Heidi Splete

A higher percentage of family physicians quit during the early months of the pandemic than the average yearly percentage that did in the prior decade, according to data from Canada.

The researchers conducted two analyses of billing claims data for family physicians practicing in Ontario. They examined data for a period from 2010 to 2019 – before the onset of the pandemic – and from 2019 through 2020. The findings were published in Annals of Family Medicine.

Overall, the proportion of family physicians who stopped working rose from an average of 1.6% each year for the period between 2010 and 2019 to 3% in the period from 2019 to 2020. The pandemic data set included 12,247 physicians in Ontario. Of these, 385 (3.1%) reported no billings in the first 6 months of the pandemic.

Compared with family physicians billing for work during the pandemic, those reporting no billings were significantly more likely to be 75 years or older (13.0% vs. 3.4%), to have patient panels of less than 500 patients (40.0% vs. 25.8%), and to be eligible for fee-for-service reimbursement (37.7% vs. 24.9%; P less than .001 for all). The family physicians who reported no billing early in the pandemic also had fewer billing days in the previous year (mean of 73 days vs. 101 days, P less than .001).

In a regression analysis, the absolute increase in the percentage of family physicians who stopped working was 0.3% per year from 2010 to 2019, but rose to 1.2% between 2019 and 2020.

Challenges to family physicians in Ontario in the early months of the COVID-19 pandemic included reduced revenue, inability to keep offices fully staffed, and problems obtaining enough personal protective equipment. Such challenges may have prompted some family physicians to stop working prematurely, but more research is needed in other settings, wrote study author Tara Kiran, MD, of the University of Toronto, and colleagues.

“There were a lot of stories and suggestions that more family physicians were choosing to retire due to COVID,” Michael Green, MD, a coauthor of the paper, said in an interview. “Given the preexisting shortages we thought it would be important to see if this was true, and how big of an issue it was,” he said.

Although the absolute number of primary care physicians who stopped working is small, the implications are large given the ongoing shortage of family physicians in Canada, the researchers wrote.

The characteristics of physicians stopping work, such as older age and smaller practice size, were consistent with that of physicians preparing for retirement, the researchers noted. In addition, 56% of the family physicians who stopped working during the pandemic practiced in a patient enrollment model, in which patients are enrolled and between 15% and 70% of payment is based on age and sex. In this study, approximately 80% of physicians worked in this model. The remaining 20% operated in independent, fee-for-service practices.

“Although we cannot directly attribute causation, we hypothesize that some family physicians accelerated their retirement plans because of the pandemic,” the researchers noted. They proposed that possible reasons include health concerns, increased costs of infection prevention and control, reduced revenue from office visits, and burnout. The current study did not examine these issues.

Additional studies are needed to understand the impact on population health, the researchers concluded, but they estimated that the number of family physicians who stopped work during the pandemic would have provided care for approximately 170,000 patients.

The study findings reflect a genuine turnover by family physicians, vs. a departure from family practice to a fellowship and practice in another specialty, Dr. Green said. “We looked at physician billings to determine who stopped practicing, so we report only on those who stopped billing the Ontario Health Insurance Program altogether,” he explained.

The ongoing pandemic accelerated the issue of an upcoming wave of physician retirements and added to an already large number of people without a family physician, Dr. Green noted.

“We know there will be significant shortages of family physicians if we don’t modernize our ways of delivering primary care,” said Dr. Green. More research is needed on how to support family doctors with teams and administrative supports to allow them to provide high quality care to more patients, he said. Better models to estimate health workforce needs in primary care are needed as well, he added.

In the United States, a physician shortage has been growing since before the pandemic, according to a report published in 2021 by the Association of American Medical Colleges. In this report, “The Complexities of Physician Supply and Demand: Projections from 2019 to 2034,” the authors specifically projected a primary care physician shortage of 17,800 to 48,000 by 2034. This projection is in part based on an increase in the percentage of the U.S. population aged 65 years and older, which will increase the demand for care, according to the authors. The report also confirmed that many U.S. physicians are approaching retirement age and that more than two of five active physicians will be 65 years or older within the next 10 years.

However, the authors of this U.S. report acknowledged that the impact of the pandemic on existing primary care shortages remains unclear.

“There are still many unknowns about the direct short-term and long-term impacts of COVID-19 on the physician workforce, and it may be several years before those impacts are clearly understood,” they said in the executive summary of their report.

Alison N. Huffstetler, MD, a coauthor of a recent report that tried to identify the active primary care workforce in Virginia, said, “We know from other research that there are not enough primary care doctors, right now, to do the work that needs to be done – some citations have noted it would take a primary care doc over 20 hours a day just to provide preventive care.

“As our population continues to age, live longer, and need more complex care management, we must ensure we have an accountable, accessible, and knowledgeable primary care network to care for our communities,” she said.
 

Current state of primary care in Virginia

The study by Dr. Huffstetler, of Virginia Commonwealth University, Richmond, and colleagues was published in Annals of Family Medicine. It used a novel strategy involving the analysis of state all-payer claims data to determine how many physicians were practicing primary care in Virginia.

The researchers used the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD) and identified all Virginia physicians and their specialties through the NPPES between 2015 and 2019. Active physicians were defined as those with at least one claim in the VA-APCD during the study period. They identified 20,976 active physicians in Virginia, 28.1% of whom were classified as primary care. Of these, 52% were family medicine physicians, 18.5% were internal medicine physicians, 16.8% were pediatricians, 11.8% were ob.gyns., and 0.5% were other specialists.

Clinician specialties were identified via specialty codes from the NPPES. Physicians were identified as primary care providers in two ways. The first way was by identifying those who had a National Uniform Claim Committee (NUCC) taxonomy of family medicine. The NUCC identifies a provider’s specialty using several levels of classification based on board certification and subspecialty certification data. The second identifier was having been a physician who had billed for at least 10 wellness visit codes from Jan. 1, 2019, through Dec. 31, 2019.

Over the 5-year study period (2015-2019), the counts and percentages of primary care physicians in the workforce remained stable, and the overall number of physicians in the state increased by 3.5%, the researchers noted. A total of 60.45% of all physicians and 60.87% of primary care physicians remained active, and 11.66% of all physicians had a claim in only 1 of the 5 years.
 

How distribution and access impact patients

In an interview, Dr. Huffstetler said the study she and colleagues authored “offers a transparent and reproducible process for identifying primary care physicians in a state, where they practice, and what changes in staffing occur over time.”

“In Virginia, this is particularly important, as we recently expanded Medicaid, making primary care more affordable for over 500,000 people,” she said. “We also saw the importance of distribution and accessibility to primary care over the past 3 years of COVID. In order to adequately prepare for community needs in the coming years, we must know who is providing primary care, and where they are.”

However, the model used in this study has its limitations, Dr. Huffstetler said, including the lack of a definitive definition of primary care using claims data.

“We used a data-informed wellness visit threshold, but it is likely that primary care is delivered in some locations without claims that are reflected by a wellness visit, and we hope to look at scope in the future to help refine these results,” she said.
 

Canadian study shows pandemic’s impact on patient care

“The pandemic’s impact on primary care remains palpable, and Dr. Kiran’s team has done an excellent analysis on the practice trends during the past several years,” Dr. Huffstetler said.

“The Canadian analysis uses claims in a similar manner to our study; however, it appears that they already knew who the FPs were in Ontario,” Dr. Huffstetler noted. “Their claims threshold of 50 for active practice was higher than ours, at only 1. Should those FPs have moved to a different specialty, the physicians would still have claims for the patients seen in other subspecialties. As such, I don’t suspect that their analysis miscalculated those that transitioned, rather than stopped practice,” she explained.

The Ontario study was supported by the Initial Credential Evaluation Service, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care, as well as by the Canadian Institutes of Health Research. Additional support came from the INSPIRE Primary Health Care Research Program, which is also funded by the Ontario Ministry of Health and Long-Term Care. The researchers had no financial conflicts to disclose.

The Virginia study was supported by the Department of Medical Assistance Services and the National Center for Advancing Translational Sciences. The researchers had no financial conflicts to disclose.

The supply and demand report was conducted for the AAMC by IHS Markit, a global information company.

A higher percentage of family physicians quit during the early months of the pandemic than the average yearly percentage that did in the prior decade, according to data from Canada.

The researchers conducted two analyses of billing claims data for family physicians practicing in Ontario. They examined data for a period from 2010 to 2019 – before the onset of the pandemic – and from 2019 through 2020. The findings were published in Annals of Family Medicine.

Overall, the proportion of family physicians who stopped working rose from an average of 1.6% each year for the period between 2010 and 2019 to 3% in the period from 2019 to 2020. The pandemic data set included 12,247 physicians in Ontario. Of these, 385 (3.1%) reported no billings in the first 6 months of the pandemic.

Compared with family physicians billing for work during the pandemic, those reporting no billings were significantly more likely to be 75 years or older (13.0% vs. 3.4%), to have patient panels of less than 500 patients (40.0% vs. 25.8%), and to be eligible for fee-for-service reimbursement (37.7% vs. 24.9%; P less than .001 for all). The family physicians who reported no billing early in the pandemic also had fewer billing days in the previous year (mean of 73 days vs. 101 days, P less than .001).

In a regression analysis, the absolute increase in the percentage of family physicians who stopped working was 0.3% per year from 2010 to 2019, but rose to 1.2% between 2019 and 2020.

Challenges to family physicians in Ontario in the early months of the COVID-19 pandemic included reduced revenue, inability to keep offices fully staffed, and problems obtaining enough personal protective equipment. Such challenges may have prompted some family physicians to stop working prematurely, but more research is needed in other settings, wrote study author Tara Kiran, MD, of the University of Toronto, and colleagues.

“There were a lot of stories and suggestions that more family physicians were choosing to retire due to COVID,” Michael Green, MD, a coauthor of the paper, said in an interview. “Given the preexisting shortages we thought it would be important to see if this was true, and how big of an issue it was,” he said.

Although the absolute number of primary care physicians who stopped working is small, the implications are large given the ongoing shortage of family physicians in Canada, the researchers wrote.

The characteristics of physicians stopping work, such as older age and smaller practice size, were consistent with that of physicians preparing for retirement, the researchers noted. In addition, 56% of the family physicians who stopped working during the pandemic practiced in a patient enrollment model, in which patients are enrolled and between 15% and 70% of payment is based on age and sex. In this study, approximately 80% of physicians worked in this model. The remaining 20% operated in independent, fee-for-service practices.

“Although we cannot directly attribute causation, we hypothesize that some family physicians accelerated their retirement plans because of the pandemic,” the researchers noted. They proposed that possible reasons include health concerns, increased costs of infection prevention and control, reduced revenue from office visits, and burnout. The current study did not examine these issues.

Additional studies are needed to understand the impact on population health, the researchers concluded, but they estimated that the number of family physicians who stopped work during the pandemic would have provided care for approximately 170,000 patients.

The study findings reflect a genuine turnover by family physicians, vs. a departure from family practice to a fellowship and practice in another specialty, Dr. Green said. “We looked at physician billings to determine who stopped practicing, so we report only on those who stopped billing the Ontario Health Insurance Program altogether,” he explained.

The ongoing pandemic accelerated the issue of an upcoming wave of physician retirements and added to an already large number of people without a family physician, Dr. Green noted.

“We know there will be significant shortages of family physicians if we don’t modernize our ways of delivering primary care,” said Dr. Green. More research is needed on how to support family doctors with teams and administrative supports to allow them to provide high quality care to more patients, he said. Better models to estimate health workforce needs in primary care are needed as well, he added.

In the United States, a physician shortage has been growing since before the pandemic, according to a report published in 2021 by the Association of American Medical Colleges. In this report, “The Complexities of Physician Supply and Demand: Projections from 2019 to 2034,” the authors specifically projected a primary care physician shortage of 17,800 to 48,000 by 2034. This projection is in part based on an increase in the percentage of the U.S. population aged 65 years and older, which will increase the demand for care, according to the authors. The report also confirmed that many U.S. physicians are approaching retirement age and that more than two of five active physicians will be 65 years or older within the next 10 years.

However, the authors of this U.S. report acknowledged that the impact of the pandemic on existing primary care shortages remains unclear.

“There are still many unknowns about the direct short-term and long-term impacts of COVID-19 on the physician workforce, and it may be several years before those impacts are clearly understood,” they said in the executive summary of their report.

Alison N. Huffstetler, MD, a coauthor of a recent report that tried to identify the active primary care workforce in Virginia, said, “We know from other research that there are not enough primary care doctors, right now, to do the work that needs to be done – some citations have noted it would take a primary care doc over 20 hours a day just to provide preventive care.

“As our population continues to age, live longer, and need more complex care management, we must ensure we have an accountable, accessible, and knowledgeable primary care network to care for our communities,” she said.
 

Current state of primary care in Virginia

The study by Dr. Huffstetler, of Virginia Commonwealth University, Richmond, and colleagues was published in Annals of Family Medicine. It used a novel strategy involving the analysis of state all-payer claims data to determine how many physicians were practicing primary care in Virginia.

The researchers used the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD) and identified all Virginia physicians and their specialties through the NPPES between 2015 and 2019. Active physicians were defined as those with at least one claim in the VA-APCD during the study period. They identified 20,976 active physicians in Virginia, 28.1% of whom were classified as primary care. Of these, 52% were family medicine physicians, 18.5% were internal medicine physicians, 16.8% were pediatricians, 11.8% were ob.gyns., and 0.5% were other specialists.

Clinician specialties were identified via specialty codes from the NPPES. Physicians were identified as primary care providers in two ways. The first way was by identifying those who had a National Uniform Claim Committee (NUCC) taxonomy of family medicine. The NUCC identifies a provider’s specialty using several levels of classification based on board certification and subspecialty certification data. The second identifier was having been a physician who had billed for at least 10 wellness visit codes from Jan. 1, 2019, through Dec. 31, 2019.

Over the 5-year study period (2015-2019), the counts and percentages of primary care physicians in the workforce remained stable, and the overall number of physicians in the state increased by 3.5%, the researchers noted. A total of 60.45% of all physicians and 60.87% of primary care physicians remained active, and 11.66% of all physicians had a claim in only 1 of the 5 years.
 

How distribution and access impact patients

In an interview, Dr. Huffstetler said the study she and colleagues authored “offers a transparent and reproducible process for identifying primary care physicians in a state, where they practice, and what changes in staffing occur over time.”

“In Virginia, this is particularly important, as we recently expanded Medicaid, making primary care more affordable for over 500,000 people,” she said. “We also saw the importance of distribution and accessibility to primary care over the past 3 years of COVID. In order to adequately prepare for community needs in the coming years, we must know who is providing primary care, and where they are.”

However, the model used in this study has its limitations, Dr. Huffstetler said, including the lack of a definitive definition of primary care using claims data.

“We used a data-informed wellness visit threshold, but it is likely that primary care is delivered in some locations without claims that are reflected by a wellness visit, and we hope to look at scope in the future to help refine these results,” she said.
 

Canadian study shows pandemic’s impact on patient care

“The pandemic’s impact on primary care remains palpable, and Dr. Kiran’s team has done an excellent analysis on the practice trends during the past several years,” Dr. Huffstetler said.

“The Canadian analysis uses claims in a similar manner to our study; however, it appears that they already knew who the FPs were in Ontario,” Dr. Huffstetler noted. “Their claims threshold of 50 for active practice was higher than ours, at only 1. Should those FPs have moved to a different specialty, the physicians would still have claims for the patients seen in other subspecialties. As such, I don’t suspect that their analysis miscalculated those that transitioned, rather than stopped practice,” she explained.

The Ontario study was supported by the Initial Credential Evaluation Service, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care, as well as by the Canadian Institutes of Health Research. Additional support came from the INSPIRE Primary Health Care Research Program, which is also funded by the Ontario Ministry of Health and Long-Term Care. The researchers had no financial conflicts to disclose.

The Virginia study was supported by the Department of Medical Assistance Services and the National Center for Advancing Translational Sciences. The researchers had no financial conflicts to disclose.

The supply and demand report was conducted for the AAMC by IHS Markit, a global information company.

A higher percentage of family physicians quit during the early months of the pandemic than the average yearly percentage that did in the prior decade, according to data from Canada.

The researchers conducted two analyses of billing claims data for family physicians practicing in Ontario. They examined data for a period from 2010 to 2019 – before the onset of the pandemic – and from 2019 through 2020. The findings were published in Annals of Family Medicine.

Overall, the proportion of family physicians who stopped working rose from an average of 1.6% each year for the period between 2010 and 2019 to 3% in the period from 2019 to 2020. The pandemic data set included 12,247 physicians in Ontario. Of these, 385 (3.1%) reported no billings in the first 6 months of the pandemic.

Compared with family physicians billing for work during the pandemic, those reporting no billings were significantly more likely to be 75 years or older (13.0% vs. 3.4%), to have patient panels of less than 500 patients (40.0% vs. 25.8%), and to be eligible for fee-for-service reimbursement (37.7% vs. 24.9%; P less than .001 for all). The family physicians who reported no billing early in the pandemic also had fewer billing days in the previous year (mean of 73 days vs. 101 days, P less than .001).

In a regression analysis, the absolute increase in the percentage of family physicians who stopped working was 0.3% per year from 2010 to 2019, but rose to 1.2% between 2019 and 2020.

Challenges to family physicians in Ontario in the early months of the COVID-19 pandemic included reduced revenue, inability to keep offices fully staffed, and problems obtaining enough personal protective equipment. Such challenges may have prompted some family physicians to stop working prematurely, but more research is needed in other settings, wrote study author Tara Kiran, MD, of the University of Toronto, and colleagues.

“There were a lot of stories and suggestions that more family physicians were choosing to retire due to COVID,” Michael Green, MD, a coauthor of the paper, said in an interview. “Given the preexisting shortages we thought it would be important to see if this was true, and how big of an issue it was,” he said.

Although the absolute number of primary care physicians who stopped working is small, the implications are large given the ongoing shortage of family physicians in Canada, the researchers wrote.

The characteristics of physicians stopping work, such as older age and smaller practice size, were consistent with that of physicians preparing for retirement, the researchers noted. In addition, 56% of the family physicians who stopped working during the pandemic practiced in a patient enrollment model, in which patients are enrolled and between 15% and 70% of payment is based on age and sex. In this study, approximately 80% of physicians worked in this model. The remaining 20% operated in independent, fee-for-service practices.

“Although we cannot directly attribute causation, we hypothesize that some family physicians accelerated their retirement plans because of the pandemic,” the researchers noted. They proposed that possible reasons include health concerns, increased costs of infection prevention and control, reduced revenue from office visits, and burnout. The current study did not examine these issues.

Additional studies are needed to understand the impact on population health, the researchers concluded, but they estimated that the number of family physicians who stopped work during the pandemic would have provided care for approximately 170,000 patients.

The study findings reflect a genuine turnover by family physicians, vs. a departure from family practice to a fellowship and practice in another specialty, Dr. Green said. “We looked at physician billings to determine who stopped practicing, so we report only on those who stopped billing the Ontario Health Insurance Program altogether,” he explained.

The ongoing pandemic accelerated the issue of an upcoming wave of physician retirements and added to an already large number of people without a family physician, Dr. Green noted.

“We know there will be significant shortages of family physicians if we don’t modernize our ways of delivering primary care,” said Dr. Green. More research is needed on how to support family doctors with teams and administrative supports to allow them to provide high quality care to more patients, he said. Better models to estimate health workforce needs in primary care are needed as well, he added.

In the United States, a physician shortage has been growing since before the pandemic, according to a report published in 2021 by the Association of American Medical Colleges. In this report, “The Complexities of Physician Supply and Demand: Projections from 2019 to 2034,” the authors specifically projected a primary care physician shortage of 17,800 to 48,000 by 2034. This projection is in part based on an increase in the percentage of the U.S. population aged 65 years and older, which will increase the demand for care, according to the authors. The report also confirmed that many U.S. physicians are approaching retirement age and that more than two of five active physicians will be 65 years or older within the next 10 years.

However, the authors of this U.S. report acknowledged that the impact of the pandemic on existing primary care shortages remains unclear.

“There are still many unknowns about the direct short-term and long-term impacts of COVID-19 on the physician workforce, and it may be several years before those impacts are clearly understood,” they said in the executive summary of their report.

Alison N. Huffstetler, MD, a coauthor of a recent report that tried to identify the active primary care workforce in Virginia, said, “We know from other research that there are not enough primary care doctors, right now, to do the work that needs to be done – some citations have noted it would take a primary care doc over 20 hours a day just to provide preventive care.

“As our population continues to age, live longer, and need more complex care management, we must ensure we have an accountable, accessible, and knowledgeable primary care network to care for our communities,” she said.
 

Current state of primary care in Virginia

The study by Dr. Huffstetler, of Virginia Commonwealth University, Richmond, and colleagues was published in Annals of Family Medicine. It used a novel strategy involving the analysis of state all-payer claims data to determine how many physicians were practicing primary care in Virginia.

The researchers used the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD) and identified all Virginia physicians and their specialties through the NPPES between 2015 and 2019. Active physicians were defined as those with at least one claim in the VA-APCD during the study period. They identified 20,976 active physicians in Virginia, 28.1% of whom were classified as primary care. Of these, 52% were family medicine physicians, 18.5% were internal medicine physicians, 16.8% were pediatricians, 11.8% were ob.gyns., and 0.5% were other specialists.

Clinician specialties were identified via specialty codes from the NPPES. Physicians were identified as primary care providers in two ways. The first way was by identifying those who had a National Uniform Claim Committee (NUCC) taxonomy of family medicine. The NUCC identifies a provider’s specialty using several levels of classification based on board certification and subspecialty certification data. The second identifier was having been a physician who had billed for at least 10 wellness visit codes from Jan. 1, 2019, through Dec. 31, 2019.

Over the 5-year study period (2015-2019), the counts and percentages of primary care physicians in the workforce remained stable, and the overall number of physicians in the state increased by 3.5%, the researchers noted. A total of 60.45% of all physicians and 60.87% of primary care physicians remained active, and 11.66% of all physicians had a claim in only 1 of the 5 years.
 

How distribution and access impact patients

In an interview, Dr. Huffstetler said the study she and colleagues authored “offers a transparent and reproducible process for identifying primary care physicians in a state, where they practice, and what changes in staffing occur over time.”

“In Virginia, this is particularly important, as we recently expanded Medicaid, making primary care more affordable for over 500,000 people,” she said. “We also saw the importance of distribution and accessibility to primary care over the past 3 years of COVID. In order to adequately prepare for community needs in the coming years, we must know who is providing primary care, and where they are.”

However, the model used in this study has its limitations, Dr. Huffstetler said, including the lack of a definitive definition of primary care using claims data.

“We used a data-informed wellness visit threshold, but it is likely that primary care is delivered in some locations without claims that are reflected by a wellness visit, and we hope to look at scope in the future to help refine these results,” she said.
 

Canadian study shows pandemic’s impact on patient care

“The pandemic’s impact on primary care remains palpable, and Dr. Kiran’s team has done an excellent analysis on the practice trends during the past several years,” Dr. Huffstetler said.

“The Canadian analysis uses claims in a similar manner to our study; however, it appears that they already knew who the FPs were in Ontario,” Dr. Huffstetler noted. “Their claims threshold of 50 for active practice was higher than ours, at only 1. Should those FPs have moved to a different specialty, the physicians would still have claims for the patients seen in other subspecialties. As such, I don’t suspect that their analysis miscalculated those that transitioned, rather than stopped practice,” she explained.

The Ontario study was supported by the Initial Credential Evaluation Service, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care, as well as by the Canadian Institutes of Health Research. Additional support came from the INSPIRE Primary Health Care Research Program, which is also funded by the Ontario Ministry of Health and Long-Term Care. The researchers had no financial conflicts to disclose.

The Virginia study was supported by the Department of Medical Assistance Services and the National Center for Advancing Translational Sciences. The researchers had no financial conflicts to disclose.

The supply and demand report was conducted for the AAMC by IHS Markit, a global information company.

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

Prompt diagnosis of idiopathic pulmonary fibrosis is essential to reduce mortality, and improving education of primary care providers can help, suggests a new white paper.

The nonspecific nature of the symptoms of idiopathic pulmonary fibrosis (IPF) especially in early stages, and the relative rarity of IPF compared with other conditions that have similar symptoms, may contribute to a delay in diagnosis in the primary care setting, wrote Daniel F. Dilling, MD, of Loyola University Chicago, Maywood, Ill., and colleagues in Chest: Clinical Perspectives (Dilling et al. State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis. Chest. 2022).

“We have learned over and over again through research, and also through talking with our own patients with IPF, that there is often a long lag between the first signs of the disease and a diagnosis of IPF,” corresponding author Dr. Dilling said in an interview.

“Even some pulmonary specialists can be uncertain about how to approach the diagnosis when a CT scan or other test first suggests the possibility; this can cost a patient precious time, as being on drug therapy earlier can result in preservation of lung function,” he said. “By sounding the alarm bell with this paper, we hope to promote awareness and education/training within the primary care community as well as the pulmonary community, and also to make all of them aware of the possibility of referral to specialty ILD [interstitial lung disease] centers when desired and possible,” he added.  

The researchers conducted a pair of online surveys to inform the development of improving education on IPF among primary care providers.

In the white paper, which can be accessed online, the authors reported results of the surveys. One included 100 general pulmonologists and the other included 306 primary care physicians (156 practiced family physicians and 150 practiced general internal medicine). The data were collected between April 11, 2022, and May 16, 2022. Participants were asked to respond to a patient case scenario of a 55-year-old woman with nonspecific symptoms such as shortness of breath on moderate exertion, cough, exhaustion, and trouble sleeping.

The PCPs were most likely to evaluate the patient for a cardiac condition (46%), 25% would evaluate for chronic obstructive pulmonary disease (COPD), and 23% for asthma. More than half (58%) ranked progressive fibrosing ILD as one of their bottom two diagnoses.

A total of 87% of PCPs said they would begin a diagnostic workup to evaluate symptoms if the patient had no preexisting respiratory disease, compared with 61% for patients with a respiratory diagnosis.

Although 93% of PCPs cited a chest x-ray as part of the initial patient workup, fewer than half said they would order an echocardiogram, spirometry, or pulmonary function test (PFT), and 11% said they would include diffusion capacity testing in the initial workup.

In addition, PCPs were less likely to ask patients about issues that might prompt an IPF diagnosis, such as exposures to agents through work, hobbies, the environment, or comorbidities.

In the pulmonology survey, more than 75% of respondents cited patient history, high-resolution tomography scan, serologic testing, and review for autoimmune disease symptoms as first steps in a diagnostic response to patients with suspected IPF.
 

Differences between PCPs’ and pulmonolgists’ responses

Both PCPs and pulmonologists responded to several questions to assess knowledge and opinion gaps related to IPF. Overall, pulmonologists were more likely than PCPs to cite both imaging and testing issues and waiting 6-8 weeks after symptom onset before imaging as contributing factors to diagnostic delays.

PCPs more often expressed beliefs that delayed diagnosis had little impact on a patient with IPF, and that the treatments may be worse than the disease.

Dr. Dilling said he was not surprised by the survey findings, as similar clues about the underdiagnosis of IPF have surfaced in prior studies.

“We need to get the word out to primary care physicians, to pulmonary physicians, and even to the public, that idiopathic pulmonary fibrosis and other forms of interstitial lung disease are out there and prevalent, and that making the right diagnosis in a timely way can lead to better outcomes for patients,” he said.

The take-home message for primary care is to think outside the COPD box, said Dr. Dilling. “Just because someone has shortness of breath or cough and used to smoke does not automatically mean that they have COPD,” he emphasized. “Listen carefully for crackles (rales) on exam. Get spirometry or PFTs before you secure the diagnosis of COPD, or else you will be missing all of your cases of pulmonary fibrosis; think of pulmonary fibrosis and use imaging to help guide your diagnosis,” he said.

The authors suggested several education goals for PCPs, including establishing the importance of early evaluation, outlining the correct approach to a patient workup, encouraging prompt referral, and empowering PCPs as part of the team approach to IPF patients’ care. For pulmonologists, only 11% of those surveyed said they were aware of the latest developments in antifibrotic research, and education efforts might include information about drug pipelines and clinical trials, as well as technology.

Looking ahead, “We need to better understand how to find the pulmonary fibrosis in the community,” Dr. Dilling said. This understanding may come in part from greater education and awareness, he noted. However, eventually there may be ways to enhance the reading of PFTs and of CT scans through artificial intelligence technologies that would not only prompt clinicians to recognize what they are seeing, but would prompt them to refer and send the patient on the correct diagnostic path as soon as possible, he added.
 

Key message: Include ILD in differential diagnosis of patients with shortness of breath and/or cough

Advances in diagnostics and therapies for interstitial lung disease can take time to be absorbed and adopted, and patients with ILD and pulmonologists caring for ILD, specifically IPF, continue to report delays in diagnosis and therapy, said Krishna Thavarajah, MD, a pulmonologist at Henry Ford Hospital, Detroit, Mich., in an interview.

The current study findings of the time to diagnosis and the approach to patient workups echo her own clinical experience, Dr. Thavarajah said. “There is a delay in IPF diagnosis as physicians look to more common diagnoses, such as cardiac disease or chronic obstructive pulmonary disease, prior to pursuit of additional workup, and the attitude toward treatment has, in some ways, lagged behind advances in therapy, including timing and feasibility of therapy for IPF,” she said.

The key message for primary care physicians is to include ILD in the differential diagnosis of patients with shortness of breath and/or cough, especially if the initial cardiac and pulmonary test (meaning at least a chest x-ray and pulmonary function tests, including a diffusion capacity) are not pointing to an alternative cause within 3 months of presentation, Dr. Thavarajah said.

Once IPF is diagnosed, primary care clinicians should know that there are FDA-approved therapies that improve survival, said Dr. Thavarajah. “There are identifiable and treatable comorbid conditions,” she added. “The statement of ‘time lost is lung lost’ sums up the care of an IPF patient; partnerships between primary care clinicians, pulmonologists, and referral centers can provide the patient multiple levels of support with quality-of-life interventions, treatments, and also clinical trials, delivered by a team of providers,” she said. 
In the wake of the current study, more research is needed with outcome studies regarding educational interventions targeting primary care and pulmonologists on appropriate workup, timing of workup, and current therapy for IPF patients, she added.

The white paper received no outside funding. The authors and Dr. Thavarajah had no financial conflicts to disclose.
 

Prompt diagnosis of idiopathic pulmonary fibrosis is essential to reduce mortality, and improving education of primary care providers can help, suggests a new white paper.

The nonspecific nature of the symptoms of idiopathic pulmonary fibrosis (IPF) especially in early stages, and the relative rarity of IPF compared with other conditions that have similar symptoms, may contribute to a delay in diagnosis in the primary care setting, wrote Daniel F. Dilling, MD, of Loyola University Chicago, Maywood, Ill., and colleagues in Chest: Clinical Perspectives (Dilling et al. State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis. Chest. 2022).

“We have learned over and over again through research, and also through talking with our own patients with IPF, that there is often a long lag between the first signs of the disease and a diagnosis of IPF,” corresponding author Dr. Dilling said in an interview.

“Even some pulmonary specialists can be uncertain about how to approach the diagnosis when a CT scan or other test first suggests the possibility; this can cost a patient precious time, as being on drug therapy earlier can result in preservation of lung function,” he said. “By sounding the alarm bell with this paper, we hope to promote awareness and education/training within the primary care community as well as the pulmonary community, and also to make all of them aware of the possibility of referral to specialty ILD [interstitial lung disease] centers when desired and possible,” he added.  

The researchers conducted a pair of online surveys to inform the development of improving education on IPF among primary care providers.

In the white paper, which can be accessed online, the authors reported results of the surveys. One included 100 general pulmonologists and the other included 306 primary care physicians (156 practiced family physicians and 150 practiced general internal medicine). The data were collected between April 11, 2022, and May 16, 2022. Participants were asked to respond to a patient case scenario of a 55-year-old woman with nonspecific symptoms such as shortness of breath on moderate exertion, cough, exhaustion, and trouble sleeping.

The PCPs were most likely to evaluate the patient for a cardiac condition (46%), 25% would evaluate for chronic obstructive pulmonary disease (COPD), and 23% for asthma. More than half (58%) ranked progressive fibrosing ILD as one of their bottom two diagnoses.

A total of 87% of PCPs said they would begin a diagnostic workup to evaluate symptoms if the patient had no preexisting respiratory disease, compared with 61% for patients with a respiratory diagnosis.

Although 93% of PCPs cited a chest x-ray as part of the initial patient workup, fewer than half said they would order an echocardiogram, spirometry, or pulmonary function test (PFT), and 11% said they would include diffusion capacity testing in the initial workup.

In addition, PCPs were less likely to ask patients about issues that might prompt an IPF diagnosis, such as exposures to agents through work, hobbies, the environment, or comorbidities.

In the pulmonology survey, more than 75% of respondents cited patient history, high-resolution tomography scan, serologic testing, and review for autoimmune disease symptoms as first steps in a diagnostic response to patients with suspected IPF.
 

Differences between PCPs’ and pulmonolgists’ responses

Both PCPs and pulmonologists responded to several questions to assess knowledge and opinion gaps related to IPF. Overall, pulmonologists were more likely than PCPs to cite both imaging and testing issues and waiting 6-8 weeks after symptom onset before imaging as contributing factors to diagnostic delays.

PCPs more often expressed beliefs that delayed diagnosis had little impact on a patient with IPF, and that the treatments may be worse than the disease.

Dr. Dilling said he was not surprised by the survey findings, as similar clues about the underdiagnosis of IPF have surfaced in prior studies.

“We need to get the word out to primary care physicians, to pulmonary physicians, and even to the public, that idiopathic pulmonary fibrosis and other forms of interstitial lung disease are out there and prevalent, and that making the right diagnosis in a timely way can lead to better outcomes for patients,” he said.

The take-home message for primary care is to think outside the COPD box, said Dr. Dilling. “Just because someone has shortness of breath or cough and used to smoke does not automatically mean that they have COPD,” he emphasized. “Listen carefully for crackles (rales) on exam. Get spirometry or PFTs before you secure the diagnosis of COPD, or else you will be missing all of your cases of pulmonary fibrosis; think of pulmonary fibrosis and use imaging to help guide your diagnosis,” he said.

The authors suggested several education goals for PCPs, including establishing the importance of early evaluation, outlining the correct approach to a patient workup, encouraging prompt referral, and empowering PCPs as part of the team approach to IPF patients’ care. For pulmonologists, only 11% of those surveyed said they were aware of the latest developments in antifibrotic research, and education efforts might include information about drug pipelines and clinical trials, as well as technology.

Looking ahead, “We need to better understand how to find the pulmonary fibrosis in the community,” Dr. Dilling said. This understanding may come in part from greater education and awareness, he noted. However, eventually there may be ways to enhance the reading of PFTs and of CT scans through artificial intelligence technologies that would not only prompt clinicians to recognize what they are seeing, but would prompt them to refer and send the patient on the correct diagnostic path as soon as possible, he added.
 

Key message: Include ILD in differential diagnosis of patients with shortness of breath and/or cough

Advances in diagnostics and therapies for interstitial lung disease can take time to be absorbed and adopted, and patients with ILD and pulmonologists caring for ILD, specifically IPF, continue to report delays in diagnosis and therapy, said Krishna Thavarajah, MD, a pulmonologist at Henry Ford Hospital, Detroit, Mich., in an interview.

The current study findings of the time to diagnosis and the approach to patient workups echo her own clinical experience, Dr. Thavarajah said. “There is a delay in IPF diagnosis as physicians look to more common diagnoses, such as cardiac disease or chronic obstructive pulmonary disease, prior to pursuit of additional workup, and the attitude toward treatment has, in some ways, lagged behind advances in therapy, including timing and feasibility of therapy for IPF,” she said.

The key message for primary care physicians is to include ILD in the differential diagnosis of patients with shortness of breath and/or cough, especially if the initial cardiac and pulmonary test (meaning at least a chest x-ray and pulmonary function tests, including a diffusion capacity) are not pointing to an alternative cause within 3 months of presentation, Dr. Thavarajah said.

Once IPF is diagnosed, primary care clinicians should know that there are FDA-approved therapies that improve survival, said Dr. Thavarajah. “There are identifiable and treatable comorbid conditions,” she added. “The statement of ‘time lost is lung lost’ sums up the care of an IPF patient; partnerships between primary care clinicians, pulmonologists, and referral centers can provide the patient multiple levels of support with quality-of-life interventions, treatments, and also clinical trials, delivered by a team of providers,” she said. 
In the wake of the current study, more research is needed with outcome studies regarding educational interventions targeting primary care and pulmonologists on appropriate workup, timing of workup, and current therapy for IPF patients, she added.

The white paper received no outside funding. The authors and Dr. Thavarajah had no financial conflicts to disclose.
 

Prompt diagnosis of idiopathic pulmonary fibrosis is essential to reduce mortality, and improving education of primary care providers can help, suggests a new white paper.

The nonspecific nature of the symptoms of idiopathic pulmonary fibrosis (IPF) especially in early stages, and the relative rarity of IPF compared with other conditions that have similar symptoms, may contribute to a delay in diagnosis in the primary care setting, wrote Daniel F. Dilling, MD, of Loyola University Chicago, Maywood, Ill., and colleagues in Chest: Clinical Perspectives (Dilling et al. State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis. Chest. 2022).

“We have learned over and over again through research, and also through talking with our own patients with IPF, that there is often a long lag between the first signs of the disease and a diagnosis of IPF,” corresponding author Dr. Dilling said in an interview.

“Even some pulmonary specialists can be uncertain about how to approach the diagnosis when a CT scan or other test first suggests the possibility; this can cost a patient precious time, as being on drug therapy earlier can result in preservation of lung function,” he said. “By sounding the alarm bell with this paper, we hope to promote awareness and education/training within the primary care community as well as the pulmonary community, and also to make all of them aware of the possibility of referral to specialty ILD [interstitial lung disease] centers when desired and possible,” he added.  

The researchers conducted a pair of online surveys to inform the development of improving education on IPF among primary care providers.

In the white paper, which can be accessed online, the authors reported results of the surveys. One included 100 general pulmonologists and the other included 306 primary care physicians (156 practiced family physicians and 150 practiced general internal medicine). The data were collected between April 11, 2022, and May 16, 2022. Participants were asked to respond to a patient case scenario of a 55-year-old woman with nonspecific symptoms such as shortness of breath on moderate exertion, cough, exhaustion, and trouble sleeping.

The PCPs were most likely to evaluate the patient for a cardiac condition (46%), 25% would evaluate for chronic obstructive pulmonary disease (COPD), and 23% for asthma. More than half (58%) ranked progressive fibrosing ILD as one of their bottom two diagnoses.

A total of 87% of PCPs said they would begin a diagnostic workup to evaluate symptoms if the patient had no preexisting respiratory disease, compared with 61% for patients with a respiratory diagnosis.

Although 93% of PCPs cited a chest x-ray as part of the initial patient workup, fewer than half said they would order an echocardiogram, spirometry, or pulmonary function test (PFT), and 11% said they would include diffusion capacity testing in the initial workup.

In addition, PCPs were less likely to ask patients about issues that might prompt an IPF diagnosis, such as exposures to agents through work, hobbies, the environment, or comorbidities.

In the pulmonology survey, more than 75% of respondents cited patient history, high-resolution tomography scan, serologic testing, and review for autoimmune disease symptoms as first steps in a diagnostic response to patients with suspected IPF.
 

Differences between PCPs’ and pulmonolgists’ responses

Both PCPs and pulmonologists responded to several questions to assess knowledge and opinion gaps related to IPF. Overall, pulmonologists were more likely than PCPs to cite both imaging and testing issues and waiting 6-8 weeks after symptom onset before imaging as contributing factors to diagnostic delays.

PCPs more often expressed beliefs that delayed diagnosis had little impact on a patient with IPF, and that the treatments may be worse than the disease.

Dr. Dilling said he was not surprised by the survey findings, as similar clues about the underdiagnosis of IPF have surfaced in prior studies.

“We need to get the word out to primary care physicians, to pulmonary physicians, and even to the public, that idiopathic pulmonary fibrosis and other forms of interstitial lung disease are out there and prevalent, and that making the right diagnosis in a timely way can lead to better outcomes for patients,” he said.

The take-home message for primary care is to think outside the COPD box, said Dr. Dilling. “Just because someone has shortness of breath or cough and used to smoke does not automatically mean that they have COPD,” he emphasized. “Listen carefully for crackles (rales) on exam. Get spirometry or PFTs before you secure the diagnosis of COPD, or else you will be missing all of your cases of pulmonary fibrosis; think of pulmonary fibrosis and use imaging to help guide your diagnosis,” he said.

The authors suggested several education goals for PCPs, including establishing the importance of early evaluation, outlining the correct approach to a patient workup, encouraging prompt referral, and empowering PCPs as part of the team approach to IPF patients’ care. For pulmonologists, only 11% of those surveyed said they were aware of the latest developments in antifibrotic research, and education efforts might include information about drug pipelines and clinical trials, as well as technology.

Looking ahead, “We need to better understand how to find the pulmonary fibrosis in the community,” Dr. Dilling said. This understanding may come in part from greater education and awareness, he noted. However, eventually there may be ways to enhance the reading of PFTs and of CT scans through artificial intelligence technologies that would not only prompt clinicians to recognize what they are seeing, but would prompt them to refer and send the patient on the correct diagnostic path as soon as possible, he added.
 

Key message: Include ILD in differential diagnosis of patients with shortness of breath and/or cough

Advances in diagnostics and therapies for interstitial lung disease can take time to be absorbed and adopted, and patients with ILD and pulmonologists caring for ILD, specifically IPF, continue to report delays in diagnosis and therapy, said Krishna Thavarajah, MD, a pulmonologist at Henry Ford Hospital, Detroit, Mich., in an interview.

The current study findings of the time to diagnosis and the approach to patient workups echo her own clinical experience, Dr. Thavarajah said. “There is a delay in IPF diagnosis as physicians look to more common diagnoses, such as cardiac disease or chronic obstructive pulmonary disease, prior to pursuit of additional workup, and the attitude toward treatment has, in some ways, lagged behind advances in therapy, including timing and feasibility of therapy for IPF,” she said.

The key message for primary care physicians is to include ILD in the differential diagnosis of patients with shortness of breath and/or cough, especially if the initial cardiac and pulmonary test (meaning at least a chest x-ray and pulmonary function tests, including a diffusion capacity) are not pointing to an alternative cause within 3 months of presentation, Dr. Thavarajah said.

Once IPF is diagnosed, primary care clinicians should know that there are FDA-approved therapies that improve survival, said Dr. Thavarajah. “There are identifiable and treatable comorbid conditions,” she added. “The statement of ‘time lost is lung lost’ sums up the care of an IPF patient; partnerships between primary care clinicians, pulmonologists, and referral centers can provide the patient multiple levels of support with quality-of-life interventions, treatments, and also clinical trials, delivered by a team of providers,” she said. 
In the wake of the current study, more research is needed with outcome studies regarding educational interventions targeting primary care and pulmonologists on appropriate workup, timing of workup, and current therapy for IPF patients, she added.

The white paper received no outside funding. The authors and Dr. Thavarajah had no financial conflicts to disclose.
 

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.

Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.

Catalin205/Thinkstock

In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.

Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.

Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.

The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.

All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.

Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.

“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.

The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.

“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.

The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.

The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.

The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.

Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.

Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.

Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.

In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.

Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, their use was associated with a significant reduction in the need for mechanical ventilation (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).

Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).

“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.

The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.

Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.

Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.

In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.

Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, their use was associated with a significant reduction in the need for mechanical ventilation (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).

Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).

“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.

The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.

Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.

Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.

In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.

Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, their use was associated with a significant reduction in the need for mechanical ventilation (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).

Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).

“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.

The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Adults with asthma who received mindfulness training showed significant improvement in symptoms compared to those who did not receive such training, based on data from 73 individuals.

Although previous research shows the contribution of psychological factors to poor asthma control and exacerbations, the ability of mindfulness-based stress reduction (MBSR) to improve asthma symptoms in particular has not been well studied, wrote Estelle T. Higgins, BA, of the University of Wisconsin, Madison, and colleagues.

“Though the focus of mindfulness training is not symptom reduction, this is frequently the result in populations with chronic medical illness,” they wrote. The researchers hypothesized that MBSR training would reduce the effect of psychological distress on asthma control and inflammation compared to asthma patients in a waitlist control group.

In a study published in Brain, Behavior, & Immunity – Health, the researchers randomized 38 adults with asthma to a program of MBSR and 24 to a waitlist. The participants ranged in age from 18 to 65 years, with a mean of 38.1 years, and 43 were female. All patients had an asthma diagnosis for at least 6 months; airway inflammation was based on measures of fraction of exhaled nitric oxide (FeNO) ≥ 30 ppb, 138 blood eosinophil count ≥ 150 cells/mcL, or percent sputum eosinophils ≥ 2% of total leukocytes. Individuals with ongoing medical conditions other than asthma were excluded.

The MBSR group had seven clinical data collection visits at approximately 1-month intervals. MBSR training sessions occurred within classes offered to the community over a period of 8 weekly sessions and one 6-hour retreat, and included breath-focused attention, body scan, and mindful awareness in seated positions, walking, and yoga. Participants completed questionnaires about mindfulness, distress, depression, and anxiety symptoms. These were assessed at baseline, post intervention, and at study completion. Chronic stress level was determined at baseline only.

The primary outcome was asthma control based on the Asthma Control Questionnaire 6-item version (ACQ6) Minimally Important Difference.

Overall, asthma control improved significantly among those randomized to MBSR compared to waitlisted controls (P = .01) and this difference persisted at 4 months after the intervention.

Nearly one-third (32%) of the MBSR participants met the criteria for clinically significant improvement in asthma symptoms, compared to 12% of those on the wait list.

In addition, MBSR-related improvement in asthma control was significantly associated with a reduced distress (P = .043), and was especially effective for individuals with the highest levels of depressive symptoms at baseline, the researchers noted. Individuals who received MBSR also showed significantly reduced levels of exhaled nitric oxide compared to waitlist controls (P < .05).

The study findings were limited by the lack of an active control group, the researchers noted. “Though a wait-list control group was employed to control for variation in outcome measures over time, it is possible that effects reported here were driven by factors that are not specific to training in mindfulness, such as social support or expectancy effects,” they wrote. However, the results support the value of mindfulness in reducing psychological stress, FeNO, and impairments related to asthma that were sustained over time, they said. The results also support the potential of MBSR to both augment and reduce the need for pharmacological treatment in asthma, and mindfulness may be an effective way to improve overall disease control by reducing the contribution of psychological factors to asthma morbidity, they concluded.

The study was supported by the National Center for Complementary and Integrative Health. Coauthor Richard J. Davidson, MD, is the founder and president, and serves on the board of directors for the nonprofit organization, Healthy Minds Innovations Inc. The researchers had no financial conflicts to disclose.

Adults with asthma who received mindfulness training showed significant improvement in symptoms compared to those who did not receive such training, based on data from 73 individuals.

Although previous research shows the contribution of psychological factors to poor asthma control and exacerbations, the ability of mindfulness-based stress reduction (MBSR) to improve asthma symptoms in particular has not been well studied, wrote Estelle T. Higgins, BA, of the University of Wisconsin, Madison, and colleagues.

“Though the focus of mindfulness training is not symptom reduction, this is frequently the result in populations with chronic medical illness,” they wrote. The researchers hypothesized that MBSR training would reduce the effect of psychological distress on asthma control and inflammation compared to asthma patients in a waitlist control group.

In a study published in Brain, Behavior, & Immunity – Health, the researchers randomized 38 adults with asthma to a program of MBSR and 24 to a waitlist. The participants ranged in age from 18 to 65 years, with a mean of 38.1 years, and 43 were female. All patients had an asthma diagnosis for at least 6 months; airway inflammation was based on measures of fraction of exhaled nitric oxide (FeNO) ≥ 30 ppb, 138 blood eosinophil count ≥ 150 cells/mcL, or percent sputum eosinophils ≥ 2% of total leukocytes. Individuals with ongoing medical conditions other than asthma were excluded.

The MBSR group had seven clinical data collection visits at approximately 1-month intervals. MBSR training sessions occurred within classes offered to the community over a period of 8 weekly sessions and one 6-hour retreat, and included breath-focused attention, body scan, and mindful awareness in seated positions, walking, and yoga. Participants completed questionnaires about mindfulness, distress, depression, and anxiety symptoms. These were assessed at baseline, post intervention, and at study completion. Chronic stress level was determined at baseline only.

The primary outcome was asthma control based on the Asthma Control Questionnaire 6-item version (ACQ6) Minimally Important Difference.

Overall, asthma control improved significantly among those randomized to MBSR compared to waitlisted controls (P = .01) and this difference persisted at 4 months after the intervention.

Nearly one-third (32%) of the MBSR participants met the criteria for clinically significant improvement in asthma symptoms, compared to 12% of those on the wait list.

In addition, MBSR-related improvement in asthma control was significantly associated with a reduced distress (P = .043), and was especially effective for individuals with the highest levels of depressive symptoms at baseline, the researchers noted. Individuals who received MBSR also showed significantly reduced levels of exhaled nitric oxide compared to waitlist controls (P < .05).

The study findings were limited by the lack of an active control group, the researchers noted. “Though a wait-list control group was employed to control for variation in outcome measures over time, it is possible that effects reported here were driven by factors that are not specific to training in mindfulness, such as social support or expectancy effects,” they wrote. However, the results support the value of mindfulness in reducing psychological stress, FeNO, and impairments related to asthma that were sustained over time, they said. The results also support the potential of MBSR to both augment and reduce the need for pharmacological treatment in asthma, and mindfulness may be an effective way to improve overall disease control by reducing the contribution of psychological factors to asthma morbidity, they concluded.

The study was supported by the National Center for Complementary and Integrative Health. Coauthor Richard J. Davidson, MD, is the founder and president, and serves on the board of directors for the nonprofit organization, Healthy Minds Innovations Inc. The researchers had no financial conflicts to disclose.

Adults with asthma who received mindfulness training showed significant improvement in symptoms compared to those who did not receive such training, based on data from 73 individuals.

Although previous research shows the contribution of psychological factors to poor asthma control and exacerbations, the ability of mindfulness-based stress reduction (MBSR) to improve asthma symptoms in particular has not been well studied, wrote Estelle T. Higgins, BA, of the University of Wisconsin, Madison, and colleagues.

“Though the focus of mindfulness training is not symptom reduction, this is frequently the result in populations with chronic medical illness,” they wrote. The researchers hypothesized that MBSR training would reduce the effect of psychological distress on asthma control and inflammation compared to asthma patients in a waitlist control group.

In a study published in Brain, Behavior, & Immunity – Health, the researchers randomized 38 adults with asthma to a program of MBSR and 24 to a waitlist. The participants ranged in age from 18 to 65 years, with a mean of 38.1 years, and 43 were female. All patients had an asthma diagnosis for at least 6 months; airway inflammation was based on measures of fraction of exhaled nitric oxide (FeNO) ≥ 30 ppb, 138 blood eosinophil count ≥ 150 cells/mcL, or percent sputum eosinophils ≥ 2% of total leukocytes. Individuals with ongoing medical conditions other than asthma were excluded.

The MBSR group had seven clinical data collection visits at approximately 1-month intervals. MBSR training sessions occurred within classes offered to the community over a period of 8 weekly sessions and one 6-hour retreat, and included breath-focused attention, body scan, and mindful awareness in seated positions, walking, and yoga. Participants completed questionnaires about mindfulness, distress, depression, and anxiety symptoms. These were assessed at baseline, post intervention, and at study completion. Chronic stress level was determined at baseline only.

The primary outcome was asthma control based on the Asthma Control Questionnaire 6-item version (ACQ6) Minimally Important Difference.

Overall, asthma control improved significantly among those randomized to MBSR compared to waitlisted controls (P = .01) and this difference persisted at 4 months after the intervention.

Nearly one-third (32%) of the MBSR participants met the criteria for clinically significant improvement in asthma symptoms, compared to 12% of those on the wait list.

In addition, MBSR-related improvement in asthma control was significantly associated with a reduced distress (P = .043), and was especially effective for individuals with the highest levels of depressive symptoms at baseline, the researchers noted. Individuals who received MBSR also showed significantly reduced levels of exhaled nitric oxide compared to waitlist controls (P < .05).

The study findings were limited by the lack of an active control group, the researchers noted. “Though a wait-list control group was employed to control for variation in outcome measures over time, it is possible that effects reported here were driven by factors that are not specific to training in mindfulness, such as social support or expectancy effects,” they wrote. However, the results support the value of mindfulness in reducing psychological stress, FeNO, and impairments related to asthma that were sustained over time, they said. The results also support the potential of MBSR to both augment and reduce the need for pharmacological treatment in asthma, and mindfulness may be an effective way to improve overall disease control by reducing the contribution of psychological factors to asthma morbidity, they concluded.

The study was supported by the National Center for Complementary and Integrative Health. Coauthor Richard J. Davidson, MD, is the founder and president, and serves on the board of directors for the nonprofit organization, Healthy Minds Innovations Inc. The researchers had no financial conflicts to disclose.

Individuals with depression who had high levels of C-reactive protein responded poorly to selected serotonin reuptake inhibitors compared to those with lower CRP levels, based on data from more than 900 patients.

C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.

In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.

CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).

The researchers compared efficacy in different groups according to CRP levels.

Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).

A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.

“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.

No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.

No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.

The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.

However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Individuals with depression who had high levels of C-reactive protein responded poorly to selected serotonin reuptake inhibitors compared to those with lower CRP levels, based on data from more than 900 patients.

C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.

In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.

CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).

The researchers compared efficacy in different groups according to CRP levels.

Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).

A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.

“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.

No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.

No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.

The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.

However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Individuals with depression who had high levels of C-reactive protein responded poorly to selected serotonin reuptake inhibitors compared to those with lower CRP levels, based on data from more than 900 patients.

C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.

In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.

CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).

The researchers compared efficacy in different groups according to CRP levels.

Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).

A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.

“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.

No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.

No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.

The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.

However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Maternal mortality in the United States has been rising for several decades, but actions taken at the community level, as well as larger public health initiatives, have the potential to slow this trend, according to experts at a webinar sponsored by the National Institute for Health Care Management.

Maternal mortality in the United States increased by 14% from 2018 to 2020, according to data from the Centers for Disease Control and Prevention’s National Center for Health Statistics.

However, more than 80% of pregnancy-related deaths are preventable, according to 2017-2019 data from the Maternal Mortality Review Committees published online by the CDC. MMRCs include representatives of diverse clinical and nonclinical backgrounds who review the circumstances of pregnancy-related deaths.

In a webinar presented on Sept. 20, the NIHCM enlisted a panel of experts to discuss maternal mortality, the effect of changes to reproductive rights, and potential strategies to improve maternal health outcomes.

Maternal mortality is defined as “death while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of pregnancy, from any cause related to pregnancy or its management,” according to the CDC.

Importantly, mortality rates in the United States are approximately three times higher in Black women compared with White women, said Ndidiamaka Amutah-Onukagha, PhD, MPH, of the Tufts University Center for Black Maternal Health & Reproductive Justice. Dr. Amutah-Onukagha addressed some of the potential issues that appear to drive the disparity in care.

The lack of diversity in the health care workforce has a significant effect on patient outcomes, Dr. Amutah-Onukagha said. Overall, Black newborns are more than twice as likely as White newborns to die during their first year of life, but this number is cut in half when Black infants are cared for by Black physicians, she emphasized.

Other factors that may affect disparities in maternal health care include limited access to prenatal care, discriminatory hospital protocols, and mistreatment by health care professionals, said Dr. Amutah-Onukagha. She cited data showing that maternal mortality rates were higher in rural compared with urban areas. “According to the American Hospital Association, half of rural hospitals have no obstetric care, leaving mothers in maternity care deserts; this exacerbates existing disparities,” she said.

In the webinar, Sindhu Srinivas, MD, a maternal-fetal medicine specialist at the University of Pennsylvania, explained how patient, community, and system factors play a role in the disparities in maternal care.

Overall, Black women have to travel further to receive care, which has implications for high-risk pregnancies, and patients on Medicaid have to wait longer for care, and are less likely to be referred, she added. Black women also have higher rates of preexisting conditions compared with other populations that put them in the high-risk category, such as high blood pressure, diabetes, obesity, or being HIV positive, she said.

Other factors contributing to persistent disparities in maternal care include sociodemographics, patient beliefs and knowledge, and psychological issues including stress, said Dr. Srinivas. Community factors, such as social networks, safety, and poverty, also play a role, as do clinician factors of implicit bias and communication skills, she said.

Strategies to reduce disparity

Dr. Srinivas presented several strategies to reduce disparities at various levels. At the policy level, interventions such as establishing a Maternal Mortality Review Committee, establishing a perinatal quality collaborative, and extending Medicaid for a full year postpartum could help improve outcomes, she said. Dr. Srinivas also encouraged clinicians to report maternal mortality data stratified by race and ethnicity, and to participate in the Alliance for Innovation on Maternal Health program (AIM), an initiative in partnership with the American College of Obstetrics and Gynecology.

Dr. Srinivas also proposed maternal health policies to develop payment models “to sustain and scale innovative solutions, and “preserve access to contraception and abortion care.”

For clinicians looking to have an immediate impact, the panelists agreed that working with community health centers can make a significant difference by improving access to maternal care. Consider opportunities for partnership between hospitals and health care delivery centers in the community, said Dr. Srinivas.

Also, don’t underestimate the value of doulas in the birthing process, Dr. Amutah-Onukagha said. She urged clinicians to advocate for doula reimbursement and to take advantage of opportunities for doulas to work with pregnant individuals at the community levels. Data suggest that doulas are associated with increased maternal care visits and with breastfeeding, she noted.

Adam Myers, MD, of the Blue Cross Blue Shield Association, also contributed to the webinar discussion with a key point: Having financial means and commercial coverage is not a buffer against adverse maternal outcomes for racial minorities.

Dr. Myers cited the latest Health of America Report, which included data up to April 2021 with surveys of Medicaid members and their experiences. According to the report, rates of severe maternal mortality (SMM) increased by 9% for commercially and Medicaid-insured women between 2018 and 2020.

Among commercially insured women, SMM was 53% higher among Black women than White women; among Medicaid-insured women, Black women had a 73% higher rate of SMM, compared with White women.

In addition, the report showed that significantly more mothers of color were not able to complete the recommended series of prenatal visits, mainly for reasons of scheduling and transportation, which were greater barriers than COVID-19, Dr. Myers said.

Based on the data, one specific risk profile rose to the top: “We believe women of color aged 35 or higher with comorbid conditions should be treated as very high risk for SMM,” Dr. Myers emphasized. He stressed the need to focus on transportation and scheduling barriers and expressed support for partnerships and health care delivery centers in the community to mitigate these issues.

Finally, Dr. Srinivas encouraged clinicians to have confidence in their expertise and make themselves heard to help their patients and improve maternal health for all. “Use your voice,” said Dr. Srinivas, “As physicians we don’t think of that as an important aspect of our work, or that we can’t articulate, but remember that we are experts, and sharing stories of patients who are impacted is incredibly powerful,” she said.

The presenters had no relevant financial conflicts to disclose.

Maternal mortality in the United States has been rising for several decades, but actions taken at the community level, as well as larger public health initiatives, have the potential to slow this trend, according to experts at a webinar sponsored by the National Institute for Health Care Management.

Maternal mortality in the United States increased by 14% from 2018 to 2020, according to data from the Centers for Disease Control and Prevention’s National Center for Health Statistics.

However, more than 80% of pregnancy-related deaths are preventable, according to 2017-2019 data from the Maternal Mortality Review Committees published online by the CDC. MMRCs include representatives of diverse clinical and nonclinical backgrounds who review the circumstances of pregnancy-related deaths.

In a webinar presented on Sept. 20, the NIHCM enlisted a panel of experts to discuss maternal mortality, the effect of changes to reproductive rights, and potential strategies to improve maternal health outcomes.

Maternal mortality is defined as “death while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of pregnancy, from any cause related to pregnancy or its management,” according to the CDC.

Importantly, mortality rates in the United States are approximately three times higher in Black women compared with White women, said Ndidiamaka Amutah-Onukagha, PhD, MPH, of the Tufts University Center for Black Maternal Health & Reproductive Justice. Dr. Amutah-Onukagha addressed some of the potential issues that appear to drive the disparity in care.

The lack of diversity in the health care workforce has a significant effect on patient outcomes, Dr. Amutah-Onukagha said. Overall, Black newborns are more than twice as likely as White newborns to die during their first year of life, but this number is cut in half when Black infants are cared for by Black physicians, she emphasized.

Other factors that may affect disparities in maternal health care include limited access to prenatal care, discriminatory hospital protocols, and mistreatment by health care professionals, said Dr. Amutah-Onukagha. She cited data showing that maternal mortality rates were higher in rural compared with urban areas. “According to the American Hospital Association, half of rural hospitals have no obstetric care, leaving mothers in maternity care deserts; this exacerbates existing disparities,” she said.

In the webinar, Sindhu Srinivas, MD, a maternal-fetal medicine specialist at the University of Pennsylvania, explained how patient, community, and system factors play a role in the disparities in maternal care.

Overall, Black women have to travel further to receive care, which has implications for high-risk pregnancies, and patients on Medicaid have to wait longer for care, and are less likely to be referred, she added. Black women also have higher rates of preexisting conditions compared with other populations that put them in the high-risk category, such as high blood pressure, diabetes, obesity, or being HIV positive, she said.

Other factors contributing to persistent disparities in maternal care include sociodemographics, patient beliefs and knowledge, and psychological issues including stress, said Dr. Srinivas. Community factors, such as social networks, safety, and poverty, also play a role, as do clinician factors of implicit bias and communication skills, she said.

Strategies to reduce disparity

Dr. Srinivas presented several strategies to reduce disparities at various levels. At the policy level, interventions such as establishing a Maternal Mortality Review Committee, establishing a perinatal quality collaborative, and extending Medicaid for a full year postpartum could help improve outcomes, she said. Dr. Srinivas also encouraged clinicians to report maternal mortality data stratified by race and ethnicity, and to participate in the Alliance for Innovation on Maternal Health program (AIM), an initiative in partnership with the American College of Obstetrics and Gynecology.

Dr. Srinivas also proposed maternal health policies to develop payment models “to sustain and scale innovative solutions, and “preserve access to contraception and abortion care.”

For clinicians looking to have an immediate impact, the panelists agreed that working with community health centers can make a significant difference by improving access to maternal care. Consider opportunities for partnership between hospitals and health care delivery centers in the community, said Dr. Srinivas.

Also, don’t underestimate the value of doulas in the birthing process, Dr. Amutah-Onukagha said. She urged clinicians to advocate for doula reimbursement and to take advantage of opportunities for doulas to work with pregnant individuals at the community levels. Data suggest that doulas are associated with increased maternal care visits and with breastfeeding, she noted.

Adam Myers, MD, of the Blue Cross Blue Shield Association, also contributed to the webinar discussion with a key point: Having financial means and commercial coverage is not a buffer against adverse maternal outcomes for racial minorities.

Dr. Myers cited the latest Health of America Report, which included data up to April 2021 with surveys of Medicaid members and their experiences. According to the report, rates of severe maternal mortality (SMM) increased by 9% for commercially and Medicaid-insured women between 2018 and 2020.

Among commercially insured women, SMM was 53% higher among Black women than White women; among Medicaid-insured women, Black women had a 73% higher rate of SMM, compared with White women.

In addition, the report showed that significantly more mothers of color were not able to complete the recommended series of prenatal visits, mainly for reasons of scheduling and transportation, which were greater barriers than COVID-19, Dr. Myers said.

Based on the data, one specific risk profile rose to the top: “We believe women of color aged 35 or higher with comorbid conditions should be treated as very high risk for SMM,” Dr. Myers emphasized. He stressed the need to focus on transportation and scheduling barriers and expressed support for partnerships and health care delivery centers in the community to mitigate these issues.

Finally, Dr. Srinivas encouraged clinicians to have confidence in their expertise and make themselves heard to help their patients and improve maternal health for all. “Use your voice,” said Dr. Srinivas, “As physicians we don’t think of that as an important aspect of our work, or that we can’t articulate, but remember that we are experts, and sharing stories of patients who are impacted is incredibly powerful,” she said.

The presenters had no relevant financial conflicts to disclose.

Maternal mortality in the United States has been rising for several decades, but actions taken at the community level, as well as larger public health initiatives, have the potential to slow this trend, according to experts at a webinar sponsored by the National Institute for Health Care Management.

Maternal mortality in the United States increased by 14% from 2018 to 2020, according to data from the Centers for Disease Control and Prevention’s National Center for Health Statistics.

However, more than 80% of pregnancy-related deaths are preventable, according to 2017-2019 data from the Maternal Mortality Review Committees published online by the CDC. MMRCs include representatives of diverse clinical and nonclinical backgrounds who review the circumstances of pregnancy-related deaths.

In a webinar presented on Sept. 20, the NIHCM enlisted a panel of experts to discuss maternal mortality, the effect of changes to reproductive rights, and potential strategies to improve maternal health outcomes.

Maternal mortality is defined as “death while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of pregnancy, from any cause related to pregnancy or its management,” according to the CDC.

Importantly, mortality rates in the United States are approximately three times higher in Black women compared with White women, said Ndidiamaka Amutah-Onukagha, PhD, MPH, of the Tufts University Center for Black Maternal Health & Reproductive Justice. Dr. Amutah-Onukagha addressed some of the potential issues that appear to drive the disparity in care.

The lack of diversity in the health care workforce has a significant effect on patient outcomes, Dr. Amutah-Onukagha said. Overall, Black newborns are more than twice as likely as White newborns to die during their first year of life, but this number is cut in half when Black infants are cared for by Black physicians, she emphasized.

Other factors that may affect disparities in maternal health care include limited access to prenatal care, discriminatory hospital protocols, and mistreatment by health care professionals, said Dr. Amutah-Onukagha. She cited data showing that maternal mortality rates were higher in rural compared with urban areas. “According to the American Hospital Association, half of rural hospitals have no obstetric care, leaving mothers in maternity care deserts; this exacerbates existing disparities,” she said.

In the webinar, Sindhu Srinivas, MD, a maternal-fetal medicine specialist at the University of Pennsylvania, explained how patient, community, and system factors play a role in the disparities in maternal care.

Overall, Black women have to travel further to receive care, which has implications for high-risk pregnancies, and patients on Medicaid have to wait longer for care, and are less likely to be referred, she added. Black women also have higher rates of preexisting conditions compared with other populations that put them in the high-risk category, such as high blood pressure, diabetes, obesity, or being HIV positive, she said.

Other factors contributing to persistent disparities in maternal care include sociodemographics, patient beliefs and knowledge, and psychological issues including stress, said Dr. Srinivas. Community factors, such as social networks, safety, and poverty, also play a role, as do clinician factors of implicit bias and communication skills, she said.

Strategies to reduce disparity

Dr. Srinivas presented several strategies to reduce disparities at various levels. At the policy level, interventions such as establishing a Maternal Mortality Review Committee, establishing a perinatal quality collaborative, and extending Medicaid for a full year postpartum could help improve outcomes, she said. Dr. Srinivas also encouraged clinicians to report maternal mortality data stratified by race and ethnicity, and to participate in the Alliance for Innovation on Maternal Health program (AIM), an initiative in partnership with the American College of Obstetrics and Gynecology.

Dr. Srinivas also proposed maternal health policies to develop payment models “to sustain and scale innovative solutions, and “preserve access to contraception and abortion care.”

For clinicians looking to have an immediate impact, the panelists agreed that working with community health centers can make a significant difference by improving access to maternal care. Consider opportunities for partnership between hospitals and health care delivery centers in the community, said Dr. Srinivas.

Also, don’t underestimate the value of doulas in the birthing process, Dr. Amutah-Onukagha said. She urged clinicians to advocate for doula reimbursement and to take advantage of opportunities for doulas to work with pregnant individuals at the community levels. Data suggest that doulas are associated with increased maternal care visits and with breastfeeding, she noted.

Adam Myers, MD, of the Blue Cross Blue Shield Association, also contributed to the webinar discussion with a key point: Having financial means and commercial coverage is not a buffer against adverse maternal outcomes for racial minorities.

Dr. Myers cited the latest Health of America Report, which included data up to April 2021 with surveys of Medicaid members and their experiences. According to the report, rates of severe maternal mortality (SMM) increased by 9% for commercially and Medicaid-insured women between 2018 and 2020.

Among commercially insured women, SMM was 53% higher among Black women than White women; among Medicaid-insured women, Black women had a 73% higher rate of SMM, compared with White women.

In addition, the report showed that significantly more mothers of color were not able to complete the recommended series of prenatal visits, mainly for reasons of scheduling and transportation, which were greater barriers than COVID-19, Dr. Myers said.

Based on the data, one specific risk profile rose to the top: “We believe women of color aged 35 or higher with comorbid conditions should be treated as very high risk for SMM,” Dr. Myers emphasized. He stressed the need to focus on transportation and scheduling barriers and expressed support for partnerships and health care delivery centers in the community to mitigate these issues.

Finally, Dr. Srinivas encouraged clinicians to have confidence in their expertise and make themselves heard to help their patients and improve maternal health for all. “Use your voice,” said Dr. Srinivas, “As physicians we don’t think of that as an important aspect of our work, or that we can’t articulate, but remember that we are experts, and sharing stories of patients who are impacted is incredibly powerful,” she said.

The presenters had no relevant financial conflicts to disclose.

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Individuals with esophageal dysmotility had significantly higher scores on measures of airway reflux symptoms, based on data from 441 patients.

Many patients with chronic respiratory diseases experience persistent symptoms despite optimal treatment, and the reason is often unclear and frustrating for clinicians and patients, Dominic L. Sykes, MD, of Hull (England) University Teaching Hospitals NHS Trust, and colleagues wrote.

Although more studies in recent years have explored the association between gastroesophageal reflux and respiratory diseases such as asthma and chronic obstructive pulmonary disease, data on a potential link between esophageal motility and respiratory disease in adults are limited, they noted.

In a study published in Respiratory Medicine, the researchers reviewed data from 441 adults with refractory respiratory symptoms who were treated at a single center between Jan. 1, 2011, and Dec. 1, 2021. Symptoms included persistent cough and breathlessness despite optimal medication. The participants underwent examination with high-resolution esophageal manometry (HROM). Airway reflux was measured using the Hull Airways Reflux Questionnaire (HARQ). The mean age of the patients was 56.5 years, and 64% were women.

Overall, the most common diagnoses were chronic cough (77%), asthma (10%), and interstitial lung disease (7%). The prevalence of esophageal dysmotility was 66%. Patients with esophageal dysmotility had significantly higher HARQ scores than those with normal motility (40.6 vs. 35.3; P < .001). Approximately one-third of the patients had normal motility (34.5%) on HROM, 54% had ineffective esophageal motility, 7.3% had absent contractility, 3.2% had esophageal-gastric junction outflow obstruction, 0.5% had distal esophageal spasm, 0.5% has achalasia, and one patient had hypercontractile esophagus.

No significant differences in manometric diagnoses appeared between men and women. In addition, HARQ scores showed a significant inverse correlation with esophageal contractility as measured by distal contractile integral (DCI).

“The proportion of patients with esophageal dysmotility is consistently high over a range of respiratory diseases, including interstitial lung disease (72%), airways disease (57%), and chronic cough (68%),” and the findings suggest that esophageal disease may play a role in patients with persistent respiratory symptoms, they noted.

The study authors proposed that “impaired peristaltic activity of the esophagus, leading to aspiration of gaseous nonacidic refluxate into the airways, may be a contributor in the development and progression of respiratory disease.” They added that the HARQ offers clinicians a useful screening tool for assessing the need for esophageal study in patients with persistent respiratory symptoms that should be used before considering antireflux surgery.

The study findings were limited by several factors including the lack of lung function data for patients with airway disease and ILD and the inability to show causality between esophageal dysmotility and refractory respiratory symptoms, the researchers noted. Other limitations include the retrospective design, and the lack of data on symptom severity and the subsequent impact on outcomes.

However, the results support the need for additional research into the relationship between esophageal dysmotility, lung function, and symptom burden in chronic respiratory disease, and may inform investigations of therapeutic targets, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Individuals with esophageal dysmotility had significantly higher scores on measures of airway reflux symptoms, based on data from 441 patients.

Many patients with chronic respiratory diseases experience persistent symptoms despite optimal treatment, and the reason is often unclear and frustrating for clinicians and patients, Dominic L. Sykes, MD, of Hull (England) University Teaching Hospitals NHS Trust, and colleagues wrote.

Although more studies in recent years have explored the association between gastroesophageal reflux and respiratory diseases such as asthma and chronic obstructive pulmonary disease, data on a potential link between esophageal motility and respiratory disease in adults are limited, they noted.

In a study published in Respiratory Medicine, the researchers reviewed data from 441 adults with refractory respiratory symptoms who were treated at a single center between Jan. 1, 2011, and Dec. 1, 2021. Symptoms included persistent cough and breathlessness despite optimal medication. The participants underwent examination with high-resolution esophageal manometry (HROM). Airway reflux was measured using the Hull Airways Reflux Questionnaire (HARQ). The mean age of the patients was 56.5 years, and 64% were women.

Overall, the most common diagnoses were chronic cough (77%), asthma (10%), and interstitial lung disease (7%). The prevalence of esophageal dysmotility was 66%. Patients with esophageal dysmotility had significantly higher HARQ scores than those with normal motility (40.6 vs. 35.3; P < .001). Approximately one-third of the patients had normal motility (34.5%) on HROM, 54% had ineffective esophageal motility, 7.3% had absent contractility, 3.2% had esophageal-gastric junction outflow obstruction, 0.5% had distal esophageal spasm, 0.5% has achalasia, and one patient had hypercontractile esophagus.

No significant differences in manometric diagnoses appeared between men and women. In addition, HARQ scores showed a significant inverse correlation with esophageal contractility as measured by distal contractile integral (DCI).

“The proportion of patients with esophageal dysmotility is consistently high over a range of respiratory diseases, including interstitial lung disease (72%), airways disease (57%), and chronic cough (68%),” and the findings suggest that esophageal disease may play a role in patients with persistent respiratory symptoms, they noted.

The study authors proposed that “impaired peristaltic activity of the esophagus, leading to aspiration of gaseous nonacidic refluxate into the airways, may be a contributor in the development and progression of respiratory disease.” They added that the HARQ offers clinicians a useful screening tool for assessing the need for esophageal study in patients with persistent respiratory symptoms that should be used before considering antireflux surgery.

The study findings were limited by several factors including the lack of lung function data for patients with airway disease and ILD and the inability to show causality between esophageal dysmotility and refractory respiratory symptoms, the researchers noted. Other limitations include the retrospective design, and the lack of data on symptom severity and the subsequent impact on outcomes.

However, the results support the need for additional research into the relationship between esophageal dysmotility, lung function, and symptom burden in chronic respiratory disease, and may inform investigations of therapeutic targets, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Individuals with esophageal dysmotility had significantly higher scores on measures of airway reflux symptoms, based on data from 441 patients.

Many patients with chronic respiratory diseases experience persistent symptoms despite optimal treatment, and the reason is often unclear and frustrating for clinicians and patients, Dominic L. Sykes, MD, of Hull (England) University Teaching Hospitals NHS Trust, and colleagues wrote.

Although more studies in recent years have explored the association between gastroesophageal reflux and respiratory diseases such as asthma and chronic obstructive pulmonary disease, data on a potential link between esophageal motility and respiratory disease in adults are limited, they noted.

In a study published in Respiratory Medicine, the researchers reviewed data from 441 adults with refractory respiratory symptoms who were treated at a single center between Jan. 1, 2011, and Dec. 1, 2021. Symptoms included persistent cough and breathlessness despite optimal medication. The participants underwent examination with high-resolution esophageal manometry (HROM). Airway reflux was measured using the Hull Airways Reflux Questionnaire (HARQ). The mean age of the patients was 56.5 years, and 64% were women.

Overall, the most common diagnoses were chronic cough (77%), asthma (10%), and interstitial lung disease (7%). The prevalence of esophageal dysmotility was 66%. Patients with esophageal dysmotility had significantly higher HARQ scores than those with normal motility (40.6 vs. 35.3; P < .001). Approximately one-third of the patients had normal motility (34.5%) on HROM, 54% had ineffective esophageal motility, 7.3% had absent contractility, 3.2% had esophageal-gastric junction outflow obstruction, 0.5% had distal esophageal spasm, 0.5% has achalasia, and one patient had hypercontractile esophagus.

No significant differences in manometric diagnoses appeared between men and women. In addition, HARQ scores showed a significant inverse correlation with esophageal contractility as measured by distal contractile integral (DCI).

“The proportion of patients with esophageal dysmotility is consistently high over a range of respiratory diseases, including interstitial lung disease (72%), airways disease (57%), and chronic cough (68%),” and the findings suggest that esophageal disease may play a role in patients with persistent respiratory symptoms, they noted.

The study authors proposed that “impaired peristaltic activity of the esophagus, leading to aspiration of gaseous nonacidic refluxate into the airways, may be a contributor in the development and progression of respiratory disease.” They added that the HARQ offers clinicians a useful screening tool for assessing the need for esophageal study in patients with persistent respiratory symptoms that should be used before considering antireflux surgery.

The study findings were limited by several factors including the lack of lung function data for patients with airway disease and ILD and the inability to show causality between esophageal dysmotility and refractory respiratory symptoms, the researchers noted. Other limitations include the retrospective design, and the lack of data on symptom severity and the subsequent impact on outcomes.

However, the results support the need for additional research into the relationship between esophageal dysmotility, lung function, and symptom burden in chronic respiratory disease, and may inform investigations of therapeutic targets, they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.