racial categories as biologically distinct and instead focus on long-overlooked sociodemographic and modifiable lifestyle

factors. The role of diet, exercise, body mass index, smoking, and vascular comorbidities as risk factors associated with worse MS outcomes has been previously shown; however, these factors have not been rigorously assessed in underrepresented populations with MS. Recent studies focused on uncovering what drives the differences in MS severity in underrepresented populations disagree on the role biological differences, socioeconomic disparities, and structural racism in both healthcare settings and society play in answering this question. While it is plausible that a combination of these factors might explain our observations, more research on larger, underserved patient populations and better-defined measures of socioeconomic differences are needed to answer this complex question. 

         The path of recognizing and correcting our mistakes is not simple but must be done, and our underrepresented minority patients depend on our swift action. There are many places where we as a field of experts can and must do better—in communities, healthcare systems, and society in general. 

       Increasing community health literacy around MS, rebuilding trust, and addressing structural racism on every level is important. Outreach and educational programs that include in-person meetings and leverage social media platforms can help empower patients and their families—and hopefully increase trust in healthcare providers. Devising targeted interventions focusing on modifiable factors of a healthy lifestyle such as diet and exercise can increase community engagement and strengthen the support system for our patients. Increasing diversity in our own field of physicians, nurses, and other healthcare providers can also aid in strengthening mutual relationships. 

         Improving access to comprehensive MS care for underrepresented minorities who very often also lack robust insurance coverage is paramount. Recipients of comprehensive care are more likely to participate in research, as these patients receive more well-rounded care and have a lower risk of mismanaged comorbidities. Their involvement in the treatment plan is higher, which also improves compliance with treatment. Patients in comprehensive care centers are more likely to receive newer treatment agents with better efficacy without hindrance of monitoring barriers, and they are likely to benefit from treatment strategies using newly approved agents soon after US Food and Drug Administration approval. 

          Increasing research participation and, ideally, conducting a clinical trial devoted solely to studying MS in underrepresented minorities is something for which we should actively strive. Identifying the main factors prohibiting enrollment and retention of a high number of minority participants in trials is critical to success. Multiple deterrents in day-to-day life, very often directly connected to economic hardship and racism, pose a very real threat to equitable trial participation. To even consider a successful trial for underrepresented minorities, we must do better in devising strategies and accommodations to help overcome those barriers. 

         The underserved minorities with MS deserve and need our attention and focus. These patients have largely been neglected and forgotten, but now are emerging at the forefront of our attention—where they belong. 

One of the most rewarding things about serving as editor of GI & Hepatology News is to consider new content that will further engage and bring value to our readership. In addition to reporting on scientific advances from our GI journals that can inform frontline clinical care of patients with gastrointestinal conditions, we have launched several new columns over the past year, including our monthly Member Spotlight and quarterly Health Policy and Advocacy columns, to diversify our content.

In our September 2023 issue, in addition to debuting a new cover design, we are pleased to introduce yet another new offering – the “Ethics Corner” column. It is intended to highlight important ethical considerations and challenges arising in GI practice and offer practical guidance on how to navigate them. In our inaugural Ethics Corner, AGA Ethics Committee members Dr. Sheldon Sloan and Dr. David Drew discuss the “good, the bad, and the ugly” of direct-to-consumer advertising (DTCA). They highlight the pros and cons of DTCA from an ethical perspective, illustrate how DTCA can impact everyday clinical interactions with patients, and provide insight into how to navigate these challenging conversations. We hope you enjoy this new addition to the newspaper and welcome your ideas for future Ethics Corner columns and other content.

Also in this month’s issue, we update you on AGA’s response to the American College of Physicians’ recent decision to recommend against initiating colon cancer screening at age 45, contrary to the recommendation of the GI community. We also present a story on Humira biosimilars and how they are likely to impact clinical practice. Finally, our September Member Spotlight features GI dietitian Renee Euler, MS, RD, LD, who discusses the intersection between diet and GI disorders, the importance of a team approach to GI care, and her work as a liaison between the AGA and Academy of Nutrition and Dietetics.

We hope you enjoy these, and all the stories featured in our September issue.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

One of the most rewarding things about serving as editor of GI & Hepatology News is to consider new content that will further engage and bring value to our readership. In addition to reporting on scientific advances from our GI journals that can inform frontline clinical care of patients with gastrointestinal conditions, we have launched several new columns over the past year, including our monthly Member Spotlight and quarterly Health Policy and Advocacy columns, to diversify our content.

In our September 2023 issue, in addition to debuting a new cover design, we are pleased to introduce yet another new offering – the “Ethics Corner” column. It is intended to highlight important ethical considerations and challenges arising in GI practice and offer practical guidance on how to navigate them. In our inaugural Ethics Corner, AGA Ethics Committee members Dr. Sheldon Sloan and Dr. David Drew discuss the “good, the bad, and the ugly” of direct-to-consumer advertising (DTCA). They highlight the pros and cons of DTCA from an ethical perspective, illustrate how DTCA can impact everyday clinical interactions with patients, and provide insight into how to navigate these challenging conversations. We hope you enjoy this new addition to the newspaper and welcome your ideas for future Ethics Corner columns and other content.

Also in this month’s issue, we update you on AGA’s response to the American College of Physicians’ recent decision to recommend against initiating colon cancer screening at age 45, contrary to the recommendation of the GI community. We also present a story on Humira biosimilars and how they are likely to impact clinical practice. Finally, our September Member Spotlight features GI dietitian Renee Euler, MS, RD, LD, who discusses the intersection between diet and GI disorders, the importance of a team approach to GI care, and her work as a liaison between the AGA and Academy of Nutrition and Dietetics.

We hope you enjoy these, and all the stories featured in our September issue.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

One of the most rewarding things about serving as editor of GI & Hepatology News is to consider new content that will further engage and bring value to our readership. In addition to reporting on scientific advances from our GI journals that can inform frontline clinical care of patients with gastrointestinal conditions, we have launched several new columns over the past year, including our monthly Member Spotlight and quarterly Health Policy and Advocacy columns, to diversify our content.

In our September 2023 issue, in addition to debuting a new cover design, we are pleased to introduce yet another new offering – the “Ethics Corner” column. It is intended to highlight important ethical considerations and challenges arising in GI practice and offer practical guidance on how to navigate them. In our inaugural Ethics Corner, AGA Ethics Committee members Dr. Sheldon Sloan and Dr. David Drew discuss the “good, the bad, and the ugly” of direct-to-consumer advertising (DTCA). They highlight the pros and cons of DTCA from an ethical perspective, illustrate how DTCA can impact everyday clinical interactions with patients, and provide insight into how to navigate these challenging conversations. We hope you enjoy this new addition to the newspaper and welcome your ideas for future Ethics Corner columns and other content.

Also in this month’s issue, we update you on AGA’s response to the American College of Physicians’ recent decision to recommend against initiating colon cancer screening at age 45, contrary to the recommendation of the GI community. We also present a story on Humira biosimilars and how they are likely to impact clinical practice. Finally, our September Member Spotlight features GI dietitian Renee Euler, MS, RD, LD, who discusses the intersection between diet and GI disorders, the importance of a team approach to GI care, and her work as a liaison between the AGA and Academy of Nutrition and Dietetics.

We hope you enjoy these, and all the stories featured in our September issue.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Dear colleagues,

We are all part of one of the most exciting and varied fields of medicine and hope to have long and productive careers. In this month’s AGA Perspectives we explore two different impediments to longevity as a gastroenterologist: work-related disability and burnout.

Physician burnout has reached almost epidemic levels in medicine and is best approached in a multimodal manner, incorporating both institutional and individual changes. Dr. Sumeet Tewani discusses ways in which groups and institutions can foster physician wellness to reduce burnout. In particular, he will explore how flexibility in work schedules, among other initiatives, can improve workplace morale. In an accompanying perspective, Dr. Anna Lipowska and Dr. Amandeep Shergill explore how to incorporate ergonomics in endoscopy to prevent injury. Endoscopic practice, with its repetitive tasks and physical demands, can predispose to injury at all levels of training and experience. Ergonomics is thus a critical topic that is unfortunately covered too little, if at all, in our endoscopy training.

We hope these essays will help your medical practice and welcome your thoughts on these important issues at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Fostering physician wellness to prevent burnout

BY SUMEET TEWANI, MD 

Gastroenterology can be a challenging field, both professionally and personally, as it requires providers to have high clinical knowledge, expertise, and emotional intelligence. Burnout is a state of emotional, physical, and mental exhaustion, depersonalization, and a reduced sense of personal accomplishment, caused by prolonged or excessive stress. Burnout can be a serious and progressive chronic condition that negatively impacts the provider and patient experience, with serious consequences on the provider’s health, job performance, patient satisfaction, and personal relationships.

Adopting strategies to combat burnout are of vital importance to promoting provider wellness, a healthy work environment, and positive interactions with colleagues, staff, and patients. This also positively impacts providers’ out-of-work experiences and relationships. Here I discuss factors that affect burnout, and methods our practice has adopted to combat burnout on an institutional level and on an individual level.

Rockford Gastroenterology Associates

Multiple factors affecting burnout have been identified, including individual factors, work volume, professional risk and responsibility, resources, and relationships with colleagues and patients. Practicing gastroenterology frequently requires long and irregular work hours, heavy workloads, large panels of complex patients, invasive procedures, and high amounts of stress. Additional stressors may include an inefficient work environment, inadequate support, and loss of value and meaning in work. Nearly 50% of physicians meet criteria for burnout, citing such reasons as excessive bureaucratic tasks, lack of control, flexibility and autonomy, lack of peer respect, increasing computerization of practice, and lack of respect from patients.
 

Preventing burnout

When coping with burnout, many providers choose positive mechanisms such as exercise, listening to music, meditation, and talking with family and friends. Others become more isolated, eat junk food or binge eat, or turn to drug or alcohol abuse. Our primary approach to preventing burnout at an individual level is to ensure providers have access to self-care techniques such as stress management and mindfulness, and to encourage wellness with regular exercise and healthy habits. Promoting a culture of work-life balance requires providing adequate time for personal activities and hobbies, rest, relaxation, and spending time with family and friends. Allowing providers to personally shape their career paths aligns their personal and professional goals, leading to greater satisfaction. To this end, providers may become involved in clinical research, medical education, and clinical and administrative committees through the practice, local medical school and hospitals, and local and national societies. We provide ample vacation time and CME opportunities for our providers. Vacation time is flexible and can be taken in half-day or full-day increments, or on an hourly basis for personal time as necessary. This allows for enhanced flexibility with scheduling time off from work.

On an institutional level, leadership plays a prime role in creating a healthy work environment. Having good leaders influences the well-being and satisfaction of everyone within the organization. Leaders can have a positive impact by aligning values and work culture, using incentives in a productive manner, and promoting strategies to reduce burnout. Involving physician partners in leadership on a rotating basis allows them to better understand the roles of the leaders in the organization and empowers them to have a voice in changing policies to reduce administrative burdens and foster wellness.

We promote the concept of working together as a team for the success of the practice. All partners have an equal say in the management of the group. We eliminated the stress of competition within the group, equalizing pay across all physician partners, while maintaining equal exposure to work and equal time off from work. This levels the playing field between physicians who have varied interests and expertise, so that everyone is working towards the success of the practice and not individual compensation. To that end, our providers do not have individual offices, but work out of a “bullpen” with an open concept where we have individual workspaces and interact with each other continuously throughout the day. This promotes cohesion and teamwork between the providers for all our patients and promotes professional relationships and peer support. Efforts to promote workplace morale include access to a fully stocked deli and a newly installed espresso machine.
 

The concept of teamwork

The concept of teamwork also needs to pervade through the entire organization. To manage the demands of a busy workday, we have directly trained advanced practice nurses in the clinic and inpatient settings, allowing our physicians to increase throughput and procedures while maintaining a high level of patient care, satisfaction, and efficiency. Providers report excessive administrative tasks and frustration with the electronic health record as major factors contributing to burnout. Delegating tasks to staff, commensurate with their training and scope of practice, alleviates some of this burden. Each of the providers in our practice has a triage nurse who functions in a key capacity to ensure the appropriate clinical and administrative tasks are complete. Medical scribes, medical assistants, nurses, and physician assistants can be utilized for data entry and other tasks. We have developed templates within the electronic health record that can be standardized across the practice. Promoting teamwork with staff also means respecting the staff and understanding their needs. A highly functioning health care team can provide comprehensive care proactively and efficiently, with improved professional satisfaction.

In summary, I identify several ways to promote physician wellness. Every GI practice should strive to implement local approaches to prevent physician burnout and help maintain a happy and productive workforce.

Dr. Tewani is a gastroenterologist with Rockford Gastroenterology Associates in Rockford, Ill. He has no relevant disclosures.

References

1. Koval ML. Medscape gastroenterologist lifestyle, happiness & burnout report 2023: Contentment amid stress. Medscape. 24 Feb 2023.

2. Ong J et al. The prevalence of burnout, risk factors, and job-related stressors in gastroenterologists: A systematic review. J Gastroenterol Hepatol. 2021 Sep;36(9):2338-48.

3. Anderson J et al. Strategies to combat physician burnout in gastroenterology. Am J Gastroenterol. 2017 Sep;112(9):1356-9.

4. Keswani R et al. Burnout in gastroenterologists and how to prevent it. Gastroenterology. 2014 Jul;147(1):11-4.

The hazards of endoscopy: Ergonomics guide the way

BY ANNA LIPOWSKA, MD, AND AMANDEEP SHERGILL, MD, MS

Preventing disability and promoting a long and successful endoscopic career involves proactive measures to support well-being, and ergonomics plays a key role. Ergonomics is the science of fitting a job to the worker, with a primary goal of working smarter and safer. When hazards are identified, mitigation measures, guided by a hierarchy of controls, must be implemented that improve the fit of the tool, task and job to the worker in order to reduce the risk of endoscopy-related injury (ERI). As more women enter the field and as the overall GI physician population ages, ensuring that endoscopy is designed to be safely performed within the capacity of a diverse group of workers will be critical to creating an inclusive and equitable work environment.

Chicago Medicine

Ergonomic education is foundational: Awareness of ERI risk factors allows endoscopists to identify hazards and advocate for effective control solutions. Ergonomic education materials are available through all of the major GI societies. A road map for implementing an endoscopy ergonomics program has been previously published and provides guidance on risk assessment and mitigation measures.

Respect pain

Overuse injuries occur when the physical demands of a job are greater than tissue tolerances, leading to cumulative microtrauma. The first sign of microtraumatic injury is discomfort and pain. Studies have demonstrated that an estimated three-quarters of gastroenterologists experience ERI, with 20% requiring time off work and 12% requiring surgery. Gastroenterology trainees are also at risk, with 20% of surveyed fellows endorsing overuse injury, some even requiring work-related leaves of absence. In the early stages of ERI, aching and tiredness occur during the work shift only. In the intermediate stage, aching and tiredness occur early in the work shift and persist at night, and may be associated with a reduced capacity for repetitive work. In the late stages, aching, fatigue and weakness persist at rest and may be associated with inability to sleep and to perform light duties. Pain is an important signal indicating mitigation measures are required to control exposures.

Utilize the hierarchy of controls

The responsibility for adoption of ergonomically friendly practices does not lie solely with the physician; both institutional and industry-level support are key to its success. The hierarchy of controls defines which actions will best mitigate exposures to hazards in the workplace, highlighting that modifications to personal practice have the smallest impact. Current endoscope design does not accommodate the full range of hand strengths and sizes and contributes to ERI.

University of Illinois at Chicago

Advancements at the industry level by eliminating or substituting hazards, or designing engineering controls to reduce exposure, will be most effective at preventing distal upper extremity ERI. The next most effective controls are at the institutional level, with endoscopy units ensuring access to engineering controls and implementing effective administrative controls. For example, institutional support and investment in adjustable workstations is imperative to accommodate a range of anthropometric dimensions of the population. Support for ergonomic education, scheduling changes and a culture where safety is a priority can help reduce exposure to hazards and injury risk.

Adjust the endoscopy suite to achieve a comfortable position before every procedure

Neutral body posture is our position of greatest comfort and maximum strength, and any deviation from neutral posture decreases the amount of force the muscles can produce and causes the muscles to fatigue sooner. The most important factor affecting the endoscopists’ overall posture is the monitor position and height. Monitors must be adjustable. Place the monitor directly in front of you, with the center of the screen 15-25 degrees below eye height for a neutral neck position and resting eye position. Procedure bed height should be adjusted 0-10 cm below elbow height to allow for neutral elbow postures and relaxed shoulders. Antifatigue mats and shoes with supportive insoles can reduce fatigue. Two-piece lead aprons distribute a portion of the static load to the hips and decrease back strain. Incorporate a preprocedure ergonomic time-out, to assess proper room set up, body mechanics, equipment and team preparedness.

Give yourself a break

Breaks should be built into the endoscopy schedule, especially for a full day of endoscopy. At a minimum, incorporate microbreaks during procedures, which have been found to alleviate pain and improve performance. Exercises and stretching can be incorporated between cases, including routines designed specifically for endoscopists.

Getting older isn’t for the weak

Currently, 50% of our gastroenterologists are over 55 years old. The aging process leads to a distinct muscle mass and strength loss. Women are already at a disadvantage because, on average, they have less muscle mass than men in all age groups. Muscle starts to deteriorate when we reach our 30s, and after age 40, we lose on average 8% of our muscle mass every decade which accelerates at an even faster rate after age 60. Both resistance and aerobic exercise can be very useful to counteract sarcopenia and maintain strength. Given the physical demands of endoscopy, exercise can help safeguard career longevity and maintain overall wellness. Multiple resources are available to tailor a program that fits your time, budget and needs.

Optimize all of your workstations

Prolonged computer use and desk work is also a significant part of a gastroenterologist’s profession. If using a sitting desk, chair height should allow for 90-degree flexion at the hips and knees and for feet to rest flatly on the floor. The chair should also provide adequate back support for a relaxed upright position. Similar to endoscopy, place the monitor directly in front with the center of the screen slightly below eye level. For mouse and keyboard placement, aim to have the elbows at or slightly below 90 degrees and one’s wrists and fingers in neutral position.

Endoscopy can be hazardous to the endoscopists’ health. Incorporating ergonomic principles creates a safer and more efficient work environment. At the individual level, ergonomically optimized postures during endoscopy as well as during computer-related tasks, room set up, inclusion of microbreaks, and protective exercises can help decrease the risk of repetitive strain injury and prevent disability. Importantly, change at the industry and institutional level has the greatest potential for positive impact. Adoption of ergonomic practices promotes career longevity and ensures that gastroenterologists can continue successful and long careers and provide quality care to their patients without compromising their own health.

Dr. Lipowska is an assistant professor in the division of gastroenterology and hepatology, University of Illinois at Chicago. She disclosed no conflicts. Dr. Shergill is chief of gastroenterology for the San Francisco VA Health Care System. She disclosed consulting work for Boston Scientific and Neptune Medical, honoraria for visiting professorship with Intuitive Surgical, and a research gift from Pentax.

References

Shergill AK. Top tips for implementing an endoscopy ergonomics program. Gastrointest Endosc. 2023 Feb;97(2):361-4.

Pawa S et al. Are all endoscopy-related musculoskeletal injuries created equal? Results of a national gender-based survey. Am J Gastroenterol. 2021;116(3):530-8.

Austin K et al. Musculoskeletal injuries are commonly reported among gastroenterology trainees: Results of a national survey. Dig Dis Sci. 2019;64(6):1439-47.

Lipowska A et al. Ergonomics in the unit: Modeling the environment around the endoscopist. Tech Innov Gastrointest Endosc. 2021;23(3):256-62.

Park A et al. Intraoperative “Micro Breaks” with a targeted stretching enhance surgeon physical function and mental focus: A multicenter cohort study. Ann Surg. 2017;265(2):340-6.

Shergill A et al. Ergonomic endoscopy: An oxymoron or realistic goal? Gastrointest Endosc. 2019;90(6):966-70.

Dear colleagues,

We are all part of one of the most exciting and varied fields of medicine and hope to have long and productive careers. In this month’s AGA Perspectives we explore two different impediments to longevity as a gastroenterologist: work-related disability and burnout.

Physician burnout has reached almost epidemic levels in medicine and is best approached in a multimodal manner, incorporating both institutional and individual changes. Dr. Sumeet Tewani discusses ways in which groups and institutions can foster physician wellness to reduce burnout. In particular, he will explore how flexibility in work schedules, among other initiatives, can improve workplace morale. In an accompanying perspective, Dr. Anna Lipowska and Dr. Amandeep Shergill explore how to incorporate ergonomics in endoscopy to prevent injury. Endoscopic practice, with its repetitive tasks and physical demands, can predispose to injury at all levels of training and experience. Ergonomics is thus a critical topic that is unfortunately covered too little, if at all, in our endoscopy training.

We hope these essays will help your medical practice and welcome your thoughts on these important issues at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Fostering physician wellness to prevent burnout

BY SUMEET TEWANI, MD 

Gastroenterology can be a challenging field, both professionally and personally, as it requires providers to have high clinical knowledge, expertise, and emotional intelligence. Burnout is a state of emotional, physical, and mental exhaustion, depersonalization, and a reduced sense of personal accomplishment, caused by prolonged or excessive stress. Burnout can be a serious and progressive chronic condition that negatively impacts the provider and patient experience, with serious consequences on the provider’s health, job performance, patient satisfaction, and personal relationships.

Adopting strategies to combat burnout are of vital importance to promoting provider wellness, a healthy work environment, and positive interactions with colleagues, staff, and patients. This also positively impacts providers’ out-of-work experiences and relationships. Here I discuss factors that affect burnout, and methods our practice has adopted to combat burnout on an institutional level and on an individual level.

Rockford Gastroenterology Associates

Multiple factors affecting burnout have been identified, including individual factors, work volume, professional risk and responsibility, resources, and relationships with colleagues and patients. Practicing gastroenterology frequently requires long and irregular work hours, heavy workloads, large panels of complex patients, invasive procedures, and high amounts of stress. Additional stressors may include an inefficient work environment, inadequate support, and loss of value and meaning in work. Nearly 50% of physicians meet criteria for burnout, citing such reasons as excessive bureaucratic tasks, lack of control, flexibility and autonomy, lack of peer respect, increasing computerization of practice, and lack of respect from patients.
 

Preventing burnout

When coping with burnout, many providers choose positive mechanisms such as exercise, listening to music, meditation, and talking with family and friends. Others become more isolated, eat junk food or binge eat, or turn to drug or alcohol abuse. Our primary approach to preventing burnout at an individual level is to ensure providers have access to self-care techniques such as stress management and mindfulness, and to encourage wellness with regular exercise and healthy habits. Promoting a culture of work-life balance requires providing adequate time for personal activities and hobbies, rest, relaxation, and spending time with family and friends. Allowing providers to personally shape their career paths aligns their personal and professional goals, leading to greater satisfaction. To this end, providers may become involved in clinical research, medical education, and clinical and administrative committees through the practice, local medical school and hospitals, and local and national societies. We provide ample vacation time and CME opportunities for our providers. Vacation time is flexible and can be taken in half-day or full-day increments, or on an hourly basis for personal time as necessary. This allows for enhanced flexibility with scheduling time off from work.

On an institutional level, leadership plays a prime role in creating a healthy work environment. Having good leaders influences the well-being and satisfaction of everyone within the organization. Leaders can have a positive impact by aligning values and work culture, using incentives in a productive manner, and promoting strategies to reduce burnout. Involving physician partners in leadership on a rotating basis allows them to better understand the roles of the leaders in the organization and empowers them to have a voice in changing policies to reduce administrative burdens and foster wellness.

We promote the concept of working together as a team for the success of the practice. All partners have an equal say in the management of the group. We eliminated the stress of competition within the group, equalizing pay across all physician partners, while maintaining equal exposure to work and equal time off from work. This levels the playing field between physicians who have varied interests and expertise, so that everyone is working towards the success of the practice and not individual compensation. To that end, our providers do not have individual offices, but work out of a “bullpen” with an open concept where we have individual workspaces and interact with each other continuously throughout the day. This promotes cohesion and teamwork between the providers for all our patients and promotes professional relationships and peer support. Efforts to promote workplace morale include access to a fully stocked deli and a newly installed espresso machine.
 

The concept of teamwork

The concept of teamwork also needs to pervade through the entire organization. To manage the demands of a busy workday, we have directly trained advanced practice nurses in the clinic and inpatient settings, allowing our physicians to increase throughput and procedures while maintaining a high level of patient care, satisfaction, and efficiency. Providers report excessive administrative tasks and frustration with the electronic health record as major factors contributing to burnout. Delegating tasks to staff, commensurate with their training and scope of practice, alleviates some of this burden. Each of the providers in our practice has a triage nurse who functions in a key capacity to ensure the appropriate clinical and administrative tasks are complete. Medical scribes, medical assistants, nurses, and physician assistants can be utilized for data entry and other tasks. We have developed templates within the electronic health record that can be standardized across the practice. Promoting teamwork with staff also means respecting the staff and understanding their needs. A highly functioning health care team can provide comprehensive care proactively and efficiently, with improved professional satisfaction.

In summary, I identify several ways to promote physician wellness. Every GI practice should strive to implement local approaches to prevent physician burnout and help maintain a happy and productive workforce.

Dr. Tewani is a gastroenterologist with Rockford Gastroenterology Associates in Rockford, Ill. He has no relevant disclosures.

References

1. Koval ML. Medscape gastroenterologist lifestyle, happiness & burnout report 2023: Contentment amid stress. Medscape. 24 Feb 2023.

2. Ong J et al. The prevalence of burnout, risk factors, and job-related stressors in gastroenterologists: A systematic review. J Gastroenterol Hepatol. 2021 Sep;36(9):2338-48.

3. Anderson J et al. Strategies to combat physician burnout in gastroenterology. Am J Gastroenterol. 2017 Sep;112(9):1356-9.

4. Keswani R et al. Burnout in gastroenterologists and how to prevent it. Gastroenterology. 2014 Jul;147(1):11-4.

The hazards of endoscopy: Ergonomics guide the way

BY ANNA LIPOWSKA, MD, AND AMANDEEP SHERGILL, MD, MS

Preventing disability and promoting a long and successful endoscopic career involves proactive measures to support well-being, and ergonomics plays a key role. Ergonomics is the science of fitting a job to the worker, with a primary goal of working smarter and safer. When hazards are identified, mitigation measures, guided by a hierarchy of controls, must be implemented that improve the fit of the tool, task and job to the worker in order to reduce the risk of endoscopy-related injury (ERI). As more women enter the field and as the overall GI physician population ages, ensuring that endoscopy is designed to be safely performed within the capacity of a diverse group of workers will be critical to creating an inclusive and equitable work environment.

Chicago Medicine

Ergonomic education is foundational: Awareness of ERI risk factors allows endoscopists to identify hazards and advocate for effective control solutions. Ergonomic education materials are available through all of the major GI societies. A road map for implementing an endoscopy ergonomics program has been previously published and provides guidance on risk assessment and mitigation measures.

Respect pain

Overuse injuries occur when the physical demands of a job are greater than tissue tolerances, leading to cumulative microtrauma. The first sign of microtraumatic injury is discomfort and pain. Studies have demonstrated that an estimated three-quarters of gastroenterologists experience ERI, with 20% requiring time off work and 12% requiring surgery. Gastroenterology trainees are also at risk, with 20% of surveyed fellows endorsing overuse injury, some even requiring work-related leaves of absence. In the early stages of ERI, aching and tiredness occur during the work shift only. In the intermediate stage, aching and tiredness occur early in the work shift and persist at night, and may be associated with a reduced capacity for repetitive work. In the late stages, aching, fatigue and weakness persist at rest and may be associated with inability to sleep and to perform light duties. Pain is an important signal indicating mitigation measures are required to control exposures.

Utilize the hierarchy of controls

The responsibility for adoption of ergonomically friendly practices does not lie solely with the physician; both institutional and industry-level support are key to its success. The hierarchy of controls defines which actions will best mitigate exposures to hazards in the workplace, highlighting that modifications to personal practice have the smallest impact. Current endoscope design does not accommodate the full range of hand strengths and sizes and contributes to ERI.

University of Illinois at Chicago

Advancements at the industry level by eliminating or substituting hazards, or designing engineering controls to reduce exposure, will be most effective at preventing distal upper extremity ERI. The next most effective controls are at the institutional level, with endoscopy units ensuring access to engineering controls and implementing effective administrative controls. For example, institutional support and investment in adjustable workstations is imperative to accommodate a range of anthropometric dimensions of the population. Support for ergonomic education, scheduling changes and a culture where safety is a priority can help reduce exposure to hazards and injury risk.

Adjust the endoscopy suite to achieve a comfortable position before every procedure

Neutral body posture is our position of greatest comfort and maximum strength, and any deviation from neutral posture decreases the amount of force the muscles can produce and causes the muscles to fatigue sooner. The most important factor affecting the endoscopists’ overall posture is the monitor position and height. Monitors must be adjustable. Place the monitor directly in front of you, with the center of the screen 15-25 degrees below eye height for a neutral neck position and resting eye position. Procedure bed height should be adjusted 0-10 cm below elbow height to allow for neutral elbow postures and relaxed shoulders. Antifatigue mats and shoes with supportive insoles can reduce fatigue. Two-piece lead aprons distribute a portion of the static load to the hips and decrease back strain. Incorporate a preprocedure ergonomic time-out, to assess proper room set up, body mechanics, equipment and team preparedness.

Give yourself a break

Breaks should be built into the endoscopy schedule, especially for a full day of endoscopy. At a minimum, incorporate microbreaks during procedures, which have been found to alleviate pain and improve performance. Exercises and stretching can be incorporated between cases, including routines designed specifically for endoscopists.

Getting older isn’t for the weak

Currently, 50% of our gastroenterologists are over 55 years old. The aging process leads to a distinct muscle mass and strength loss. Women are already at a disadvantage because, on average, they have less muscle mass than men in all age groups. Muscle starts to deteriorate when we reach our 30s, and after age 40, we lose on average 8% of our muscle mass every decade which accelerates at an even faster rate after age 60. Both resistance and aerobic exercise can be very useful to counteract sarcopenia and maintain strength. Given the physical demands of endoscopy, exercise can help safeguard career longevity and maintain overall wellness. Multiple resources are available to tailor a program that fits your time, budget and needs.

Optimize all of your workstations

Prolonged computer use and desk work is also a significant part of a gastroenterologist’s profession. If using a sitting desk, chair height should allow for 90-degree flexion at the hips and knees and for feet to rest flatly on the floor. The chair should also provide adequate back support for a relaxed upright position. Similar to endoscopy, place the monitor directly in front with the center of the screen slightly below eye level. For mouse and keyboard placement, aim to have the elbows at or slightly below 90 degrees and one’s wrists and fingers in neutral position.

Endoscopy can be hazardous to the endoscopists’ health. Incorporating ergonomic principles creates a safer and more efficient work environment. At the individual level, ergonomically optimized postures during endoscopy as well as during computer-related tasks, room set up, inclusion of microbreaks, and protective exercises can help decrease the risk of repetitive strain injury and prevent disability. Importantly, change at the industry and institutional level has the greatest potential for positive impact. Adoption of ergonomic practices promotes career longevity and ensures that gastroenterologists can continue successful and long careers and provide quality care to their patients without compromising their own health.

Dr. Lipowska is an assistant professor in the division of gastroenterology and hepatology, University of Illinois at Chicago. She disclosed no conflicts. Dr. Shergill is chief of gastroenterology for the San Francisco VA Health Care System. She disclosed consulting work for Boston Scientific and Neptune Medical, honoraria for visiting professorship with Intuitive Surgical, and a research gift from Pentax.

References

Shergill AK. Top tips for implementing an endoscopy ergonomics program. Gastrointest Endosc. 2023 Feb;97(2):361-4.

Pawa S et al. Are all endoscopy-related musculoskeletal injuries created equal? Results of a national gender-based survey. Am J Gastroenterol. 2021;116(3):530-8.

Austin K et al. Musculoskeletal injuries are commonly reported among gastroenterology trainees: Results of a national survey. Dig Dis Sci. 2019;64(6):1439-47.

Lipowska A et al. Ergonomics in the unit: Modeling the environment around the endoscopist. Tech Innov Gastrointest Endosc. 2021;23(3):256-62.

Park A et al. Intraoperative “Micro Breaks” with a targeted stretching enhance surgeon physical function and mental focus: A multicenter cohort study. Ann Surg. 2017;265(2):340-6.

Shergill A et al. Ergonomic endoscopy: An oxymoron or realistic goal? Gastrointest Endosc. 2019;90(6):966-70.

Dear colleagues,

We are all part of one of the most exciting and varied fields of medicine and hope to have long and productive careers. In this month’s AGA Perspectives we explore two different impediments to longevity as a gastroenterologist: work-related disability and burnout.

Physician burnout has reached almost epidemic levels in medicine and is best approached in a multimodal manner, incorporating both institutional and individual changes. Dr. Sumeet Tewani discusses ways in which groups and institutions can foster physician wellness to reduce burnout. In particular, he will explore how flexibility in work schedules, among other initiatives, can improve workplace morale. In an accompanying perspective, Dr. Anna Lipowska and Dr. Amandeep Shergill explore how to incorporate ergonomics in endoscopy to prevent injury. Endoscopic practice, with its repetitive tasks and physical demands, can predispose to injury at all levels of training and experience. Ergonomics is thus a critical topic that is unfortunately covered too little, if at all, in our endoscopy training.

We hope these essays will help your medical practice and welcome your thoughts on these important issues at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Fostering physician wellness to prevent burnout

BY SUMEET TEWANI, MD 

Gastroenterology can be a challenging field, both professionally and personally, as it requires providers to have high clinical knowledge, expertise, and emotional intelligence. Burnout is a state of emotional, physical, and mental exhaustion, depersonalization, and a reduced sense of personal accomplishment, caused by prolonged or excessive stress. Burnout can be a serious and progressive chronic condition that negatively impacts the provider and patient experience, with serious consequences on the provider’s health, job performance, patient satisfaction, and personal relationships.

Adopting strategies to combat burnout are of vital importance to promoting provider wellness, a healthy work environment, and positive interactions with colleagues, staff, and patients. This also positively impacts providers’ out-of-work experiences and relationships. Here I discuss factors that affect burnout, and methods our practice has adopted to combat burnout on an institutional level and on an individual level.

Rockford Gastroenterology Associates

Multiple factors affecting burnout have been identified, including individual factors, work volume, professional risk and responsibility, resources, and relationships with colleagues and patients. Practicing gastroenterology frequently requires long and irregular work hours, heavy workloads, large panels of complex patients, invasive procedures, and high amounts of stress. Additional stressors may include an inefficient work environment, inadequate support, and loss of value and meaning in work. Nearly 50% of physicians meet criteria for burnout, citing such reasons as excessive bureaucratic tasks, lack of control, flexibility and autonomy, lack of peer respect, increasing computerization of practice, and lack of respect from patients.
 

Preventing burnout

When coping with burnout, many providers choose positive mechanisms such as exercise, listening to music, meditation, and talking with family and friends. Others become more isolated, eat junk food or binge eat, or turn to drug or alcohol abuse. Our primary approach to preventing burnout at an individual level is to ensure providers have access to self-care techniques such as stress management and mindfulness, and to encourage wellness with regular exercise and healthy habits. Promoting a culture of work-life balance requires providing adequate time for personal activities and hobbies, rest, relaxation, and spending time with family and friends. Allowing providers to personally shape their career paths aligns their personal and professional goals, leading to greater satisfaction. To this end, providers may become involved in clinical research, medical education, and clinical and administrative committees through the practice, local medical school and hospitals, and local and national societies. We provide ample vacation time and CME opportunities for our providers. Vacation time is flexible and can be taken in half-day or full-day increments, or on an hourly basis for personal time as necessary. This allows for enhanced flexibility with scheduling time off from work.

On an institutional level, leadership plays a prime role in creating a healthy work environment. Having good leaders influences the well-being and satisfaction of everyone within the organization. Leaders can have a positive impact by aligning values and work culture, using incentives in a productive manner, and promoting strategies to reduce burnout. Involving physician partners in leadership on a rotating basis allows them to better understand the roles of the leaders in the organization and empowers them to have a voice in changing policies to reduce administrative burdens and foster wellness.

We promote the concept of working together as a team for the success of the practice. All partners have an equal say in the management of the group. We eliminated the stress of competition within the group, equalizing pay across all physician partners, while maintaining equal exposure to work and equal time off from work. This levels the playing field between physicians who have varied interests and expertise, so that everyone is working towards the success of the practice and not individual compensation. To that end, our providers do not have individual offices, but work out of a “bullpen” with an open concept where we have individual workspaces and interact with each other continuously throughout the day. This promotes cohesion and teamwork between the providers for all our patients and promotes professional relationships and peer support. Efforts to promote workplace morale include access to a fully stocked deli and a newly installed espresso machine.
 

The concept of teamwork

The concept of teamwork also needs to pervade through the entire organization. To manage the demands of a busy workday, we have directly trained advanced practice nurses in the clinic and inpatient settings, allowing our physicians to increase throughput and procedures while maintaining a high level of patient care, satisfaction, and efficiency. Providers report excessive administrative tasks and frustration with the electronic health record as major factors contributing to burnout. Delegating tasks to staff, commensurate with their training and scope of practice, alleviates some of this burden. Each of the providers in our practice has a triage nurse who functions in a key capacity to ensure the appropriate clinical and administrative tasks are complete. Medical scribes, medical assistants, nurses, and physician assistants can be utilized for data entry and other tasks. We have developed templates within the electronic health record that can be standardized across the practice. Promoting teamwork with staff also means respecting the staff and understanding their needs. A highly functioning health care team can provide comprehensive care proactively and efficiently, with improved professional satisfaction.

In summary, I identify several ways to promote physician wellness. Every GI practice should strive to implement local approaches to prevent physician burnout and help maintain a happy and productive workforce.

Dr. Tewani is a gastroenterologist with Rockford Gastroenterology Associates in Rockford, Ill. He has no relevant disclosures.

References

1. Koval ML. Medscape gastroenterologist lifestyle, happiness & burnout report 2023: Contentment amid stress. Medscape. 24 Feb 2023.

2. Ong J et al. The prevalence of burnout, risk factors, and job-related stressors in gastroenterologists: A systematic review. J Gastroenterol Hepatol. 2021 Sep;36(9):2338-48.

3. Anderson J et al. Strategies to combat physician burnout in gastroenterology. Am J Gastroenterol. 2017 Sep;112(9):1356-9.

4. Keswani R et al. Burnout in gastroenterologists and how to prevent it. Gastroenterology. 2014 Jul;147(1):11-4.

The hazards of endoscopy: Ergonomics guide the way

BY ANNA LIPOWSKA, MD, AND AMANDEEP SHERGILL, MD, MS

Preventing disability and promoting a long and successful endoscopic career involves proactive measures to support well-being, and ergonomics plays a key role. Ergonomics is the science of fitting a job to the worker, with a primary goal of working smarter and safer. When hazards are identified, mitigation measures, guided by a hierarchy of controls, must be implemented that improve the fit of the tool, task and job to the worker in order to reduce the risk of endoscopy-related injury (ERI). As more women enter the field and as the overall GI physician population ages, ensuring that endoscopy is designed to be safely performed within the capacity of a diverse group of workers will be critical to creating an inclusive and equitable work environment.

Chicago Medicine

Ergonomic education is foundational: Awareness of ERI risk factors allows endoscopists to identify hazards and advocate for effective control solutions. Ergonomic education materials are available through all of the major GI societies. A road map for implementing an endoscopy ergonomics program has been previously published and provides guidance on risk assessment and mitigation measures.

Respect pain

Overuse injuries occur when the physical demands of a job are greater than tissue tolerances, leading to cumulative microtrauma. The first sign of microtraumatic injury is discomfort and pain. Studies have demonstrated that an estimated three-quarters of gastroenterologists experience ERI, with 20% requiring time off work and 12% requiring surgery. Gastroenterology trainees are also at risk, with 20% of surveyed fellows endorsing overuse injury, some even requiring work-related leaves of absence. In the early stages of ERI, aching and tiredness occur during the work shift only. In the intermediate stage, aching and tiredness occur early in the work shift and persist at night, and may be associated with a reduced capacity for repetitive work. In the late stages, aching, fatigue and weakness persist at rest and may be associated with inability to sleep and to perform light duties. Pain is an important signal indicating mitigation measures are required to control exposures.

Utilize the hierarchy of controls

The responsibility for adoption of ergonomically friendly practices does not lie solely with the physician; both institutional and industry-level support are key to its success. The hierarchy of controls defines which actions will best mitigate exposures to hazards in the workplace, highlighting that modifications to personal practice have the smallest impact. Current endoscope design does not accommodate the full range of hand strengths and sizes and contributes to ERI.

University of Illinois at Chicago

Advancements at the industry level by eliminating or substituting hazards, or designing engineering controls to reduce exposure, will be most effective at preventing distal upper extremity ERI. The next most effective controls are at the institutional level, with endoscopy units ensuring access to engineering controls and implementing effective administrative controls. For example, institutional support and investment in adjustable workstations is imperative to accommodate a range of anthropometric dimensions of the population. Support for ergonomic education, scheduling changes and a culture where safety is a priority can help reduce exposure to hazards and injury risk.

Adjust the endoscopy suite to achieve a comfortable position before every procedure

Neutral body posture is our position of greatest comfort and maximum strength, and any deviation from neutral posture decreases the amount of force the muscles can produce and causes the muscles to fatigue sooner. The most important factor affecting the endoscopists’ overall posture is the monitor position and height. Monitors must be adjustable. Place the monitor directly in front of you, with the center of the screen 15-25 degrees below eye height for a neutral neck position and resting eye position. Procedure bed height should be adjusted 0-10 cm below elbow height to allow for neutral elbow postures and relaxed shoulders. Antifatigue mats and shoes with supportive insoles can reduce fatigue. Two-piece lead aprons distribute a portion of the static load to the hips and decrease back strain. Incorporate a preprocedure ergonomic time-out, to assess proper room set up, body mechanics, equipment and team preparedness.

Give yourself a break

Breaks should be built into the endoscopy schedule, especially for a full day of endoscopy. At a minimum, incorporate microbreaks during procedures, which have been found to alleviate pain and improve performance. Exercises and stretching can be incorporated between cases, including routines designed specifically for endoscopists.

Getting older isn’t for the weak

Currently, 50% of our gastroenterologists are over 55 years old. The aging process leads to a distinct muscle mass and strength loss. Women are already at a disadvantage because, on average, they have less muscle mass than men in all age groups. Muscle starts to deteriorate when we reach our 30s, and after age 40, we lose on average 8% of our muscle mass every decade which accelerates at an even faster rate after age 60. Both resistance and aerobic exercise can be very useful to counteract sarcopenia and maintain strength. Given the physical demands of endoscopy, exercise can help safeguard career longevity and maintain overall wellness. Multiple resources are available to tailor a program that fits your time, budget and needs.

Optimize all of your workstations

Prolonged computer use and desk work is also a significant part of a gastroenterologist’s profession. If using a sitting desk, chair height should allow for 90-degree flexion at the hips and knees and for feet to rest flatly on the floor. The chair should also provide adequate back support for a relaxed upright position. Similar to endoscopy, place the monitor directly in front with the center of the screen slightly below eye level. For mouse and keyboard placement, aim to have the elbows at or slightly below 90 degrees and one’s wrists and fingers in neutral position.

Endoscopy can be hazardous to the endoscopists’ health. Incorporating ergonomic principles creates a safer and more efficient work environment. At the individual level, ergonomically optimized postures during endoscopy as well as during computer-related tasks, room set up, inclusion of microbreaks, and protective exercises can help decrease the risk of repetitive strain injury and prevent disability. Importantly, change at the industry and institutional level has the greatest potential for positive impact. Adoption of ergonomic practices promotes career longevity and ensures that gastroenterologists can continue successful and long careers and provide quality care to their patients without compromising their own health.

Dr. Lipowska is an assistant professor in the division of gastroenterology and hepatology, University of Illinois at Chicago. She disclosed no conflicts. Dr. Shergill is chief of gastroenterology for the San Francisco VA Health Care System. She disclosed consulting work for Boston Scientific and Neptune Medical, honoraria for visiting professorship with Intuitive Surgical, and a research gift from Pentax.

References

Shergill AK. Top tips for implementing an endoscopy ergonomics program. Gastrointest Endosc. 2023 Feb;97(2):361-4.

Pawa S et al. Are all endoscopy-related musculoskeletal injuries created equal? Results of a national gender-based survey. Am J Gastroenterol. 2021;116(3):530-8.

Austin K et al. Musculoskeletal injuries are commonly reported among gastroenterology trainees: Results of a national survey. Dig Dis Sci. 2019;64(6):1439-47.

Lipowska A et al. Ergonomics in the unit: Modeling the environment around the endoscopist. Tech Innov Gastrointest Endosc. 2021;23(3):256-62.

Park A et al. Intraoperative “Micro Breaks” with a targeted stretching enhance surgeon physical function and mental focus: A multicenter cohort study. Ann Surg. 2017;265(2):340-6.

Shergill A et al. Ergonomic endoscopy: An oxymoron or realistic goal? Gastrointest Endosc. 2019;90(6):966-70.

The gluten-free section in the grocery store didn’t exist when Renee Euler, MS, RD, LD, was diagnosed with celiac disease 30 years ago. A physician handed her a fax about the gluten-free diet from a national support group and said: “Here, read this.”

There was no Google to inform decisions. Patients had to rely on fact sheets or a book from the library.

Courtesy Erin Smith

Q: What fears did you have to push past to get to where you are in your career?

Ms. Euler: Leaving a successful career as a landscape architect and going back to school was definitely a huge hurdle. When I started my practice in 2017, in my area there were no outpatient GI dietitians providing specialized care for adults with conditions like celiac disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). I was starting out with no real support.

Realizing that I was going to start a private practice of my own to help the people I wanted to help, was another big fear. “Am I going to succeed? Am I going to fail? What’s going to happen?” But over the years, my practice has grown as I learned to bill insurance and started receiving referrals from a large local GI practice, both of which have been the keys to my success. I have also limited my practice to GI clients so that I can focus my attention on this specialized area of nutrition and stay up to date on the latest developments.
 

Q: What interests you about the intersection between diet and GI disorders?

Ms. Euler: It’s not just about diet. We’re learning so much about how the gut microbiome can have a potential impact [on other parts of our health]. It’s interesting in terms of how we respond to certain foods, for instance, could affect our mental health. This especially applies to IBS and how the microbiome might be connected to these conditions.

It’s very challenging. There is so much information out there that is not super accurate, or it’s misleading.
 

Q: You serve as a liaison between the American Gastroenterological Association and the Academy of Nutrition and Dietetics. As a nutritionist with a focus on GI, how do you work with gastroenterologists to manage GI disorders?

Ms. Euler: Some of the dietary therapies that GI doctors recommend don’t provide sufficient guidance. They hand out that two-page fact sheet about diet and send the patient on their way. A lot of these diets have more nuance than what can be expressed in a two-page handout.

Many times, the physician doesn’t know the nuance, or they don’t have time to go over it. That’s where we can really help.

Patients often want diet to be the answer. They want to be told: “You need to eat this and only this, and everything will be fine, and diet’s going to change your world, and you won’t have to take medication.”

What they often don’t realize and understand, is a lot of these dietary therapies are not black and white. Celiac disease means a gluten-free diet for life. But a lot of these dietary therapies that get thrown out to patients as a possibility, like low FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), are not lifetime diets. They’re tools for us to use to find out what the offending foods are for this person, and what can we do to get their symptoms under control.
 

Q: What is the biggest practice-related challenge in getting patients to alter their diet to improve their symptoms?

Ms. Euler: A lot of patients that come to me already have over restricted diets. They’re trying to solve things themselves. Rightfully so, a lot of them have a lot of food fears because they have been living with very uncomfortable symptoms for years, and they’re trying to find answers. Those food fears unfortunately are reinforced by social media and the news.

One of my biggest challenges with those clients is working through that process of building their confidence to broaden their diets and add foods back in, without causing their symptoms to flare up. The goal is to get them back on track to having a nutritious diet while trying to manage symptoms.
 

Q: Can you give me an anecdotal example of a case that wasn’t easy, and you ended up helping that person?

Ms. Euler: I had a patient who had been listening to all the wellness gurus. She was overrestricted to the point of eating just 10 different foods due to allergic and GI symptoms. Patients like this are definitely a challenge because you have to reorient them to the fact that what they’re doing isn’t necessarily working,

My initial assessments are 90 minutes long, so I have a lot of time to sit with a patient and hear their story and understand their background.

I suggested to the patient: “Why don’t we try adding these foods back in, but eliminating these other types of foods and see whether that would help?” 48 hours later, she sent me an email, telling me that she and her husband had talked this through, and they thought I hit the nail on the head: She was focusing on the wrong foods which were causing problems. Those are always great messages to get from patients, when they say: “Oh my gosh, I hadn’t even considered that.”
 

Q: Describe how you would spend a free Saturday afternoon.

Ms. Euler: They’re so rare – those free Saturday afternoons, but it would probably be a good book that would turn into a nap on the couch.

LIGHTNING ROUND

Do you prefer texting or talking?

Talking in person



What’s your favorite breakfast?

Greek yogurt with fiber, flax seeds, and berries



What’s your favorite junk food?

Ice cream



What’s your favorite fruit?

Garden grown strawberries



What’s your favorite holiday?

Thanksgiving



What’s your favorite type of music?

Jazz



If you weren’t a GI nutritionist, what would you be?

Probably a landscape architect.

The gluten-free section in the grocery store didn’t exist when Renee Euler, MS, RD, LD, was diagnosed with celiac disease 30 years ago. A physician handed her a fax about the gluten-free diet from a national support group and said: “Here, read this.”

There was no Google to inform decisions. Patients had to rely on fact sheets or a book from the library.

Courtesy Erin Smith

Q: What fears did you have to push past to get to where you are in your career?

Ms. Euler: Leaving a successful career as a landscape architect and going back to school was definitely a huge hurdle. When I started my practice in 2017, in my area there were no outpatient GI dietitians providing specialized care for adults with conditions like celiac disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). I was starting out with no real support.

Realizing that I was going to start a private practice of my own to help the people I wanted to help, was another big fear. “Am I going to succeed? Am I going to fail? What’s going to happen?” But over the years, my practice has grown as I learned to bill insurance and started receiving referrals from a large local GI practice, both of which have been the keys to my success. I have also limited my practice to GI clients so that I can focus my attention on this specialized area of nutrition and stay up to date on the latest developments.
 

Q: What interests you about the intersection between diet and GI disorders?

Ms. Euler: It’s not just about diet. We’re learning so much about how the gut microbiome can have a potential impact [on other parts of our health]. It’s interesting in terms of how we respond to certain foods, for instance, could affect our mental health. This especially applies to IBS and how the microbiome might be connected to these conditions.

It’s very challenging. There is so much information out there that is not super accurate, or it’s misleading.
 

Q: You serve as a liaison between the American Gastroenterological Association and the Academy of Nutrition and Dietetics. As a nutritionist with a focus on GI, how do you work with gastroenterologists to manage GI disorders?

Ms. Euler: Some of the dietary therapies that GI doctors recommend don’t provide sufficient guidance. They hand out that two-page fact sheet about diet and send the patient on their way. A lot of these diets have more nuance than what can be expressed in a two-page handout.

Many times, the physician doesn’t know the nuance, or they don’t have time to go over it. That’s where we can really help.

Patients often want diet to be the answer. They want to be told: “You need to eat this and only this, and everything will be fine, and diet’s going to change your world, and you won’t have to take medication.”

What they often don’t realize and understand, is a lot of these dietary therapies are not black and white. Celiac disease means a gluten-free diet for life. But a lot of these dietary therapies that get thrown out to patients as a possibility, like low FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), are not lifetime diets. They’re tools for us to use to find out what the offending foods are for this person, and what can we do to get their symptoms under control.
 

Q: What is the biggest practice-related challenge in getting patients to alter their diet to improve their symptoms?

Ms. Euler: A lot of patients that come to me already have over restricted diets. They’re trying to solve things themselves. Rightfully so, a lot of them have a lot of food fears because they have been living with very uncomfortable symptoms for years, and they’re trying to find answers. Those food fears unfortunately are reinforced by social media and the news.

One of my biggest challenges with those clients is working through that process of building their confidence to broaden their diets and add foods back in, without causing their symptoms to flare up. The goal is to get them back on track to having a nutritious diet while trying to manage symptoms.
 

Q: Can you give me an anecdotal example of a case that wasn’t easy, and you ended up helping that person?

Ms. Euler: I had a patient who had been listening to all the wellness gurus. She was overrestricted to the point of eating just 10 different foods due to allergic and GI symptoms. Patients like this are definitely a challenge because you have to reorient them to the fact that what they’re doing isn’t necessarily working,

My initial assessments are 90 minutes long, so I have a lot of time to sit with a patient and hear their story and understand their background.

I suggested to the patient: “Why don’t we try adding these foods back in, but eliminating these other types of foods and see whether that would help?” 48 hours later, she sent me an email, telling me that she and her husband had talked this through, and they thought I hit the nail on the head: She was focusing on the wrong foods which were causing problems. Those are always great messages to get from patients, when they say: “Oh my gosh, I hadn’t even considered that.”
 

Q: Describe how you would spend a free Saturday afternoon.

Ms. Euler: They’re so rare – those free Saturday afternoons, but it would probably be a good book that would turn into a nap on the couch.

LIGHTNING ROUND

Do you prefer texting or talking?

Talking in person



What’s your favorite breakfast?

Greek yogurt with fiber, flax seeds, and berries



What’s your favorite junk food?

Ice cream



What’s your favorite fruit?

Garden grown strawberries



What’s your favorite holiday?

Thanksgiving



What’s your favorite type of music?

Jazz



If you weren’t a GI nutritionist, what would you be?

Probably a landscape architect.

The gluten-free section in the grocery store didn’t exist when Renee Euler, MS, RD, LD, was diagnosed with celiac disease 30 years ago. A physician handed her a fax about the gluten-free diet from a national support group and said: “Here, read this.”

There was no Google to inform decisions. Patients had to rely on fact sheets or a book from the library.

Courtesy Erin Smith

Q: What fears did you have to push past to get to where you are in your career?

Ms. Euler: Leaving a successful career as a landscape architect and going back to school was definitely a huge hurdle. When I started my practice in 2017, in my area there were no outpatient GI dietitians providing specialized care for adults with conditions like celiac disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). I was starting out with no real support.

Realizing that I was going to start a private practice of my own to help the people I wanted to help, was another big fear. “Am I going to succeed? Am I going to fail? What’s going to happen?” But over the years, my practice has grown as I learned to bill insurance and started receiving referrals from a large local GI practice, both of which have been the keys to my success. I have also limited my practice to GI clients so that I can focus my attention on this specialized area of nutrition and stay up to date on the latest developments.
 

Q: What interests you about the intersection between diet and GI disorders?

Ms. Euler: It’s not just about diet. We’re learning so much about how the gut microbiome can have a potential impact [on other parts of our health]. It’s interesting in terms of how we respond to certain foods, for instance, could affect our mental health. This especially applies to IBS and how the microbiome might be connected to these conditions.

It’s very challenging. There is so much information out there that is not super accurate, or it’s misleading.
 

Q: You serve as a liaison between the American Gastroenterological Association and the Academy of Nutrition and Dietetics. As a nutritionist with a focus on GI, how do you work with gastroenterologists to manage GI disorders?

Ms. Euler: Some of the dietary therapies that GI doctors recommend don’t provide sufficient guidance. They hand out that two-page fact sheet about diet and send the patient on their way. A lot of these diets have more nuance than what can be expressed in a two-page handout.

Many times, the physician doesn’t know the nuance, or they don’t have time to go over it. That’s where we can really help.

Patients often want diet to be the answer. They want to be told: “You need to eat this and only this, and everything will be fine, and diet’s going to change your world, and you won’t have to take medication.”

What they often don’t realize and understand, is a lot of these dietary therapies are not black and white. Celiac disease means a gluten-free diet for life. But a lot of these dietary therapies that get thrown out to patients as a possibility, like low FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), are not lifetime diets. They’re tools for us to use to find out what the offending foods are for this person, and what can we do to get their symptoms under control.
 

Q: What is the biggest practice-related challenge in getting patients to alter their diet to improve their symptoms?

Ms. Euler: A lot of patients that come to me already have over restricted diets. They’re trying to solve things themselves. Rightfully so, a lot of them have a lot of food fears because they have been living with very uncomfortable symptoms for years, and they’re trying to find answers. Those food fears unfortunately are reinforced by social media and the news.

One of my biggest challenges with those clients is working through that process of building their confidence to broaden their diets and add foods back in, without causing their symptoms to flare up. The goal is to get them back on track to having a nutritious diet while trying to manage symptoms.
 

Q: Can you give me an anecdotal example of a case that wasn’t easy, and you ended up helping that person?

Ms. Euler: I had a patient who had been listening to all the wellness gurus. She was overrestricted to the point of eating just 10 different foods due to allergic and GI symptoms. Patients like this are definitely a challenge because you have to reorient them to the fact that what they’re doing isn’t necessarily working,

My initial assessments are 90 minutes long, so I have a lot of time to sit with a patient and hear their story and understand their background.

I suggested to the patient: “Why don’t we try adding these foods back in, but eliminating these other types of foods and see whether that would help?” 48 hours later, she sent me an email, telling me that she and her husband had talked this through, and they thought I hit the nail on the head: She was focusing on the wrong foods which were causing problems. Those are always great messages to get from patients, when they say: “Oh my gosh, I hadn’t even considered that.”
 

Q: Describe how you would spend a free Saturday afternoon.

Ms. Euler: They’re so rare – those free Saturday afternoons, but it would probably be a good book that would turn into a nap on the couch.

LIGHTNING ROUND

Do you prefer texting or talking?

Talking in person



What’s your favorite breakfast?

Greek yogurt with fiber, flax seeds, and berries



What’s your favorite junk food?

Ice cream



What’s your favorite fruit?

Garden grown strawberries



What’s your favorite holiday?

Thanksgiving



What’s your favorite type of music?

Jazz



If you weren’t a GI nutritionist, what would you be?

Probably a landscape architect.

Mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin lymphoma that is characterized by t(11;14) and cyclin D1 overexpression. It is also known to be clinically heterogenous, with disease presentations ranging from indolent to aggressive. Baseline risk can be determined on the basis of a combination of clinical and pathologic features. A key prognostic tool, for example, is the Mantle Cell Lymphoma International Prognostic Index-Combined (MIPI-c), which integrates the standard MIPI clinical factors (age, performance status, lactate dehydrogenase, and leukocyte count) with estimates of proliferation (Ki-67).¹ Other features, including the presence of TP53 alterations, have also been associated with poor outcomes, even with intensive therapy.²

Recently, a study aimed to further refine prognostication in MCL in order to identify high-risk patients that may be more likely to benefit from novel treatment strategies (Scheubeck et al). This retrospective study included 684 patients with MCL from the MCL-Younger and MCL-Elderly trials with evaluable data for Ki-67 or p53 expression (a surrogate for TP53 alterations). Patients were classified as having high-risk disease on the basis of a high-risk MIPI-c or p53 expression > 50% or as having low-risk disease on the basis of low, low-intermediate, or high-intermediate MIPI-c and p53 expression ≤ 50%. Patients with high-risk disease had significantly shorter median failure-free survival (1.1 vs 5.6 years; P < .0001) and overall survival (2.2 vs 13.2 years; P < .0001) compared with those with low-risk disease. The differences were confirmed in two validation cohorts from the Italian MCL0208 and Nordic-MCL4 trials. These data highlight the poor outcomes of conventional therapy in patients with high-risk MCL. Evaluation of novel approaches should be considered in these patients.

Bruton tyrosine kinase (BTK) inhibitors have been promising options for patients with MCL, including those with high-risk features. Acalabrutinib is a second-generation covalent BTK inhibitor that is approved by the US Food and Drug Administration for patients who have received at least one prior line of therapy. The final results of the single-arm, phase 2 ACE-LY-004 study recently demonstrated long-term safety and efficacy in patients with relapsed/refractory MCL (Le Gouill et al). The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, the median duration of response and progression-free survival were 28.6 months (95% CI 17.5-39.1) and 22.0 months (95% CI 16.6-33.3), respectively. Responses were also seen in patients with high-risk features, including blastoid morphology, high-risk MIPI score, and high Ki-67. No new safety signals were observed. This study confirms the role of BTK inhibitors in MCL and providers longer-term estimates of response. Evaluation of BTK inhibitors in earlier lines of therapy and in combination with other agents are ongoing.

Although the majority of patients with MCL will have favorable responses to initial therapy, those with high-risk features, particularly TP53 aberrations, have poor outcomes with standard approaches. Despite a growing number of treatment options in the relapsed setting, such as targeted therapies and chimeric antigen receptor (CAR) T-cell therapy, relapses remain common. Allogenic stem cell transplantation can be associated with prolonged response for patients with relapsed MCL, though it has the potential for significant treatment-associated toxicity.

Recently, prolonged follow-up of a retrospective cohort of patients with MCL, including a subset with TP53 aberrations, was reported (Lew et al). Thirty-six patients with MCL were included, including 13 with TP53-mutated disease. A subset of patients (61%) received an allogeneic transplant in first remission. The estimated overall survival rates after allogenic transplant were 56% (95% CI 36%-72%) at 10 years for the overall cohort and 59% (95% CI 21%-75%) at 4 years for patients with TP53-mutated disease at median follow-ups of 10.8 and 4.2 years, respectively. No relapses were observed in the TP53-mutated subset beyond 6 months after transplantation. These data suggest a potentially curative option for patients with high-risk MCL. Given the availability of CAR T-cell therapy, the optimal timing of allogenic stem cell transplant has become less clear for patients with TP53-mutant disease. Although this study was small and retrospective, these data are encouraging for patients with high-risk disease.

Additional References

1.            Hoster E, Rosenwald A, Berger F, et al. Prognostic value of Ki-67 index, cytology, and growth pattern in mantle-cell lymphoma: Results from randomized trials of the European Mantle Cell Lymphoma Network. J Clin Oncol. 2016;34:1386-1394. doi: 10.1200/JCO.2015.63.8387

2.            Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017;130:1903-1910. doi: 10.1182/blood-2017-04-77973

Mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin lymphoma that is characterized by t(11;14) and cyclin D1 overexpression. It is also known to be clinically heterogenous, with disease presentations ranging from indolent to aggressive. Baseline risk can be determined on the basis of a combination of clinical and pathologic features. A key prognostic tool, for example, is the Mantle Cell Lymphoma International Prognostic Index-Combined (MIPI-c), which integrates the standard MIPI clinical factors (age, performance status, lactate dehydrogenase, and leukocyte count) with estimates of proliferation (Ki-67).¹ Other features, including the presence of TP53 alterations, have also been associated with poor outcomes, even with intensive therapy.²

Recently, a study aimed to further refine prognostication in MCL in order to identify high-risk patients that may be more likely to benefit from novel treatment strategies (Scheubeck et al). This retrospective study included 684 patients with MCL from the MCL-Younger and MCL-Elderly trials with evaluable data for Ki-67 or p53 expression (a surrogate for TP53 alterations). Patients were classified as having high-risk disease on the basis of a high-risk MIPI-c or p53 expression > 50% or as having low-risk disease on the basis of low, low-intermediate, or high-intermediate MIPI-c and p53 expression ≤ 50%. Patients with high-risk disease had significantly shorter median failure-free survival (1.1 vs 5.6 years; P < .0001) and overall survival (2.2 vs 13.2 years; P < .0001) compared with those with low-risk disease. The differences were confirmed in two validation cohorts from the Italian MCL0208 and Nordic-MCL4 trials. These data highlight the poor outcomes of conventional therapy in patients with high-risk MCL. Evaluation of novel approaches should be considered in these patients.

Bruton tyrosine kinase (BTK) inhibitors have been promising options for patients with MCL, including those with high-risk features. Acalabrutinib is a second-generation covalent BTK inhibitor that is approved by the US Food and Drug Administration for patients who have received at least one prior line of therapy. The final results of the single-arm, phase 2 ACE-LY-004 study recently demonstrated long-term safety and efficacy in patients with relapsed/refractory MCL (Le Gouill et al). The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, the median duration of response and progression-free survival were 28.6 months (95% CI 17.5-39.1) and 22.0 months (95% CI 16.6-33.3), respectively. Responses were also seen in patients with high-risk features, including blastoid morphology, high-risk MIPI score, and high Ki-67. No new safety signals were observed. This study confirms the role of BTK inhibitors in MCL and providers longer-term estimates of response. Evaluation of BTK inhibitors in earlier lines of therapy and in combination with other agents are ongoing.

Although the majority of patients with MCL will have favorable responses to initial therapy, those with high-risk features, particularly TP53 aberrations, have poor outcomes with standard approaches. Despite a growing number of treatment options in the relapsed setting, such as targeted therapies and chimeric antigen receptor (CAR) T-cell therapy, relapses remain common. Allogenic stem cell transplantation can be associated with prolonged response for patients with relapsed MCL, though it has the potential for significant treatment-associated toxicity.

Recently, prolonged follow-up of a retrospective cohort of patients with MCL, including a subset with TP53 aberrations, was reported (Lew et al). Thirty-six patients with MCL were included, including 13 with TP53-mutated disease. A subset of patients (61%) received an allogeneic transplant in first remission. The estimated overall survival rates after allogenic transplant were 56% (95% CI 36%-72%) at 10 years for the overall cohort and 59% (95% CI 21%-75%) at 4 years for patients with TP53-mutated disease at median follow-ups of 10.8 and 4.2 years, respectively. No relapses were observed in the TP53-mutated subset beyond 6 months after transplantation. These data suggest a potentially curative option for patients with high-risk MCL. Given the availability of CAR T-cell therapy, the optimal timing of allogenic stem cell transplant has become less clear for patients with TP53-mutant disease. Although this study was small and retrospective, these data are encouraging for patients with high-risk disease.

Additional References

1.            Hoster E, Rosenwald A, Berger F, et al. Prognostic value of Ki-67 index, cytology, and growth pattern in mantle-cell lymphoma: Results from randomized trials of the European Mantle Cell Lymphoma Network. J Clin Oncol. 2016;34:1386-1394. doi: 10.1200/JCO.2015.63.8387

2.            Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017;130:1903-1910. doi: 10.1182/blood-2017-04-77973

Mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin lymphoma that is characterized by t(11;14) and cyclin D1 overexpression. It is also known to be clinically heterogenous, with disease presentations ranging from indolent to aggressive. Baseline risk can be determined on the basis of a combination of clinical and pathologic features. A key prognostic tool, for example, is the Mantle Cell Lymphoma International Prognostic Index-Combined (MIPI-c), which integrates the standard MIPI clinical factors (age, performance status, lactate dehydrogenase, and leukocyte count) with estimates of proliferation (Ki-67).¹ Other features, including the presence of TP53 alterations, have also been associated with poor outcomes, even with intensive therapy.²

Recently, a study aimed to further refine prognostication in MCL in order to identify high-risk patients that may be more likely to benefit from novel treatment strategies (Scheubeck et al). This retrospective study included 684 patients with MCL from the MCL-Younger and MCL-Elderly trials with evaluable data for Ki-67 or p53 expression (a surrogate for TP53 alterations). Patients were classified as having high-risk disease on the basis of a high-risk MIPI-c or p53 expression > 50% or as having low-risk disease on the basis of low, low-intermediate, or high-intermediate MIPI-c and p53 expression ≤ 50%. Patients with high-risk disease had significantly shorter median failure-free survival (1.1 vs 5.6 years; P < .0001) and overall survival (2.2 vs 13.2 years; P < .0001) compared with those with low-risk disease. The differences were confirmed in two validation cohorts from the Italian MCL0208 and Nordic-MCL4 trials. These data highlight the poor outcomes of conventional therapy in patients with high-risk MCL. Evaluation of novel approaches should be considered in these patients.

Bruton tyrosine kinase (BTK) inhibitors have been promising options for patients with MCL, including those with high-risk features. Acalabrutinib is a second-generation covalent BTK inhibitor that is approved by the US Food and Drug Administration for patients who have received at least one prior line of therapy. The final results of the single-arm, phase 2 ACE-LY-004 study recently demonstrated long-term safety and efficacy in patients with relapsed/refractory MCL (Le Gouill et al). The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, the median duration of response and progression-free survival were 28.6 months (95% CI 17.5-39.1) and 22.0 months (95% CI 16.6-33.3), respectively. Responses were also seen in patients with high-risk features, including blastoid morphology, high-risk MIPI score, and high Ki-67. No new safety signals were observed. This study confirms the role of BTK inhibitors in MCL and providers longer-term estimates of response. Evaluation of BTK inhibitors in earlier lines of therapy and in combination with other agents are ongoing.

Although the majority of patients with MCL will have favorable responses to initial therapy, those with high-risk features, particularly TP53 aberrations, have poor outcomes with standard approaches. Despite a growing number of treatment options in the relapsed setting, such as targeted therapies and chimeric antigen receptor (CAR) T-cell therapy, relapses remain common. Allogenic stem cell transplantation can be associated with prolonged response for patients with relapsed MCL, though it has the potential for significant treatment-associated toxicity.

Recently, prolonged follow-up of a retrospective cohort of patients with MCL, including a subset with TP53 aberrations, was reported (Lew et al). Thirty-six patients with MCL were included, including 13 with TP53-mutated disease. A subset of patients (61%) received an allogeneic transplant in first remission. The estimated overall survival rates after allogenic transplant were 56% (95% CI 36%-72%) at 10 years for the overall cohort and 59% (95% CI 21%-75%) at 4 years for patients with TP53-mutated disease at median follow-ups of 10.8 and 4.2 years, respectively. No relapses were observed in the TP53-mutated subset beyond 6 months after transplantation. These data suggest a potentially curative option for patients with high-risk MCL. Given the availability of CAR T-cell therapy, the optimal timing of allogenic stem cell transplant has become less clear for patients with TP53-mutant disease. Although this study was small and retrospective, these data are encouraging for patients with high-risk disease.

Additional References

1.            Hoster E, Rosenwald A, Berger F, et al. Prognostic value of Ki-67 index, cytology, and growth pattern in mantle-cell lymphoma: Results from randomized trials of the European Mantle Cell Lymphoma Network. J Clin Oncol. 2016;34:1386-1394. doi: 10.1200/JCO.2015.63.8387

2.            Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017;130:1903-1910. doi: 10.1182/blood-2017-04-77973

Anti-drug antibody (ADA) testing for biologics, particularly anti–tumor necrosis factor (TNF) agents, has been commercially available for several years, though its clinical use in rheumatoid arthritis (RA) is not known owing to lack of prospective data. Bitoun and colleagues analyzed data from the European ABI-RA registry to evaluate the association between ADA and the anti–TNF monoclonal antibodies (mAb) etanercept, tocilizumab, and rituximab, and clinical response (as measured by disease activity scores, inflammatory markers, and European Alliance of Associations for Rheumatology [EULAR] response rate). Higher rates of ADA positivity were seen in patients treated with rituximab (50%), anti-TNF mAb (38%), and tocilizumab (20%) compared with etanercept (6%). Patients who had a positive ADA test were less likely to have a EULAR response. In addition, patients treated with methotrexate were less likely to have persistent ADA. Though the study was not powered enough to detect differences between the drug classes, the evidence presented is compelling and suggests a role for measuring ADA in patients with RA who do not respond to treatment.

RA is well-known to be associated with cardiovascular disease, particularly atherosclerotic disease and heart failure, but its association with valvular heart disease and its progression has not been well-explored in the literature. Johnson and colleagues performed a cohort study of over 73,000 patients with RA in the Veterans Health Administration (VHA) system compared with 640,000 patients without RA to evaluate the incidence of aortic stenosis, need for intervention, and risk for death. Though the overall incidence rate was low (about 3%), patients with RA had a higher risk for aortic stenosis, with a hazard ratio of 1.48 compared with those without RA, as well as a higher risk for aortic valve replacement and aortic stenosis–related death. The risk for aortic stenosis was associated with hypertension, stroke, and other cardiovascular disease, as well as a body mass index > 30 kg/m², although not with a history of smoking or diabetes. Because the study was performed using data from the VHA — that is, from predominantly male patients — this finding may not be generalizable. In addition, the diagnosis of aortic stenosis is generally reliant on echocardiography and may be detected while searching for other conditions not evaluated here (such as pericarditis). As such, these findings would not support routine screening in patients with RA without other reasons for suspicion of valvular heart disease.

In particular, the increase in cardiovascular risk associated with glucocorticoid therapy in patients with RA has received increased scrutiny, along with other side effects of systemic glucocorticoids. In a recent retrospective study, So and colleagues examined the clinical data of over 12,000 patients with RA treated in public hospitals in Hong Kong with a mean of 9 years of follow-up. Consistent with prior studies, systemic glucocorticoid use (prednisolone equivalent > 5 mg daily) was associated with an increased risk for adverse cardiovascular events, whereas lower doses did not increase cardiovascular risk. Because the data on some disease activity measures and traditional cardiovascular risk factors (such as smoking or obesity) were not available in the database, the study supports, but does not expand on, prior evidence regarding cardiovascular risk.

Almayali and colleagues also looked at glucocorticoid therapy in RA in a follow-up study to the previously published pragmatic randomized double-blinded placebo-controlled GLORIA study, which evaluated the effects of 5 mg/d prednisolone added to standard care for 2 years in patients with active RA who were age 65 years or older. In the current study, 191 patients out of the initial 451 were followed for 3 months and prednisolone tapered off. Patients who tapered off prednisolone had, as expected, an increased risk for flare but no evidence of adrenal insufficiency. Although, again, this is not likely to change practice, it does suggest that glucocorticoid tapering is a reasonable goal in RA therapeutic trials.

Anti-drug antibody (ADA) testing for biologics, particularly anti–tumor necrosis factor (TNF) agents, has been commercially available for several years, though its clinical use in rheumatoid arthritis (RA) is not known owing to lack of prospective data. Bitoun and colleagues analyzed data from the European ABI-RA registry to evaluate the association between ADA and the anti–TNF monoclonal antibodies (mAb) etanercept, tocilizumab, and rituximab, and clinical response (as measured by disease activity scores, inflammatory markers, and European Alliance of Associations for Rheumatology [EULAR] response rate). Higher rates of ADA positivity were seen in patients treated with rituximab (50%), anti-TNF mAb (38%), and tocilizumab (20%) compared with etanercept (6%). Patients who had a positive ADA test were less likely to have a EULAR response. In addition, patients treated with methotrexate were less likely to have persistent ADA. Though the study was not powered enough to detect differences between the drug classes, the evidence presented is compelling and suggests a role for measuring ADA in patients with RA who do not respond to treatment.

RA is well-known to be associated with cardiovascular disease, particularly atherosclerotic disease and heart failure, but its association with valvular heart disease and its progression has not been well-explored in the literature. Johnson and colleagues performed a cohort study of over 73,000 patients with RA in the Veterans Health Administration (VHA) system compared with 640,000 patients without RA to evaluate the incidence of aortic stenosis, need for intervention, and risk for death. Though the overall incidence rate was low (about 3%), patients with RA had a higher risk for aortic stenosis, with a hazard ratio of 1.48 compared with those without RA, as well as a higher risk for aortic valve replacement and aortic stenosis–related death. The risk for aortic stenosis was associated with hypertension, stroke, and other cardiovascular disease, as well as a body mass index > 30 kg/m², although not with a history of smoking or diabetes. Because the study was performed using data from the VHA — that is, from predominantly male patients — this finding may not be generalizable. In addition, the diagnosis of aortic stenosis is generally reliant on echocardiography and may be detected while searching for other conditions not evaluated here (such as pericarditis). As such, these findings would not support routine screening in patients with RA without other reasons for suspicion of valvular heart disease.

In particular, the increase in cardiovascular risk associated with glucocorticoid therapy in patients with RA has received increased scrutiny, along with other side effects of systemic glucocorticoids. In a recent retrospective study, So and colleagues examined the clinical data of over 12,000 patients with RA treated in public hospitals in Hong Kong with a mean of 9 years of follow-up. Consistent with prior studies, systemic glucocorticoid use (prednisolone equivalent > 5 mg daily) was associated with an increased risk for adverse cardiovascular events, whereas lower doses did not increase cardiovascular risk. Because the data on some disease activity measures and traditional cardiovascular risk factors (such as smoking or obesity) were not available in the database, the study supports, but does not expand on, prior evidence regarding cardiovascular risk.

Almayali and colleagues also looked at glucocorticoid therapy in RA in a follow-up study to the previously published pragmatic randomized double-blinded placebo-controlled GLORIA study, which evaluated the effects of 5 mg/d prednisolone added to standard care for 2 years in patients with active RA who were age 65 years or older. In the current study, 191 patients out of the initial 451 were followed for 3 months and prednisolone tapered off. Patients who tapered off prednisolone had, as expected, an increased risk for flare but no evidence of adrenal insufficiency. Although, again, this is not likely to change practice, it does suggest that glucocorticoid tapering is a reasonable goal in RA therapeutic trials.

Anti-drug antibody (ADA) testing for biologics, particularly anti–tumor necrosis factor (TNF) agents, has been commercially available for several years, though its clinical use in rheumatoid arthritis (RA) is not known owing to lack of prospective data. Bitoun and colleagues analyzed data from the European ABI-RA registry to evaluate the association between ADA and the anti–TNF monoclonal antibodies (mAb) etanercept, tocilizumab, and rituximab, and clinical response (as measured by disease activity scores, inflammatory markers, and European Alliance of Associations for Rheumatology [EULAR] response rate). Higher rates of ADA positivity were seen in patients treated with rituximab (50%), anti-TNF mAb (38%), and tocilizumab (20%) compared with etanercept (6%). Patients who had a positive ADA test were less likely to have a EULAR response. In addition, patients treated with methotrexate were less likely to have persistent ADA. Though the study was not powered enough to detect differences between the drug classes, the evidence presented is compelling and suggests a role for measuring ADA in patients with RA who do not respond to treatment.

RA is well-known to be associated with cardiovascular disease, particularly atherosclerotic disease and heart failure, but its association with valvular heart disease and its progression has not been well-explored in the literature. Johnson and colleagues performed a cohort study of over 73,000 patients with RA in the Veterans Health Administration (VHA) system compared with 640,000 patients without RA to evaluate the incidence of aortic stenosis, need for intervention, and risk for death. Though the overall incidence rate was low (about 3%), patients with RA had a higher risk for aortic stenosis, with a hazard ratio of 1.48 compared with those without RA, as well as a higher risk for aortic valve replacement and aortic stenosis–related death. The risk for aortic stenosis was associated with hypertension, stroke, and other cardiovascular disease, as well as a body mass index > 30 kg/m², although not with a history of smoking or diabetes. Because the study was performed using data from the VHA — that is, from predominantly male patients — this finding may not be generalizable. In addition, the diagnosis of aortic stenosis is generally reliant on echocardiography and may be detected while searching for other conditions not evaluated here (such as pericarditis). As such, these findings would not support routine screening in patients with RA without other reasons for suspicion of valvular heart disease.

In particular, the increase in cardiovascular risk associated with glucocorticoid therapy in patients with RA has received increased scrutiny, along with other side effects of systemic glucocorticoids. In a recent retrospective study, So and colleagues examined the clinical data of over 12,000 patients with RA treated in public hospitals in Hong Kong with a mean of 9 years of follow-up. Consistent with prior studies, systemic glucocorticoid use (prednisolone equivalent > 5 mg daily) was associated with an increased risk for adverse cardiovascular events, whereas lower doses did not increase cardiovascular risk. Because the data on some disease activity measures and traditional cardiovascular risk factors (such as smoking or obesity) were not available in the database, the study supports, but does not expand on, prior evidence regarding cardiovascular risk.

Almayali and colleagues also looked at glucocorticoid therapy in RA in a follow-up study to the previously published pragmatic randomized double-blinded placebo-controlled GLORIA study, which evaluated the effects of 5 mg/d prednisolone added to standard care for 2 years in patients with active RA who were age 65 years or older. In the current study, 191 patients out of the initial 451 were followed for 3 months and prednisolone tapered off. Patients who tapered off prednisolone had, as expected, an increased risk for flare but no evidence of adrenal insufficiency. Although, again, this is not likely to change practice, it does suggest that glucocorticoid tapering is a reasonable goal in RA therapeutic trials.

Rheumatology care can save health systems more than $2,700 per patient per year, according to a new report from the American College of Rheumatology.

In a white paper and corresponding position statement, the organization outlined how rheumatology care delivers financial benefits for health systems.

The work also highlighted prior research on the positive outcomes associated with rheumatology care, including a decline in hip and knee replacements for patients with rheumatoid arthritis after the introduction of biologics, while the total number of hip and knee replacements for patients with osteoarthritis increased, as well as lower 30-day readmission rates among patients with systemic lupus erythematosus with access to a rheumatology clinic post discharge.

“Many rheumatologists can attest to the value they bring to the care team at a health care system,” said Christina Downey, MD, an assistant professor of medicine at Loma Linda (Calif.) University, in a press release. She is the lead author of the white paper and chair of the ACR’s Government Affairs Committee. “Our goal with the paper and position statement is to emphasize what that value looks like from a preventive and financial perspective. A rheumatologist on the care team benefits patients, practices, and the economy.”

The analysis used adjusted claims insurance data to compare markets with a high vs. low supply of rheumatologists. A high supply was defined as at least 1.5 rheumatologists per 100,000 population, whereas a low supply was less than this amount. On average, markets with a high supply of rheumatologists had lower emergency department (ED) and hospitalization costs per patient per year.

A version of this article first appeared on Medscape.com.

Rheumatology care can save health systems more than $2,700 per patient per year, according to a new report from the American College of Rheumatology.

In a white paper and corresponding position statement, the organization outlined how rheumatology care delivers financial benefits for health systems.

The work also highlighted prior research on the positive outcomes associated with rheumatology care, including a decline in hip and knee replacements for patients with rheumatoid arthritis after the introduction of biologics, while the total number of hip and knee replacements for patients with osteoarthritis increased, as well as lower 30-day readmission rates among patients with systemic lupus erythematosus with access to a rheumatology clinic post discharge.

“Many rheumatologists can attest to the value they bring to the care team at a health care system,” said Christina Downey, MD, an assistant professor of medicine at Loma Linda (Calif.) University, in a press release. She is the lead author of the white paper and chair of the ACR’s Government Affairs Committee. “Our goal with the paper and position statement is to emphasize what that value looks like from a preventive and financial perspective. A rheumatologist on the care team benefits patients, practices, and the economy.”

The analysis used adjusted claims insurance data to compare markets with a high vs. low supply of rheumatologists. A high supply was defined as at least 1.5 rheumatologists per 100,000 population, whereas a low supply was less than this amount. On average, markets with a high supply of rheumatologists had lower emergency department (ED) and hospitalization costs per patient per year.

A version of this article first appeared on Medscape.com.

Rheumatology care can save health systems more than $2,700 per patient per year, according to a new report from the American College of Rheumatology.

In a white paper and corresponding position statement, the organization outlined how rheumatology care delivers financial benefits for health systems.

The work also highlighted prior research on the positive outcomes associated with rheumatology care, including a decline in hip and knee replacements for patients with rheumatoid arthritis after the introduction of biologics, while the total number of hip and knee replacements for patients with osteoarthritis increased, as well as lower 30-day readmission rates among patients with systemic lupus erythematosus with access to a rheumatology clinic post discharge.

“Many rheumatologists can attest to the value they bring to the care team at a health care system,” said Christina Downey, MD, an assistant professor of medicine at Loma Linda (Calif.) University, in a press release. She is the lead author of the white paper and chair of the ACR’s Government Affairs Committee. “Our goal with the paper and position statement is to emphasize what that value looks like from a preventive and financial perspective. A rheumatologist on the care team benefits patients, practices, and the economy.”

The analysis used adjusted claims insurance data to compare markets with a high vs. low supply of rheumatologists. A high supply was defined as at least 1.5 rheumatologists per 100,000 population, whereas a low supply was less than this amount. On average, markets with a high supply of rheumatologists had lower emergency department (ED) and hospitalization costs per patient per year.

A version of this article first appeared on Medscape.com.

The use of proton pump inhibitors (PPI) can affect the bioavailability and effectiveness of concomitant medications, including cancer therapies. A retrospective study by Lee and colleagues aimed to identify the clinical outcomes of patients with hormone receptor–positive (HR+) and human epidermal growth factor receptor 2–negative advanced or metastatic BC who were concomitantly using PPI and palbociclib. The study included 1310 patients, of which 344 received concomitant PPI plus palbociclib and 966 patients received palbociclib alone. Results showed that patients who received concomitant PPI plus palbociclib had significantly shorter progression-free survival (hazard ratio 1.76; 95% CI 1.46-2.13) and overall survival (hazard ratio 2.72; 95% CI 2.07-3.53) rates compared with those who received palbociclib alone. These results suggest that the concomitant use of PPI with palbociclib may alter the therapeutic efficacy of the drug. More research studies are needed to confirm these findings.

Pfeiler and colleagues examined the association of BMI with side effects, treatment discontinuation, and efficacy of palbociclib. This study looked at 5698 patients with early-stage HR+ BC who received palbociclib plus endocrine therapy as part of a preplanned analysis of the PALLAS trial. Results showed that in women who received adjuvant palbociclib, higher BMI was associated with a significantly lower rate of neutropenia (odds ratio for a 1-unit change in BMI 0.93; 95% CI 0.92-0.95) and a lower rate of treatment discontinuation (adjusted hazard ratio for a 10-unit change in BMI 0.75; 95% CI 0.67-0.83) compared with normal-weight patients. No effect of BMI on palbociclib efficacy was observed at 31 months of follow-up. Further studies are needed to validate these findings in different cohorts.

In cases of early-stage breast cancer (clinical T1, T2) where patients undergo upfront breast-conserving therapy and sentinel lymph node biopsy (SLNB), completion of axillary lymph node dissection (CLND) is often omitted if only one or two positive sentinel lymph nodes are detected. A study by Zaveri and colleagues looked at outcomes among 548 patients with cT1-2 N0 BC who were treated with upfront mastectomy and had one or two positive lymph nodes on SLNB. The 5-year cumulative incidence rate of overall locoregional recurrence was comparable between patients who underwent vs those who did not undergo CLND (1.8% vs 1.3%; P = .93); receipt of post-mastectomy radiation therapy did not affect the locoregional recurrence rate in both categories of patients who underwent SLNB alone and SLNB with CLND (P = .1638). These results suggest that CLND may not necessarily improve outcomes in this patient population. Larger prospective studies are needed to confirm these findings.

The use of proton pump inhibitors (PPI) can affect the bioavailability and effectiveness of concomitant medications, including cancer therapies. A retrospective study by Lee and colleagues aimed to identify the clinical outcomes of patients with hormone receptor–positive (HR+) and human epidermal growth factor receptor 2–negative advanced or metastatic BC who were concomitantly using PPI and palbociclib. The study included 1310 patients, of which 344 received concomitant PPI plus palbociclib and 966 patients received palbociclib alone. Results showed that patients who received concomitant PPI plus palbociclib had significantly shorter progression-free survival (hazard ratio 1.76; 95% CI 1.46-2.13) and overall survival (hazard ratio 2.72; 95% CI 2.07-3.53) rates compared with those who received palbociclib alone. These results suggest that the concomitant use of PPI with palbociclib may alter the therapeutic efficacy of the drug. More research studies are needed to confirm these findings.

Pfeiler and colleagues examined the association of BMI with side effects, treatment discontinuation, and efficacy of palbociclib. This study looked at 5698 patients with early-stage HR+ BC who received palbociclib plus endocrine therapy as part of a preplanned analysis of the PALLAS trial. Results showed that in women who received adjuvant palbociclib, higher BMI was associated with a significantly lower rate of neutropenia (odds ratio for a 1-unit change in BMI 0.93; 95% CI 0.92-0.95) and a lower rate of treatment discontinuation (adjusted hazard ratio for a 10-unit change in BMI 0.75; 95% CI 0.67-0.83) compared with normal-weight patients. No effect of BMI on palbociclib efficacy was observed at 31 months of follow-up. Further studies are needed to validate these findings in different cohorts.

In cases of early-stage breast cancer (clinical T1, T2) where patients undergo upfront breast-conserving therapy and sentinel lymph node biopsy (SLNB), completion of axillary lymph node dissection (CLND) is often omitted if only one or two positive sentinel lymph nodes are detected. A study by Zaveri and colleagues looked at outcomes among 548 patients with cT1-2 N0 BC who were treated with upfront mastectomy and had one or two positive lymph nodes on SLNB. The 5-year cumulative incidence rate of overall locoregional recurrence was comparable between patients who underwent vs those who did not undergo CLND (1.8% vs 1.3%; P = .93); receipt of post-mastectomy radiation therapy did not affect the locoregional recurrence rate in both categories of patients who underwent SLNB alone and SLNB with CLND (P = .1638). These results suggest that CLND may not necessarily improve outcomes in this patient population. Larger prospective studies are needed to confirm these findings.

The use of proton pump inhibitors (PPI) can affect the bioavailability and effectiveness of concomitant medications, including cancer therapies. A retrospective study by Lee and colleagues aimed to identify the clinical outcomes of patients with hormone receptor–positive (HR+) and human epidermal growth factor receptor 2–negative advanced or metastatic BC who were concomitantly using PPI and palbociclib. The study included 1310 patients, of which 344 received concomitant PPI plus palbociclib and 966 patients received palbociclib alone. Results showed that patients who received concomitant PPI plus palbociclib had significantly shorter progression-free survival (hazard ratio 1.76; 95% CI 1.46-2.13) and overall survival (hazard ratio 2.72; 95% CI 2.07-3.53) rates compared with those who received palbociclib alone. These results suggest that the concomitant use of PPI with palbociclib may alter the therapeutic efficacy of the drug. More research studies are needed to confirm these findings.

Pfeiler and colleagues examined the association of BMI with side effects, treatment discontinuation, and efficacy of palbociclib. This study looked at 5698 patients with early-stage HR+ BC who received palbociclib plus endocrine therapy as part of a preplanned analysis of the PALLAS trial. Results showed that in women who received adjuvant palbociclib, higher BMI was associated with a significantly lower rate of neutropenia (odds ratio for a 1-unit change in BMI 0.93; 95% CI 0.92-0.95) and a lower rate of treatment discontinuation (adjusted hazard ratio for a 10-unit change in BMI 0.75; 95% CI 0.67-0.83) compared with normal-weight patients. No effect of BMI on palbociclib efficacy was observed at 31 months of follow-up. Further studies are needed to validate these findings in different cohorts.

In cases of early-stage breast cancer (clinical T1, T2) where patients undergo upfront breast-conserving therapy and sentinel lymph node biopsy (SLNB), completion of axillary lymph node dissection (CLND) is often omitted if only one or two positive sentinel lymph nodes are detected. A study by Zaveri and colleagues looked at outcomes among 548 patients with cT1-2 N0 BC who were treated with upfront mastectomy and had one or two positive lymph nodes on SLNB. The 5-year cumulative incidence rate of overall locoregional recurrence was comparable between patients who underwent vs those who did not undergo CLND (1.8% vs 1.3%; P = .93); receipt of post-mastectomy radiation therapy did not affect the locoregional recurrence rate in both categories of patients who underwent SLNB alone and SLNB with CLND (P = .1638). These results suggest that CLND may not necessarily improve outcomes in this patient population. Larger prospective studies are needed to confirm these findings.

A year after celebrating the approval of the first treatment for repigmentation of vitiligo, dermatologists describe how topical ruxolitinib has advanced the outlook for patients with the disease and what’s next in the pipeline.

The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.

Dr. Chovatiya

“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”

He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)

This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.

Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)

Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
 

Good experiences with payers at safety-net hospital

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.

Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.

From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.

In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.

Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.

Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.

“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”

To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
 

Data spotlight success in adolescents

Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.

Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.

The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.

The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.

At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
 

New excitement in the field

Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.

“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.

NYU Langone Health

Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.

Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.

He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.

“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.

Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”

When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.

He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.

Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
 

Lead investigator adds observations

David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.

In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”

Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.

“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.

He provided several observations about people who have stopped taking the medication.

“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”

He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.

“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.

As for phototherapy, he said, the combination with topical ruxolitinib is being studied.

“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.

In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.

“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
 

Next in the pipeline

Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.

Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.

“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.

He pointed out that longer-term safety data will be available because it is already on the market for alopecia.

Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.

Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.

The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.

“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”

Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.

A version of this article appeared on Medscape.com.

A year after celebrating the approval of the first treatment for repigmentation of vitiligo, dermatologists describe how topical ruxolitinib has advanced the outlook for patients with the disease and what’s next in the pipeline.

The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.

Dr. Chovatiya

“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”

He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)

This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.

Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)

Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
 

Good experiences with payers at safety-net hospital

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.

Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.

From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.

In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.

Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.

Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.

“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”

To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
 

Data spotlight success in adolescents

Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.

Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.

The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.

The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.

At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
 

New excitement in the field

Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.

“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.

NYU Langone Health

Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.

Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.

He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.

“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.

Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”

When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.

He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.

Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
 

Lead investigator adds observations

David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.

In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”

Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.

“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.

He provided several observations about people who have stopped taking the medication.

“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”

He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.

“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.

As for phototherapy, he said, the combination with topical ruxolitinib is being studied.

“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.

In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.

“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
 

Next in the pipeline

Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.

Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.

“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.

He pointed out that longer-term safety data will be available because it is already on the market for alopecia.

Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.

Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.

The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.

“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”

Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.

A version of this article appeared on Medscape.com.

A year after celebrating the approval of the first treatment for repigmentation of vitiligo, dermatologists describe how topical ruxolitinib has advanced the outlook for patients with the disease and what’s next in the pipeline.

The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.

Dr. Chovatiya

“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”

He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)

This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.

Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)

Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
 

Good experiences with payers at safety-net hospital

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.

Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.

From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.

In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.

Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.

Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.

“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”

To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
 

Data spotlight success in adolescents

Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.

Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.

The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.

The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.

At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
 

New excitement in the field

Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.

“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.

NYU Langone Health

Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.

Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.

He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.

“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.

Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”

When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.

He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.

Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
 

Lead investigator adds observations

David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.

In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”

Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.

“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.

He provided several observations about people who have stopped taking the medication.

“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”

He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.

“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.

As for phototherapy, he said, the combination with topical ruxolitinib is being studied.

“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.

In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.

“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
 

Next in the pipeline

Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.

Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.

“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.

He pointed out that longer-term safety data will be available because it is already on the market for alopecia.

Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.

Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.

The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.

“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”

Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.

A version of this article appeared on Medscape.com.

It’s an ongoing debate in the diabetes world: Is it ideal to consume a very-low-carbohydrate diet, or is it better to go with moderate amounts of healthful carbs?

At the annual scientific sessions of the American Diabetes Association, Carol F. Kirkpatrick, PhD, RDN, spoke first, arguing in favor of diets consisting of moderate, high-quality carbohydrates.

Dina Hafez Griauzde, MD, countered that very-low-carbohydrate diets are more beneficial for people with diabetes, primarily type 2 diabetes.

Both speakers based their arguments on published evidence but agreed in the end that discussion with patients about individual dietary preferences should play a major role in the ultimate decision.
 

Moderate-carbohydrate eating is best

Dr. Kirkpatrick began by explaining that definitions of “low carb” vary in the literature, which makes comparisons between studies difficult. On the basis of a 2019 review that she coauthored, “moderate” carbohydrate consumption was defined as a diet in which 26%-44% of total daily calories are from carbohydrates. “Low” carbohydrate consumption was defined as a diet in which 10%-25% of calories were from carbohydrates. Consuming less than 10% was defined as a very-low-carbohydrate diet (i.e., a ketogenic diet).

Across studies, she noted, the literature shows that within the first 6 months weight loss is typically greater with carbohydrate-restricted diets than with higher-carbohydrate diets, but that by 1 year and beyond weight loss is similar.

“That can be partly due to the difficulty in people maintaining that very severe dietary restriction, although ... we can all acknowledge that it’s difficult for patients to adhere to any dietary pattern, so for sure by 12 months, the difference in the weight loss is gone between the two,” said Dr. Kirkpatrick, of Midwest Biomedical Research, Pocatello, Idaho.

In a recent meta-analysis of 35 trials that examined the dose-dependent effects of carbohydrate restriction for patients with type 2 diabetes, there was a significant decrease in weight as carbohydrates were reduced. But by 12 months (17 trials), the greatest weight reduction was seen at 35% carbohydrate intake.

“It may just be that people were able to adhere to that moderate intake better,” she explained.

Regarding lipids, in her 2019 review and in several meta-analyses since, the effects on low-density lipoprotein cholesterol (LDL-C) varied. For some patients, adhering to a low-carb diet led to reductions in LDL-C, especially if the participants also lost weight, whereas in other patients, a low-carb diet led to an increase in LDL-C.

Either way, a high intake of saturated fatty acids is key to an increase in LDL-C, Dr. Kirkpatrick noted. “So, it’s important that, if a patient chooses to follow a very low carbohydrate diet or any kind of dietary pattern that restricts carbohydrate, that they replace the carbohydrate with unsaturated fat and not saturated fatty acid foods to avoid that increase in LDL-C.”

Generally, the evidence also shows that carbohydrate restriction typically leads to lower triglyceride levels and higher high-density lipoprotein (HDL) cholesterol levels. However, the same meta-analysis showed that the greatest reduction in LDL-C occurred at about 40% carbohydrate consumption.

Another recent meta-analysis showed that LDL-C rose significantly by an average 12.4 mg/dL with very-low-carb (3%-30%) diets, but only slightly, by 0.4 mg/dL, with moderate carb (40%-45%) intake.

Consuming very-low-carb diets did lead to greater reductions in triglycerides, compared with consuming moderate carb diets (23.9 mg/dL vs. 8.9 mg/dL).

“However, in terms of cardiovascular health, we are not entirely sure what that means. ... We have to look at the overall results in the presence of both triglyceride lowering as well as LDL cholesterol,” Dr. Kirkpatrick noted.

Carbohydrate restriction did consistently lead to lower hemoglobin A1c levels by an average of 0.4, 0.6, and 1.0 percentage points at 6 months for diets of 40%, 30%, and 15% carbohydrate, respectively. However, by 12 months, the effect had waned to 0.15, 0.2, and 0.4 A1c percentage points.

“Again, carbohydrate restriction, especially severe, is difficult for people to adhere to, and moderate carbohydrate intake would allow our patients to consume an appropriate amount of carbohydrate and still achieve improved glycemic control,” Dr. Kirkpatrick said.

Two large randomized controlled trials – PREDIMED and CORDIOPREV – examined the effects of the Mediterranean diet on cardiovascular disease prevention. Both showed a decrease in cardiovascular events with the Mediterranean diet, which involves consuming moderate amounts of carbohydrates.

“The Mediterranean dietary pattern has the strongest evidence for benefit, and it’s moderate in carbohydrates,” she concluded.
 

Very-low-carbohydrate eating is best

Dr. Griauzde was a last-minute replacement speaker for William S. Yancy Jr, MD, of Duke University, Durham, N.C., and presented his slides. She argued that consuming a very low carb diet improves glycemia and that it does not increase but possibly lowers cardiovascular risk.

She began by noting that prior to the discovery of insulin very-low-carb diets had been consumed for over a century to prolong life for people with type 1 diabetes.

“We have long recognized the deleterious role of carbohydrate in type 1 diabetes management, and we have increasingly recognized that role in the management of type 2 diabetes,” said Dr. Griauzde of the University of Michigan in Ann Arbor.

In a small study that compared maintaining a very-low-carb diet for 2 weeks with maintaining a high-carb diet for 2 weeks, total glucose areas under the curve were substantially lower (P < .05) during the low-carb phase, while A1c levels dropped from 7.3% to 6.8% (P = .006).

“We don’t see those outcomes with meds,” Dr. Griauzde noted, adding, “A diet very low in carbohydrates is one of the most potent tools we have to help our patients achieve glycemic control.”

Dr. Griauzde said that the carbohydrate-insulin model provides an explanation for why dietary carbohydrates are particularly obesogenic and metabolically harmful. That model contrasts with the energy balance model, which suggests that all calories are equal.

The rationale of the carbohydrate-insulin model is that dietary carbohydrate – either sugar or starch – raises serum glucose and insulin levels. A carbohydrate-restricted diet therefore reduces the dietary contribution to serum glucose, which then results in lower insulin levels. Insulin is a potent stimulator of lipogenesis (fat storage), and it is a potent inhibitor of lipolysis (the burning of fat). By lowering insulin levels, stored body fat is burned, serum ketone levels increase, and body weight is lowered.

This model suggests that, when insulin levels are chronically high because of excess carbohydrate consumption, circulating fuels are lowered, which leads to an increase in hunger and to overeating. This was demonstrated in a study that compared different levels of isocaloric glycemic index diets in 12 teenage boys with overweight or obesity. The higher-carbohydrate meals led to higher glucose and insulin levels and more food consumption.

In a systematic review of 13 trials of restricted-carbohydrate diets (< 45% carbohydrates) for adults with diabetes, the degree of improvement in A1c level correlated with the degree of carbohydrate restriction over 2-26 weeks (P = .013).

And in a network meta-analysis of 56 trials that compared nine diets among a total of 4,937 participants with type 2 diabetes, one conclusion was that “for reducing A1c, the low-carbohydrate diet was ranked as the best dietary approach (SUCRA: 84%), followed by the Mediterranean diet (80%), and Paleolithic diet (76%), compared with a control diet.”

Regarding the criticism that very-low-carbohydrate diets are high in saturated fat and therefore raise the risk of cardiovascular disease, Dr. Griauzde pointed to another meta-analysis of 21 prospective studies with more than 300,000 participants with 5-25 years of follow-up. In that analysis, the intake of saturated fat was not associated with an increased risk of cardiovascular disease or stroke.

Furthermore, a 12-week randomized controlled trial that involved 40 adults with overweight also suggested that a very-low-carb diet may be superior to a low-fat diet in improving aspects of the metabolic syndrome, including body mass index, lipid levels, and insulin sensitivity. Small LDL particles, which are more atherogenic than larger LDL particles, also decreased despite a threefold increase in saturated fat intake.
 

Rebuttals: Overall diet, patient preference matter

During the rebuttals, Dr. Kirkpatrick pointed out that large LDL particles are also atherogenic. In addition, she noted that the studies that showed that saturated fat isn’t associated with cardiovascular disease didn’t consider the macronutrients that replaced the saturated fat.

“It really is about increasing consumption of foods that we know are associated with cardiovascular benefit, including plant-based foods that are high quality and not refined carbohydrates ... and healthy protein sources. ... Hopefully we can step away from just looking at macronutrients and look at the total amount of food that people are choosing to eat.”

Importantly, Dr. Kirkpatrick said, patients need to be asked about their current dietary patterns and preferences. “Interventions should be patient centered and sensitive to cultural differences. Personalized lifestyle interventions increase the likelihood of success.”

Dr. Griauzde pointed out that newer antiobesity drugs can be added to any diet to decrease appetite and enhance adherence.

Dr. Griauzde also observed, “We can label a very-low-carbohydrate diet ‘extreme,’ but maybe, from the patient’s perspective, it’s extreme to take 200 units of insulin a day. If you can give them the opportunity to discontinue use of the insulin by following a very-low-carbohydrate dietary pattern, that is the opportunity that our patients deserve to have.”

But overall, she agreed with Dr. Kirkpatrick about individualizing any dietary approach: “We will never know from any of the trials that have been done or that will be done in the future what diet is best for an individual patient. ... Our job is to help our patients find the dietary approach that works best for them.”

Dr. Kirkpatrick is a clinical scientist with Midwest Biomedical Research, which has received funding from various food and pharmaceutical companies. She has not received any direct funding. Dr. Yancy is a consultant for The Simply Good Foods Co. Dr. Griauzde has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

It’s an ongoing debate in the diabetes world: Is it ideal to consume a very-low-carbohydrate diet, or is it better to go with moderate amounts of healthful carbs?

At the annual scientific sessions of the American Diabetes Association, Carol F. Kirkpatrick, PhD, RDN, spoke first, arguing in favor of diets consisting of moderate, high-quality carbohydrates.

Dina Hafez Griauzde, MD, countered that very-low-carbohydrate diets are more beneficial for people with diabetes, primarily type 2 diabetes.

Both speakers based their arguments on published evidence but agreed in the end that discussion with patients about individual dietary preferences should play a major role in the ultimate decision.
 

Moderate-carbohydrate eating is best

Dr. Kirkpatrick began by explaining that definitions of “low carb” vary in the literature, which makes comparisons between studies difficult. On the basis of a 2019 review that she coauthored, “moderate” carbohydrate consumption was defined as a diet in which 26%-44% of total daily calories are from carbohydrates. “Low” carbohydrate consumption was defined as a diet in which 10%-25% of calories were from carbohydrates. Consuming less than 10% was defined as a very-low-carbohydrate diet (i.e., a ketogenic diet).

Across studies, she noted, the literature shows that within the first 6 months weight loss is typically greater with carbohydrate-restricted diets than with higher-carbohydrate diets, but that by 1 year and beyond weight loss is similar.

“That can be partly due to the difficulty in people maintaining that very severe dietary restriction, although ... we can all acknowledge that it’s difficult for patients to adhere to any dietary pattern, so for sure by 12 months, the difference in the weight loss is gone between the two,” said Dr. Kirkpatrick, of Midwest Biomedical Research, Pocatello, Idaho.

In a recent meta-analysis of 35 trials that examined the dose-dependent effects of carbohydrate restriction for patients with type 2 diabetes, there was a significant decrease in weight as carbohydrates were reduced. But by 12 months (17 trials), the greatest weight reduction was seen at 35% carbohydrate intake.

“It may just be that people were able to adhere to that moderate intake better,” she explained.

Regarding lipids, in her 2019 review and in several meta-analyses since, the effects on low-density lipoprotein cholesterol (LDL-C) varied. For some patients, adhering to a low-carb diet led to reductions in LDL-C, especially if the participants also lost weight, whereas in other patients, a low-carb diet led to an increase in LDL-C.

Either way, a high intake of saturated fatty acids is key to an increase in LDL-C, Dr. Kirkpatrick noted. “So, it’s important that, if a patient chooses to follow a very low carbohydrate diet or any kind of dietary pattern that restricts carbohydrate, that they replace the carbohydrate with unsaturated fat and not saturated fatty acid foods to avoid that increase in LDL-C.”

Generally, the evidence also shows that carbohydrate restriction typically leads to lower triglyceride levels and higher high-density lipoprotein (HDL) cholesterol levels. However, the same meta-analysis showed that the greatest reduction in LDL-C occurred at about 40% carbohydrate consumption.

Another recent meta-analysis showed that LDL-C rose significantly by an average 12.4 mg/dL with very-low-carb (3%-30%) diets, but only slightly, by 0.4 mg/dL, with moderate carb (40%-45%) intake.

Consuming very-low-carb diets did lead to greater reductions in triglycerides, compared with consuming moderate carb diets (23.9 mg/dL vs. 8.9 mg/dL).

“However, in terms of cardiovascular health, we are not entirely sure what that means. ... We have to look at the overall results in the presence of both triglyceride lowering as well as LDL cholesterol,” Dr. Kirkpatrick noted.

Carbohydrate restriction did consistently lead to lower hemoglobin A1c levels by an average of 0.4, 0.6, and 1.0 percentage points at 6 months for diets of 40%, 30%, and 15% carbohydrate, respectively. However, by 12 months, the effect had waned to 0.15, 0.2, and 0.4 A1c percentage points.

“Again, carbohydrate restriction, especially severe, is difficult for people to adhere to, and moderate carbohydrate intake would allow our patients to consume an appropriate amount of carbohydrate and still achieve improved glycemic control,” Dr. Kirkpatrick said.

Two large randomized controlled trials – PREDIMED and CORDIOPREV – examined the effects of the Mediterranean diet on cardiovascular disease prevention. Both showed a decrease in cardiovascular events with the Mediterranean diet, which involves consuming moderate amounts of carbohydrates.

“The Mediterranean dietary pattern has the strongest evidence for benefit, and it’s moderate in carbohydrates,” she concluded.
 

Very-low-carbohydrate eating is best

Dr. Griauzde was a last-minute replacement speaker for William S. Yancy Jr, MD, of Duke University, Durham, N.C., and presented his slides. She argued that consuming a very low carb diet improves glycemia and that it does not increase but possibly lowers cardiovascular risk.

She began by noting that prior to the discovery of insulin very-low-carb diets had been consumed for over a century to prolong life for people with type 1 diabetes.

“We have long recognized the deleterious role of carbohydrate in type 1 diabetes management, and we have increasingly recognized that role in the management of type 2 diabetes,” said Dr. Griauzde of the University of Michigan in Ann Arbor.

In a small study that compared maintaining a very-low-carb diet for 2 weeks with maintaining a high-carb diet for 2 weeks, total glucose areas under the curve were substantially lower (P < .05) during the low-carb phase, while A1c levels dropped from 7.3% to 6.8% (P = .006).

“We don’t see those outcomes with meds,” Dr. Griauzde noted, adding, “A diet very low in carbohydrates is one of the most potent tools we have to help our patients achieve glycemic control.”

Dr. Griauzde said that the carbohydrate-insulin model provides an explanation for why dietary carbohydrates are particularly obesogenic and metabolically harmful. That model contrasts with the energy balance model, which suggests that all calories are equal.

The rationale of the carbohydrate-insulin model is that dietary carbohydrate – either sugar or starch – raises serum glucose and insulin levels. A carbohydrate-restricted diet therefore reduces the dietary contribution to serum glucose, which then results in lower insulin levels. Insulin is a potent stimulator of lipogenesis (fat storage), and it is a potent inhibitor of lipolysis (the burning of fat). By lowering insulin levels, stored body fat is burned, serum ketone levels increase, and body weight is lowered.

This model suggests that, when insulin levels are chronically high because of excess carbohydrate consumption, circulating fuels are lowered, which leads to an increase in hunger and to overeating. This was demonstrated in a study that compared different levels of isocaloric glycemic index diets in 12 teenage boys with overweight or obesity. The higher-carbohydrate meals led to higher glucose and insulin levels and more food consumption.

In a systematic review of 13 trials of restricted-carbohydrate diets (< 45% carbohydrates) for adults with diabetes, the degree of improvement in A1c level correlated with the degree of carbohydrate restriction over 2-26 weeks (P = .013).

And in a network meta-analysis of 56 trials that compared nine diets among a total of 4,937 participants with type 2 diabetes, one conclusion was that “for reducing A1c, the low-carbohydrate diet was ranked as the best dietary approach (SUCRA: 84%), followed by the Mediterranean diet (80%), and Paleolithic diet (76%), compared with a control diet.”

Regarding the criticism that very-low-carbohydrate diets are high in saturated fat and therefore raise the risk of cardiovascular disease, Dr. Griauzde pointed to another meta-analysis of 21 prospective studies with more than 300,000 participants with 5-25 years of follow-up. In that analysis, the intake of saturated fat was not associated with an increased risk of cardiovascular disease or stroke.

Furthermore, a 12-week randomized controlled trial that involved 40 adults with overweight also suggested that a very-low-carb diet may be superior to a low-fat diet in improving aspects of the metabolic syndrome, including body mass index, lipid levels, and insulin sensitivity. Small LDL particles, which are more atherogenic than larger LDL particles, also decreased despite a threefold increase in saturated fat intake.
 

Rebuttals: Overall diet, patient preference matter

During the rebuttals, Dr. Kirkpatrick pointed out that large LDL particles are also atherogenic. In addition, she noted that the studies that showed that saturated fat isn’t associated with cardiovascular disease didn’t consider the macronutrients that replaced the saturated fat.

“It really is about increasing consumption of foods that we know are associated with cardiovascular benefit, including plant-based foods that are high quality and not refined carbohydrates ... and healthy protein sources. ... Hopefully we can step away from just looking at macronutrients and look at the total amount of food that people are choosing to eat.”

Importantly, Dr. Kirkpatrick said, patients need to be asked about their current dietary patterns and preferences. “Interventions should be patient centered and sensitive to cultural differences. Personalized lifestyle interventions increase the likelihood of success.”

Dr. Griauzde pointed out that newer antiobesity drugs can be added to any diet to decrease appetite and enhance adherence.

Dr. Griauzde also observed, “We can label a very-low-carbohydrate diet ‘extreme,’ but maybe, from the patient’s perspective, it’s extreme to take 200 units of insulin a day. If you can give them the opportunity to discontinue use of the insulin by following a very-low-carbohydrate dietary pattern, that is the opportunity that our patients deserve to have.”

But overall, she agreed with Dr. Kirkpatrick about individualizing any dietary approach: “We will never know from any of the trials that have been done or that will be done in the future what diet is best for an individual patient. ... Our job is to help our patients find the dietary approach that works best for them.”

Dr. Kirkpatrick is a clinical scientist with Midwest Biomedical Research, which has received funding from various food and pharmaceutical companies. She has not received any direct funding. Dr. Yancy is a consultant for The Simply Good Foods Co. Dr. Griauzde has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

It’s an ongoing debate in the diabetes world: Is it ideal to consume a very-low-carbohydrate diet, or is it better to go with moderate amounts of healthful carbs?

At the annual scientific sessions of the American Diabetes Association, Carol F. Kirkpatrick, PhD, RDN, spoke first, arguing in favor of diets consisting of moderate, high-quality carbohydrates.

Dina Hafez Griauzde, MD, countered that very-low-carbohydrate diets are more beneficial for people with diabetes, primarily type 2 diabetes.

Both speakers based their arguments on published evidence but agreed in the end that discussion with patients about individual dietary preferences should play a major role in the ultimate decision.
 

Moderate-carbohydrate eating is best

Dr. Kirkpatrick began by explaining that definitions of “low carb” vary in the literature, which makes comparisons between studies difficult. On the basis of a 2019 review that she coauthored, “moderate” carbohydrate consumption was defined as a diet in which 26%-44% of total daily calories are from carbohydrates. “Low” carbohydrate consumption was defined as a diet in which 10%-25% of calories were from carbohydrates. Consuming less than 10% was defined as a very-low-carbohydrate diet (i.e., a ketogenic diet).

Across studies, she noted, the literature shows that within the first 6 months weight loss is typically greater with carbohydrate-restricted diets than with higher-carbohydrate diets, but that by 1 year and beyond weight loss is similar.

“That can be partly due to the difficulty in people maintaining that very severe dietary restriction, although ... we can all acknowledge that it’s difficult for patients to adhere to any dietary pattern, so for sure by 12 months, the difference in the weight loss is gone between the two,” said Dr. Kirkpatrick, of Midwest Biomedical Research, Pocatello, Idaho.

In a recent meta-analysis of 35 trials that examined the dose-dependent effects of carbohydrate restriction for patients with type 2 diabetes, there was a significant decrease in weight as carbohydrates were reduced. But by 12 months (17 trials), the greatest weight reduction was seen at 35% carbohydrate intake.

“It may just be that people were able to adhere to that moderate intake better,” she explained.

Regarding lipids, in her 2019 review and in several meta-analyses since, the effects on low-density lipoprotein cholesterol (LDL-C) varied. For some patients, adhering to a low-carb diet led to reductions in LDL-C, especially if the participants also lost weight, whereas in other patients, a low-carb diet led to an increase in LDL-C.

Either way, a high intake of saturated fatty acids is key to an increase in LDL-C, Dr. Kirkpatrick noted. “So, it’s important that, if a patient chooses to follow a very low carbohydrate diet or any kind of dietary pattern that restricts carbohydrate, that they replace the carbohydrate with unsaturated fat and not saturated fatty acid foods to avoid that increase in LDL-C.”

Generally, the evidence also shows that carbohydrate restriction typically leads to lower triglyceride levels and higher high-density lipoprotein (HDL) cholesterol levels. However, the same meta-analysis showed that the greatest reduction in LDL-C occurred at about 40% carbohydrate consumption.

Another recent meta-analysis showed that LDL-C rose significantly by an average 12.4 mg/dL with very-low-carb (3%-30%) diets, but only slightly, by 0.4 mg/dL, with moderate carb (40%-45%) intake.

Consuming very-low-carb diets did lead to greater reductions in triglycerides, compared with consuming moderate carb diets (23.9 mg/dL vs. 8.9 mg/dL).

“However, in terms of cardiovascular health, we are not entirely sure what that means. ... We have to look at the overall results in the presence of both triglyceride lowering as well as LDL cholesterol,” Dr. Kirkpatrick noted.

Carbohydrate restriction did consistently lead to lower hemoglobin A1c levels by an average of 0.4, 0.6, and 1.0 percentage points at 6 months for diets of 40%, 30%, and 15% carbohydrate, respectively. However, by 12 months, the effect had waned to 0.15, 0.2, and 0.4 A1c percentage points.

“Again, carbohydrate restriction, especially severe, is difficult for people to adhere to, and moderate carbohydrate intake would allow our patients to consume an appropriate amount of carbohydrate and still achieve improved glycemic control,” Dr. Kirkpatrick said.

Two large randomized controlled trials – PREDIMED and CORDIOPREV – examined the effects of the Mediterranean diet on cardiovascular disease prevention. Both showed a decrease in cardiovascular events with the Mediterranean diet, which involves consuming moderate amounts of carbohydrates.

“The Mediterranean dietary pattern has the strongest evidence for benefit, and it’s moderate in carbohydrates,” she concluded.
 

Very-low-carbohydrate eating is best

Dr. Griauzde was a last-minute replacement speaker for William S. Yancy Jr, MD, of Duke University, Durham, N.C., and presented his slides. She argued that consuming a very low carb diet improves glycemia and that it does not increase but possibly lowers cardiovascular risk.

She began by noting that prior to the discovery of insulin very-low-carb diets had been consumed for over a century to prolong life for people with type 1 diabetes.

“We have long recognized the deleterious role of carbohydrate in type 1 diabetes management, and we have increasingly recognized that role in the management of type 2 diabetes,” said Dr. Griauzde of the University of Michigan in Ann Arbor.

In a small study that compared maintaining a very-low-carb diet for 2 weeks with maintaining a high-carb diet for 2 weeks, total glucose areas under the curve were substantially lower (P < .05) during the low-carb phase, while A1c levels dropped from 7.3% to 6.8% (P = .006).

“We don’t see those outcomes with meds,” Dr. Griauzde noted, adding, “A diet very low in carbohydrates is one of the most potent tools we have to help our patients achieve glycemic control.”

Dr. Griauzde said that the carbohydrate-insulin model provides an explanation for why dietary carbohydrates are particularly obesogenic and metabolically harmful. That model contrasts with the energy balance model, which suggests that all calories are equal.

The rationale of the carbohydrate-insulin model is that dietary carbohydrate – either sugar or starch – raises serum glucose and insulin levels. A carbohydrate-restricted diet therefore reduces the dietary contribution to serum glucose, which then results in lower insulin levels. Insulin is a potent stimulator of lipogenesis (fat storage), and it is a potent inhibitor of lipolysis (the burning of fat). By lowering insulin levels, stored body fat is burned, serum ketone levels increase, and body weight is lowered.

This model suggests that, when insulin levels are chronically high because of excess carbohydrate consumption, circulating fuels are lowered, which leads to an increase in hunger and to overeating. This was demonstrated in a study that compared different levels of isocaloric glycemic index diets in 12 teenage boys with overweight or obesity. The higher-carbohydrate meals led to higher glucose and insulin levels and more food consumption.

In a systematic review of 13 trials of restricted-carbohydrate diets (< 45% carbohydrates) for adults with diabetes, the degree of improvement in A1c level correlated with the degree of carbohydrate restriction over 2-26 weeks (P = .013).

And in a network meta-analysis of 56 trials that compared nine diets among a total of 4,937 participants with type 2 diabetes, one conclusion was that “for reducing A1c, the low-carbohydrate diet was ranked as the best dietary approach (SUCRA: 84%), followed by the Mediterranean diet (80%), and Paleolithic diet (76%), compared with a control diet.”

Regarding the criticism that very-low-carbohydrate diets are high in saturated fat and therefore raise the risk of cardiovascular disease, Dr. Griauzde pointed to another meta-analysis of 21 prospective studies with more than 300,000 participants with 5-25 years of follow-up. In that analysis, the intake of saturated fat was not associated with an increased risk of cardiovascular disease or stroke.

Furthermore, a 12-week randomized controlled trial that involved 40 adults with overweight also suggested that a very-low-carb diet may be superior to a low-fat diet in improving aspects of the metabolic syndrome, including body mass index, lipid levels, and insulin sensitivity. Small LDL particles, which are more atherogenic than larger LDL particles, also decreased despite a threefold increase in saturated fat intake.
 

Rebuttals: Overall diet, patient preference matter

During the rebuttals, Dr. Kirkpatrick pointed out that large LDL particles are also atherogenic. In addition, she noted that the studies that showed that saturated fat isn’t associated with cardiovascular disease didn’t consider the macronutrients that replaced the saturated fat.

“It really is about increasing consumption of foods that we know are associated with cardiovascular benefit, including plant-based foods that are high quality and not refined carbohydrates ... and healthy protein sources. ... Hopefully we can step away from just looking at macronutrients and look at the total amount of food that people are choosing to eat.”

Importantly, Dr. Kirkpatrick said, patients need to be asked about their current dietary patterns and preferences. “Interventions should be patient centered and sensitive to cultural differences. Personalized lifestyle interventions increase the likelihood of success.”

Dr. Griauzde pointed out that newer antiobesity drugs can be added to any diet to decrease appetite and enhance adherence.

Dr. Griauzde also observed, “We can label a very-low-carbohydrate diet ‘extreme,’ but maybe, from the patient’s perspective, it’s extreme to take 200 units of insulin a day. If you can give them the opportunity to discontinue use of the insulin by following a very-low-carbohydrate dietary pattern, that is the opportunity that our patients deserve to have.”

But overall, she agreed with Dr. Kirkpatrick about individualizing any dietary approach: “We will never know from any of the trials that have been done or that will be done in the future what diet is best for an individual patient. ... Our job is to help our patients find the dietary approach that works best for them.”

Dr. Kirkpatrick is a clinical scientist with Midwest Biomedical Research, which has received funding from various food and pharmaceutical companies. She has not received any direct funding. Dr. Yancy is a consultant for The Simply Good Foods Co. Dr. Griauzde has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.