IBD & Intestinal Disorders

It’s been over 2 decades since 37-year-old Joshua Denton was diagnosed with ulcerative colitis.

Controlling the physical symptoms of comorbidities, such as inflammatory bowel disease, have been possible, but he was surprised when depression and anxiety set in.

“You’re dealing with what I call the anxiety of the unknown. What does this mean?” said Mr. Denton, who serves as a patient advocate with Color of Crohn’s & Chronic Illness, a nonprofit group aimed at improving quality of life for racial-ethnic minorities. “When you understand that it’s autoimmune that is chronic and incurable, you’re wondering, ‘Am I going to have a chance to get better in terms of my quality-of-life? Is it going to get worse?’ It indirectly builds this level of anxiety.”

Mr. Denton described a level of anxiety and depression that other patients living with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, described in a recent survey from the American Gastroenterological Association. Survey results, released in March, show how emotional and social challenges are top of mind for patients living with IBD, but not so much for gastroenterologists who said they’re more concerned about treating physical health than emotional health and believe mental health is sufficiently addressed in their patients’ IBD care.

In response, the AGA has launched the My IBD Life campaign to provide resources to patients and help their health care providers become active partners in psychosocial care.

Discussions about mental health challenges are difficult for both physician and patients. For patients, they may be unwilling to talk to their physicians out of concern of being a burden, while physicians may be reluctant to pry or intrude. “I want to dispel the myth to the patients (and tell them) that your doctor actually would love to know, but is afraid to pry. And to the doctor: Your patient wants you to know, but is afraid to be a burden,” said Laurie A. Keefer, PhD, a psychologist at Icahn School of Medicine at Mount Sinai, New York, who specializes in the psychosocial care of patients with chronic digestive diseases and serves as an adviser to the My IBD Life campaign, which was launched to support both patients living with IBD and their health care providers.

But “prying” in this way is important, Dr. Keefer said. Depression and anxiety can have wide-ranging effects on patient outcomes. Depressed patients may not follow through with medication refills or may be more accepting of disability, while anxiety can lead to worries about colonoscopies or surgeries, which can lead to avoidance. “I always tell GI providers, if you can’t figure out why someone never follows through with that test or that procedure, consider anxiety before you assume that it’s just nonadherence. Anxiety and depression really affect how somebody follows the requirements they need to manage their disease,” said Dr. Keefer.
 

Rates of anxiety among patients are increasing

The survey included 1,026 adults (18-59 years) with IBD and of these, 63% reported having comorbid conditions, such as anxiety (36%) and depression (35%). These rates are significantly higher than in the general population – at 19% and 8%, respectively. The rate of anxiety among patients with IBD has increased since AGA conducted a similar survey in 2017.

Patients reported that they were most concerned with the ways that IBD affects their mental health or emotional health and day-to-day life. Many said their providers were more concerned about treating them physically than emotionally and expressed a need for additional information on IBD treatment options (37%) and medications (35%). They also desired more information about the impact on emotional and mental health (25%), which has increased since the 2017 survey.

The No. 1 concern for patients was the need to consider bathroom logistics when away from home (7.03 on a scale of 1-10). The second most popular concern was mental and emotional health with a rating of 6.51 on a 1-10 scale. Thirty percent requested more information about diet and 27% asked for more information about general IBD symptoms.

Both patients and providers were less satisfied with emotional and social care than physical care for IBD. Among patients, women and those between ages 18 and 39 said they were the least satisfied with their care.

“We must always consider the mind and body together when managing a chronic disease, and IBD is no exception,” Dr. Keefer said. “We also know that failure to address emotional concerns in IBD leads to poorer disease outcomes, not just reduced quality of life.”

The surveys also highlighted different experiences among communities. For instance, people of color, particularly those in the Black community, were more likely to report that their IBD journey was impacted by their personal identity, whether by race, ethnicity, culture, sexual orientation, gender identity, or age.

In contrast, a companion survey of 117 gastroenterologists found that providers are focused on physical health over emotional health (8.34 on a scale of 1-10), but they reported having sufficiently addressed concerns their patients may have expressed about mental health issues. At the same time, many also said they feel more equipped to treat their patients physically rather than emotionally.

The provider survey showed their biggest challenge was in securing insurance authorizations for medications.

Mr. Denton encourages all patients to be as transparent as possible with their providers and family members.

“I firmly believe you cannot internalize the experience and keep it to yourself. I strongly encourage other patients with IBD to continue to push themselves to be as transparent as possible with their loved ones and health care professionals, because the more we talk about it, the more we can humanize the experience and allow people that aren’t health care professionals to have a more empathetic understanding of what we’re dealing with which in turn, hopefully, will provide better support and resources,” Mr. Denton said.

The My IBD Life website provides resources for patients to navigate a range of common scenarios, including conversations about new medications, workplace concerns, intimacy and relationships, vacations and travel, and medical procedures and surgeries. An interactive 3D graphic demonstrates how IBD affects the body, and videos of patients highlight personal experiences and ways to build emotional resilience.

The My IBD Life campaign is supported by an independent grant from Bristol Myers Squibb.

It’s been over 2 decades since 37-year-old Joshua Denton was diagnosed with ulcerative colitis.

Controlling the physical symptoms of comorbidities, such as inflammatory bowel disease, have been possible, but he was surprised when depression and anxiety set in.

“You’re dealing with what I call the anxiety of the unknown. What does this mean?” said Mr. Denton, who serves as a patient advocate with Color of Crohn’s & Chronic Illness, a nonprofit group aimed at improving quality of life for racial-ethnic minorities. “When you understand that it’s autoimmune that is chronic and incurable, you’re wondering, ‘Am I going to have a chance to get better in terms of my quality-of-life? Is it going to get worse?’ It indirectly builds this level of anxiety.”

Mr. Denton described a level of anxiety and depression that other patients living with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, described in a recent survey from the American Gastroenterological Association. Survey results, released in March, show how emotional and social challenges are top of mind for patients living with IBD, but not so much for gastroenterologists who said they’re more concerned about treating physical health than emotional health and believe mental health is sufficiently addressed in their patients’ IBD care.

In response, the AGA has launched the My IBD Life campaign to provide resources to patients and help their health care providers become active partners in psychosocial care.

Discussions about mental health challenges are difficult for both physician and patients. For patients, they may be unwilling to talk to their physicians out of concern of being a burden, while physicians may be reluctant to pry or intrude. “I want to dispel the myth to the patients (and tell them) that your doctor actually would love to know, but is afraid to pry. And to the doctor: Your patient wants you to know, but is afraid to be a burden,” said Laurie A. Keefer, PhD, a psychologist at Icahn School of Medicine at Mount Sinai, New York, who specializes in the psychosocial care of patients with chronic digestive diseases and serves as an adviser to the My IBD Life campaign, which was launched to support both patients living with IBD and their health care providers.

But “prying” in this way is important, Dr. Keefer said. Depression and anxiety can have wide-ranging effects on patient outcomes. Depressed patients may not follow through with medication refills or may be more accepting of disability, while anxiety can lead to worries about colonoscopies or surgeries, which can lead to avoidance. “I always tell GI providers, if you can’t figure out why someone never follows through with that test or that procedure, consider anxiety before you assume that it’s just nonadherence. Anxiety and depression really affect how somebody follows the requirements they need to manage their disease,” said Dr. Keefer.
 

Rates of anxiety among patients are increasing

The survey included 1,026 adults (18-59 years) with IBD and of these, 63% reported having comorbid conditions, such as anxiety (36%) and depression (35%). These rates are significantly higher than in the general population – at 19% and 8%, respectively. The rate of anxiety among patients with IBD has increased since AGA conducted a similar survey in 2017.

Patients reported that they were most concerned with the ways that IBD affects their mental health or emotional health and day-to-day life. Many said their providers were more concerned about treating them physically than emotionally and expressed a need for additional information on IBD treatment options (37%) and medications (35%). They also desired more information about the impact on emotional and mental health (25%), which has increased since the 2017 survey.

The No. 1 concern for patients was the need to consider bathroom logistics when away from home (7.03 on a scale of 1-10). The second most popular concern was mental and emotional health with a rating of 6.51 on a 1-10 scale. Thirty percent requested more information about diet and 27% asked for more information about general IBD symptoms.

Both patients and providers were less satisfied with emotional and social care than physical care for IBD. Among patients, women and those between ages 18 and 39 said they were the least satisfied with their care.

“We must always consider the mind and body together when managing a chronic disease, and IBD is no exception,” Dr. Keefer said. “We also know that failure to address emotional concerns in IBD leads to poorer disease outcomes, not just reduced quality of life.”

The surveys also highlighted different experiences among communities. For instance, people of color, particularly those in the Black community, were more likely to report that their IBD journey was impacted by their personal identity, whether by race, ethnicity, culture, sexual orientation, gender identity, or age.

In contrast, a companion survey of 117 gastroenterologists found that providers are focused on physical health over emotional health (8.34 on a scale of 1-10), but they reported having sufficiently addressed concerns their patients may have expressed about mental health issues. At the same time, many also said they feel more equipped to treat their patients physically rather than emotionally.

The provider survey showed their biggest challenge was in securing insurance authorizations for medications.

Mr. Denton encourages all patients to be as transparent as possible with their providers and family members.

“I firmly believe you cannot internalize the experience and keep it to yourself. I strongly encourage other patients with IBD to continue to push themselves to be as transparent as possible with their loved ones and health care professionals, because the more we talk about it, the more we can humanize the experience and allow people that aren’t health care professionals to have a more empathetic understanding of what we’re dealing with which in turn, hopefully, will provide better support and resources,” Mr. Denton said.

The My IBD Life website provides resources for patients to navigate a range of common scenarios, including conversations about new medications, workplace concerns, intimacy and relationships, vacations and travel, and medical procedures and surgeries. An interactive 3D graphic demonstrates how IBD affects the body, and videos of patients highlight personal experiences and ways to build emotional resilience.

The My IBD Life campaign is supported by an independent grant from Bristol Myers Squibb.

It’s been over 2 decades since 37-year-old Joshua Denton was diagnosed with ulcerative colitis.

Controlling the physical symptoms of comorbidities, such as inflammatory bowel disease, have been possible, but he was surprised when depression and anxiety set in.

“You’re dealing with what I call the anxiety of the unknown. What does this mean?” said Mr. Denton, who serves as a patient advocate with Color of Crohn’s & Chronic Illness, a nonprofit group aimed at improving quality of life for racial-ethnic minorities. “When you understand that it’s autoimmune that is chronic and incurable, you’re wondering, ‘Am I going to have a chance to get better in terms of my quality-of-life? Is it going to get worse?’ It indirectly builds this level of anxiety.”

Mr. Denton described a level of anxiety and depression that other patients living with inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, described in a recent survey from the American Gastroenterological Association. Survey results, released in March, show how emotional and social challenges are top of mind for patients living with IBD, but not so much for gastroenterologists who said they’re more concerned about treating physical health than emotional health and believe mental health is sufficiently addressed in their patients’ IBD care.

In response, the AGA has launched the My IBD Life campaign to provide resources to patients and help their health care providers become active partners in psychosocial care.

Discussions about mental health challenges are difficult for both physician and patients. For patients, they may be unwilling to talk to their physicians out of concern of being a burden, while physicians may be reluctant to pry or intrude. “I want to dispel the myth to the patients (and tell them) that your doctor actually would love to know, but is afraid to pry. And to the doctor: Your patient wants you to know, but is afraid to be a burden,” said Laurie A. Keefer, PhD, a psychologist at Icahn School of Medicine at Mount Sinai, New York, who specializes in the psychosocial care of patients with chronic digestive diseases and serves as an adviser to the My IBD Life campaign, which was launched to support both patients living with IBD and their health care providers.

But “prying” in this way is important, Dr. Keefer said. Depression and anxiety can have wide-ranging effects on patient outcomes. Depressed patients may not follow through with medication refills or may be more accepting of disability, while anxiety can lead to worries about colonoscopies or surgeries, which can lead to avoidance. “I always tell GI providers, if you can’t figure out why someone never follows through with that test or that procedure, consider anxiety before you assume that it’s just nonadherence. Anxiety and depression really affect how somebody follows the requirements they need to manage their disease,” said Dr. Keefer.
 

Rates of anxiety among patients are increasing

The survey included 1,026 adults (18-59 years) with IBD and of these, 63% reported having comorbid conditions, such as anxiety (36%) and depression (35%). These rates are significantly higher than in the general population – at 19% and 8%, respectively. The rate of anxiety among patients with IBD has increased since AGA conducted a similar survey in 2017.

Patients reported that they were most concerned with the ways that IBD affects their mental health or emotional health and day-to-day life. Many said their providers were more concerned about treating them physically than emotionally and expressed a need for additional information on IBD treatment options (37%) and medications (35%). They also desired more information about the impact on emotional and mental health (25%), which has increased since the 2017 survey.

The No. 1 concern for patients was the need to consider bathroom logistics when away from home (7.03 on a scale of 1-10). The second most popular concern was mental and emotional health with a rating of 6.51 on a 1-10 scale. Thirty percent requested more information about diet and 27% asked for more information about general IBD symptoms.

Both patients and providers were less satisfied with emotional and social care than physical care for IBD. Among patients, women and those between ages 18 and 39 said they were the least satisfied with their care.

“We must always consider the mind and body together when managing a chronic disease, and IBD is no exception,” Dr. Keefer said. “We also know that failure to address emotional concerns in IBD leads to poorer disease outcomes, not just reduced quality of life.”

The surveys also highlighted different experiences among communities. For instance, people of color, particularly those in the Black community, were more likely to report that their IBD journey was impacted by their personal identity, whether by race, ethnicity, culture, sexual orientation, gender identity, or age.

In contrast, a companion survey of 117 gastroenterologists found that providers are focused on physical health over emotional health (8.34 on a scale of 1-10), but they reported having sufficiently addressed concerns their patients may have expressed about mental health issues. At the same time, many also said they feel more equipped to treat their patients physically rather than emotionally.

The provider survey showed their biggest challenge was in securing insurance authorizations for medications.

Mr. Denton encourages all patients to be as transparent as possible with their providers and family members.

“I firmly believe you cannot internalize the experience and keep it to yourself. I strongly encourage other patients with IBD to continue to push themselves to be as transparent as possible with their loved ones and health care professionals, because the more we talk about it, the more we can humanize the experience and allow people that aren’t health care professionals to have a more empathetic understanding of what we’re dealing with which in turn, hopefully, will provide better support and resources,” Mr. Denton said.

The My IBD Life website provides resources for patients to navigate a range of common scenarios, including conversations about new medications, workplace concerns, intimacy and relationships, vacations and travel, and medical procedures and surgeries. An interactive 3D graphic demonstrates how IBD affects the body, and videos of patients highlight personal experiences and ways to build emotional resilience.

The My IBD Life campaign is supported by an independent grant from Bristol Myers Squibb.

Alpha-gal syndrome is an increasingly common cause of gastrointestinal issues that remains underrecognized by the medical community, according to an American Gastroenterological Association clinical practice update.

Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.

“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.

To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.

“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”

Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.

“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.

In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.

Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.

“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.

Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.

The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.

The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.

Alpha-gal syndrome is an increasingly common cause of gastrointestinal issues that remains underrecognized by the medical community, according to an American Gastroenterological Association clinical practice update.

Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.

“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.

To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.

“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”

Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.

“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.

In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.

Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.

“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.

Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.

The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.

The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.

Alpha-gal syndrome is an increasingly common cause of gastrointestinal issues that remains underrecognized by the medical community, according to an American Gastroenterological Association clinical practice update.

Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.

“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.

To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.

“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”

Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.

“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.

In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.

Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.

“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.

Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.

The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.

The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.

Vedolizumab appears to be effective at reducing intestinal inflammation and inducing remission in patients who developed chronic pouchitis after undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, according to a phase 4 trial.

The incidence of modified Pouchitis Disease Activity Index (mPDAI)–defined remission after 14 weeks was 31% for vedolizumab, compared with 10% for placebo.

“Vedolizumab works in both ulcerative colitis and Crohn’s disease, so it appeared rational to test its efficacy in chronic, antibiotic-resistant pouchitis,” lead author Simon Travis, DPhil, professor of clinical gastroenterology at the University of Oxford’s Kennedy Institute of Rheumatology and Translational Gastroenterology Unit in the United Kingdom, said in an interview.

“Vedolizumab works for antibiotic-resistant pouchitis,” he said. “It is the first advanced therapy licensed for chronic pouchitis in Europe and can be a game changer for patients who develop pouchitis after experiencing ulcerative colitis severe enough to need colectomy who might have thought that surgery would be the ultimate solution.”

The study was published online in The New England Journal of Medicine.


 

Treating chronic pouchitis

About half of patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA will develop pouchitis within 5 years, the authors write. Among those, about one-fifth will have chronic pouchitis, with symptoms that last longer than 4 weeks. Symptoms include increased stool frequency, abdominal pain, fecal urgency, and impaired quality of life.

Typically, antibiotics are recommended as first-line treatment for acute pouchitis, but antibiotic resistance is common. Previous studies have suggested that tumor necrosis factor antagonists and the monoclonal antibodies vedolizumab and ustekinumab may be effective in pouchitis that is refractory to antibiotics.

The U.S. Food and Drug Administration has approved vedolizumab as a treatment for moderate to severe ulcerative colitis and Crohn’s disease. In early 2022, the European Commission approved vedolizumab for adult patients with moderate to severe active chronic pouchitis who had undergone proctocolectomy with IPAA and had an inadequate response to antibiotic therapy. The approval was based on results from the EARNEST trial.

As part of the EARNEST trial, Dr. Travis and colleagues at 31 sites in North America and Europe conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab for chronic pouchitis after IPAA for ulcerative colitis.

Between October 2016 and March 2020, researchers identified 102 adult patients who met the study criteria. They were eligible if they had undergone proctocolectomy at least 1 year before screening and had active chronic pouchitis, which was defined by an mPDAI score of 5 or more and a minimum subscore of 2 on the endoscopic domain.

After a 28-day screening period, patients were randomly assigned in a 1:1 ratio to receive 300 mg of intravenous vedolizumab or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All patients also received 500 mg of oral ciprofloxacin twice daily from weeks 1 to 4. Additional courses of antibiotics were allowed, as needed, for pouchitis flares that occurred after week 14.

The primary endpoint was mPDAI-defined remission, or an mPDAI score of 4 or less and a reduction of 2 or more points on the 12-point scale at week 14.

Other endpoints included mPDAI-defined remission at week 34, mPDAI-defined response (a reduction of 2 or more points) at weeks 14 and 34, and PDAI-defined remission (a PDAI score of 6 or less and a reduction of 3 or more points on the 18-point scale) at weeks 14 and 34. The mPDAI is based on clinical symptoms and endoscopic findings, whereas the PDAI is based on clinical symptoms, endoscopic findings, and histologic findings.

Overall, 36 patients (71%) in the vedolizumab group and 32 patients (63%) in the placebo group completed treatment and received all infusions through week 30. Eight patients in each group discontinued vedolizumab or placebo owing to a lack of efficacy. Demographic and clinical characteristics were similar in the two groups – about 84% of the patients were White, and the majority were men.

At the 14-week mark, 16 of 51 patients (31%) in the vedolizumab group and 5 of 51 patients (10%) in the placebo group achieved mPDAI-defined remission (a 21–percentage point difference; 95% CI, 5-38; P = .01). At week 34, 35% of the vedolizumab group and 18% of the placebo group reached remission. A post hoc analysis found that a high percentage of patients in the vedolizumab group reached remission regardless of whether concomitant antibiotics were used before week 14 or 34.

“Concomitant antibiotic use after week 4 was reported in a higher percentage of patients in the vedolizumab group than in the placebo group, a finding that was unexpected,” the authors write. “However, the use of additional antibiotics was not considered to be a treatment failure because antibiotics are the current standard of care for chronic pouchitis.”
 

Additional findings

Vedolizumab showed major differences in the other endpoints as well. The percentage of patients with PDAI-defined remission was 35% in the vedolizumab group versus 10% in the placebo group at week 14, and 37% versus 18% at week 34.

The percentage of patients with mPDAI-defined response at week 14 was 63% among the vedolizumab group and 33% among the placebo group. By week 34, the between-group difference was 51% versus 29%.

Vedolizumab also showed greater changes in total PDAI scores, including endoscopic and histologic subscores, as well as remission and response defined by the Inflammatory Bowel Disease Questionnaire (IBDQ). However, there were no significant differences in changes from baseline for the IBDQ or the Cleveland Global Quality of Life (CGQL) score.

The vedolizumab group had a higher percentage of patients with sustained mPDAI-defined remission (difference, 22 percentage points; 95% CI, 6-37) and sustained PDAI-defined remission (difference, 23 percentage points; 95% CI, 8-39).

Adverse events were reported in 47 patients (92%) in the vedolizumab group and 44 patients (86%) in the placebo group. Pouchitis was reported as an adverse event in 24 patients (47%) in the vedolizumab group and 20 patients (39%) in the placebo group. More patients in the vedolizumab group also reported upper respiratory tract infections and headaches.

Serious adverse events occurred in three patients (6%) in the vedolizumab group and four patients (8%) in the placebo group. One adverse event led to discontinuation of vedolizumab, and no serious adverse events were related to vedolizumab or led to discontinuation of vedolizumab.
 

‘Landmark study’

“This is a landmark study that shows us that a biologic that we have used for Crohn’s disease and ulcerative colitis may also be used to treat chronic pouchitis. This is a large unmet need for our patients and an important advancement for the field,” Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic, told this news organization.

The Cleveland Clinic has one of the highest referral rates in the country for IPAA, noted Dr. Regueiro, who wasn’t involved with this study. Colleagues are currently conducting studies to determine who may develop pouchitis and understand why certain patients develop pouchitis after the procedure, he said.

One question the EARNEST trial leaves unanswered is whether vedolizumab will be required as a sustained medicine to control pouchitis or could be stopped at some point, he said. “My sense is that, as is the case with any IBD, chronic treatment will be required,” he added.

The higher rate of ciprofloxacin use among patients who received vedolizumab is interesting, Dr. Regueiro said.

“[The researchers] note that ciprofloxacin was used for symptoms and do not know if there was active inflammation. It’s possible that bacterial overgrowth caused symptoms and the antibiotic treated that, and in a study this small, it is difficult to say anything more,” he said.

The study was sponsored by Takeda, the manufacturer of vedolizumab. Several authors reported speaking fees and consultant roles for numerous pharmaceutical companies, including Takeda. Three of the authors are employees of Takeda. Dr. Regueiro reported no relevant disclosures.

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

Vedolizumab appears to be effective at reducing intestinal inflammation and inducing remission in patients who developed chronic pouchitis after undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, according to a phase 4 trial.

The incidence of modified Pouchitis Disease Activity Index (mPDAI)–defined remission after 14 weeks was 31% for vedolizumab, compared with 10% for placebo.

“Vedolizumab works in both ulcerative colitis and Crohn’s disease, so it appeared rational to test its efficacy in chronic, antibiotic-resistant pouchitis,” lead author Simon Travis, DPhil, professor of clinical gastroenterology at the University of Oxford’s Kennedy Institute of Rheumatology and Translational Gastroenterology Unit in the United Kingdom, said in an interview.

“Vedolizumab works for antibiotic-resistant pouchitis,” he said. “It is the first advanced therapy licensed for chronic pouchitis in Europe and can be a game changer for patients who develop pouchitis after experiencing ulcerative colitis severe enough to need colectomy who might have thought that surgery would be the ultimate solution.”

The study was published online in The New England Journal of Medicine.


 

Treating chronic pouchitis

About half of patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA will develop pouchitis within 5 years, the authors write. Among those, about one-fifth will have chronic pouchitis, with symptoms that last longer than 4 weeks. Symptoms include increased stool frequency, abdominal pain, fecal urgency, and impaired quality of life.

Typically, antibiotics are recommended as first-line treatment for acute pouchitis, but antibiotic resistance is common. Previous studies have suggested that tumor necrosis factor antagonists and the monoclonal antibodies vedolizumab and ustekinumab may be effective in pouchitis that is refractory to antibiotics.

The U.S. Food and Drug Administration has approved vedolizumab as a treatment for moderate to severe ulcerative colitis and Crohn’s disease. In early 2022, the European Commission approved vedolizumab for adult patients with moderate to severe active chronic pouchitis who had undergone proctocolectomy with IPAA and had an inadequate response to antibiotic therapy. The approval was based on results from the EARNEST trial.

As part of the EARNEST trial, Dr. Travis and colleagues at 31 sites in North America and Europe conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab for chronic pouchitis after IPAA for ulcerative colitis.

Between October 2016 and March 2020, researchers identified 102 adult patients who met the study criteria. They were eligible if they had undergone proctocolectomy at least 1 year before screening and had active chronic pouchitis, which was defined by an mPDAI score of 5 or more and a minimum subscore of 2 on the endoscopic domain.

After a 28-day screening period, patients were randomly assigned in a 1:1 ratio to receive 300 mg of intravenous vedolizumab or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All patients also received 500 mg of oral ciprofloxacin twice daily from weeks 1 to 4. Additional courses of antibiotics were allowed, as needed, for pouchitis flares that occurred after week 14.

The primary endpoint was mPDAI-defined remission, or an mPDAI score of 4 or less and a reduction of 2 or more points on the 12-point scale at week 14.

Other endpoints included mPDAI-defined remission at week 34, mPDAI-defined response (a reduction of 2 or more points) at weeks 14 and 34, and PDAI-defined remission (a PDAI score of 6 or less and a reduction of 3 or more points on the 18-point scale) at weeks 14 and 34. The mPDAI is based on clinical symptoms and endoscopic findings, whereas the PDAI is based on clinical symptoms, endoscopic findings, and histologic findings.

Overall, 36 patients (71%) in the vedolizumab group and 32 patients (63%) in the placebo group completed treatment and received all infusions through week 30. Eight patients in each group discontinued vedolizumab or placebo owing to a lack of efficacy. Demographic and clinical characteristics were similar in the two groups – about 84% of the patients were White, and the majority were men.

At the 14-week mark, 16 of 51 patients (31%) in the vedolizumab group and 5 of 51 patients (10%) in the placebo group achieved mPDAI-defined remission (a 21–percentage point difference; 95% CI, 5-38; P = .01). At week 34, 35% of the vedolizumab group and 18% of the placebo group reached remission. A post hoc analysis found that a high percentage of patients in the vedolizumab group reached remission regardless of whether concomitant antibiotics were used before week 14 or 34.

“Concomitant antibiotic use after week 4 was reported in a higher percentage of patients in the vedolizumab group than in the placebo group, a finding that was unexpected,” the authors write. “However, the use of additional antibiotics was not considered to be a treatment failure because antibiotics are the current standard of care for chronic pouchitis.”
 

Additional findings

Vedolizumab showed major differences in the other endpoints as well. The percentage of patients with PDAI-defined remission was 35% in the vedolizumab group versus 10% in the placebo group at week 14, and 37% versus 18% at week 34.

The percentage of patients with mPDAI-defined response at week 14 was 63% among the vedolizumab group and 33% among the placebo group. By week 34, the between-group difference was 51% versus 29%.

Vedolizumab also showed greater changes in total PDAI scores, including endoscopic and histologic subscores, as well as remission and response defined by the Inflammatory Bowel Disease Questionnaire (IBDQ). However, there were no significant differences in changes from baseline for the IBDQ or the Cleveland Global Quality of Life (CGQL) score.

The vedolizumab group had a higher percentage of patients with sustained mPDAI-defined remission (difference, 22 percentage points; 95% CI, 6-37) and sustained PDAI-defined remission (difference, 23 percentage points; 95% CI, 8-39).

Adverse events were reported in 47 patients (92%) in the vedolizumab group and 44 patients (86%) in the placebo group. Pouchitis was reported as an adverse event in 24 patients (47%) in the vedolizumab group and 20 patients (39%) in the placebo group. More patients in the vedolizumab group also reported upper respiratory tract infections and headaches.

Serious adverse events occurred in three patients (6%) in the vedolizumab group and four patients (8%) in the placebo group. One adverse event led to discontinuation of vedolizumab, and no serious adverse events were related to vedolizumab or led to discontinuation of vedolizumab.
 

‘Landmark study’

“This is a landmark study that shows us that a biologic that we have used for Crohn’s disease and ulcerative colitis may also be used to treat chronic pouchitis. This is a large unmet need for our patients and an important advancement for the field,” Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic, told this news organization.

The Cleveland Clinic has one of the highest referral rates in the country for IPAA, noted Dr. Regueiro, who wasn’t involved with this study. Colleagues are currently conducting studies to determine who may develop pouchitis and understand why certain patients develop pouchitis after the procedure, he said.

One question the EARNEST trial leaves unanswered is whether vedolizumab will be required as a sustained medicine to control pouchitis or could be stopped at some point, he said. “My sense is that, as is the case with any IBD, chronic treatment will be required,” he added.

The higher rate of ciprofloxacin use among patients who received vedolizumab is interesting, Dr. Regueiro said.

“[The researchers] note that ciprofloxacin was used for symptoms and do not know if there was active inflammation. It’s possible that bacterial overgrowth caused symptoms and the antibiotic treated that, and in a study this small, it is difficult to say anything more,” he said.

The study was sponsored by Takeda, the manufacturer of vedolizumab. Several authors reported speaking fees and consultant roles for numerous pharmaceutical companies, including Takeda. Three of the authors are employees of Takeda. Dr. Regueiro reported no relevant disclosures.

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

Vedolizumab appears to be effective at reducing intestinal inflammation and inducing remission in patients who developed chronic pouchitis after undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, according to a phase 4 trial.

The incidence of modified Pouchitis Disease Activity Index (mPDAI)–defined remission after 14 weeks was 31% for vedolizumab, compared with 10% for placebo.

“Vedolizumab works in both ulcerative colitis and Crohn’s disease, so it appeared rational to test its efficacy in chronic, antibiotic-resistant pouchitis,” lead author Simon Travis, DPhil, professor of clinical gastroenterology at the University of Oxford’s Kennedy Institute of Rheumatology and Translational Gastroenterology Unit in the United Kingdom, said in an interview.

“Vedolizumab works for antibiotic-resistant pouchitis,” he said. “It is the first advanced therapy licensed for chronic pouchitis in Europe and can be a game changer for patients who develop pouchitis after experiencing ulcerative colitis severe enough to need colectomy who might have thought that surgery would be the ultimate solution.”

The study was published online in The New England Journal of Medicine.


 

Treating chronic pouchitis

About half of patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA will develop pouchitis within 5 years, the authors write. Among those, about one-fifth will have chronic pouchitis, with symptoms that last longer than 4 weeks. Symptoms include increased stool frequency, abdominal pain, fecal urgency, and impaired quality of life.

Typically, antibiotics are recommended as first-line treatment for acute pouchitis, but antibiotic resistance is common. Previous studies have suggested that tumor necrosis factor antagonists and the monoclonal antibodies vedolizumab and ustekinumab may be effective in pouchitis that is refractory to antibiotics.

The U.S. Food and Drug Administration has approved vedolizumab as a treatment for moderate to severe ulcerative colitis and Crohn’s disease. In early 2022, the European Commission approved vedolizumab for adult patients with moderate to severe active chronic pouchitis who had undergone proctocolectomy with IPAA and had an inadequate response to antibiotic therapy. The approval was based on results from the EARNEST trial.

As part of the EARNEST trial, Dr. Travis and colleagues at 31 sites in North America and Europe conducted a phase 4, double-blind, randomized trial to evaluate vedolizumab for chronic pouchitis after IPAA for ulcerative colitis.

Between October 2016 and March 2020, researchers identified 102 adult patients who met the study criteria. They were eligible if they had undergone proctocolectomy at least 1 year before screening and had active chronic pouchitis, which was defined by an mPDAI score of 5 or more and a minimum subscore of 2 on the endoscopic domain.

After a 28-day screening period, patients were randomly assigned in a 1:1 ratio to receive 300 mg of intravenous vedolizumab or placebo on day 1 and at weeks 2, 6, 14, 22, and 30. All patients also received 500 mg of oral ciprofloxacin twice daily from weeks 1 to 4. Additional courses of antibiotics were allowed, as needed, for pouchitis flares that occurred after week 14.

The primary endpoint was mPDAI-defined remission, or an mPDAI score of 4 or less and a reduction of 2 or more points on the 12-point scale at week 14.

Other endpoints included mPDAI-defined remission at week 34, mPDAI-defined response (a reduction of 2 or more points) at weeks 14 and 34, and PDAI-defined remission (a PDAI score of 6 or less and a reduction of 3 or more points on the 18-point scale) at weeks 14 and 34. The mPDAI is based on clinical symptoms and endoscopic findings, whereas the PDAI is based on clinical symptoms, endoscopic findings, and histologic findings.

Overall, 36 patients (71%) in the vedolizumab group and 32 patients (63%) in the placebo group completed treatment and received all infusions through week 30. Eight patients in each group discontinued vedolizumab or placebo owing to a lack of efficacy. Demographic and clinical characteristics were similar in the two groups – about 84% of the patients were White, and the majority were men.

At the 14-week mark, 16 of 51 patients (31%) in the vedolizumab group and 5 of 51 patients (10%) in the placebo group achieved mPDAI-defined remission (a 21–percentage point difference; 95% CI, 5-38; P = .01). At week 34, 35% of the vedolizumab group and 18% of the placebo group reached remission. A post hoc analysis found that a high percentage of patients in the vedolizumab group reached remission regardless of whether concomitant antibiotics were used before week 14 or 34.

“Concomitant antibiotic use after week 4 was reported in a higher percentage of patients in the vedolizumab group than in the placebo group, a finding that was unexpected,” the authors write. “However, the use of additional antibiotics was not considered to be a treatment failure because antibiotics are the current standard of care for chronic pouchitis.”
 

Additional findings

Vedolizumab showed major differences in the other endpoints as well. The percentage of patients with PDAI-defined remission was 35% in the vedolizumab group versus 10% in the placebo group at week 14, and 37% versus 18% at week 34.

The percentage of patients with mPDAI-defined response at week 14 was 63% among the vedolizumab group and 33% among the placebo group. By week 34, the between-group difference was 51% versus 29%.

Vedolizumab also showed greater changes in total PDAI scores, including endoscopic and histologic subscores, as well as remission and response defined by the Inflammatory Bowel Disease Questionnaire (IBDQ). However, there were no significant differences in changes from baseline for the IBDQ or the Cleveland Global Quality of Life (CGQL) score.

The vedolizumab group had a higher percentage of patients with sustained mPDAI-defined remission (difference, 22 percentage points; 95% CI, 6-37) and sustained PDAI-defined remission (difference, 23 percentage points; 95% CI, 8-39).

Adverse events were reported in 47 patients (92%) in the vedolizumab group and 44 patients (86%) in the placebo group. Pouchitis was reported as an adverse event in 24 patients (47%) in the vedolizumab group and 20 patients (39%) in the placebo group. More patients in the vedolizumab group also reported upper respiratory tract infections and headaches.

Serious adverse events occurred in three patients (6%) in the vedolizumab group and four patients (8%) in the placebo group. One adverse event led to discontinuation of vedolizumab, and no serious adverse events were related to vedolizumab or led to discontinuation of vedolizumab.
 

‘Landmark study’

“This is a landmark study that shows us that a biologic that we have used for Crohn’s disease and ulcerative colitis may also be used to treat chronic pouchitis. This is a large unmet need for our patients and an important advancement for the field,” Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic, told this news organization.

The Cleveland Clinic has one of the highest referral rates in the country for IPAA, noted Dr. Regueiro, who wasn’t involved with this study. Colleagues are currently conducting studies to determine who may develop pouchitis and understand why certain patients develop pouchitis after the procedure, he said.

One question the EARNEST trial leaves unanswered is whether vedolizumab will be required as a sustained medicine to control pouchitis or could be stopped at some point, he said. “My sense is that, as is the case with any IBD, chronic treatment will be required,” he added.

The higher rate of ciprofloxacin use among patients who received vedolizumab is interesting, Dr. Regueiro said.

“[The researchers] note that ciprofloxacin was used for symptoms and do not know if there was active inflammation. It’s possible that bacterial overgrowth caused symptoms and the antibiotic treated that, and in a study this small, it is difficult to say anything more,” he said.

The study was sponsored by Takeda, the manufacturer of vedolizumab. Several authors reported speaking fees and consultant roles for numerous pharmaceutical companies, including Takeda. Three of the authors are employees of Takeda. Dr. Regueiro reported no relevant disclosures.

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

Working with electronic health records may be particularly burdensome for physicians who specialize in inflammatory bowel disease (IBD) or hepatology, as well as for nonphysician providers (NPPs), according to a new study.

IBD and hepatology specialists spend more time per appointment using the EHR, including for clinical review and outside of regular hours, compared with other subspecialists, the study finds. Additionally, NPPs spend more time in EHRs than physicians.

“Given the often-complicated medical histories of patients with IBD as well as the role of IBD specialists as de facto primary care providers for many patients, these findings are not surprising,” wrote authors Aman Bali, MD, and colleagues from Mayo Clinic, Jacksonville, Fla.

The finding that hepatology specialists show similar overall EHR burden as IBD specialists suggests that management of chronic disease in these patient populations may be contributing to this increased workload, they added.

The study was published online in the American Journal of Gastroenterology.
 

EHR burden dissected

Widespread adoption of EHRs has been shown to have significant benefits, but it’s also been identified as a “key driver” of physician burnout. However, the EHR burden specific to GI providers had not been well explored.

To investigate, Dr. Bali and colleagues analyzed data collected through an analytics tool in their EHR system for 41 outpatient GI providers. The data covered 2,803 clinic days and 16,407 appointments over the 6-month period of January to June 2021.

They compared metrics across provider gender; the subspecialties of IBD, hepatology (HEP), esophagus (ESO), advanced endoscopy (AE), and motility/irritable bowel syndrome (IBS); and training (physicians vs. NPPs).

Overall, 76% of providers were physicians and 24% were NPPs; 44% were women, including all the NPPs.

Among the key findings: Female and male gastroenterology providers spent a similar amount of time in the EHR per appointment (22.2 minutes and 19.4 minutes, respectively).

• IBD and hepatology specialists spent more time in the EHR per appointment than other subspecialists (38.3 minutes and 34.6 minutes for IBD and HEP, respectively, vs. 10, 11.2, and 19, for ESO, AE, and motility/IBS, respectively), including more time in clinical review. They also spent more time using the EHR outside of regularly scheduled hours per appointment.
• IBD specialists also received more messages requesting medical advice per appointment than other providers (2.4 per appointment for IBD vs. fewer than 1-1.2 per appointment for the other specialties).
• Junior faculty spent more time outside of scheduled hours, including “pajama time” (5:30 p.m.–7:00 a.m. and weekends), than senior faculty (21.1 minutes vs. 14.8 minutes per appointment) and had a lower percentage of visits closed the same day (20.3% vs. 57.1%), though comparison was limited by small sample size.
• NPPs spent more overall time in the EHR per appointment than physicians (36.2 minutes vs. 20.1 minutes), owing in part to increased time in clinical review per appointment (10.2 minutes vs. 6.6 minutes).
• NPPs received a similar number of medical advice request messages per appointment as physicians (1.4 vs. 1) but spent more time per completed message (70.9 seconds vs. 43.3 seconds).

More research needed

The findings align with a recent study that found “similar evidence of high EHR burden” for gastroenterology providers, Dr. Bali and colleagues wrote. In that study, for each hour of scheduled time, providers spent an additional 45-50 minutes on EHR-related tasks, though no statistically significant differences were identified when comparing NPPs to physicians.

Dr. Bali and colleagues said the increased EHR burden of NPPs in their study may be explained by their institution’s practice model, in which NPPs spend a significant portion of time seeing patients for follow-up visits. This allows physicians time for other tasks, such as procedures and research.

The study did not assess provider burnout and was limited to the metrics provided by their EHR system, the researchers noted. Their findings are from a single tertiary care center that was using one EHR system; the findings may not be valid in different practice settings that use different EHRs.

More data across various practice settings encompassing more providers are needed to understand the true landscape of EHR burden in gastroenterology. That knowledge will be essential to create strategies to address the problem, the researchers wrote.

The study had no external funding. The authors disclosed no relevant financial relationships.

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

Working with electronic health records may be particularly burdensome for physicians who specialize in inflammatory bowel disease (IBD) or hepatology, as well as for nonphysician providers (NPPs), according to a new study.

IBD and hepatology specialists spend more time per appointment using the EHR, including for clinical review and outside of regular hours, compared with other subspecialists, the study finds. Additionally, NPPs spend more time in EHRs than physicians.

“Given the often-complicated medical histories of patients with IBD as well as the role of IBD specialists as de facto primary care providers for many patients, these findings are not surprising,” wrote authors Aman Bali, MD, and colleagues from Mayo Clinic, Jacksonville, Fla.

The finding that hepatology specialists show similar overall EHR burden as IBD specialists suggests that management of chronic disease in these patient populations may be contributing to this increased workload, they added.

The study was published online in the American Journal of Gastroenterology.
 

EHR burden dissected

Widespread adoption of EHRs has been shown to have significant benefits, but it’s also been identified as a “key driver” of physician burnout. However, the EHR burden specific to GI providers had not been well explored.

To investigate, Dr. Bali and colleagues analyzed data collected through an analytics tool in their EHR system for 41 outpatient GI providers. The data covered 2,803 clinic days and 16,407 appointments over the 6-month period of January to June 2021.

They compared metrics across provider gender; the subspecialties of IBD, hepatology (HEP), esophagus (ESO), advanced endoscopy (AE), and motility/irritable bowel syndrome (IBS); and training (physicians vs. NPPs).

Overall, 76% of providers were physicians and 24% were NPPs; 44% were women, including all the NPPs.

Among the key findings: Female and male gastroenterology providers spent a similar amount of time in the EHR per appointment (22.2 minutes and 19.4 minutes, respectively).

• IBD and hepatology specialists spent more time in the EHR per appointment than other subspecialists (38.3 minutes and 34.6 minutes for IBD and HEP, respectively, vs. 10, 11.2, and 19, for ESO, AE, and motility/IBS, respectively), including more time in clinical review. They also spent more time using the EHR outside of regularly scheduled hours per appointment.
• IBD specialists also received more messages requesting medical advice per appointment than other providers (2.4 per appointment for IBD vs. fewer than 1-1.2 per appointment for the other specialties).
• Junior faculty spent more time outside of scheduled hours, including “pajama time” (5:30 p.m.–7:00 a.m. and weekends), than senior faculty (21.1 minutes vs. 14.8 minutes per appointment) and had a lower percentage of visits closed the same day (20.3% vs. 57.1%), though comparison was limited by small sample size.
• NPPs spent more overall time in the EHR per appointment than physicians (36.2 minutes vs. 20.1 minutes), owing in part to increased time in clinical review per appointment (10.2 minutes vs. 6.6 minutes).
• NPPs received a similar number of medical advice request messages per appointment as physicians (1.4 vs. 1) but spent more time per completed message (70.9 seconds vs. 43.3 seconds).

More research needed

The findings align with a recent study that found “similar evidence of high EHR burden” for gastroenterology providers, Dr. Bali and colleagues wrote. In that study, for each hour of scheduled time, providers spent an additional 45-50 minutes on EHR-related tasks, though no statistically significant differences were identified when comparing NPPs to physicians.

Dr. Bali and colleagues said the increased EHR burden of NPPs in their study may be explained by their institution’s practice model, in which NPPs spend a significant portion of time seeing patients for follow-up visits. This allows physicians time for other tasks, such as procedures and research.

The study did not assess provider burnout and was limited to the metrics provided by their EHR system, the researchers noted. Their findings are from a single tertiary care center that was using one EHR system; the findings may not be valid in different practice settings that use different EHRs.

More data across various practice settings encompassing more providers are needed to understand the true landscape of EHR burden in gastroenterology. That knowledge will be essential to create strategies to address the problem, the researchers wrote.

The study had no external funding. The authors disclosed no relevant financial relationships.

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

Working with electronic health records may be particularly burdensome for physicians who specialize in inflammatory bowel disease (IBD) or hepatology, as well as for nonphysician providers (NPPs), according to a new study.

IBD and hepatology specialists spend more time per appointment using the EHR, including for clinical review and outside of regular hours, compared with other subspecialists, the study finds. Additionally, NPPs spend more time in EHRs than physicians.

“Given the often-complicated medical histories of patients with IBD as well as the role of IBD specialists as de facto primary care providers for many patients, these findings are not surprising,” wrote authors Aman Bali, MD, and colleagues from Mayo Clinic, Jacksonville, Fla.

The finding that hepatology specialists show similar overall EHR burden as IBD specialists suggests that management of chronic disease in these patient populations may be contributing to this increased workload, they added.

The study was published online in the American Journal of Gastroenterology.
 

EHR burden dissected

Widespread adoption of EHRs has been shown to have significant benefits, but it’s also been identified as a “key driver” of physician burnout. However, the EHR burden specific to GI providers had not been well explored.

To investigate, Dr. Bali and colleagues analyzed data collected through an analytics tool in their EHR system for 41 outpatient GI providers. The data covered 2,803 clinic days and 16,407 appointments over the 6-month period of January to June 2021.

They compared metrics across provider gender; the subspecialties of IBD, hepatology (HEP), esophagus (ESO), advanced endoscopy (AE), and motility/irritable bowel syndrome (IBS); and training (physicians vs. NPPs).

Overall, 76% of providers were physicians and 24% were NPPs; 44% were women, including all the NPPs.

Among the key findings: Female and male gastroenterology providers spent a similar amount of time in the EHR per appointment (22.2 minutes and 19.4 minutes, respectively).

• IBD and hepatology specialists spent more time in the EHR per appointment than other subspecialists (38.3 minutes and 34.6 minutes for IBD and HEP, respectively, vs. 10, 11.2, and 19, for ESO, AE, and motility/IBS, respectively), including more time in clinical review. They also spent more time using the EHR outside of regularly scheduled hours per appointment.
• IBD specialists also received more messages requesting medical advice per appointment than other providers (2.4 per appointment for IBD vs. fewer than 1-1.2 per appointment for the other specialties).
• Junior faculty spent more time outside of scheduled hours, including “pajama time” (5:30 p.m.–7:00 a.m. and weekends), than senior faculty (21.1 minutes vs. 14.8 minutes per appointment) and had a lower percentage of visits closed the same day (20.3% vs. 57.1%), though comparison was limited by small sample size.
• NPPs spent more overall time in the EHR per appointment than physicians (36.2 minutes vs. 20.1 minutes), owing in part to increased time in clinical review per appointment (10.2 minutes vs. 6.6 minutes).
• NPPs received a similar number of medical advice request messages per appointment as physicians (1.4 vs. 1) but spent more time per completed message (70.9 seconds vs. 43.3 seconds).

More research needed

The findings align with a recent study that found “similar evidence of high EHR burden” for gastroenterology providers, Dr. Bali and colleagues wrote. In that study, for each hour of scheduled time, providers spent an additional 45-50 minutes on EHR-related tasks, though no statistically significant differences were identified when comparing NPPs to physicians.

Dr. Bali and colleagues said the increased EHR burden of NPPs in their study may be explained by their institution’s practice model, in which NPPs spend a significant portion of time seeing patients for follow-up visits. This allows physicians time for other tasks, such as procedures and research.

The study did not assess provider burnout and was limited to the metrics provided by their EHR system, the researchers noted. Their findings are from a single tertiary care center that was using one EHR system; the findings may not be valid in different practice settings that use different EHRs.

More data across various practice settings encompassing more providers are needed to understand the true landscape of EHR burden in gastroenterology. That knowledge will be essential to create strategies to address the problem, the researchers wrote.

The study had no external funding. The authors disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

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

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

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

The Food and Drug Administration has approved a citrate-free, 100 mg/mL formulation of the biosimilar adalimumab-adaz (Hyrimoz), according to a statement from manufacturer Sandoz.

Hyrimoz, a tumor necrosis factor (TNF) blocker that is biosimilar to its reference product Humira, was approved by the FDA in 2018 at a concentration of 50 mg/mL for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The high-concentration formula is indicated for these same conditions.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Sandoz said that it intends to launch the citrate-free formulation in the United States on July 1. It will be one of up to nine other adalimumab biosimilars that are expected to launch in July. On January 31, Amjevita (adalimumab-atto) became the first adalimumab biosimilar to launch in the United States.

The current label for Hyrimoz contains a black box warning emphasizing certain risks, notably the increased risk for serious infections, such as tuberculosis or sepsis, and an increased risk of malignancy, particularly lymphomas.

Adverse effects associated with Hyrimoz with an incidence greater than 10% include upper respiratory infections and sinusitis, injection-site reactions, headache, and rash.

The approval for the high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study that compared Hyrimoz 50 mg/mL and citrate-free Hyrimoz 100 mg/mL.

“This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz [100 mg/mL],” according to Sandoz, a division of Novartis.

The approval for Hyrimoz 50 mg/mL in 2018 was based on preclinical and clinical research comparing Hyrimoz and Humira. In a phase 3 trial published in the British Journal of Dermatology, which included adults with clinically stable but active moderate to severe chronic plaque psoriasis, Hyrimoz and Humira showed a similar percentage of patients met the primary endpoint of a 75% reduction or more in Psoriasis Area and Severity Index (PASI 75) score at 16 weeks, compared with baseline (66.8% and 65%, respectively).

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

The reversible oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq, AbbVie) was associated with superior endoscopic outcomes at 12 weeks and 1 year compared with placebo among people with moderately to severely active Crohn’s disease.

The findings of this subanalysis come from two phase 3 induction trials (U-EXCEL and U-EXCEED) and one maintenance study (U-ENDURE) of upadacitinib in this patient population.

“Upadacitinib shows large differences relative to placebo in endoscopic response and remission ... in a difficult-to-treat population of patients, the majority of whom had failed an advanced therapy,” lead investigator Brian Feagan, MD, senior scientific director of the GI contract research firm Alimentiv in London, Ontario, said in an interview.

“The absolute magnitude of the finding was unanticipated – a greater treatment effect than might be anticipated for these outcomes compared with other advanced treatments for Crohn’s disease in these higher-risk patients,” he said.

Dr. Feagan presented the research at the annual congress of the European Crohn’s and Colitis Organisation.
 

Research methodology

At baseline, participants had an average daily stool frequency of 4 or more and/or an abdominal pain score of 2 or greater. They also had a Simple Endoscopic Score for Crohn’s disease of 6 or more, excluding a narrowing component, or a score of 4 or more for isolated ileal Crohn’s disease.

In the treatment induction phase, patients were randomly assigned 2:1, with 674 people receiving 45 mg upadacitinib and 347 taking a placebo once daily for 12 weeks.

Participants who experienced at least a 30% decrease in stool frequency and/or daily abdominal pain scores were enrolled in the maintenance phase of the study. For this phase, patients were randomly assigned again, with 168 receiving 30 mg upadacitinib, 169 receiving 15 mg upadacitinib, and 165 taking a placebo once daily for 52 weeks.

In each induction and maintenance cohort, more than 70% of patients had failed one prior biologic therapy, with failure defined as inadequate response or intolerance. Among those who failed a previous biologic in induction, 96% had also failed prior treatment with an anti–tumor necrosis factor (anti-TNF) inhibitor.

Participants’ mean age was 38-40 years, and 52%-55% were men. Patients who had not failed previous therapy had Crohn’s disease for a median of 6-7 years. In contrast, the prior-failure group had Crohn’s disease for a median of 9-10 years.
 

Key outcomes

At 12 weeks, endoscopic response among patients who had not failed a prior biologic was 52% in the treatment group versus 16% of the placebo group. In the prior-failure group, endoscopic response was observed in 36% and 5%, respectively.

Endoscopic remission at 12 weeks among patients who had not failed a prior biologic was 36% in the treatment group versus 10% in the placebo group. In the prior-failure group, endoscopic remission was 20% in the treatment group versus 3% in those who took placebo.

Participants in the treatment groups of the 52-week maintenance phase of the study experienced higher endoscopic response and endoscopic remission rates compared with those who received placebo.

Endoscopic response in the group without prior biologic failure was 44% in the 30-mg upadacitinib group, 40% in the 15-mg group, and 18% in the placebo group. Among those with prior biologic failure, endoscopic response was seen in 39% of the 30-mg upadacitinib group, 23% of the 15-mg group, and 4% of the placebo group.

There is a “very striking difference in endoscopic response rates between the high dose and placebo,” Dr. Feagan said. “That difference here is in the response rate. You see dose separation.”

Endoscopic remission among those without prior biologic failure was observed in 34% of the 30-mg upadacitinib group, 27% of the 15-mg group, and 16% of the placebo group. Among those with prior biologic failure, endoscopic remission was seen in 27% of the 30-mg upadacitinib group, 16% of the 15-mg group, and 2% of the placebo group.

The results show “a clear advantage for the 30-mg dose versus the 15-mg in the maintenance component, especially in patients who had failed an advanced therapy,” Dr. Feagan said.
 

Safety signals

Upadacitinib was well tolerated in the induction and maintenance phases, and no new safety risks were observed compared with the known safety profile of the drug, the researchers noted.

For example, during the induction studies, the rate of any adverse event among patients without prior biologic failure was 60% in the 45-mg upadacitinib group and 53% in the placebo group. Among those who failed a prior biologic, the rates were 67% in the 45-mg upadacitinib group and 66% in the placebo group.

The adverse events were “issues that have already been identified with JAK inhibitors, the biochemical abnormalities with CPK [creatine phosphokinase] elevations and transaminase elevations,” Dr. Feagan said.

There were no cases of herpes zoster among patients who received placebo compared with five cases in the 45-mg upadacitinib group without prior biologic failure and 10 cases in the prior biologic failure group.

“The zoster signal is there even at induction with the 45-mg dose versus placebo,” Dr. Feagan said.
 

‘Encouraging’ results

The study indicates that upadacitinib is effective in improving endoscopic outcomes for patients with Crohn’s disease, regardless of their prior biologic treatments, Robin L. Dalal, MD, assistant professor of medicine at Vanderbilt University in Nashville, Tenn., said when asked to comment on the study.

“This is important because, as the treatment landscape for Crohn’s disease has expanded, sequencing of therapies has become more complex,” added Dr. Dalal, who was not involved in the research. “For upadacitinib in Crohn’s disease, prior biologic use may not be a factor in endoscopic response rates.”

The findings are “very encouraging for physicians and practitioners who treat IBD [inflammatory bowel disease] patients,” Maithili Chitnavis, MD, of the inflammatory bowel disease section at Atrium Health Gastroenterology in Charlotte, N.C., said when asked for comment.

“We clearly care about how patients feel overall, but endoscopic and histologic outcomes are important to investigate because we want to ensure there is internal healing to prevent a lot of the longstanding complications of Crohn’s disease, such as malignancy, strictures, fistulizing/penetrating disease, and need for surgery,” said Dr. Chitnavis, who was not involved with the study.

Upadacitinib is an oral agent, which distinguishes it from the injectable or infusion-based biologic therapies for Crohn’s disease, Dr. Chitnavis noted.

The finding that the medication works in patients with or without prior biologic failure is important, she said.

“With its anticipated ... approval for Crohn’s disease [by the Food and Drug Administration], it is expected that patients will have had to have demonstrated a lack of or loss of response to another biologic, specifically in the anti-TNF category (for example, infliximab, adalimumab, certolizumab) prior to starting upadacitinib due to concerns of potential side effects associated with the class of medications to which it belongs,” Dr. Chitnavis said. “Therefore, it makes it even more relevant to know how patients who have failed a prior biologic respond to this therapy.”

Dr. Feagan has reported serving as a consultant and speaker for AbbVie. Dr. Dalal has reported being a consultant for AbbVie in 2021. Dr. Chitnavis has reported no relevant financial relationships.

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

The reversible oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq, AbbVie) was associated with superior endoscopic outcomes at 12 weeks and 1 year compared with placebo among people with moderately to severely active Crohn’s disease.

The findings of this subanalysis come from two phase 3 induction trials (U-EXCEL and U-EXCEED) and one maintenance study (U-ENDURE) of upadacitinib in this patient population.

“Upadacitinib shows large differences relative to placebo in endoscopic response and remission ... in a difficult-to-treat population of patients, the majority of whom had failed an advanced therapy,” lead investigator Brian Feagan, MD, senior scientific director of the GI contract research firm Alimentiv in London, Ontario, said in an interview.

“The absolute magnitude of the finding was unanticipated – a greater treatment effect than might be anticipated for these outcomes compared with other advanced treatments for Crohn’s disease in these higher-risk patients,” he said.

Dr. Feagan presented the research at the annual congress of the European Crohn’s and Colitis Organisation.
 

Research methodology

At baseline, participants had an average daily stool frequency of 4 or more and/or an abdominal pain score of 2 or greater. They also had a Simple Endoscopic Score for Crohn’s disease of 6 or more, excluding a narrowing component, or a score of 4 or more for isolated ileal Crohn’s disease.

In the treatment induction phase, patients were randomly assigned 2:1, with 674 people receiving 45 mg upadacitinib and 347 taking a placebo once daily for 12 weeks.

Participants who experienced at least a 30% decrease in stool frequency and/or daily abdominal pain scores were enrolled in the maintenance phase of the study. For this phase, patients were randomly assigned again, with 168 receiving 30 mg upadacitinib, 169 receiving 15 mg upadacitinib, and 165 taking a placebo once daily for 52 weeks.

In each induction and maintenance cohort, more than 70% of patients had failed one prior biologic therapy, with failure defined as inadequate response or intolerance. Among those who failed a previous biologic in induction, 96% had also failed prior treatment with an anti–tumor necrosis factor (anti-TNF) inhibitor.

Participants’ mean age was 38-40 years, and 52%-55% were men. Patients who had not failed previous therapy had Crohn’s disease for a median of 6-7 years. In contrast, the prior-failure group had Crohn’s disease for a median of 9-10 years.
 

Key outcomes

At 12 weeks, endoscopic response among patients who had not failed a prior biologic was 52% in the treatment group versus 16% of the placebo group. In the prior-failure group, endoscopic response was observed in 36% and 5%, respectively.

Endoscopic remission at 12 weeks among patients who had not failed a prior biologic was 36% in the treatment group versus 10% in the placebo group. In the prior-failure group, endoscopic remission was 20% in the treatment group versus 3% in those who took placebo.

Participants in the treatment groups of the 52-week maintenance phase of the study experienced higher endoscopic response and endoscopic remission rates compared with those who received placebo.

Endoscopic response in the group without prior biologic failure was 44% in the 30-mg upadacitinib group, 40% in the 15-mg group, and 18% in the placebo group. Among those with prior biologic failure, endoscopic response was seen in 39% of the 30-mg upadacitinib group, 23% of the 15-mg group, and 4% of the placebo group.

There is a “very striking difference in endoscopic response rates between the high dose and placebo,” Dr. Feagan said. “That difference here is in the response rate. You see dose separation.”

Endoscopic remission among those without prior biologic failure was observed in 34% of the 30-mg upadacitinib group, 27% of the 15-mg group, and 16% of the placebo group. Among those with prior biologic failure, endoscopic remission was seen in 27% of the 30-mg upadacitinib group, 16% of the 15-mg group, and 2% of the placebo group.

The results show “a clear advantage for the 30-mg dose versus the 15-mg in the maintenance component, especially in patients who had failed an advanced therapy,” Dr. Feagan said.
 

Safety signals

Upadacitinib was well tolerated in the induction and maintenance phases, and no new safety risks were observed compared with the known safety profile of the drug, the researchers noted.

For example, during the induction studies, the rate of any adverse event among patients without prior biologic failure was 60% in the 45-mg upadacitinib group and 53% in the placebo group. Among those who failed a prior biologic, the rates were 67% in the 45-mg upadacitinib group and 66% in the placebo group.

The adverse events were “issues that have already been identified with JAK inhibitors, the biochemical abnormalities with CPK [creatine phosphokinase] elevations and transaminase elevations,” Dr. Feagan said.

There were no cases of herpes zoster among patients who received placebo compared with five cases in the 45-mg upadacitinib group without prior biologic failure and 10 cases in the prior biologic failure group.

“The zoster signal is there even at induction with the 45-mg dose versus placebo,” Dr. Feagan said.
 

‘Encouraging’ results

The study indicates that upadacitinib is effective in improving endoscopic outcomes for patients with Crohn’s disease, regardless of their prior biologic treatments, Robin L. Dalal, MD, assistant professor of medicine at Vanderbilt University in Nashville, Tenn., said when asked to comment on the study.

“This is important because, as the treatment landscape for Crohn’s disease has expanded, sequencing of therapies has become more complex,” added Dr. Dalal, who was not involved in the research. “For upadacitinib in Crohn’s disease, prior biologic use may not be a factor in endoscopic response rates.”

The findings are “very encouraging for physicians and practitioners who treat IBD [inflammatory bowel disease] patients,” Maithili Chitnavis, MD, of the inflammatory bowel disease section at Atrium Health Gastroenterology in Charlotte, N.C., said when asked for comment.

“We clearly care about how patients feel overall, but endoscopic and histologic outcomes are important to investigate because we want to ensure there is internal healing to prevent a lot of the longstanding complications of Crohn’s disease, such as malignancy, strictures, fistulizing/penetrating disease, and need for surgery,” said Dr. Chitnavis, who was not involved with the study.

Upadacitinib is an oral agent, which distinguishes it from the injectable or infusion-based biologic therapies for Crohn’s disease, Dr. Chitnavis noted.

The finding that the medication works in patients with or without prior biologic failure is important, she said.

“With its anticipated ... approval for Crohn’s disease [by the Food and Drug Administration], it is expected that patients will have had to have demonstrated a lack of or loss of response to another biologic, specifically in the anti-TNF category (for example, infliximab, adalimumab, certolizumab) prior to starting upadacitinib due to concerns of potential side effects associated with the class of medications to which it belongs,” Dr. Chitnavis said. “Therefore, it makes it even more relevant to know how patients who have failed a prior biologic respond to this therapy.”

Dr. Feagan has reported serving as a consultant and speaker for AbbVie. Dr. Dalal has reported being a consultant for AbbVie in 2021. Dr. Chitnavis has reported no relevant financial relationships.

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

The reversible oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq, AbbVie) was associated with superior endoscopic outcomes at 12 weeks and 1 year compared with placebo among people with moderately to severely active Crohn’s disease.

The findings of this subanalysis come from two phase 3 induction trials (U-EXCEL and U-EXCEED) and one maintenance study (U-ENDURE) of upadacitinib in this patient population.

“Upadacitinib shows large differences relative to placebo in endoscopic response and remission ... in a difficult-to-treat population of patients, the majority of whom had failed an advanced therapy,” lead investigator Brian Feagan, MD, senior scientific director of the GI contract research firm Alimentiv in London, Ontario, said in an interview.

“The absolute magnitude of the finding was unanticipated – a greater treatment effect than might be anticipated for these outcomes compared with other advanced treatments for Crohn’s disease in these higher-risk patients,” he said.

Dr. Feagan presented the research at the annual congress of the European Crohn’s and Colitis Organisation.
 

Research methodology

At baseline, participants had an average daily stool frequency of 4 or more and/or an abdominal pain score of 2 or greater. They also had a Simple Endoscopic Score for Crohn’s disease of 6 or more, excluding a narrowing component, or a score of 4 or more for isolated ileal Crohn’s disease.

In the treatment induction phase, patients were randomly assigned 2:1, with 674 people receiving 45 mg upadacitinib and 347 taking a placebo once daily for 12 weeks.

Participants who experienced at least a 30% decrease in stool frequency and/or daily abdominal pain scores were enrolled in the maintenance phase of the study. For this phase, patients were randomly assigned again, with 168 receiving 30 mg upadacitinib, 169 receiving 15 mg upadacitinib, and 165 taking a placebo once daily for 52 weeks.

In each induction and maintenance cohort, more than 70% of patients had failed one prior biologic therapy, with failure defined as inadequate response or intolerance. Among those who failed a previous biologic in induction, 96% had also failed prior treatment with an anti–tumor necrosis factor (anti-TNF) inhibitor.

Participants’ mean age was 38-40 years, and 52%-55% were men. Patients who had not failed previous therapy had Crohn’s disease for a median of 6-7 years. In contrast, the prior-failure group had Crohn’s disease for a median of 9-10 years.
 

Key outcomes

At 12 weeks, endoscopic response among patients who had not failed a prior biologic was 52% in the treatment group versus 16% of the placebo group. In the prior-failure group, endoscopic response was observed in 36% and 5%, respectively.

Endoscopic remission at 12 weeks among patients who had not failed a prior biologic was 36% in the treatment group versus 10% in the placebo group. In the prior-failure group, endoscopic remission was 20% in the treatment group versus 3% in those who took placebo.

Participants in the treatment groups of the 52-week maintenance phase of the study experienced higher endoscopic response and endoscopic remission rates compared with those who received placebo.

Endoscopic response in the group without prior biologic failure was 44% in the 30-mg upadacitinib group, 40% in the 15-mg group, and 18% in the placebo group. Among those with prior biologic failure, endoscopic response was seen in 39% of the 30-mg upadacitinib group, 23% of the 15-mg group, and 4% of the placebo group.

There is a “very striking difference in endoscopic response rates between the high dose and placebo,” Dr. Feagan said. “That difference here is in the response rate. You see dose separation.”

Endoscopic remission among those without prior biologic failure was observed in 34% of the 30-mg upadacitinib group, 27% of the 15-mg group, and 16% of the placebo group. Among those with prior biologic failure, endoscopic remission was seen in 27% of the 30-mg upadacitinib group, 16% of the 15-mg group, and 2% of the placebo group.

The results show “a clear advantage for the 30-mg dose versus the 15-mg in the maintenance component, especially in patients who had failed an advanced therapy,” Dr. Feagan said.
 

Safety signals

Upadacitinib was well tolerated in the induction and maintenance phases, and no new safety risks were observed compared with the known safety profile of the drug, the researchers noted.

For example, during the induction studies, the rate of any adverse event among patients without prior biologic failure was 60% in the 45-mg upadacitinib group and 53% in the placebo group. Among those who failed a prior biologic, the rates were 67% in the 45-mg upadacitinib group and 66% in the placebo group.

The adverse events were “issues that have already been identified with JAK inhibitors, the biochemical abnormalities with CPK [creatine phosphokinase] elevations and transaminase elevations,” Dr. Feagan said.

There were no cases of herpes zoster among patients who received placebo compared with five cases in the 45-mg upadacitinib group without prior biologic failure and 10 cases in the prior biologic failure group.

“The zoster signal is there even at induction with the 45-mg dose versus placebo,” Dr. Feagan said.
 

‘Encouraging’ results

The study indicates that upadacitinib is effective in improving endoscopic outcomes for patients with Crohn’s disease, regardless of their prior biologic treatments, Robin L. Dalal, MD, assistant professor of medicine at Vanderbilt University in Nashville, Tenn., said when asked to comment on the study.

“This is important because, as the treatment landscape for Crohn’s disease has expanded, sequencing of therapies has become more complex,” added Dr. Dalal, who was not involved in the research. “For upadacitinib in Crohn’s disease, prior biologic use may not be a factor in endoscopic response rates.”

The findings are “very encouraging for physicians and practitioners who treat IBD [inflammatory bowel disease] patients,” Maithili Chitnavis, MD, of the inflammatory bowel disease section at Atrium Health Gastroenterology in Charlotte, N.C., said when asked for comment.

“We clearly care about how patients feel overall, but endoscopic and histologic outcomes are important to investigate because we want to ensure there is internal healing to prevent a lot of the longstanding complications of Crohn’s disease, such as malignancy, strictures, fistulizing/penetrating disease, and need for surgery,” said Dr. Chitnavis, who was not involved with the study.

Upadacitinib is an oral agent, which distinguishes it from the injectable or infusion-based biologic therapies for Crohn’s disease, Dr. Chitnavis noted.

The finding that the medication works in patients with or without prior biologic failure is important, she said.

“With its anticipated ... approval for Crohn’s disease [by the Food and Drug Administration], it is expected that patients will have had to have demonstrated a lack of or loss of response to another biologic, specifically in the anti-TNF category (for example, infliximab, adalimumab, certolizumab) prior to starting upadacitinib due to concerns of potential side effects associated with the class of medications to which it belongs,” Dr. Chitnavis said. “Therefore, it makes it even more relevant to know how patients who have failed a prior biologic respond to this therapy.”

Dr. Feagan has reported serving as a consultant and speaker for AbbVie. Dr. Dalal has reported being a consultant for AbbVie in 2021. Dr. Chitnavis has reported no relevant financial relationships.

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

Diagnosed prevalent cases of ulcerative colitis (UC) in the United States and seven other countries are projected to increase from 1.9 million in 2021 to 2.1 million in 2031, at an annual growth rate of 0.63%, according to a new report by GlobalData.

The data and analytics company’s report offers projections for diagnosed incident and prevalent cases of UC in the United States, United Kingdom, Germany, Spain, Japan, Italy, France, and Canada.

In 2031, the United States will have the highest number of diagnosed prevalent cases of UC, with 655,317 cases, whereas Canada will have the fewest, with 91,186 cases, the company projects.

“UC can occur at any age, although most people are diagnosed in their mid-thirties. Men and women are equally likely to be affected, but older men are more likely to be diagnosed than older women,” Bharti Prabhakar, MPH, associate project manager at GlobalData, said in a statement.

In all eight countries, adults aged 30-69 years accounted for more than 65% of the diagnosed prevalent cases of UC, whereas those younger than 20 years made up less than 3% of the cases, GlobalData noted.
 

Incidence also rising

Diagnosed incident cases of UC in the eight countries are expected to increase from 160,122 cases in 2021 to 168,467 cases in 2031, at an annual growth rate of 0.52%, the company said.

In 2031, the United States will have the highest number of diagnosed incident cases of UC, with 104,795 cases, and France will have the fewest, with 2972 cases, the company predicted.

GlobalData epidemiologists attribute the predicted increases in UC prevalence and incidence to changes in population dynamics in each country.

The forecast is supported by historical data obtained from peer-reviewed articles and population-based studies, the firm noted.

The methodology was kept consistent across the eight countries to allow for a meaningful comparison of the forecast incident and prevalent cases of UC across these markets, GlobalData added.

“UC can affect people of any racial or ethnic group,” Ms. Prabhakar stated. “Genes, abnormal immune reactions, the microbiome, diet, stress, and the environment have all been suggested as triggers, but there is no definite evidence that any one of these factors is the cause of UC.”

Western countries have reported high incidence and prevalence of UC, Ms. Prabhaker noted. “Therefore, environmental factors may either suppress or reinforce inherent predispositions for UC and might also be crucial in triggering disease onset.”

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

Diagnosed prevalent cases of ulcerative colitis (UC) in the United States and seven other countries are projected to increase from 1.9 million in 2021 to 2.1 million in 2031, at an annual growth rate of 0.63%, according to a new report by GlobalData.

The data and analytics company’s report offers projections for diagnosed incident and prevalent cases of UC in the United States, United Kingdom, Germany, Spain, Japan, Italy, France, and Canada.

In 2031, the United States will have the highest number of diagnosed prevalent cases of UC, with 655,317 cases, whereas Canada will have the fewest, with 91,186 cases, the company projects.

“UC can occur at any age, although most people are diagnosed in their mid-thirties. Men and women are equally likely to be affected, but older men are more likely to be diagnosed than older women,” Bharti Prabhakar, MPH, associate project manager at GlobalData, said in a statement.

In all eight countries, adults aged 30-69 years accounted for more than 65% of the diagnosed prevalent cases of UC, whereas those younger than 20 years made up less than 3% of the cases, GlobalData noted.
 

Incidence also rising

Diagnosed incident cases of UC in the eight countries are expected to increase from 160,122 cases in 2021 to 168,467 cases in 2031, at an annual growth rate of 0.52%, the company said.

In 2031, the United States will have the highest number of diagnosed incident cases of UC, with 104,795 cases, and France will have the fewest, with 2972 cases, the company predicted.

GlobalData epidemiologists attribute the predicted increases in UC prevalence and incidence to changes in population dynamics in each country.

The forecast is supported by historical data obtained from peer-reviewed articles and population-based studies, the firm noted.

The methodology was kept consistent across the eight countries to allow for a meaningful comparison of the forecast incident and prevalent cases of UC across these markets, GlobalData added.

“UC can affect people of any racial or ethnic group,” Ms. Prabhakar stated. “Genes, abnormal immune reactions, the microbiome, diet, stress, and the environment have all been suggested as triggers, but there is no definite evidence that any one of these factors is the cause of UC.”

Western countries have reported high incidence and prevalence of UC, Ms. Prabhaker noted. “Therefore, environmental factors may either suppress or reinforce inherent predispositions for UC and might also be crucial in triggering disease onset.”

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

Diagnosed prevalent cases of ulcerative colitis (UC) in the United States and seven other countries are projected to increase from 1.9 million in 2021 to 2.1 million in 2031, at an annual growth rate of 0.63%, according to a new report by GlobalData.

The data and analytics company’s report offers projections for diagnosed incident and prevalent cases of UC in the United States, United Kingdom, Germany, Spain, Japan, Italy, France, and Canada.

In 2031, the United States will have the highest number of diagnosed prevalent cases of UC, with 655,317 cases, whereas Canada will have the fewest, with 91,186 cases, the company projects.

“UC can occur at any age, although most people are diagnosed in their mid-thirties. Men and women are equally likely to be affected, but older men are more likely to be diagnosed than older women,” Bharti Prabhakar, MPH, associate project manager at GlobalData, said in a statement.

In all eight countries, adults aged 30-69 years accounted for more than 65% of the diagnosed prevalent cases of UC, whereas those younger than 20 years made up less than 3% of the cases, GlobalData noted.
 

Incidence also rising

Diagnosed incident cases of UC in the eight countries are expected to increase from 160,122 cases in 2021 to 168,467 cases in 2031, at an annual growth rate of 0.52%, the company said.

In 2031, the United States will have the highest number of diagnosed incident cases of UC, with 104,795 cases, and France will have the fewest, with 2972 cases, the company predicted.

GlobalData epidemiologists attribute the predicted increases in UC prevalence and incidence to changes in population dynamics in each country.

The forecast is supported by historical data obtained from peer-reviewed articles and population-based studies, the firm noted.

The methodology was kept consistent across the eight countries to allow for a meaningful comparison of the forecast incident and prevalent cases of UC across these markets, GlobalData added.

“UC can affect people of any racial or ethnic group,” Ms. Prabhakar stated. “Genes, abnormal immune reactions, the microbiome, diet, stress, and the environment have all been suggested as triggers, but there is no definite evidence that any one of these factors is the cause of UC.”

Western countries have reported high incidence and prevalence of UC, Ms. Prabhaker noted. “Therefore, environmental factors may either suppress or reinforce inherent predispositions for UC and might also be crucial in triggering disease onset.”

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

Researchers have developed and validated an artificial intelligence (AI) tool that can accurately distinguish ulcerative colitis (UC) remission from activity (inflammation) in biopsies and help predict flare-ups.

The AI tool predicted UC disease activity with 89% accuracy and inflammation at the biopsy site with 80% accuracy. Its ability to stratify risk of UC flare was on par with human pathologists.

“This tool in the near future will speed up, simplify, and standardize histological assessment of ulcerative colitis and provide the clinician with accurate prognostic information in real time,” co–lead author Marietta Iacucci, MD, PhD, from the University of Birmingham (England), and University College Cork (Ireland), said in an interview.

“The tool needs to be refined and further validated before it is ready for daily clinical practice. That work is ongoing now,” Dr. Iacucci said.

The researchers describe their advanced AI-based computer-aided detection tool in a study published online in Gastroenterology.
 

‘Strong’ performance

They used 535 digitized biopsies from 273 patients with UC (mean age, 48 years; 41% women) to develop and test the tool. They used a subset of 118 to train it to distinguish remission from activity, 42 to calibrate it, and 375 to test it. An additional 154 biopsies from 58 patients with UC were used to externally validate the tool.

The model also was tested to predict the corresponding endoscopic assessment and occurrence of flares at 12 months.

UC disease activity was defined by three different histologic indices: the Robarts Histopathology Index (RHI), the Nancy Histological Index (NHI), and the newly developed PICaSSO Histologic Remission Index (PHRI).

The AI tool had “strong diagnostic performance to detect disease activity” (PHRI > 0) with an overall area under the receiver operating characteristic curve of 0.87 and sensitivity and specificity of 89% and 85%, respectively.

The researchers note that, while the AI tool was trained for the PHRI, its sensitivity for RHI and NHI histologic remission/activity was also high (94% and 89%, respectively).

Despite the different mix of severity grades, the AI model “maintained a good diagnostic performance, proving its applicability outside the original development setting,” they reported.

The AI tool could also predict the presence of endoscopic inflammation in the biopsy area with about 80% accuracy.

“Though imperfect, this result is consistent with human-assessed correlation between endoscopy and histology,” the researchers noted.

The model predicted the corresponding endoscopic remission/activity with 79% and 82% accuracy for UCEIS and PICaSSO, respectively.

The hazard ratios for disease flare-up between the AI system and pathologists assessed by PHRI was similar (4.64 and 3.56, respectively), “demonstrating the ability of the computer to stratify the risk of flare comparably well to pathologists,” they added. 

Both histology and outcome prediction were confirmed in the external validation cohort.

The AI system delivered results in an average of 9.8 seconds per slide.
 

Potential ‘game changer’

UC is a “complex condition to predict, and developing machine learning–derived systems to make this diagnostic job quicker and more accurate could be a game changer,” Dr. Iacucci said in a news release.

With refinement, the AI tool will have an impact on both clinical trials and daily practice, the researchers wrote. In clinical practice, histological reporting remains “largely descriptive and nonstandard, thus would greatly benefit from a quick and objective assessment. Similarly, clinical trials in UC could efficiently overcome costly central readings.”

Assessing and measuring improvement in endoscopy and histology are difficult parts of treating UC, said David Hudesman, MD, codirector of the Inflammatory Bowel Disease Center at New York University Langone Health.

“We do not know how much improvement is associated with improved long-term outcomes,” Dr. Hudesman said in an interview. “For example, does a patient need complete healing or is 50% better enough?” Dr. Hudesman was not involved with the current research.

“This study showed that AI can predict – with good accuracy – endoscopy and histology scores, as well as 1-year patient outcomes. If this is validated in larger studies, AI can help determine if we should adjust/change therapies or continue, which is very important,” he said.

This research was supported by the National Institute for Health Research Birmingham Biomedical Research Centre. Dr. Iacucci and Dr. Hudesman reported no relevant financial relationships.

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

Researchers have developed and validated an artificial intelligence (AI) tool that can accurately distinguish ulcerative colitis (UC) remission from activity (inflammation) in biopsies and help predict flare-ups.

The AI tool predicted UC disease activity with 89% accuracy and inflammation at the biopsy site with 80% accuracy. Its ability to stratify risk of UC flare was on par with human pathologists.

“This tool in the near future will speed up, simplify, and standardize histological assessment of ulcerative colitis and provide the clinician with accurate prognostic information in real time,” co–lead author Marietta Iacucci, MD, PhD, from the University of Birmingham (England), and University College Cork (Ireland), said in an interview.

“The tool needs to be refined and further validated before it is ready for daily clinical practice. That work is ongoing now,” Dr. Iacucci said.

The researchers describe their advanced AI-based computer-aided detection tool in a study published online in Gastroenterology.
 

‘Strong’ performance

They used 535 digitized biopsies from 273 patients with UC (mean age, 48 years; 41% women) to develop and test the tool. They used a subset of 118 to train it to distinguish remission from activity, 42 to calibrate it, and 375 to test it. An additional 154 biopsies from 58 patients with UC were used to externally validate the tool.

The model also was tested to predict the corresponding endoscopic assessment and occurrence of flares at 12 months.

UC disease activity was defined by three different histologic indices: the Robarts Histopathology Index (RHI), the Nancy Histological Index (NHI), and the newly developed PICaSSO Histologic Remission Index (PHRI).

The AI tool had “strong diagnostic performance to detect disease activity” (PHRI > 0) with an overall area under the receiver operating characteristic curve of 0.87 and sensitivity and specificity of 89% and 85%, respectively.

The researchers note that, while the AI tool was trained for the PHRI, its sensitivity for RHI and NHI histologic remission/activity was also high (94% and 89%, respectively).

Despite the different mix of severity grades, the AI model “maintained a good diagnostic performance, proving its applicability outside the original development setting,” they reported.

The AI tool could also predict the presence of endoscopic inflammation in the biopsy area with about 80% accuracy.

“Though imperfect, this result is consistent with human-assessed correlation between endoscopy and histology,” the researchers noted.

The model predicted the corresponding endoscopic remission/activity with 79% and 82% accuracy for UCEIS and PICaSSO, respectively.

The hazard ratios for disease flare-up between the AI system and pathologists assessed by PHRI was similar (4.64 and 3.56, respectively), “demonstrating the ability of the computer to stratify the risk of flare comparably well to pathologists,” they added. 

Both histology and outcome prediction were confirmed in the external validation cohort.

The AI system delivered results in an average of 9.8 seconds per slide.
 

Potential ‘game changer’

UC is a “complex condition to predict, and developing machine learning–derived systems to make this diagnostic job quicker and more accurate could be a game changer,” Dr. Iacucci said in a news release.

With refinement, the AI tool will have an impact on both clinical trials and daily practice, the researchers wrote. In clinical practice, histological reporting remains “largely descriptive and nonstandard, thus would greatly benefit from a quick and objective assessment. Similarly, clinical trials in UC could efficiently overcome costly central readings.”

Assessing and measuring improvement in endoscopy and histology are difficult parts of treating UC, said David Hudesman, MD, codirector of the Inflammatory Bowel Disease Center at New York University Langone Health.

“We do not know how much improvement is associated with improved long-term outcomes,” Dr. Hudesman said in an interview. “For example, does a patient need complete healing or is 50% better enough?” Dr. Hudesman was not involved with the current research.

“This study showed that AI can predict – with good accuracy – endoscopy and histology scores, as well as 1-year patient outcomes. If this is validated in larger studies, AI can help determine if we should adjust/change therapies or continue, which is very important,” he said.

This research was supported by the National Institute for Health Research Birmingham Biomedical Research Centre. Dr. Iacucci and Dr. Hudesman reported no relevant financial relationships.

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

Researchers have developed and validated an artificial intelligence (AI) tool that can accurately distinguish ulcerative colitis (UC) remission from activity (inflammation) in biopsies and help predict flare-ups.

The AI tool predicted UC disease activity with 89% accuracy and inflammation at the biopsy site with 80% accuracy. Its ability to stratify risk of UC flare was on par with human pathologists.

“This tool in the near future will speed up, simplify, and standardize histological assessment of ulcerative colitis and provide the clinician with accurate prognostic information in real time,” co–lead author Marietta Iacucci, MD, PhD, from the University of Birmingham (England), and University College Cork (Ireland), said in an interview.

“The tool needs to be refined and further validated before it is ready for daily clinical practice. That work is ongoing now,” Dr. Iacucci said.

The researchers describe their advanced AI-based computer-aided detection tool in a study published online in Gastroenterology.
 

‘Strong’ performance

They used 535 digitized biopsies from 273 patients with UC (mean age, 48 years; 41% women) to develop and test the tool. They used a subset of 118 to train it to distinguish remission from activity, 42 to calibrate it, and 375 to test it. An additional 154 biopsies from 58 patients with UC were used to externally validate the tool.

The model also was tested to predict the corresponding endoscopic assessment and occurrence of flares at 12 months.

UC disease activity was defined by three different histologic indices: the Robarts Histopathology Index (RHI), the Nancy Histological Index (NHI), and the newly developed PICaSSO Histologic Remission Index (PHRI).

The AI tool had “strong diagnostic performance to detect disease activity” (PHRI > 0) with an overall area under the receiver operating characteristic curve of 0.87 and sensitivity and specificity of 89% and 85%, respectively.

The researchers note that, while the AI tool was trained for the PHRI, its sensitivity for RHI and NHI histologic remission/activity was also high (94% and 89%, respectively).

Despite the different mix of severity grades, the AI model “maintained a good diagnostic performance, proving its applicability outside the original development setting,” they reported.

The AI tool could also predict the presence of endoscopic inflammation in the biopsy area with about 80% accuracy.

“Though imperfect, this result is consistent with human-assessed correlation between endoscopy and histology,” the researchers noted.

The model predicted the corresponding endoscopic remission/activity with 79% and 82% accuracy for UCEIS and PICaSSO, respectively.

The hazard ratios for disease flare-up between the AI system and pathologists assessed by PHRI was similar (4.64 and 3.56, respectively), “demonstrating the ability of the computer to stratify the risk of flare comparably well to pathologists,” they added. 

Both histology and outcome prediction were confirmed in the external validation cohort.

The AI system delivered results in an average of 9.8 seconds per slide.
 

Potential ‘game changer’

UC is a “complex condition to predict, and developing machine learning–derived systems to make this diagnostic job quicker and more accurate could be a game changer,” Dr. Iacucci said in a news release.

With refinement, the AI tool will have an impact on both clinical trials and daily practice, the researchers wrote. In clinical practice, histological reporting remains “largely descriptive and nonstandard, thus would greatly benefit from a quick and objective assessment. Similarly, clinical trials in UC could efficiently overcome costly central readings.”

Assessing and measuring improvement in endoscopy and histology are difficult parts of treating UC, said David Hudesman, MD, codirector of the Inflammatory Bowel Disease Center at New York University Langone Health.

“We do not know how much improvement is associated with improved long-term outcomes,” Dr. Hudesman said in an interview. “For example, does a patient need complete healing or is 50% better enough?” Dr. Hudesman was not involved with the current research.

“This study showed that AI can predict – with good accuracy – endoscopy and histology scores, as well as 1-year patient outcomes. If this is validated in larger studies, AI can help determine if we should adjust/change therapies or continue, which is very important,” he said.

This research was supported by the National Institute for Health Research Birmingham Biomedical Research Centre. Dr. Iacucci and Dr. Hudesman reported no relevant financial relationships.

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

People who have had COVID-19 have a 36% overall higher risk of developing gastrointestinal problems in the year after infection than people who have not had the illness, a large new study indicates.

The researchers estimate that, so far, SARS-CoV-2 infections have contributed to more than 6 million new cases of GI disorders in the United States and 42 million new cases worldwide.

The diagnoses more common among patients who’ve had COVID ranged from stomach upset to acute pancreatitis, say the researchers, led by Evan Xu, a data analyst at the Clinical Epidemiology Center, Research and Development Service, VA St. Louis Health Care System.

Signs and symptoms of GI problems, such as constipation and diarrhea, also were more common among patients who had had the virus, the study found.

“Altogether, our results show that people with SARS-CoV-2 infection are at increased risk of gastrointestinal disorders in the post-acute phase of COVID-19,” the researchers write. “Post-COVID care should involve attention to gastrointestinal health and disease.”

The results were published online in Nature Communications.
 

Disease risks jump

The researchers used data from the U.S. Department of Veterans Affairs national health care databases to identify 154,068 people with confirmed COVID-19 from March 1, 2020, through Jan. 15, 2021. They used statistical modeling to compare those patients with 5.6 million patients with similar characteristics who had not been infected during the same period and an historical control group of 5.9 million patients from March 1, 2018, to Dec. 31, 2019, before the virus began to spread across the globe.

The study included hospitalized and nonhospitalized COVID patients. The majority of the study population was male, but the study included almost 1.2 million female patients.

Compared with control persons, post-COVID patients’ increased risk of a GI diagnosis and the excess disease burden at 1 year, respectively, were as follows.

• 102% for cholangitis; 0.22 per 1,000 persons
• 62% for peptic ulcer disease; 1.57 per 1,000 persons
• 54% for irritable bowel syndrome; 0.44 per 1,000 persons
• 47% for acute gastritis; 0.47 per 1,000 persons
• 46% for acute pancreatitis; 0.6 per 1,000 persons
• 36% for functional dyspepsia; 0.63 per 1,000 persons
• 35% for gastroesophageal reflux disease; 15.5 per 1,000 persons

Patients who’d had the virus were also at higher risk for GI symptoms than their COVID-free peers. Their risk was 60% higher for constipation, 58% for diarrhea, 52% for vomiting, 46% for bloating, and 44% for abdominal pain, the investigators found.

The risk of developing GI symptoms increased with COVID-19 severity and was highest for those who received intensive care because of the virus, the researchers note.

Subgroup analyses found that the risks of composite gastrointestinal outcome were evident in all subgroups based on age, race, sex, obesity, smoking, cardiovascular disease, chronic kidney disease, diabetes, hyperlipidemia, and hypertension, the authors write.
 

Disease burden rises

The increased numbers of GI patients with prior SARS-CoV-2 infection are altering the burden on the health care system, senior author Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University, St. Louis, said in an interview.

The shift may be pronounced in primary care, where GI concerns should be seen as a trigger for questions about prior SARS-CoV-2 infection, Dr. Al-Aly said.

Patients may encounter longer wait times at GI clinics or may give up on trying to schedule appointments if waits become too long, he said. They may also present to emergency departments if they can’t get an outpatient appointment, he added.

Simon C. Mathews, MD, assistant professor of medicine, division of gastroenterology, Johns Hopkins Medicine, Baltimore, told this news organization that he’s seeing increased wait times since COVID emerged.

“We know that the pandemic impacted patients’ ability and willingness to seek GI care. There continues to be a long backlog for patients who are only now getting reconnected to care. As a result, our clinics are busier than ever, and our wait times for appointments are unfortunately longer than we would like,” said Dr. Mathews, who was not involved in the research.

Abdominal pain, bloating, diarrhea, and constipation continue to be among the most common symptoms Dr. Mathews sees in clinic, he said.

Kyle Staller, MD, a Massachusetts General Brigham gastroenterologist, said in an interview that it’s important to distinguish symptoms from eventual diagnoses, which lag behind.

“Are patients attributing their symptoms to COVID, or is COVID itself creating a background of inflammation or changes in the nerves that are making these symptoms more common? My suspicion is a little bit of both,” said Dr. Staller, who is director of the Gastrointestinal Motility Laboratory at Mass General, Boston.

Although his clinic is seeing patients with the GI signs and symptoms listed in the article, “we’re not seeing as much of some of the diagnoses, like peptic ulcer disease and pancreatitis,” he said. “I wonder if those may be related to some of the consequences of being critically ill in general, rather than COVID specifically. Those diagnoses I would be more skeptical about.”
 

Duration of symptoms unclear

It’s hard to tell patients how long their GI symptoms might last after COVID, given the relatively short time researchers have had to study the virus, said Dr. Staller, who was not involved in the research.

The symptoms he’s seeing in patients after COVID mimic those of postinfectious IBS, which literature says could last for months or years, Dr. Staller said. “But they should improve over time,” he added.

Senior author Dr. Al-Aly agreed that the duration of post-COVID GI symptoms is unclear.

“What I can tell you is that even people who got SARS-CoV-2 infection from March 2020 are still coming back for GI problems,” he said.

Unlike other symptoms of long COVID, such as brain fog, gastroenterologists fortunately know how to treat the GI disorders that evolve from SARS-CoV-2 infection, said Dr. Al-Aly, who has studied the long-term effects of the virus on the brain, kidneys, heart, and other organs.

All health care providers “need to be thinking about COVID as a risk factor for all these diseases” and should ask patients about SARS-CoV-2 infection when they take their histories, he said.

The authors, Dr. Staller, and Dr. Mathews report no relevant financial relationships.

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

People who have had COVID-19 have a 36% overall higher risk of developing gastrointestinal problems in the year after infection than people who have not had the illness, a large new study indicates.

The researchers estimate that, so far, SARS-CoV-2 infections have contributed to more than 6 million new cases of GI disorders in the United States and 42 million new cases worldwide.

The diagnoses more common among patients who’ve had COVID ranged from stomach upset to acute pancreatitis, say the researchers, led by Evan Xu, a data analyst at the Clinical Epidemiology Center, Research and Development Service, VA St. Louis Health Care System.

Signs and symptoms of GI problems, such as constipation and diarrhea, also were more common among patients who had had the virus, the study found.

“Altogether, our results show that people with SARS-CoV-2 infection are at increased risk of gastrointestinal disorders in the post-acute phase of COVID-19,” the researchers write. “Post-COVID care should involve attention to gastrointestinal health and disease.”

The results were published online in Nature Communications.
 

Disease risks jump

The researchers used data from the U.S. Department of Veterans Affairs national health care databases to identify 154,068 people with confirmed COVID-19 from March 1, 2020, through Jan. 15, 2021. They used statistical modeling to compare those patients with 5.6 million patients with similar characteristics who had not been infected during the same period and an historical control group of 5.9 million patients from March 1, 2018, to Dec. 31, 2019, before the virus began to spread across the globe.

The study included hospitalized and nonhospitalized COVID patients. The majority of the study population was male, but the study included almost 1.2 million female patients.

Compared with control persons, post-COVID patients’ increased risk of a GI diagnosis and the excess disease burden at 1 year, respectively, were as follows.

• 102% for cholangitis; 0.22 per 1,000 persons
• 62% for peptic ulcer disease; 1.57 per 1,000 persons
• 54% for irritable bowel syndrome; 0.44 per 1,000 persons
• 47% for acute gastritis; 0.47 per 1,000 persons
• 46% for acute pancreatitis; 0.6 per 1,000 persons
• 36% for functional dyspepsia; 0.63 per 1,000 persons
• 35% for gastroesophageal reflux disease; 15.5 per 1,000 persons

Patients who’d had the virus were also at higher risk for GI symptoms than their COVID-free peers. Their risk was 60% higher for constipation, 58% for diarrhea, 52% for vomiting, 46% for bloating, and 44% for abdominal pain, the investigators found.

The risk of developing GI symptoms increased with COVID-19 severity and was highest for those who received intensive care because of the virus, the researchers note.

Subgroup analyses found that the risks of composite gastrointestinal outcome were evident in all subgroups based on age, race, sex, obesity, smoking, cardiovascular disease, chronic kidney disease, diabetes, hyperlipidemia, and hypertension, the authors write.
 

Disease burden rises

The increased numbers of GI patients with prior SARS-CoV-2 infection are altering the burden on the health care system, senior author Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University, St. Louis, said in an interview.

The shift may be pronounced in primary care, where GI concerns should be seen as a trigger for questions about prior SARS-CoV-2 infection, Dr. Al-Aly said.

Patients may encounter longer wait times at GI clinics or may give up on trying to schedule appointments if waits become too long, he said. They may also present to emergency departments if they can’t get an outpatient appointment, he added.

Simon C. Mathews, MD, assistant professor of medicine, division of gastroenterology, Johns Hopkins Medicine, Baltimore, told this news organization that he’s seeing increased wait times since COVID emerged.

“We know that the pandemic impacted patients’ ability and willingness to seek GI care. There continues to be a long backlog for patients who are only now getting reconnected to care. As a result, our clinics are busier than ever, and our wait times for appointments are unfortunately longer than we would like,” said Dr. Mathews, who was not involved in the research.

Abdominal pain, bloating, diarrhea, and constipation continue to be among the most common symptoms Dr. Mathews sees in clinic, he said.

Kyle Staller, MD, a Massachusetts General Brigham gastroenterologist, said in an interview that it’s important to distinguish symptoms from eventual diagnoses, which lag behind.

“Are patients attributing their symptoms to COVID, or is COVID itself creating a background of inflammation or changes in the nerves that are making these symptoms more common? My suspicion is a little bit of both,” said Dr. Staller, who is director of the Gastrointestinal Motility Laboratory at Mass General, Boston.

Although his clinic is seeing patients with the GI signs and symptoms listed in the article, “we’re not seeing as much of some of the diagnoses, like peptic ulcer disease and pancreatitis,” he said. “I wonder if those may be related to some of the consequences of being critically ill in general, rather than COVID specifically. Those diagnoses I would be more skeptical about.”
 

Duration of symptoms unclear

It’s hard to tell patients how long their GI symptoms might last after COVID, given the relatively short time researchers have had to study the virus, said Dr. Staller, who was not involved in the research.

The symptoms he’s seeing in patients after COVID mimic those of postinfectious IBS, which literature says could last for months or years, Dr. Staller said. “But they should improve over time,” he added.

Senior author Dr. Al-Aly agreed that the duration of post-COVID GI symptoms is unclear.

“What I can tell you is that even people who got SARS-CoV-2 infection from March 2020 are still coming back for GI problems,” he said.

Unlike other symptoms of long COVID, such as brain fog, gastroenterologists fortunately know how to treat the GI disorders that evolve from SARS-CoV-2 infection, said Dr. Al-Aly, who has studied the long-term effects of the virus on the brain, kidneys, heart, and other organs.

All health care providers “need to be thinking about COVID as a risk factor for all these diseases” and should ask patients about SARS-CoV-2 infection when they take their histories, he said.

The authors, Dr. Staller, and Dr. Mathews report no relevant financial relationships.

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

People who have had COVID-19 have a 36% overall higher risk of developing gastrointestinal problems in the year after infection than people who have not had the illness, a large new study indicates.

The researchers estimate that, so far, SARS-CoV-2 infections have contributed to more than 6 million new cases of GI disorders in the United States and 42 million new cases worldwide.

The diagnoses more common among patients who’ve had COVID ranged from stomach upset to acute pancreatitis, say the researchers, led by Evan Xu, a data analyst at the Clinical Epidemiology Center, Research and Development Service, VA St. Louis Health Care System.

Signs and symptoms of GI problems, such as constipation and diarrhea, also were more common among patients who had had the virus, the study found.

“Altogether, our results show that people with SARS-CoV-2 infection are at increased risk of gastrointestinal disorders in the post-acute phase of COVID-19,” the researchers write. “Post-COVID care should involve attention to gastrointestinal health and disease.”

The results were published online in Nature Communications.
 

Disease risks jump

The researchers used data from the U.S. Department of Veterans Affairs national health care databases to identify 154,068 people with confirmed COVID-19 from March 1, 2020, through Jan. 15, 2021. They used statistical modeling to compare those patients with 5.6 million patients with similar characteristics who had not been infected during the same period and an historical control group of 5.9 million patients from March 1, 2018, to Dec. 31, 2019, before the virus began to spread across the globe.

The study included hospitalized and nonhospitalized COVID patients. The majority of the study population was male, but the study included almost 1.2 million female patients.

Compared with control persons, post-COVID patients’ increased risk of a GI diagnosis and the excess disease burden at 1 year, respectively, were as follows.

• 102% for cholangitis; 0.22 per 1,000 persons
• 62% for peptic ulcer disease; 1.57 per 1,000 persons
• 54% for irritable bowel syndrome; 0.44 per 1,000 persons
• 47% for acute gastritis; 0.47 per 1,000 persons
• 46% for acute pancreatitis; 0.6 per 1,000 persons
• 36% for functional dyspepsia; 0.63 per 1,000 persons
• 35% for gastroesophageal reflux disease; 15.5 per 1,000 persons

Patients who’d had the virus were also at higher risk for GI symptoms than their COVID-free peers. Their risk was 60% higher for constipation, 58% for diarrhea, 52% for vomiting, 46% for bloating, and 44% for abdominal pain, the investigators found.

The risk of developing GI symptoms increased with COVID-19 severity and was highest for those who received intensive care because of the virus, the researchers note.

Subgroup analyses found that the risks of composite gastrointestinal outcome were evident in all subgroups based on age, race, sex, obesity, smoking, cardiovascular disease, chronic kidney disease, diabetes, hyperlipidemia, and hypertension, the authors write.
 

Disease burden rises

The increased numbers of GI patients with prior SARS-CoV-2 infection are altering the burden on the health care system, senior author Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University, St. Louis, said in an interview.

The shift may be pronounced in primary care, where GI concerns should be seen as a trigger for questions about prior SARS-CoV-2 infection, Dr. Al-Aly said.

Patients may encounter longer wait times at GI clinics or may give up on trying to schedule appointments if waits become too long, he said. They may also present to emergency departments if they can’t get an outpatient appointment, he added.

Simon C. Mathews, MD, assistant professor of medicine, division of gastroenterology, Johns Hopkins Medicine, Baltimore, told this news organization that he’s seeing increased wait times since COVID emerged.

“We know that the pandemic impacted patients’ ability and willingness to seek GI care. There continues to be a long backlog for patients who are only now getting reconnected to care. As a result, our clinics are busier than ever, and our wait times for appointments are unfortunately longer than we would like,” said Dr. Mathews, who was not involved in the research.

Abdominal pain, bloating, diarrhea, and constipation continue to be among the most common symptoms Dr. Mathews sees in clinic, he said.

Kyle Staller, MD, a Massachusetts General Brigham gastroenterologist, said in an interview that it’s important to distinguish symptoms from eventual diagnoses, which lag behind.

“Are patients attributing their symptoms to COVID, or is COVID itself creating a background of inflammation or changes in the nerves that are making these symptoms more common? My suspicion is a little bit of both,” said Dr. Staller, who is director of the Gastrointestinal Motility Laboratory at Mass General, Boston.

Although his clinic is seeing patients with the GI signs and symptoms listed in the article, “we’re not seeing as much of some of the diagnoses, like peptic ulcer disease and pancreatitis,” he said. “I wonder if those may be related to some of the consequences of being critically ill in general, rather than COVID specifically. Those diagnoses I would be more skeptical about.”
 

Duration of symptoms unclear

It’s hard to tell patients how long their GI symptoms might last after COVID, given the relatively short time researchers have had to study the virus, said Dr. Staller, who was not involved in the research.

The symptoms he’s seeing in patients after COVID mimic those of postinfectious IBS, which literature says could last for months or years, Dr. Staller said. “But they should improve over time,” he added.

Senior author Dr. Al-Aly agreed that the duration of post-COVID GI symptoms is unclear.

“What I can tell you is that even people who got SARS-CoV-2 infection from March 2020 are still coming back for GI problems,” he said.

Unlike other symptoms of long COVID, such as brain fog, gastroenterologists fortunately know how to treat the GI disorders that evolve from SARS-CoV-2 infection, said Dr. Al-Aly, who has studied the long-term effects of the virus on the brain, kidneys, heart, and other organs.

All health care providers “need to be thinking about COVID as a risk factor for all these diseases” and should ask patients about SARS-CoV-2 infection when they take their histories, he said.

The authors, Dr. Staller, and Dr. Mathews report no relevant financial relationships.

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

Within the rising tide of studies extolling the benefits of artificial intelligence for improving adenoma detection during colonoscopy comes new research suggesting the contrary, at least among people with inflammatory bowel disease (IBD).

Researchers retrospectively studied almost 1,000 colonoscopies before and after introduction of an AI system (GI Genius, Medtronic) at a tertiary medical center in Israel in which a large volume of endoscopies was performed. The adenoma detection rate (ADR) was higher overall with colonoscopies that were performed before the introduction of AI, and it was significantly higher for colonoscopies performed by gastroenterologists who had 5 or more years of experience, compared with the ADR for AI-assisted colonoscopies.

The lower ADR rate in AI-assisted procedures could be the result of an overreliance on the AI technology and shorter procedure times, which may have led to an underrecognition of adenomas, lead investigator Asaf Levartovsky, MD, said in an interview.

“AI is an aid to the endoscopist, not a replacement to the endoscopist,” added Dr. Levartovsky, a gastroenterologist at Sheba Medical Center, Tel Aviv.

The results were presented as a poster at the annual congress of the European Crohn’s and Colitis Organisation, held in Copenhagen and virtually.
 

Key findings

The use of AI has recently been shown to improve colorectal cancer screening overall, the authors note. ADR is a measure of the quality of screening colonoscopies. Detection rates were at least 20% among women and 30% among men, “indicative of adequate performance.”

The ADR for people with IBD can be lower than it is for average-risk patients, however, owing to a difference in age in the two populations and the presence of dysplasia-associated lesions, as opposed to sporadic adenomas, for patients with IBD, the researchers note. There is no consensus on an acceptable ADR target for patients with IBD, and the impact of AI-assisted colonoscopy in this patient population hasn’t been explored, they add.

To learn more, Dr. Levartovsky and colleagues compared 237 screening colonoscopies conducted in the 11 months before AI was introduced at the medical center in July 2021 to 759 colonoscopies performed in the 15 months after its introduction.

The pre-AI patient group and the AI patient group were similar (mean age, 44-45 years; about 55% men in each group). Crohn’s disease was more common than ulcerative colitis (63% in the pre-AI cohort and 57% in the AI-assisted cohort).

The ADR in the pre-AI group was 6.3%, compared with 4% in the AI-assisted group (P = .15). The distinction became significant, at 7.6% versus 3.8% (P = .035), when researchers evaluated colonoscopies performed by gastroenterologists who had 5 or more years of experience.

Total procedure time was longer for the patients in the pre-AI group, at 25 minutes, compared with 21 minutes in the AI-assisted group. This difference was statistically significant (P < .0001).

“I think this poster raises questions regarding the real-world utility of AI for adenoma detection [in patients with IBD],” Dr. Levartovsky said.

Dr. Levartovsky said he was not surprised by their findings, because they are similar to those reported in a recent article from his group, although this earlier study did not focus on patients with IBD.

The research had some limitations. The study was not case-control matched, and the pre-AI group was considerably smaller than the AI group.
 

Study design a factor

The study design could account for the difference in its findings, compared with research indicating that AI-assisted colonoscopies improve ADR, Cesare Hassan, MD, associate professor of gastroenterology at Humanitas University, Milan, said in an interview.

The study was retrospective, so researchers could not randomly assign people to the AI or the no-AI group. It therefore was not possible to ensure that the prevalence of disease was equivalent between the two groups, he said.

By comparison, the previous studies showing the benefits of AI-assisted colonoscopy with regard to ADR were randomized, controlled clinical trials, Dr. Hassan said.

The study was independently supported. Dr. Levartovsky and Dr. Hassan report no relevant financial relationships.

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

Within the rising tide of studies extolling the benefits of artificial intelligence for improving adenoma detection during colonoscopy comes new research suggesting the contrary, at least among people with inflammatory bowel disease (IBD).

Researchers retrospectively studied almost 1,000 colonoscopies before and after introduction of an AI system (GI Genius, Medtronic) at a tertiary medical center in Israel in which a large volume of endoscopies was performed. The adenoma detection rate (ADR) was higher overall with colonoscopies that were performed before the introduction of AI, and it was significantly higher for colonoscopies performed by gastroenterologists who had 5 or more years of experience, compared with the ADR for AI-assisted colonoscopies.

The lower ADR rate in AI-assisted procedures could be the result of an overreliance on the AI technology and shorter procedure times, which may have led to an underrecognition of adenomas, lead investigator Asaf Levartovsky, MD, said in an interview.

“AI is an aid to the endoscopist, not a replacement to the endoscopist,” added Dr. Levartovsky, a gastroenterologist at Sheba Medical Center, Tel Aviv.

The results were presented as a poster at the annual congress of the European Crohn’s and Colitis Organisation, held in Copenhagen and virtually.
 

Key findings

The use of AI has recently been shown to improve colorectal cancer screening overall, the authors note. ADR is a measure of the quality of screening colonoscopies. Detection rates were at least 20% among women and 30% among men, “indicative of adequate performance.”

The ADR for people with IBD can be lower than it is for average-risk patients, however, owing to a difference in age in the two populations and the presence of dysplasia-associated lesions, as opposed to sporadic adenomas, for patients with IBD, the researchers note. There is no consensus on an acceptable ADR target for patients with IBD, and the impact of AI-assisted colonoscopy in this patient population hasn’t been explored, they add.

To learn more, Dr. Levartovsky and colleagues compared 237 screening colonoscopies conducted in the 11 months before AI was introduced at the medical center in July 2021 to 759 colonoscopies performed in the 15 months after its introduction.

The pre-AI patient group and the AI patient group were similar (mean age, 44-45 years; about 55% men in each group). Crohn’s disease was more common than ulcerative colitis (63% in the pre-AI cohort and 57% in the AI-assisted cohort).

The ADR in the pre-AI group was 6.3%, compared with 4% in the AI-assisted group (P = .15). The distinction became significant, at 7.6% versus 3.8% (P = .035), when researchers evaluated colonoscopies performed by gastroenterologists who had 5 or more years of experience.

Total procedure time was longer for the patients in the pre-AI group, at 25 minutes, compared with 21 minutes in the AI-assisted group. This difference was statistically significant (P < .0001).

“I think this poster raises questions regarding the real-world utility of AI for adenoma detection [in patients with IBD],” Dr. Levartovsky said.

Dr. Levartovsky said he was not surprised by their findings, because they are similar to those reported in a recent article from his group, although this earlier study did not focus on patients with IBD.

The research had some limitations. The study was not case-control matched, and the pre-AI group was considerably smaller than the AI group.
 

Study design a factor

The study design could account for the difference in its findings, compared with research indicating that AI-assisted colonoscopies improve ADR, Cesare Hassan, MD, associate professor of gastroenterology at Humanitas University, Milan, said in an interview.

The study was retrospective, so researchers could not randomly assign people to the AI or the no-AI group. It therefore was not possible to ensure that the prevalence of disease was equivalent between the two groups, he said.

By comparison, the previous studies showing the benefits of AI-assisted colonoscopy with regard to ADR were randomized, controlled clinical trials, Dr. Hassan said.

The study was independently supported. Dr. Levartovsky and Dr. Hassan report no relevant financial relationships.

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

Within the rising tide of studies extolling the benefits of artificial intelligence for improving adenoma detection during colonoscopy comes new research suggesting the contrary, at least among people with inflammatory bowel disease (IBD).

Researchers retrospectively studied almost 1,000 colonoscopies before and after introduction of an AI system (GI Genius, Medtronic) at a tertiary medical center in Israel in which a large volume of endoscopies was performed. The adenoma detection rate (ADR) was higher overall with colonoscopies that were performed before the introduction of AI, and it was significantly higher for colonoscopies performed by gastroenterologists who had 5 or more years of experience, compared with the ADR for AI-assisted colonoscopies.

The lower ADR rate in AI-assisted procedures could be the result of an overreliance on the AI technology and shorter procedure times, which may have led to an underrecognition of adenomas, lead investigator Asaf Levartovsky, MD, said in an interview.

“AI is an aid to the endoscopist, not a replacement to the endoscopist,” added Dr. Levartovsky, a gastroenterologist at Sheba Medical Center, Tel Aviv.

The results were presented as a poster at the annual congress of the European Crohn’s and Colitis Organisation, held in Copenhagen and virtually.
 

Key findings

The use of AI has recently been shown to improve colorectal cancer screening overall, the authors note. ADR is a measure of the quality of screening colonoscopies. Detection rates were at least 20% among women and 30% among men, “indicative of adequate performance.”

The ADR for people with IBD can be lower than it is for average-risk patients, however, owing to a difference in age in the two populations and the presence of dysplasia-associated lesions, as opposed to sporadic adenomas, for patients with IBD, the researchers note. There is no consensus on an acceptable ADR target for patients with IBD, and the impact of AI-assisted colonoscopy in this patient population hasn’t been explored, they add.

To learn more, Dr. Levartovsky and colleagues compared 237 screening colonoscopies conducted in the 11 months before AI was introduced at the medical center in July 2021 to 759 colonoscopies performed in the 15 months after its introduction.

The pre-AI patient group and the AI patient group were similar (mean age, 44-45 years; about 55% men in each group). Crohn’s disease was more common than ulcerative colitis (63% in the pre-AI cohort and 57% in the AI-assisted cohort).

The ADR in the pre-AI group was 6.3%, compared with 4% in the AI-assisted group (P = .15). The distinction became significant, at 7.6% versus 3.8% (P = .035), when researchers evaluated colonoscopies performed by gastroenterologists who had 5 or more years of experience.

Total procedure time was longer for the patients in the pre-AI group, at 25 minutes, compared with 21 minutes in the AI-assisted group. This difference was statistically significant (P < .0001).

“I think this poster raises questions regarding the real-world utility of AI for adenoma detection [in patients with IBD],” Dr. Levartovsky said.

Dr. Levartovsky said he was not surprised by their findings, because they are similar to those reported in a recent article from his group, although this earlier study did not focus on patients with IBD.

The research had some limitations. The study was not case-control matched, and the pre-AI group was considerably smaller than the AI group.
 

Study design a factor

The study design could account for the difference in its findings, compared with research indicating that AI-assisted colonoscopies improve ADR, Cesare Hassan, MD, associate professor of gastroenterology at Humanitas University, Milan, said in an interview.

The study was retrospective, so researchers could not randomly assign people to the AI or the no-AI group. It therefore was not possible to ensure that the prevalence of disease was equivalent between the two groups, he said.

By comparison, the previous studies showing the benefits of AI-assisted colonoscopy with regard to ADR were randomized, controlled clinical trials, Dr. Hassan said.

The study was independently supported. Dr. Levartovsky and Dr. Hassan report no relevant financial relationships.

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