As the science of Crohn’s disease (CD) rapidly evolves, AGA has issued a living guideline on the pharmacologic management of moderately to severely active CD.

The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.

It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.

“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”

Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”

Among the recommendations:

• Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
• For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
• For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
• For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
• For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
• The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
• Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.

“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.

Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.

Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”

Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.

“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”

As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”

When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).

The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”

He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”

Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”

Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”

All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.

A version of this article appeared on Medscape.com.

As the science of Crohn’s disease (CD) rapidly evolves, AGA has issued a living guideline on the pharmacologic management of moderately to severely active CD.

The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.

It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.

“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”

Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”

Among the recommendations:

• Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
• For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
• For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
• For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
• For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
• The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
• Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.

“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.

Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.

Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”

Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.

“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”

As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”

When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).

The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”

He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”

Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”

Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”

All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.

A version of this article appeared on Medscape.com.

As the science of Crohn’s disease (CD) rapidly evolves, AGA has issued a living guideline on the pharmacologic management of moderately to severely active CD.

The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.

It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.

“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”

Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”

Among the recommendations:

• Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
• For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
• For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
• For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
• For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
• The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
• Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.

“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.

Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.

Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”

Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.

“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”

As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”

When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).

The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”

He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”

Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”

Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”

All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.

A version of this article appeared on Medscape.com.

David Lieberman, MD, AGAF, spent much of his long career asking questions about everyday clinical practice in GI medicine and then researching ways to answer those questions.

“The answer to one question often leads to further questions. And I think that’s what makes this research so exciting and dynamic,” said Lieberman, professor emeritus with Oregon Health and Science University, where he served as chief of the Division of Gastroenterology and Hepatology for 24 years.

Dr. Lieberman helped establish the U.S. Multi-Society Task Force on Colorectal Cancer, which led to quality metrics for colonoscopy. He was also instrumental in creating a blood and tissue repository for colorectal cancer (CRC) research, and a national endoscopic database. 

His groundbreaking GI research in colorectal cancer screening earned him AGA’s Julius Friedenwald Medal, a top career honor. “We started off with some questions about the role of specific screening tests like colonoscopy and stool-based tests for screening,” he said. This led to the first large study about the value of screening with colonoscopy, which set the stage for current screening guidelines. Assessing more than 3,000 asymptomatic adults, Lieberman and colleagues determined that colonoscopy was more effective than sigmoidoscopy in detecting advanced colonic neoplasms. 

The next phase of research focused on how well GI doctors were performing colonoscopy, asking questions about the quality of the colonoscopies being performed, and what course of action to take in polyp discovery. “We did some work related to polyp surveillance, what happens after we take out polyps and some recommendations for the appropriate length of follow up afterwards,” he summarized. 

Most recently, Lieberman has centered his research on program effectiveness. “If you’re doing high quality colonoscopy and you’re doing appropriate surveillance, how effective is that? And what are the potential problems that might impair effectiveness?”

Adherence and participation remain significant challenges, he said. “If people don’t get the tests done, then they’re not going to be effective. Or if they get part of it done, there can be issues.”

In an interview, Lieberman discussed the reasons why people resist CRC screening, and the new technologies and research underway to make screening options more palatable for reluctant patients. 
 

What do you think are the biggest deterrents to getting screened for CRC?

Dr. Lieberman: The whole idea of dealing with a stool sample is not appealing to patients. The second issue, and this has been shown in many studies, is patients who are referred for colonoscopy may resist because they have heard stories about bowel preps and about colonoscopy itself. But there are many other reasons. I mean, there are issues with access to care that are important. What if you have a positive stool test and you need to get a colonoscopy? How do you get a colonoscopy? There are barriers in moving from one test to the other in a different setting. There are issues with having to take a day off work that’s potentially a financial hardship for some patients. If you’re taking care of elderly relatives or children or if you need transportation, that’s an issue for people.

So, there are many potential barriers, and we’ve been trying to work at a national level to try to understand these barriers and then develop tools to mitigate these problems and improve the overall participation in screening. 
 

How has the field of GI changed since you started practicing medicine? 

Dr. Lieberman: I think there have been many exciting changes in technology. The endoscopes we used when I started my career were called fiberoptic scopes. These were scopes that contained tiny glass fibers that ran the length of the scope, and they were good, but not great in terms of imaging, and sometimes they would break down. We now have digital imaging that far surpasses the quality there. We’ve come a long way in terms of things like CT scans, for example, and MRI imaging. The other big technology change has been the development of minimally invasive treatments. For example, if you have a gallstone that’s in your bile duct, we now have ways to remove that without sending the patient to surgery.

The second big change has been the assessment of quality. When I started my career in gastroenterology, we were doing a lot of things, but we didn’t necessarily know if we were doing them well. Most of us thought we were doing them well, of course, but nobody was really measuring quality. There were no quality benchmarks. And so if you don’t measure it, you don’t know. Where we are today in gastroenterology is we’re intensively concerned about quality and measuring quality in various aspects of what we do. And I think that’s a positive development. 
 

What key achievements came out of the U.S. Multi-Society Task Force on Colorectal Cancer?

Dr. Lieberman: This panel evolved because back in the early 2000s, each of the GI organizations were producing guidelines related to colon cancer screening and follow-up. And they were slightly different. This was an attempt to bring all the relevant groups together and try to align the guidelines and recommendations among the GI organizations so that there wouldn’t be a confusing message.

Over the history of this task force, which started around 2002, it’s been remarkably productive. The task force has really examined all aspects of colorectal cancer, including things like the bowel prep, quality of exams, high risk management, hereditary syndromes that can lead to the higher likelihood of developing colon cancer, polypectomy and polypectomy techniques, and screening and surveillance recommendations, which have evolved over time. It’s been, in my opinion, a remarkably productive task force and continues to this day. I’m so very proud of that group. 
 

Could you give a status update on the blood and tissue repository you created for CRC research? 

Dr. Lieberman: Our initial studies were part of a Veterans Affairs cooperative study, which is a mechanism of funding within the VA that allows us to work with multiple VA centers to collect data and information. At the very outset of this study, we were performing screening colonoscopies in individuals, and we decided to create a bio-repository that included blood samples, polyp tissue, and normal rectal tissue. The thinking was at some point we might be able to do some genomic studies that might help us predict which patients are most likely to develop colon polyps and colon cancer. All that happened in the 1990s. It was supported by the National Cancer Institute. We created this repository, which sat for a long period of time while we were waiting for the technology to develop and so that we could perform genomic studies in a cost-effective way.

We’re now at that point, which is really exciting. We’re beginning to look at this tissue and perform some genomic studies. Some of this data has been presented at national meetings. This was a precursor to creating a similar type of bio-repository in a larger VA cooperative study. CSP #577 Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) is a randomized study comparing two forms of screening, a fecal immunochemical test versus a colonoscopy. We’re in the process of enrolling 50,000 patients in that study. We have also created a blood and tissue repository, which we hope will be useful for future studies.
 

You lead the AGA CRC Task Force, which advances research and policy initiatives to improve screening rates and patient outcomes. What would you like to see in future GI research, particularly in colorectal cancer?

Dr. Lieberman: We have new blood tests coming along that are going to be very attractive to both patients and physicians. You can obtain a blood sample at a point of service and patients won’t have to deal with stool samples. We need to understand how those tests perform in clinical practice. If the test is abnormal, indicating a patient has a higher risk of colon cancer and should get a colonoscopy, are they getting that colonoscopy or not? And what are the barriers? And if it’s normal, then that patient should have a repeat test at an appropriate interval.

We know that the effectiveness of screening really depends on the participation of individuals in terms of completing the steps. We’ve published some work already on trying to understand the role of these blood tests. We expect that these tests will continue to improve over time. 

We’re also working on trying to develop these risk stratification tools that could be used in clinical practice to help figure out the most appropriate test for a particular individual. 

Let’s say you go to your doctor for colon cancer screening, and if we could determine that you are a low-risk individual, you may benefit best from having a non-invasive test, like a blood test or a stool test. Whereas if you’re a higher risk individual, you may need to have a more invasive screening test like colonoscopy. 

This falls into a concept of personalized medicine where we’re trying to use all the information we have from the medical history, and maybe genomic information that I mentioned earlier, to try to determine who needs the most intensive screening and who might benefit from less intensive screening. 

I think the most recent work is really focused on these gaps in screening. And the biggest gap are patients that get a non-invasive test, like a stool test, but do not get a colonoscopy that renders the program ineffective if they don’t get the colonoscopy. We’re trying to highlight that for primary care providers and make sure that everyone understands the importance of this follow-up. And then, trying to develop tools to help the primary care provider navigate that patient to a colonoscopy.
 

What do you think is the biggest misconception about your specialty?

Dr. Lieberman: If there’s a misconception, it’s that GI physicians are focused on procedures. I think a good GI provider should be holistic, and I think many are. What I mean by holistic is that many GI symptoms could be due to stress, medications, diet, or other aspects of behavior, and the remedy is not necessarily a procedure. I think that many GI physicians are really skilled at obtaining this information and trying to help guide the patient through some uncomfortable symptoms.

It means being more like an internist, spending time with the patient to take a detailed history and delve into many different possibilities that might be going on.

David Lieberman, MD, AGAF, spent much of his long career asking questions about everyday clinical practice in GI medicine and then researching ways to answer those questions.

“The answer to one question often leads to further questions. And I think that’s what makes this research so exciting and dynamic,” said Lieberman, professor emeritus with Oregon Health and Science University, where he served as chief of the Division of Gastroenterology and Hepatology for 24 years.

Dr. Lieberman helped establish the U.S. Multi-Society Task Force on Colorectal Cancer, which led to quality metrics for colonoscopy. He was also instrumental in creating a blood and tissue repository for colorectal cancer (CRC) research, and a national endoscopic database. 

His groundbreaking GI research in colorectal cancer screening earned him AGA’s Julius Friedenwald Medal, a top career honor. “We started off with some questions about the role of specific screening tests like colonoscopy and stool-based tests for screening,” he said. This led to the first large study about the value of screening with colonoscopy, which set the stage for current screening guidelines. Assessing more than 3,000 asymptomatic adults, Lieberman and colleagues determined that colonoscopy was more effective than sigmoidoscopy in detecting advanced colonic neoplasms. 

The next phase of research focused on how well GI doctors were performing colonoscopy, asking questions about the quality of the colonoscopies being performed, and what course of action to take in polyp discovery. “We did some work related to polyp surveillance, what happens after we take out polyps and some recommendations for the appropriate length of follow up afterwards,” he summarized. 

Most recently, Lieberman has centered his research on program effectiveness. “If you’re doing high quality colonoscopy and you’re doing appropriate surveillance, how effective is that? And what are the potential problems that might impair effectiveness?”

Adherence and participation remain significant challenges, he said. “If people don’t get the tests done, then they’re not going to be effective. Or if they get part of it done, there can be issues.”

In an interview, Lieberman discussed the reasons why people resist CRC screening, and the new technologies and research underway to make screening options more palatable for reluctant patients. 
 

What do you think are the biggest deterrents to getting screened for CRC?

Dr. Lieberman: The whole idea of dealing with a stool sample is not appealing to patients. The second issue, and this has been shown in many studies, is patients who are referred for colonoscopy may resist because they have heard stories about bowel preps and about colonoscopy itself. But there are many other reasons. I mean, there are issues with access to care that are important. What if you have a positive stool test and you need to get a colonoscopy? How do you get a colonoscopy? There are barriers in moving from one test to the other in a different setting. There are issues with having to take a day off work that’s potentially a financial hardship for some patients. If you’re taking care of elderly relatives or children or if you need transportation, that’s an issue for people.

So, there are many potential barriers, and we’ve been trying to work at a national level to try to understand these barriers and then develop tools to mitigate these problems and improve the overall participation in screening. 
 

How has the field of GI changed since you started practicing medicine? 

Dr. Lieberman: I think there have been many exciting changes in technology. The endoscopes we used when I started my career were called fiberoptic scopes. These were scopes that contained tiny glass fibers that ran the length of the scope, and they were good, but not great in terms of imaging, and sometimes they would break down. We now have digital imaging that far surpasses the quality there. We’ve come a long way in terms of things like CT scans, for example, and MRI imaging. The other big technology change has been the development of minimally invasive treatments. For example, if you have a gallstone that’s in your bile duct, we now have ways to remove that without sending the patient to surgery.

The second big change has been the assessment of quality. When I started my career in gastroenterology, we were doing a lot of things, but we didn’t necessarily know if we were doing them well. Most of us thought we were doing them well, of course, but nobody was really measuring quality. There were no quality benchmarks. And so if you don’t measure it, you don’t know. Where we are today in gastroenterology is we’re intensively concerned about quality and measuring quality in various aspects of what we do. And I think that’s a positive development. 
 

What key achievements came out of the U.S. Multi-Society Task Force on Colorectal Cancer?

Dr. Lieberman: This panel evolved because back in the early 2000s, each of the GI organizations were producing guidelines related to colon cancer screening and follow-up. And they were slightly different. This was an attempt to bring all the relevant groups together and try to align the guidelines and recommendations among the GI organizations so that there wouldn’t be a confusing message.

Over the history of this task force, which started around 2002, it’s been remarkably productive. The task force has really examined all aspects of colorectal cancer, including things like the bowel prep, quality of exams, high risk management, hereditary syndromes that can lead to the higher likelihood of developing colon cancer, polypectomy and polypectomy techniques, and screening and surveillance recommendations, which have evolved over time. It’s been, in my opinion, a remarkably productive task force and continues to this day. I’m so very proud of that group. 
 

Could you give a status update on the blood and tissue repository you created for CRC research? 

Dr. Lieberman: Our initial studies were part of a Veterans Affairs cooperative study, which is a mechanism of funding within the VA that allows us to work with multiple VA centers to collect data and information. At the very outset of this study, we were performing screening colonoscopies in individuals, and we decided to create a bio-repository that included blood samples, polyp tissue, and normal rectal tissue. The thinking was at some point we might be able to do some genomic studies that might help us predict which patients are most likely to develop colon polyps and colon cancer. All that happened in the 1990s. It was supported by the National Cancer Institute. We created this repository, which sat for a long period of time while we were waiting for the technology to develop and so that we could perform genomic studies in a cost-effective way.

We’re now at that point, which is really exciting. We’re beginning to look at this tissue and perform some genomic studies. Some of this data has been presented at national meetings. This was a precursor to creating a similar type of bio-repository in a larger VA cooperative study. CSP #577 Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) is a randomized study comparing two forms of screening, a fecal immunochemical test versus a colonoscopy. We’re in the process of enrolling 50,000 patients in that study. We have also created a blood and tissue repository, which we hope will be useful for future studies.
 

You lead the AGA CRC Task Force, which advances research and policy initiatives to improve screening rates and patient outcomes. What would you like to see in future GI research, particularly in colorectal cancer?

Dr. Lieberman: We have new blood tests coming along that are going to be very attractive to both patients and physicians. You can obtain a blood sample at a point of service and patients won’t have to deal with stool samples. We need to understand how those tests perform in clinical practice. If the test is abnormal, indicating a patient has a higher risk of colon cancer and should get a colonoscopy, are they getting that colonoscopy or not? And what are the barriers? And if it’s normal, then that patient should have a repeat test at an appropriate interval.

We know that the effectiveness of screening really depends on the participation of individuals in terms of completing the steps. We’ve published some work already on trying to understand the role of these blood tests. We expect that these tests will continue to improve over time. 

We’re also working on trying to develop these risk stratification tools that could be used in clinical practice to help figure out the most appropriate test for a particular individual. 

Let’s say you go to your doctor for colon cancer screening, and if we could determine that you are a low-risk individual, you may benefit best from having a non-invasive test, like a blood test or a stool test. Whereas if you’re a higher risk individual, you may need to have a more invasive screening test like colonoscopy. 

This falls into a concept of personalized medicine where we’re trying to use all the information we have from the medical history, and maybe genomic information that I mentioned earlier, to try to determine who needs the most intensive screening and who might benefit from less intensive screening. 

I think the most recent work is really focused on these gaps in screening. And the biggest gap are patients that get a non-invasive test, like a stool test, but do not get a colonoscopy that renders the program ineffective if they don’t get the colonoscopy. We’re trying to highlight that for primary care providers and make sure that everyone understands the importance of this follow-up. And then, trying to develop tools to help the primary care provider navigate that patient to a colonoscopy.
 

What do you think is the biggest misconception about your specialty?

Dr. Lieberman: If there’s a misconception, it’s that GI physicians are focused on procedures. I think a good GI provider should be holistic, and I think many are. What I mean by holistic is that many GI symptoms could be due to stress, medications, diet, or other aspects of behavior, and the remedy is not necessarily a procedure. I think that many GI physicians are really skilled at obtaining this information and trying to help guide the patient through some uncomfortable symptoms.

It means being more like an internist, spending time with the patient to take a detailed history and delve into many different possibilities that might be going on.

David Lieberman, MD, AGAF, spent much of his long career asking questions about everyday clinical practice in GI medicine and then researching ways to answer those questions.

“The answer to one question often leads to further questions. And I think that’s what makes this research so exciting and dynamic,” said Lieberman, professor emeritus with Oregon Health and Science University, where he served as chief of the Division of Gastroenterology and Hepatology for 24 years.

Dr. Lieberman helped establish the U.S. Multi-Society Task Force on Colorectal Cancer, which led to quality metrics for colonoscopy. He was also instrumental in creating a blood and tissue repository for colorectal cancer (CRC) research, and a national endoscopic database. 

His groundbreaking GI research in colorectal cancer screening earned him AGA’s Julius Friedenwald Medal, a top career honor. “We started off with some questions about the role of specific screening tests like colonoscopy and stool-based tests for screening,” he said. This led to the first large study about the value of screening with colonoscopy, which set the stage for current screening guidelines. Assessing more than 3,000 asymptomatic adults, Lieberman and colleagues determined that colonoscopy was more effective than sigmoidoscopy in detecting advanced colonic neoplasms. 

The next phase of research focused on how well GI doctors were performing colonoscopy, asking questions about the quality of the colonoscopies being performed, and what course of action to take in polyp discovery. “We did some work related to polyp surveillance, what happens after we take out polyps and some recommendations for the appropriate length of follow up afterwards,” he summarized. 

Most recently, Lieberman has centered his research on program effectiveness. “If you’re doing high quality colonoscopy and you’re doing appropriate surveillance, how effective is that? And what are the potential problems that might impair effectiveness?”

Adherence and participation remain significant challenges, he said. “If people don’t get the tests done, then they’re not going to be effective. Or if they get part of it done, there can be issues.”

In an interview, Lieberman discussed the reasons why people resist CRC screening, and the new technologies and research underway to make screening options more palatable for reluctant patients. 
 

What do you think are the biggest deterrents to getting screened for CRC?

Dr. Lieberman: The whole idea of dealing with a stool sample is not appealing to patients. The second issue, and this has been shown in many studies, is patients who are referred for colonoscopy may resist because they have heard stories about bowel preps and about colonoscopy itself. But there are many other reasons. I mean, there are issues with access to care that are important. What if you have a positive stool test and you need to get a colonoscopy? How do you get a colonoscopy? There are barriers in moving from one test to the other in a different setting. There are issues with having to take a day off work that’s potentially a financial hardship for some patients. If you’re taking care of elderly relatives or children or if you need transportation, that’s an issue for people.

So, there are many potential barriers, and we’ve been trying to work at a national level to try to understand these barriers and then develop tools to mitigate these problems and improve the overall participation in screening. 
 

How has the field of GI changed since you started practicing medicine? 

Dr. Lieberman: I think there have been many exciting changes in technology. The endoscopes we used when I started my career were called fiberoptic scopes. These were scopes that contained tiny glass fibers that ran the length of the scope, and they were good, but not great in terms of imaging, and sometimes they would break down. We now have digital imaging that far surpasses the quality there. We’ve come a long way in terms of things like CT scans, for example, and MRI imaging. The other big technology change has been the development of minimally invasive treatments. For example, if you have a gallstone that’s in your bile duct, we now have ways to remove that without sending the patient to surgery.

The second big change has been the assessment of quality. When I started my career in gastroenterology, we were doing a lot of things, but we didn’t necessarily know if we were doing them well. Most of us thought we were doing them well, of course, but nobody was really measuring quality. There were no quality benchmarks. And so if you don’t measure it, you don’t know. Where we are today in gastroenterology is we’re intensively concerned about quality and measuring quality in various aspects of what we do. And I think that’s a positive development. 
 

What key achievements came out of the U.S. Multi-Society Task Force on Colorectal Cancer?

Dr. Lieberman: This panel evolved because back in the early 2000s, each of the GI organizations were producing guidelines related to colon cancer screening and follow-up. And they were slightly different. This was an attempt to bring all the relevant groups together and try to align the guidelines and recommendations among the GI organizations so that there wouldn’t be a confusing message.

Over the history of this task force, which started around 2002, it’s been remarkably productive. The task force has really examined all aspects of colorectal cancer, including things like the bowel prep, quality of exams, high risk management, hereditary syndromes that can lead to the higher likelihood of developing colon cancer, polypectomy and polypectomy techniques, and screening and surveillance recommendations, which have evolved over time. It’s been, in my opinion, a remarkably productive task force and continues to this day. I’m so very proud of that group. 
 

Could you give a status update on the blood and tissue repository you created for CRC research? 

Dr. Lieberman: Our initial studies were part of a Veterans Affairs cooperative study, which is a mechanism of funding within the VA that allows us to work with multiple VA centers to collect data and information. At the very outset of this study, we were performing screening colonoscopies in individuals, and we decided to create a bio-repository that included blood samples, polyp tissue, and normal rectal tissue. The thinking was at some point we might be able to do some genomic studies that might help us predict which patients are most likely to develop colon polyps and colon cancer. All that happened in the 1990s. It was supported by the National Cancer Institute. We created this repository, which sat for a long period of time while we were waiting for the technology to develop and so that we could perform genomic studies in a cost-effective way.

We’re now at that point, which is really exciting. We’re beginning to look at this tissue and perform some genomic studies. Some of this data has been presented at national meetings. This was a precursor to creating a similar type of bio-repository in a larger VA cooperative study. CSP #577 Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) is a randomized study comparing two forms of screening, a fecal immunochemical test versus a colonoscopy. We’re in the process of enrolling 50,000 patients in that study. We have also created a blood and tissue repository, which we hope will be useful for future studies.
 

You lead the AGA CRC Task Force, which advances research and policy initiatives to improve screening rates and patient outcomes. What would you like to see in future GI research, particularly in colorectal cancer?

Dr. Lieberman: We have new blood tests coming along that are going to be very attractive to both patients and physicians. You can obtain a blood sample at a point of service and patients won’t have to deal with stool samples. We need to understand how those tests perform in clinical practice. If the test is abnormal, indicating a patient has a higher risk of colon cancer and should get a colonoscopy, are they getting that colonoscopy or not? And what are the barriers? And if it’s normal, then that patient should have a repeat test at an appropriate interval.

We know that the effectiveness of screening really depends on the participation of individuals in terms of completing the steps. We’ve published some work already on trying to understand the role of these blood tests. We expect that these tests will continue to improve over time. 

We’re also working on trying to develop these risk stratification tools that could be used in clinical practice to help figure out the most appropriate test for a particular individual. 

Let’s say you go to your doctor for colon cancer screening, and if we could determine that you are a low-risk individual, you may benefit best from having a non-invasive test, like a blood test or a stool test. Whereas if you’re a higher risk individual, you may need to have a more invasive screening test like colonoscopy. 

This falls into a concept of personalized medicine where we’re trying to use all the information we have from the medical history, and maybe genomic information that I mentioned earlier, to try to determine who needs the most intensive screening and who might benefit from less intensive screening. 

I think the most recent work is really focused on these gaps in screening. And the biggest gap are patients that get a non-invasive test, like a stool test, but do not get a colonoscopy that renders the program ineffective if they don’t get the colonoscopy. We’re trying to highlight that for primary care providers and make sure that everyone understands the importance of this follow-up. And then, trying to develop tools to help the primary care provider navigate that patient to a colonoscopy.
 

What do you think is the biggest misconception about your specialty?

Dr. Lieberman: If there’s a misconception, it’s that GI physicians are focused on procedures. I think a good GI provider should be holistic, and I think many are. What I mean by holistic is that many GI symptoms could be due to stress, medications, diet, or other aspects of behavior, and the remedy is not necessarily a procedure. I think that many GI physicians are really skilled at obtaining this information and trying to help guide the patient through some uncomfortable symptoms.

It means being more like an internist, spending time with the patient to take a detailed history and delve into many different possibilities that might be going on.

Nonselective beta-blockers (NSBBs) appear to reduce mortality among patients with gastric varices, according to investigators.

In a real-world dataset of patients with gastric varices, NSBBs were associated with a 38% reduced mortality rate, supporting the common belief that protective effects extend across different types of varices, lead author Rebecca H. Moon, MD, of Kaiser Permanente Los Angeles Medical Center, and colleagues, reported.

“Overall, numerous randomized trials have established NSBB efficacy in primary and secondary prevention of esophageal variceal hemorrhage,” the investigators wrote in Gastro Hep Advances. “While these benefits are presumed to extend to gastric varices, empirical data on NSBB efficacy in gastric varices management remain scarce.”

To address this knowledge gap, Moon and colleagues conducted a retrospective cohort study of 1,276 adults (aged 18-75 years) diagnosed with gastric varices between 2015 and 2021 within the Kaiser Permanente Southern California system.

Patients were followed through February 2022. Those with splenectomy, transjugular intrahepatic portosystemic shunt (TIPS) performed outside the system, or use of more than one type of NSBB were excluded. NSBB exposure was defined as therapy initiated within 1 year before or after variceal diagnosis.

Outcomes included gastric and esophageal variceal hemorrhage, TIPS, liver transplantation, and mortality. Multivariable logistic regression was used to compare NSBB users with nonusers and to assess individual effects of different NSBBs while adjusting for baseline characteristics.

The study population had a mean age of 58 years with a male predominance (63%). Approximately half (48%) of the patients were Hispanic. Common comorbidities included hypertension (66%), obesity (49%), and type 2 diabetes (45%). More than half of the patients (52.6%) had coexisting esophageal varices, 38% had ascites, and 22% had a history of hepatic encephalopathy.

In total, 767 patients (62%) received an NSBB. Propranolol and nadolol were most commonly prescribed, while carvedilol use was rare. Median follow-up was 1.1 years.

Overall, 40% of patients died during the study period. Mortality was significantly lower among NSBB users compared with nonusers (39.2% vs 50.9%), corresponding to a 38% reduced risk (odds ratio [OR], 0.62; 95% CI, 0.46–0.84). Nadolol was associated with the lowest mortality risk (OR, 0.55; 95% CI, 0.38–0.79), followed by propranolol (OR, 0.71; 95% CI, 0.50–1.00). Carvedilol use was too infrequent for meaningful analysis.

Rates of gastric variceal hemorrhage (7%), esophageal variceal hemorrhage (22%), TIPS (4%), and liver transplantation (5%) did not differ significantly between NSBB and non-NSBB groups.

“The observed reduction in mortality among NSBB users, particularly those on nadolol, suggests a potential survival benefit,” the investigators wrote. “However, the lack of statistically significant differences in other clinical outcomes, including gastric variceal hemorrhage, esophageal variceal hemorrhage, TIPS, and liver transplantation, indicates that the primary benefit of NSBBs in gastric varices management may be limited to mortality reduction rather than prevention of other complications.”

Moon and colleagues went on to call for additional research.

“Further prospective studies are needed to elucidate the effects of NSBBs on gastric varices and to refine treatment strategies for this high-risk population,” they wrote. “Given the substantial mortality associated with gastric variceal hemorrhage, continued research into novel therapeutic approaches is essential to improving outcomes for patients with gastric varices.”

Publication costs were covered by Kaiser Permanente Los Angeles Medical Education and Research. The investigators disclosed no conflicts of interest.

Nonselective beta-blockers (NSBBs) appear to reduce mortality among patients with gastric varices, according to investigators.

In a real-world dataset of patients with gastric varices, NSBBs were associated with a 38% reduced mortality rate, supporting the common belief that protective effects extend across different types of varices, lead author Rebecca H. Moon, MD, of Kaiser Permanente Los Angeles Medical Center, and colleagues, reported.

“Overall, numerous randomized trials have established NSBB efficacy in primary and secondary prevention of esophageal variceal hemorrhage,” the investigators wrote in Gastro Hep Advances. “While these benefits are presumed to extend to gastric varices, empirical data on NSBB efficacy in gastric varices management remain scarce.”

To address this knowledge gap, Moon and colleagues conducted a retrospective cohort study of 1,276 adults (aged 18-75 years) diagnosed with gastric varices between 2015 and 2021 within the Kaiser Permanente Southern California system.

Patients were followed through February 2022. Those with splenectomy, transjugular intrahepatic portosystemic shunt (TIPS) performed outside the system, or use of more than one type of NSBB were excluded. NSBB exposure was defined as therapy initiated within 1 year before or after variceal diagnosis.

Outcomes included gastric and esophageal variceal hemorrhage, TIPS, liver transplantation, and mortality. Multivariable logistic regression was used to compare NSBB users with nonusers and to assess individual effects of different NSBBs while adjusting for baseline characteristics.

The study population had a mean age of 58 years with a male predominance (63%). Approximately half (48%) of the patients were Hispanic. Common comorbidities included hypertension (66%), obesity (49%), and type 2 diabetes (45%). More than half of the patients (52.6%) had coexisting esophageal varices, 38% had ascites, and 22% had a history of hepatic encephalopathy.

In total, 767 patients (62%) received an NSBB. Propranolol and nadolol were most commonly prescribed, while carvedilol use was rare. Median follow-up was 1.1 years.

Overall, 40% of patients died during the study period. Mortality was significantly lower among NSBB users compared with nonusers (39.2% vs 50.9%), corresponding to a 38% reduced risk (odds ratio [OR], 0.62; 95% CI, 0.46–0.84). Nadolol was associated with the lowest mortality risk (OR, 0.55; 95% CI, 0.38–0.79), followed by propranolol (OR, 0.71; 95% CI, 0.50–1.00). Carvedilol use was too infrequent for meaningful analysis.

Rates of gastric variceal hemorrhage (7%), esophageal variceal hemorrhage (22%), TIPS (4%), and liver transplantation (5%) did not differ significantly between NSBB and non-NSBB groups.

“The observed reduction in mortality among NSBB users, particularly those on nadolol, suggests a potential survival benefit,” the investigators wrote. “However, the lack of statistically significant differences in other clinical outcomes, including gastric variceal hemorrhage, esophageal variceal hemorrhage, TIPS, and liver transplantation, indicates that the primary benefit of NSBBs in gastric varices management may be limited to mortality reduction rather than prevention of other complications.”

Moon and colleagues went on to call for additional research.

“Further prospective studies are needed to elucidate the effects of NSBBs on gastric varices and to refine treatment strategies for this high-risk population,” they wrote. “Given the substantial mortality associated with gastric variceal hemorrhage, continued research into novel therapeutic approaches is essential to improving outcomes for patients with gastric varices.”

Publication costs were covered by Kaiser Permanente Los Angeles Medical Education and Research. The investigators disclosed no conflicts of interest.

Nonselective beta-blockers (NSBBs) appear to reduce mortality among patients with gastric varices, according to investigators.

In a real-world dataset of patients with gastric varices, NSBBs were associated with a 38% reduced mortality rate, supporting the common belief that protective effects extend across different types of varices, lead author Rebecca H. Moon, MD, of Kaiser Permanente Los Angeles Medical Center, and colleagues, reported.

“Overall, numerous randomized trials have established NSBB efficacy in primary and secondary prevention of esophageal variceal hemorrhage,” the investigators wrote in Gastro Hep Advances. “While these benefits are presumed to extend to gastric varices, empirical data on NSBB efficacy in gastric varices management remain scarce.”

To address this knowledge gap, Moon and colleagues conducted a retrospective cohort study of 1,276 adults (aged 18-75 years) diagnosed with gastric varices between 2015 and 2021 within the Kaiser Permanente Southern California system.

Patients were followed through February 2022. Those with splenectomy, transjugular intrahepatic portosystemic shunt (TIPS) performed outside the system, or use of more than one type of NSBB were excluded. NSBB exposure was defined as therapy initiated within 1 year before or after variceal diagnosis.

Outcomes included gastric and esophageal variceal hemorrhage, TIPS, liver transplantation, and mortality. Multivariable logistic regression was used to compare NSBB users with nonusers and to assess individual effects of different NSBBs while adjusting for baseline characteristics.

The study population had a mean age of 58 years with a male predominance (63%). Approximately half (48%) of the patients were Hispanic. Common comorbidities included hypertension (66%), obesity (49%), and type 2 diabetes (45%). More than half of the patients (52.6%) had coexisting esophageal varices, 38% had ascites, and 22% had a history of hepatic encephalopathy.

In total, 767 patients (62%) received an NSBB. Propranolol and nadolol were most commonly prescribed, while carvedilol use was rare. Median follow-up was 1.1 years.

Overall, 40% of patients died during the study period. Mortality was significantly lower among NSBB users compared with nonusers (39.2% vs 50.9%), corresponding to a 38% reduced risk (odds ratio [OR], 0.62; 95% CI, 0.46–0.84). Nadolol was associated with the lowest mortality risk (OR, 0.55; 95% CI, 0.38–0.79), followed by propranolol (OR, 0.71; 95% CI, 0.50–1.00). Carvedilol use was too infrequent for meaningful analysis.

Rates of gastric variceal hemorrhage (7%), esophageal variceal hemorrhage (22%), TIPS (4%), and liver transplantation (5%) did not differ significantly between NSBB and non-NSBB groups.

“The observed reduction in mortality among NSBB users, particularly those on nadolol, suggests a potential survival benefit,” the investigators wrote. “However, the lack of statistically significant differences in other clinical outcomes, including gastric variceal hemorrhage, esophageal variceal hemorrhage, TIPS, and liver transplantation, indicates that the primary benefit of NSBBs in gastric varices management may be limited to mortality reduction rather than prevention of other complications.”

Moon and colleagues went on to call for additional research.

“Further prospective studies are needed to elucidate the effects of NSBBs on gastric varices and to refine treatment strategies for this high-risk population,” they wrote. “Given the substantial mortality associated with gastric variceal hemorrhage, continued research into novel therapeutic approaches is essential to improving outcomes for patients with gastric varices.”

Publication costs were covered by Kaiser Permanente Los Angeles Medical Education and Research. The investigators disclosed no conflicts of interest.

The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.

IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.

Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.

IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.

The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.

The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.

The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: [email protected].

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

The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.

IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.

Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.

IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.

The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.

The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.

The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: [email protected].

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

The FDA has granted Cleveland Diagnostics' IsoPSA test premarket approval (PMA) to help detect prostate cancer in men aged ≥ 50 years with elevated PSA levels.

IsoPSA is a blood assay that detects variations of the PSA protein that signal a higher likelihood of high-grade tumors. It is one of several biomarker tests included in the National Comprehensive Cancer Network's guidelines on early detection of prostate cancer.

Cleveland Diagnostics noted that 75% of prostate biopsies are negative for high-grade disease. IsoPSA and similar tests aim to help identify men who need a biopsy while allowing others avoid an unnecessary procedure.

IsoPSA has been available since 2020 under the FDA's Laboratory-Developed Test rubric, meaning that blood samples had to be shipped for analysis to Cleveland Diagnostics' lab. With the PMA, testing can now be done at CLIA-certified labs across the country.

The company expects the approval should increase access to IsoPSA and reduce turnaround time. "We remain focused on executing our commercial strategy and expanding access to IsoPSA," company President and CEO Arnon Chait, PhD, said in a press release.

The approval was based, in part, on a prospective validation study of 888 men scheduled for prostate biopsy. IsoPSA demonstrated an AUC of 0.783 for high-grade tumors, with a sensitivity of 90.2% and a specificity of 45.5%. In a real-world clinical utility study with 900 patients, IsoPSA testing led to a 55% decrease in biopsy recommendations.

The test is covered by Medicare and a growing number of commercial payers, Cleveland Diagnostics said.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism Fellow. Email: [email protected].

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

PHOENIX — Patients treated for cancer with immune checkpoint inhibitors (ICIs) who develop the drugs’ known side effects of diarrhea and colitis experience increased risk of adenomas in the colon — potentially compounding their cancer burden to include a risk for colon cancer, new research showed.

“The cancer population is already at a higher baseline adenoma risk, and our findings show that ICI-mediated diarrhea and colitis compounds this,” said first author Tanvi Gupta, MD, Department of Internal Medicine, The University of Texas Health Science Center, Houston, in presenting the findings at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

“The study supports a risk-stratified approach to surveillance colonoscopy perhaps within 1 year of ICI-mediated diarrhea and colitis, or earlier if risk factors present,” she said.

ICIs, such as PD-1 and PD-L1 inhibitors, have emerged as highly effective front-line treatments for various cancers, however, diarrhea and colitis are among their most notorious off-target adverse effects, believed to be caused by excessive inflammatory activity from the therapy.

Interestingly, prolonged courses of colitis of more than 3 months have in fact been associated with improved long-term outcomes and survival related to the cancer being treated.

However, prolonged inflammation of the intestine is not without key risks, including compromised colonic mucosa, and such complications are particularly concerning considering indications that the colitis can persist for years even after ICIs are discontinued, the authors noted.

With a previous small study from the researchers at MD Anderson suggesting a higher risk for adenomas associated with ICI-mediated diarrhea and colitis within 1 year of diagnosis, Gupta and colleagues investigated the effects in a larger retrospective study, enrolling 248 patients treated for cancer at MD Anderson from 2010 to 2025.

All patients had developed ICI-mediated diarrhea and/or colitis, confirmed by colonoscopy within 90 days of onset, and all underwent a subsequent colonoscopy at any time point.

The patients, who had a median age of about 63.1 years, were 57.9% men and 90.3% White individuals. Of the patients, 43.7% had been treated with either PD-1 or PD-L1 inhibitors, whereas 42.5% received combination therapy including CTLA-4 inhibitors.

Patients’ predominant cancer types were melanoma and genitourinary malignancies. About 65% had cancer stage IV.

They were compared with a group of historical control individuals who had been treated with ICIs but did not develop diarrhea/colitis, and who had normal baseline and follow-up colonoscopies.

Overall, 71, or nearly 30% of the patients, developed adenomas on follow-up colonoscopies at least 6 months later, with more than 50% of the adenomas developing rapidly, within 7.5 months of ICI-mediated diarrhea and colitis onset. Rates subsequently declined over the following 6 years.

Of 210 who developed ICI-mediated diarrhea and colitis and had baseline and 1-year colonoscopies, those with baseline polyps had an increased risk for detection of adenomas on follow-up endoscopy compared with those with no baseline polyps (33.9% vs 15.9%; P = .004).

However, compared with the patients who were treated with ICIs but did not develop diarrhea and colitis (n = 31), those who did develop the side effects had a higher risk of developing adenomas, even if they had no prior history of polyps (n = 139; P = .002).

Likewise, among those with active histological inflammation at baseline, the risk for adenoma development was higher among those with baseline adenomas vs no adenomas (32.6% vs 15.8%; P = .014), but the risk was higher even among those with no baseline polyps but who did have active inflammation compared with those with ICI treatment but none of the gastrointestinal (GI) side effects (P = .003).

Of those who did develop adenomas, tubular adenomas were the most common types of adenomas, increasing from a median of 46.4% of polyps per patient at baseline to 87.5% at a follow-up endoscopy.

And the size of adenomas increased, with the rate of those under 5 mm at baseline of 100% dropping to 83.3% at the follow-up colonoscopy.

Overall, the findings underscore the role of ICI-mediated diarrhea and colitis in adenoma development.

“We know the cancer population is at a higher baseline risk of adenomas, and ICI-mediated diarrhea and colitis compounds this,” Gupta said.

Importantly, the findings indicate that “histological inflammation drives mucosal injury and adenoma development, regardless of baseline polyps.”
 

Findings Raise Questions of Surveillance

Danny Issa, MD, an interventional endoscopist and assistant professor of medicine of David Geffen School of Medicine at UCLA, who co-moderated the study, noted that, while longer-term studies are needed, “it’s an interesting study and eye-opening for the many patients on these medications now — but we do need more data.”

“The key question raised is are these patients at a higher risk for colon cancer? It’s possible, and it’s important for clinicians to keep that in mind,” he told GI & Hepatology News.

Further commenting, session co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Paramus, New Jersey, noted the alarming context of ICIs already being used for an existing cancer in the first place.

“So they have one type of cancer and now these patients may be at a higher risk for getting adenomas linked to colon cancer, and so an important question is how often to follow-up on these patients,” she said.

The study’s senior author, Yinghong Wang, MD, PhD, a professor and director of the Oncology-GI Toxicity program at MD Anderson, noted that at MD Anderson, “we routinely offer the first surveillance colonoscopy 1 year after the index ICI-mediated diarrhea and colitis.”

“The following surveillance interval will be based on the finding of this first surveillance colonoscopy,” she told GI & Hepatology News.

Wang recommended that others treating ICI-mediated diarrhea and colitis should follow suit, “given the higher incidence and rapid development of colonic adenomas during this time frame.”

Gupta, Wang, and Chokhavatia had no disclosures to report. Issa reported relationships with Boston Scientific and Eli Lilly.

A version of this article appeared on Medscape.com.

PHOENIX — Patients treated for cancer with immune checkpoint inhibitors (ICIs) who develop the drugs’ known side effects of diarrhea and colitis experience increased risk of adenomas in the colon — potentially compounding their cancer burden to include a risk for colon cancer, new research showed.

“The cancer population is already at a higher baseline adenoma risk, and our findings show that ICI-mediated diarrhea and colitis compounds this,” said first author Tanvi Gupta, MD, Department of Internal Medicine, The University of Texas Health Science Center, Houston, in presenting the findings at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

“The study supports a risk-stratified approach to surveillance colonoscopy perhaps within 1 year of ICI-mediated diarrhea and colitis, or earlier if risk factors present,” she said.

ICIs, such as PD-1 and PD-L1 inhibitors, have emerged as highly effective front-line treatments for various cancers, however, diarrhea and colitis are among their most notorious off-target adverse effects, believed to be caused by excessive inflammatory activity from the therapy.

Interestingly, prolonged courses of colitis of more than 3 months have in fact been associated with improved long-term outcomes and survival related to the cancer being treated.

However, prolonged inflammation of the intestine is not without key risks, including compromised colonic mucosa, and such complications are particularly concerning considering indications that the colitis can persist for years even after ICIs are discontinued, the authors noted.

With a previous small study from the researchers at MD Anderson suggesting a higher risk for adenomas associated with ICI-mediated diarrhea and colitis within 1 year of diagnosis, Gupta and colleagues investigated the effects in a larger retrospective study, enrolling 248 patients treated for cancer at MD Anderson from 2010 to 2025.

All patients had developed ICI-mediated diarrhea and/or colitis, confirmed by colonoscopy within 90 days of onset, and all underwent a subsequent colonoscopy at any time point.

The patients, who had a median age of about 63.1 years, were 57.9% men and 90.3% White individuals. Of the patients, 43.7% had been treated with either PD-1 or PD-L1 inhibitors, whereas 42.5% received combination therapy including CTLA-4 inhibitors.

Patients’ predominant cancer types were melanoma and genitourinary malignancies. About 65% had cancer stage IV.

They were compared with a group of historical control individuals who had been treated with ICIs but did not develop diarrhea/colitis, and who had normal baseline and follow-up colonoscopies.

Overall, 71, or nearly 30% of the patients, developed adenomas on follow-up colonoscopies at least 6 months later, with more than 50% of the adenomas developing rapidly, within 7.5 months of ICI-mediated diarrhea and colitis onset. Rates subsequently declined over the following 6 years.

Of 210 who developed ICI-mediated diarrhea and colitis and had baseline and 1-year colonoscopies, those with baseline polyps had an increased risk for detection of adenomas on follow-up endoscopy compared with those with no baseline polyps (33.9% vs 15.9%; P = .004).

However, compared with the patients who were treated with ICIs but did not develop diarrhea and colitis (n = 31), those who did develop the side effects had a higher risk of developing adenomas, even if they had no prior history of polyps (n = 139; P = .002).

Likewise, among those with active histological inflammation at baseline, the risk for adenoma development was higher among those with baseline adenomas vs no adenomas (32.6% vs 15.8%; P = .014), but the risk was higher even among those with no baseline polyps but who did have active inflammation compared with those with ICI treatment but none of the gastrointestinal (GI) side effects (P = .003).

Of those who did develop adenomas, tubular adenomas were the most common types of adenomas, increasing from a median of 46.4% of polyps per patient at baseline to 87.5% at a follow-up endoscopy.

And the size of adenomas increased, with the rate of those under 5 mm at baseline of 100% dropping to 83.3% at the follow-up colonoscopy.

Overall, the findings underscore the role of ICI-mediated diarrhea and colitis in adenoma development.

“We know the cancer population is at a higher baseline risk of adenomas, and ICI-mediated diarrhea and colitis compounds this,” Gupta said.

Importantly, the findings indicate that “histological inflammation drives mucosal injury and adenoma development, regardless of baseline polyps.”
 

Findings Raise Questions of Surveillance

Danny Issa, MD, an interventional endoscopist and assistant professor of medicine of David Geffen School of Medicine at UCLA, who co-moderated the study, noted that, while longer-term studies are needed, “it’s an interesting study and eye-opening for the many patients on these medications now — but we do need more data.”

“The key question raised is are these patients at a higher risk for colon cancer? It’s possible, and it’s important for clinicians to keep that in mind,” he told GI & Hepatology News.

Further commenting, session co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Paramus, New Jersey, noted the alarming context of ICIs already being used for an existing cancer in the first place.

“So they have one type of cancer and now these patients may be at a higher risk for getting adenomas linked to colon cancer, and so an important question is how often to follow-up on these patients,” she said.

The study’s senior author, Yinghong Wang, MD, PhD, a professor and director of the Oncology-GI Toxicity program at MD Anderson, noted that at MD Anderson, “we routinely offer the first surveillance colonoscopy 1 year after the index ICI-mediated diarrhea and colitis.”

“The following surveillance interval will be based on the finding of this first surveillance colonoscopy,” she told GI & Hepatology News.

Wang recommended that others treating ICI-mediated diarrhea and colitis should follow suit, “given the higher incidence and rapid development of colonic adenomas during this time frame.”

Gupta, Wang, and Chokhavatia had no disclosures to report. Issa reported relationships with Boston Scientific and Eli Lilly.

A version of this article appeared on Medscape.com.

PHOENIX — Patients treated for cancer with immune checkpoint inhibitors (ICIs) who develop the drugs’ known side effects of diarrhea and colitis experience increased risk of adenomas in the colon — potentially compounding their cancer burden to include a risk for colon cancer, new research showed.

“The cancer population is already at a higher baseline adenoma risk, and our findings show that ICI-mediated diarrhea and colitis compounds this,” said first author Tanvi Gupta, MD, Department of Internal Medicine, The University of Texas Health Science Center, Houston, in presenting the findings at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

“The study supports a risk-stratified approach to surveillance colonoscopy perhaps within 1 year of ICI-mediated diarrhea and colitis, or earlier if risk factors present,” she said.

ICIs, such as PD-1 and PD-L1 inhibitors, have emerged as highly effective front-line treatments for various cancers, however, diarrhea and colitis are among their most notorious off-target adverse effects, believed to be caused by excessive inflammatory activity from the therapy.

Interestingly, prolonged courses of colitis of more than 3 months have in fact been associated with improved long-term outcomes and survival related to the cancer being treated.

However, prolonged inflammation of the intestine is not without key risks, including compromised colonic mucosa, and such complications are particularly concerning considering indications that the colitis can persist for years even after ICIs are discontinued, the authors noted.

With a previous small study from the researchers at MD Anderson suggesting a higher risk for adenomas associated with ICI-mediated diarrhea and colitis within 1 year of diagnosis, Gupta and colleagues investigated the effects in a larger retrospective study, enrolling 248 patients treated for cancer at MD Anderson from 2010 to 2025.

All patients had developed ICI-mediated diarrhea and/or colitis, confirmed by colonoscopy within 90 days of onset, and all underwent a subsequent colonoscopy at any time point.

The patients, who had a median age of about 63.1 years, were 57.9% men and 90.3% White individuals. Of the patients, 43.7% had been treated with either PD-1 or PD-L1 inhibitors, whereas 42.5% received combination therapy including CTLA-4 inhibitors.

Patients’ predominant cancer types were melanoma and genitourinary malignancies. About 65% had cancer stage IV.

They were compared with a group of historical control individuals who had been treated with ICIs but did not develop diarrhea/colitis, and who had normal baseline and follow-up colonoscopies.

Overall, 71, or nearly 30% of the patients, developed adenomas on follow-up colonoscopies at least 6 months later, with more than 50% of the adenomas developing rapidly, within 7.5 months of ICI-mediated diarrhea and colitis onset. Rates subsequently declined over the following 6 years.

Of 210 who developed ICI-mediated diarrhea and colitis and had baseline and 1-year colonoscopies, those with baseline polyps had an increased risk for detection of adenomas on follow-up endoscopy compared with those with no baseline polyps (33.9% vs 15.9%; P = .004).

However, compared with the patients who were treated with ICIs but did not develop diarrhea and colitis (n = 31), those who did develop the side effects had a higher risk of developing adenomas, even if they had no prior history of polyps (n = 139; P = .002).

Likewise, among those with active histological inflammation at baseline, the risk for adenoma development was higher among those with baseline adenomas vs no adenomas (32.6% vs 15.8%; P = .014), but the risk was higher even among those with no baseline polyps but who did have active inflammation compared with those with ICI treatment but none of the gastrointestinal (GI) side effects (P = .003).

Of those who did develop adenomas, tubular adenomas were the most common types of adenomas, increasing from a median of 46.4% of polyps per patient at baseline to 87.5% at a follow-up endoscopy.

And the size of adenomas increased, with the rate of those under 5 mm at baseline of 100% dropping to 83.3% at the follow-up colonoscopy.

Overall, the findings underscore the role of ICI-mediated diarrhea and colitis in adenoma development.

“We know the cancer population is at a higher baseline risk of adenomas, and ICI-mediated diarrhea and colitis compounds this,” Gupta said.

Importantly, the findings indicate that “histological inflammation drives mucosal injury and adenoma development, regardless of baseline polyps.”
 

Findings Raise Questions of Surveillance

Danny Issa, MD, an interventional endoscopist and assistant professor of medicine of David Geffen School of Medicine at UCLA, who co-moderated the study, noted that, while longer-term studies are needed, “it’s an interesting study and eye-opening for the many patients on these medications now — but we do need more data.”

“The key question raised is are these patients at a higher risk for colon cancer? It’s possible, and it’s important for clinicians to keep that in mind,” he told GI & Hepatology News.

Further commenting, session co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Paramus, New Jersey, noted the alarming context of ICIs already being used for an existing cancer in the first place.

“So they have one type of cancer and now these patients may be at a higher risk for getting adenomas linked to colon cancer, and so an important question is how often to follow-up on these patients,” she said.

The study’s senior author, Yinghong Wang, MD, PhD, a professor and director of the Oncology-GI Toxicity program at MD Anderson, noted that at MD Anderson, “we routinely offer the first surveillance colonoscopy 1 year after the index ICI-mediated diarrhea and colitis.”

“The following surveillance interval will be based on the finding of this first surveillance colonoscopy,” she told GI & Hepatology News.

Wang recommended that others treating ICI-mediated diarrhea and colitis should follow suit, “given the higher incidence and rapid development of colonic adenomas during this time frame.”

Gupta, Wang, and Chokhavatia had no disclosures to report. Issa reported relationships with Boston Scientific and Eli Lilly.

A version of this article appeared on Medscape.com.

The risk of death in patients with posttraumatic epilepsy (PTE) varies dramatically by type of brain injury, with some facing twice the mortality rate as those with other forms of epilepsy, according to a new study of Veterans Health Administration data. 

Of 210,182 veterans with epilepsy followed for a median of 6 years, those who developed PTE after diffuse cerebral injury, focal cerebral injury, or skull/facial fractures had 16% to 18% higher mortality rates than veterans with nontraumatic epilepsy (NTE) the study found. Published in Neurology, the analysis was completed by Zulfi Haneef, MBBS, MD, of Baylor College of Medicine Medical Center, and colleagues. 

Young patients who developed PTE after extracerebral hemorrhage faced the highest risk — double the mortality rate of those with NTE.

“These numbers are striking considering that the group against which these rates are compared — other causes of epilepsy — itself suffers from a high mortality rate,” Haneef said in an interview with Federal Practitioner. “Our findings argue for risk-stratified follow-up in PTE based on the underlying TBI [traumatic brain injury] mechanism and age at epilepsy onset.”

How Common is PTE?

PTE is defined as “long-term predisposition to developing recurrent and unprovoked seizures caused by a traumatic brain injury,” according to neurologist Edilberto Amorim, MD, of University of California at San Francisco Weill Institute for Neurosciences, who was not involved with the study but is familiar with its findings. “We do not fully understand why some people with a traumatic brain injury develop epilepsy and others do not, but the risk is higher with more severe types of TBI.”

PTE accounts for about 5% of all epilepsy cases, Amorim said. The study cites research linking PTE to mortality risk that’s 1.75 to 2.30 higher than in people without epilepsy. 

Haneef said the study aimed to shed light on mortality in PTE. “Although epilepsy and TBI are each linked to higher mortality, it had never been conclusively shown that PTE specifically carries higher mortality than nontraumatic epilepsy,” he said. “We set out to answer that question in a large national veterans cohort and to see whether mortality differs by the type of antecedent TBI.”

Methodology and Findings

Researchers tracked 210,182 veterans diagnosed with epilepsy from 2005 to 2022 through the end of 2024: 28,832 with PTE (mean onset age 52.6 years, 7.4% female, 74.2% White, 16.2% Black) and 181,350 with NTE (mean onset age 60.9 years, 8.5% female, 71.0% White, 21.4% Black).

Patients with PTE were defined as having had documentation of TBI within 5 years previous to receiving an epilepsy diagnosis.

Among those with NTE (median follow-up, 6.0 years), 51.1% died. In the PTE group (median follow-up, 6.4 years), 37.3% died.

After adjustment for differences in age, sex, and comorbidities, the risk of mortality in PTE was slightly higher than in NTE (adjusted hazard ratio [aHR], 1.02); the risk was lower for the concussive TBI subtype (aHR, 0.91, both P < .05). “The underlying injury in concussion

is likely to be less severe compared with structural TBI, which may have led to the lower relative mortality observed,” the authors wrote. 

However, risk of mortality in PTE was higher than in NTE for cases with underlying TBI subtypes of skull/facial fracture (aHR, 1.18), diffuse cerebral injury (aHR, 1.17), and focal cerebral injury (aHR, 1.16).

“These injuries are associated with greater structural brain damage and sustained neuroinflammation, which are factors linked to harder-to-treat (drug-resistant) epilepsy, which carries higher mortality,” Haneef said. “They may also coexist with extracranial trauma and medical comorbidity that compound long-term risk.”

Among various age groups, there was a notably higher risk of mortality linked to patients aged 18 to 39 years at onset with extracerebral PTE (aHR, 2.02, vs NTE): “In younger patients, extracerebral bleeds (eg, subdural, epidural, and subarachnoid) may reflect higher-energy trauma and more aggressive secondary cascades, amplifying epilepsy severity and longer lifetime exposure to risk. Mechanistic differences in hemorrhage types across ages may also contribute,” Haneef said. 

Perspective on Findings

Amorim said the new research is “very useful,” although it has limitations that are common in large database studies. “A key point that this study highlights is the variability in the impact of TBI type on mortality and the differential risk across different age groups,” he said. 

As for the higher risk in younger people, Amorim said this may be related to severity of injury: “Older patients often have TBI after falls, while younger patients are more frequently involved in traffic accidents or victims of violence,” he said

In the big picture, Amorim said, “studies like this highlight the importance of moving beyond a one-size-fits-all approach in epilepsy care. Understanding the nuances of posttraumatic epilepsy—how the type of injury, age, and other factors affect outcomes—can help us personalize treatment and counseling and maybe even guide future research into preventing or mitigating epilepsy after brain injury. New methods to automate review of medical records with higher resolution, such as large language models and natural language processing, may make this type of study with large databases even more comprehensive and impactful.”

Haneef said the findings highlight the importance of recognizing PTE as a higher-risk epilepsy and prioritizing early specialty care, especially after focal/diffuse brain injury or fracture. “Screen proactively for drug resistance and fast-track definitive therapies—surgery and device-based therapies—when indicated,” Haneef said. “Management should also include optimized antiseizure therapy, comorbidity control, and safety counseling, since many deaths may be preventable with coordinated multidisciplinary care.”

Haneef added that clinicians should “pay particular attention to younger PTE patients with extracerebral hemorrhage, who showed the greatest relative mortality.”

He also noted that the US Department of Veterans Affairs has comprehensive Epilepsy Centers of Excellence across the country.

The US Department of Defense (DoD) funded the study. Haneef discloses DoD funding, and another author discloses DoD and VA funding. Other authors have no disclosures. 

Amorim discloses funding from DoD, NIH, American Heart Association, Regents of the University of California, Cures Within Reach, Zoll Foundation, and Hellman Foundation.

The risk of death in patients with posttraumatic epilepsy (PTE) varies dramatically by type of brain injury, with some facing twice the mortality rate as those with other forms of epilepsy, according to a new study of Veterans Health Administration data. 

Of 210,182 veterans with epilepsy followed for a median of 6 years, those who developed PTE after diffuse cerebral injury, focal cerebral injury, or skull/facial fractures had 16% to 18% higher mortality rates than veterans with nontraumatic epilepsy (NTE) the study found. Published in Neurology, the analysis was completed by Zulfi Haneef, MBBS, MD, of Baylor College of Medicine Medical Center, and colleagues. 

Young patients who developed PTE after extracerebral hemorrhage faced the highest risk — double the mortality rate of those with NTE.

“These numbers are striking considering that the group against which these rates are compared — other causes of epilepsy — itself suffers from a high mortality rate,” Haneef said in an interview with Federal Practitioner. “Our findings argue for risk-stratified follow-up in PTE based on the underlying TBI [traumatic brain injury] mechanism and age at epilepsy onset.”

How Common is PTE?

PTE is defined as “long-term predisposition to developing recurrent and unprovoked seizures caused by a traumatic brain injury,” according to neurologist Edilberto Amorim, MD, of University of California at San Francisco Weill Institute for Neurosciences, who was not involved with the study but is familiar with its findings. “We do not fully understand why some people with a traumatic brain injury develop epilepsy and others do not, but the risk is higher with more severe types of TBI.”

PTE accounts for about 5% of all epilepsy cases, Amorim said. The study cites research linking PTE to mortality risk that’s 1.75 to 2.30 higher than in people without epilepsy. 

Haneef said the study aimed to shed light on mortality in PTE. “Although epilepsy and TBI are each linked to higher mortality, it had never been conclusively shown that PTE specifically carries higher mortality than nontraumatic epilepsy,” he said. “We set out to answer that question in a large national veterans cohort and to see whether mortality differs by the type of antecedent TBI.”

Methodology and Findings

Researchers tracked 210,182 veterans diagnosed with epilepsy from 2005 to 2022 through the end of 2024: 28,832 with PTE (mean onset age 52.6 years, 7.4% female, 74.2% White, 16.2% Black) and 181,350 with NTE (mean onset age 60.9 years, 8.5% female, 71.0% White, 21.4% Black).

Patients with PTE were defined as having had documentation of TBI within 5 years previous to receiving an epilepsy diagnosis.

Among those with NTE (median follow-up, 6.0 years), 51.1% died. In the PTE group (median follow-up, 6.4 years), 37.3% died.

After adjustment for differences in age, sex, and comorbidities, the risk of mortality in PTE was slightly higher than in NTE (adjusted hazard ratio [aHR], 1.02); the risk was lower for the concussive TBI subtype (aHR, 0.91, both P < .05). “The underlying injury in concussion

is likely to be less severe compared with structural TBI, which may have led to the lower relative mortality observed,” the authors wrote. 

However, risk of mortality in PTE was higher than in NTE for cases with underlying TBI subtypes of skull/facial fracture (aHR, 1.18), diffuse cerebral injury (aHR, 1.17), and focal cerebral injury (aHR, 1.16).

“These injuries are associated with greater structural brain damage and sustained neuroinflammation, which are factors linked to harder-to-treat (drug-resistant) epilepsy, which carries higher mortality,” Haneef said. “They may also coexist with extracranial trauma and medical comorbidity that compound long-term risk.”

Among various age groups, there was a notably higher risk of mortality linked to patients aged 18 to 39 years at onset with extracerebral PTE (aHR, 2.02, vs NTE): “In younger patients, extracerebral bleeds (eg, subdural, epidural, and subarachnoid) may reflect higher-energy trauma and more aggressive secondary cascades, amplifying epilepsy severity and longer lifetime exposure to risk. Mechanistic differences in hemorrhage types across ages may also contribute,” Haneef said. 

Perspective on Findings

Amorim said the new research is “very useful,” although it has limitations that are common in large database studies. “A key point that this study highlights is the variability in the impact of TBI type on mortality and the differential risk across different age groups,” he said. 

As for the higher risk in younger people, Amorim said this may be related to severity of injury: “Older patients often have TBI after falls, while younger patients are more frequently involved in traffic accidents or victims of violence,” he said

In the big picture, Amorim said, “studies like this highlight the importance of moving beyond a one-size-fits-all approach in epilepsy care. Understanding the nuances of posttraumatic epilepsy—how the type of injury, age, and other factors affect outcomes—can help us personalize treatment and counseling and maybe even guide future research into preventing or mitigating epilepsy after brain injury. New methods to automate review of medical records with higher resolution, such as large language models and natural language processing, may make this type of study with large databases even more comprehensive and impactful.”

Haneef said the findings highlight the importance of recognizing PTE as a higher-risk epilepsy and prioritizing early specialty care, especially after focal/diffuse brain injury or fracture. “Screen proactively for drug resistance and fast-track definitive therapies—surgery and device-based therapies—when indicated,” Haneef said. “Management should also include optimized antiseizure therapy, comorbidity control, and safety counseling, since many deaths may be preventable with coordinated multidisciplinary care.”

Haneef added that clinicians should “pay particular attention to younger PTE patients with extracerebral hemorrhage, who showed the greatest relative mortality.”

He also noted that the US Department of Veterans Affairs has comprehensive Epilepsy Centers of Excellence across the country.

The US Department of Defense (DoD) funded the study. Haneef discloses DoD funding, and another author discloses DoD and VA funding. Other authors have no disclosures. 

Amorim discloses funding from DoD, NIH, American Heart Association, Regents of the University of California, Cures Within Reach, Zoll Foundation, and Hellman Foundation.

The risk of death in patients with posttraumatic epilepsy (PTE) varies dramatically by type of brain injury, with some facing twice the mortality rate as those with other forms of epilepsy, according to a new study of Veterans Health Administration data. 

Of 210,182 veterans with epilepsy followed for a median of 6 years, those who developed PTE after diffuse cerebral injury, focal cerebral injury, or skull/facial fractures had 16% to 18% higher mortality rates than veterans with nontraumatic epilepsy (NTE) the study found. Published in Neurology, the analysis was completed by Zulfi Haneef, MBBS, MD, of Baylor College of Medicine Medical Center, and colleagues. 

Young patients who developed PTE after extracerebral hemorrhage faced the highest risk — double the mortality rate of those with NTE.

“These numbers are striking considering that the group against which these rates are compared — other causes of epilepsy — itself suffers from a high mortality rate,” Haneef said in an interview with Federal Practitioner. “Our findings argue for risk-stratified follow-up in PTE based on the underlying TBI [traumatic brain injury] mechanism and age at epilepsy onset.”

How Common is PTE?

PTE is defined as “long-term predisposition to developing recurrent and unprovoked seizures caused by a traumatic brain injury,” according to neurologist Edilberto Amorim, MD, of University of California at San Francisco Weill Institute for Neurosciences, who was not involved with the study but is familiar with its findings. “We do not fully understand why some people with a traumatic brain injury develop epilepsy and others do not, but the risk is higher with more severe types of TBI.”

PTE accounts for about 5% of all epilepsy cases, Amorim said. The study cites research linking PTE to mortality risk that’s 1.75 to 2.30 higher than in people without epilepsy. 

Haneef said the study aimed to shed light on mortality in PTE. “Although epilepsy and TBI are each linked to higher mortality, it had never been conclusively shown that PTE specifically carries higher mortality than nontraumatic epilepsy,” he said. “We set out to answer that question in a large national veterans cohort and to see whether mortality differs by the type of antecedent TBI.”

Methodology and Findings

Researchers tracked 210,182 veterans diagnosed with epilepsy from 2005 to 2022 through the end of 2024: 28,832 with PTE (mean onset age 52.6 years, 7.4% female, 74.2% White, 16.2% Black) and 181,350 with NTE (mean onset age 60.9 years, 8.5% female, 71.0% White, 21.4% Black).

Patients with PTE were defined as having had documentation of TBI within 5 years previous to receiving an epilepsy diagnosis.

Among those with NTE (median follow-up, 6.0 years), 51.1% died. In the PTE group (median follow-up, 6.4 years), 37.3% died.

After adjustment for differences in age, sex, and comorbidities, the risk of mortality in PTE was slightly higher than in NTE (adjusted hazard ratio [aHR], 1.02); the risk was lower for the concussive TBI subtype (aHR, 0.91, both P < .05). “The underlying injury in concussion

is likely to be less severe compared with structural TBI, which may have led to the lower relative mortality observed,” the authors wrote. 

However, risk of mortality in PTE was higher than in NTE for cases with underlying TBI subtypes of skull/facial fracture (aHR, 1.18), diffuse cerebral injury (aHR, 1.17), and focal cerebral injury (aHR, 1.16).

“These injuries are associated with greater structural brain damage and sustained neuroinflammation, which are factors linked to harder-to-treat (drug-resistant) epilepsy, which carries higher mortality,” Haneef said. “They may also coexist with extracranial trauma and medical comorbidity that compound long-term risk.”

Among various age groups, there was a notably higher risk of mortality linked to patients aged 18 to 39 years at onset with extracerebral PTE (aHR, 2.02, vs NTE): “In younger patients, extracerebral bleeds (eg, subdural, epidural, and subarachnoid) may reflect higher-energy trauma and more aggressive secondary cascades, amplifying epilepsy severity and longer lifetime exposure to risk. Mechanistic differences in hemorrhage types across ages may also contribute,” Haneef said. 

Perspective on Findings

Amorim said the new research is “very useful,” although it has limitations that are common in large database studies. “A key point that this study highlights is the variability in the impact of TBI type on mortality and the differential risk across different age groups,” he said. 

As for the higher risk in younger people, Amorim said this may be related to severity of injury: “Older patients often have TBI after falls, while younger patients are more frequently involved in traffic accidents or victims of violence,” he said

In the big picture, Amorim said, “studies like this highlight the importance of moving beyond a one-size-fits-all approach in epilepsy care. Understanding the nuances of posttraumatic epilepsy—how the type of injury, age, and other factors affect outcomes—can help us personalize treatment and counseling and maybe even guide future research into preventing or mitigating epilepsy after brain injury. New methods to automate review of medical records with higher resolution, such as large language models and natural language processing, may make this type of study with large databases even more comprehensive and impactful.”

Haneef said the findings highlight the importance of recognizing PTE as a higher-risk epilepsy and prioritizing early specialty care, especially after focal/diffuse brain injury or fracture. “Screen proactively for drug resistance and fast-track definitive therapies—surgery and device-based therapies—when indicated,” Haneef said. “Management should also include optimized antiseizure therapy, comorbidity control, and safety counseling, since many deaths may be preventable with coordinated multidisciplinary care.”

Haneef added that clinicians should “pay particular attention to younger PTE patients with extracerebral hemorrhage, who showed the greatest relative mortality.”

He also noted that the US Department of Veterans Affairs has comprehensive Epilepsy Centers of Excellence across the country.

The US Department of Defense (DoD) funded the study. Haneef discloses DoD funding, and another author discloses DoD and VA funding. Other authors have no disclosures. 

Amorim discloses funding from DoD, NIH, American Heart Association, Regents of the University of California, Cures Within Reach, Zoll Foundation, and Hellman Foundation.

After decades of successful growth, the ambulatory surgery center (ASC) model may be turning a corner, opening up opportunity for office-based endoscopy models, according to a recent practice management editorial published in Clinical Gastroenterology and Hepatology.

Although office endoscopy has been an option, it hasn’t always felt practical or financially viable in the past. However, the paradigm appears to be shifting as ASC-based revenue streams show signs of stress and fail to keep pace with inflation. As healthcare regulatory and economic environments continue to change, gastroenterologists need a new model to support equity, efficiency, and growth in gastrointestinal (GI) care delivery, the authors wrote.

“Through the course of my 40-year career, I’ve been hit with a lot of changes related to regulations, insurance, and the market. You can’t stay entrenched in your old ways. You have to remain pivotable and come up with new strategic positions,” said Lawrence Kosinski, MD, AGAF, lead author and founder of SonarMD and VOCnomics.

During his private practice career, Kosinski built one of the largest GI practices in Illinois, which had seven ASCs and is now part of one of the largest GI groups in the country. Across 30 years of experience with ASCs, Kosinski has watched the reimbursement for professional services decline, as well as for added revenue streams such as pathology and anesthesia.

Looking for a better solution, Kosinski served on the governing board for the American Gastroenterological Association as the councilor for development and growth. During the past 3 years, he has spoken with GI practices and worked with a national anesthesia company — Ambulatory Anesthesia Care — to better understand the office endoscopy setting.

“In the ’90s, all I wanted was to have an ASC because that was in vogue,” he said. “But if you look critically at what has happened to the business of outpatient endoscopy in the past 25 years, you’ll see that professional fees haven’t kept up, and trying to replace that lost revenue is a losing battle.”
 

Considering Financial Shifts

Since 2001, professional reimbursement for colonoscopies has fallen by more than 40% while ASC revenue has risen, decreasing the percentage of revenue from professional fees (from 34% to 23%) and increasing the facility component (from 44% to 60%), Kosinski and colleagues wrote.

When looking at profit, compression of professional service fees appears even greater, especially with surging costs of anesthesia care due to high demand and provider shortages. Beyond that, about a third of ASCs are owned at least partially by national entities, as of 2024, leading to even lower realization of profit.

“The profit margins have really been crushed, so what is a GI doc to do? Go where there is opportunity,” Kosinski said. “The difference between hospitals and ASCs has been compressed, so what about the office?”

The proposed 2026 Medicare Physician Fee Schedule includes a 14% increase in reimbursement for office-based procedures, including endoscopy, as well as a 7% decrease for facility-based procedures.

In several states — such as Illinois, Oregon, Virginia, Washington, and Wisconsin — health plans are introducing programs to promote the transition of outpatient endoscopy to office settings rather than hospital-based or ASC-based settings due to costs, the authors wrote.

“The decision to start offering office-based endoscopy services was an easy one for our practice, as it provides a way for us to provide patients convenient, easy-to-access endoscopy that is high quality yet much more affordable than hospital-based settings,” said Neil Gupta, MD, managing partner at Midwest Digestive Health & Nutrition in Des Plaines, Illinois.

The practice has used office-based endoscopy for nearly 2 years, Gupta said, performing about 5000 GI endoscopy procedures per year.

“As we all try to find better ways to provide high-quality but affordable care for patients, office-based endoscopy is a great way to help achieve those goals,” he said. “Healthcare professionals and patients should all be asking, ‘What type of site am I getting my GI endoscopy scheduled at — hospital, surgery center, or physician’s office?’”
 

Regaining Autonomy and Time

Beyond the financial dynamics, office-based endoscopy can help independent GI practices regain control of their work and time and build sustainable growth for the future, Kosinski and colleagues wrote.

Looking ahead, office-based models can also provide the agility and infrastructure to compete in value-based care models, they wrote. In turn, value-based models can create relevance and resilience in a continually changing healthcare environment.

Without the involvement of ASC managers, investors, or health system partners, physicians retain control of scheduling, clinical protocols, financial decisions, and operational workflows, the authors wrote. This could create better alignment with personal preferences, clinical judgment, and patient needs, they noted.

“GI physicians should no longer feel trapped in a hospital setting where they lack independence and influence over decision-making,” said Rock Rockett, PhD, owner and principal consultant of Rockett Healthcare Strategies, which partners with GI groups nationwide to help with development, accreditation, and payer contracting for office endoscopy.

“GI physicians should also no longer feel trapped in a ‘bad marriage’ with partners in an ASC or partners in a practice who create a difficult work environment,” he said. “The viability of office endoscopy allows them to strike out on their own or set up a new partnership on more equitable terms that are attractive for them.”

Patient safety and quality also appear to be similar or better in office-based settings, based on benchmarking data analyzed so far. Hospital transfers were lower, falls were similar, and patient experience was positive, the authors wrote.

At the same time, Kosinski and colleagues noted the difficulty in shifting to office-based models. Most practices have committed to ASCs, for instance, and adding an office-based room can be challenging. Otherwise, practices already use their available office space and don’t have extra rooms available. In that case, an office endoscopy suite may be best suited for expansion sites, allowing practices to grow into new service areas, they wrote.

“You can’t fight the market. You have to focus on what the market wants and needs,” Kosinski said. “To do that, you have to be able to pivot and change direction, looking for new ways to change your mission. This could be an option to do that.”

Kosinski, Gupta, and Rockett declared having no conflicts of interest other than their current employments.
 

A version of this article appeared on Medscape.com.

After decades of successful growth, the ambulatory surgery center (ASC) model may be turning a corner, opening up opportunity for office-based endoscopy models, according to a recent practice management editorial published in Clinical Gastroenterology and Hepatology.

Although office endoscopy has been an option, it hasn’t always felt practical or financially viable in the past. However, the paradigm appears to be shifting as ASC-based revenue streams show signs of stress and fail to keep pace with inflation. As healthcare regulatory and economic environments continue to change, gastroenterologists need a new model to support equity, efficiency, and growth in gastrointestinal (GI) care delivery, the authors wrote.

“Through the course of my 40-year career, I’ve been hit with a lot of changes related to regulations, insurance, and the market. You can’t stay entrenched in your old ways. You have to remain pivotable and come up with new strategic positions,” said Lawrence Kosinski, MD, AGAF, lead author and founder of SonarMD and VOCnomics.

During his private practice career, Kosinski built one of the largest GI practices in Illinois, which had seven ASCs and is now part of one of the largest GI groups in the country. Across 30 years of experience with ASCs, Kosinski has watched the reimbursement for professional services decline, as well as for added revenue streams such as pathology and anesthesia.

Looking for a better solution, Kosinski served on the governing board for the American Gastroenterological Association as the councilor for development and growth. During the past 3 years, he has spoken with GI practices and worked with a national anesthesia company — Ambulatory Anesthesia Care — to better understand the office endoscopy setting.

“In the ’90s, all I wanted was to have an ASC because that was in vogue,” he said. “But if you look critically at what has happened to the business of outpatient endoscopy in the past 25 years, you’ll see that professional fees haven’t kept up, and trying to replace that lost revenue is a losing battle.”
 

Considering Financial Shifts

Since 2001, professional reimbursement for colonoscopies has fallen by more than 40% while ASC revenue has risen, decreasing the percentage of revenue from professional fees (from 34% to 23%) and increasing the facility component (from 44% to 60%), Kosinski and colleagues wrote.

When looking at profit, compression of professional service fees appears even greater, especially with surging costs of anesthesia care due to high demand and provider shortages. Beyond that, about a third of ASCs are owned at least partially by national entities, as of 2024, leading to even lower realization of profit.

“The profit margins have really been crushed, so what is a GI doc to do? Go where there is opportunity,” Kosinski said. “The difference between hospitals and ASCs has been compressed, so what about the office?”

The proposed 2026 Medicare Physician Fee Schedule includes a 14% increase in reimbursement for office-based procedures, including endoscopy, as well as a 7% decrease for facility-based procedures.

In several states — such as Illinois, Oregon, Virginia, Washington, and Wisconsin — health plans are introducing programs to promote the transition of outpatient endoscopy to office settings rather than hospital-based or ASC-based settings due to costs, the authors wrote.

“The decision to start offering office-based endoscopy services was an easy one for our practice, as it provides a way for us to provide patients convenient, easy-to-access endoscopy that is high quality yet much more affordable than hospital-based settings,” said Neil Gupta, MD, managing partner at Midwest Digestive Health & Nutrition in Des Plaines, Illinois.

The practice has used office-based endoscopy for nearly 2 years, Gupta said, performing about 5000 GI endoscopy procedures per year.

“As we all try to find better ways to provide high-quality but affordable care for patients, office-based endoscopy is a great way to help achieve those goals,” he said. “Healthcare professionals and patients should all be asking, ‘What type of site am I getting my GI endoscopy scheduled at — hospital, surgery center, or physician’s office?’”
 

Regaining Autonomy and Time

Beyond the financial dynamics, office-based endoscopy can help independent GI practices regain control of their work and time and build sustainable growth for the future, Kosinski and colleagues wrote.

Looking ahead, office-based models can also provide the agility and infrastructure to compete in value-based care models, they wrote. In turn, value-based models can create relevance and resilience in a continually changing healthcare environment.

Without the involvement of ASC managers, investors, or health system partners, physicians retain control of scheduling, clinical protocols, financial decisions, and operational workflows, the authors wrote. This could create better alignment with personal preferences, clinical judgment, and patient needs, they noted.

“GI physicians should no longer feel trapped in a hospital setting where they lack independence and influence over decision-making,” said Rock Rockett, PhD, owner and principal consultant of Rockett Healthcare Strategies, which partners with GI groups nationwide to help with development, accreditation, and payer contracting for office endoscopy.

“GI physicians should also no longer feel trapped in a ‘bad marriage’ with partners in an ASC or partners in a practice who create a difficult work environment,” he said. “The viability of office endoscopy allows them to strike out on their own or set up a new partnership on more equitable terms that are attractive for them.”

Patient safety and quality also appear to be similar or better in office-based settings, based on benchmarking data analyzed so far. Hospital transfers were lower, falls were similar, and patient experience was positive, the authors wrote.

At the same time, Kosinski and colleagues noted the difficulty in shifting to office-based models. Most practices have committed to ASCs, for instance, and adding an office-based room can be challenging. Otherwise, practices already use their available office space and don’t have extra rooms available. In that case, an office endoscopy suite may be best suited for expansion sites, allowing practices to grow into new service areas, they wrote.

“You can’t fight the market. You have to focus on what the market wants and needs,” Kosinski said. “To do that, you have to be able to pivot and change direction, looking for new ways to change your mission. This could be an option to do that.”

Kosinski, Gupta, and Rockett declared having no conflicts of interest other than their current employments.
 

A version of this article appeared on Medscape.com.

After decades of successful growth, the ambulatory surgery center (ASC) model may be turning a corner, opening up opportunity for office-based endoscopy models, according to a recent practice management editorial published in Clinical Gastroenterology and Hepatology.

Although office endoscopy has been an option, it hasn’t always felt practical or financially viable in the past. However, the paradigm appears to be shifting as ASC-based revenue streams show signs of stress and fail to keep pace with inflation. As healthcare regulatory and economic environments continue to change, gastroenterologists need a new model to support equity, efficiency, and growth in gastrointestinal (GI) care delivery, the authors wrote.

“Through the course of my 40-year career, I’ve been hit with a lot of changes related to regulations, insurance, and the market. You can’t stay entrenched in your old ways. You have to remain pivotable and come up with new strategic positions,” said Lawrence Kosinski, MD, AGAF, lead author and founder of SonarMD and VOCnomics.

During his private practice career, Kosinski built one of the largest GI practices in Illinois, which had seven ASCs and is now part of one of the largest GI groups in the country. Across 30 years of experience with ASCs, Kosinski has watched the reimbursement for professional services decline, as well as for added revenue streams such as pathology and anesthesia.

Looking for a better solution, Kosinski served on the governing board for the American Gastroenterological Association as the councilor for development and growth. During the past 3 years, he has spoken with GI practices and worked with a national anesthesia company — Ambulatory Anesthesia Care — to better understand the office endoscopy setting.

“In the ’90s, all I wanted was to have an ASC because that was in vogue,” he said. “But if you look critically at what has happened to the business of outpatient endoscopy in the past 25 years, you’ll see that professional fees haven’t kept up, and trying to replace that lost revenue is a losing battle.”
 

Considering Financial Shifts

Since 2001, professional reimbursement for colonoscopies has fallen by more than 40% while ASC revenue has risen, decreasing the percentage of revenue from professional fees (from 34% to 23%) and increasing the facility component (from 44% to 60%), Kosinski and colleagues wrote.

When looking at profit, compression of professional service fees appears even greater, especially with surging costs of anesthesia care due to high demand and provider shortages. Beyond that, about a third of ASCs are owned at least partially by national entities, as of 2024, leading to even lower realization of profit.

“The profit margins have really been crushed, so what is a GI doc to do? Go where there is opportunity,” Kosinski said. “The difference between hospitals and ASCs has been compressed, so what about the office?”

The proposed 2026 Medicare Physician Fee Schedule includes a 14% increase in reimbursement for office-based procedures, including endoscopy, as well as a 7% decrease for facility-based procedures.

In several states — such as Illinois, Oregon, Virginia, Washington, and Wisconsin — health plans are introducing programs to promote the transition of outpatient endoscopy to office settings rather than hospital-based or ASC-based settings due to costs, the authors wrote.

“The decision to start offering office-based endoscopy services was an easy one for our practice, as it provides a way for us to provide patients convenient, easy-to-access endoscopy that is high quality yet much more affordable than hospital-based settings,” said Neil Gupta, MD, managing partner at Midwest Digestive Health & Nutrition in Des Plaines, Illinois.

The practice has used office-based endoscopy for nearly 2 years, Gupta said, performing about 5000 GI endoscopy procedures per year.

“As we all try to find better ways to provide high-quality but affordable care for patients, office-based endoscopy is a great way to help achieve those goals,” he said. “Healthcare professionals and patients should all be asking, ‘What type of site am I getting my GI endoscopy scheduled at — hospital, surgery center, or physician’s office?’”
 

Regaining Autonomy and Time

Beyond the financial dynamics, office-based endoscopy can help independent GI practices regain control of their work and time and build sustainable growth for the future, Kosinski and colleagues wrote.

Looking ahead, office-based models can also provide the agility and infrastructure to compete in value-based care models, they wrote. In turn, value-based models can create relevance and resilience in a continually changing healthcare environment.

Without the involvement of ASC managers, investors, or health system partners, physicians retain control of scheduling, clinical protocols, financial decisions, and operational workflows, the authors wrote. This could create better alignment with personal preferences, clinical judgment, and patient needs, they noted.

“GI physicians should no longer feel trapped in a hospital setting where they lack independence and influence over decision-making,” said Rock Rockett, PhD, owner and principal consultant of Rockett Healthcare Strategies, which partners with GI groups nationwide to help with development, accreditation, and payer contracting for office endoscopy.

“GI physicians should also no longer feel trapped in a ‘bad marriage’ with partners in an ASC or partners in a practice who create a difficult work environment,” he said. “The viability of office endoscopy allows them to strike out on their own or set up a new partnership on more equitable terms that are attractive for them.”

Patient safety and quality also appear to be similar or better in office-based settings, based on benchmarking data analyzed so far. Hospital transfers were lower, falls were similar, and patient experience was positive, the authors wrote.

At the same time, Kosinski and colleagues noted the difficulty in shifting to office-based models. Most practices have committed to ASCs, for instance, and adding an office-based room can be challenging. Otherwise, practices already use their available office space and don’t have extra rooms available. In that case, an office endoscopy suite may be best suited for expansion sites, allowing practices to grow into new service areas, they wrote.

“You can’t fight the market. You have to focus on what the market wants and needs,” Kosinski said. “To do that, you have to be able to pivot and change direction, looking for new ways to change your mission. This could be an option to do that.”

Kosinski, Gupta, and Rockett declared having no conflicts of interest other than their current employments.
 

A version of this article appeared on Medscape.com.

PHOENIX — Seladelpar, a first-in-class, selective peroxisome proliferator-activated receptor delta agonist, shows significant improvement across key pruritus outcomes in patients with primary biliary cholangitis (PBC), supporting the drug’s benefits for the large percentage of patients who may fail to improve with or become intolerant of standard PBC therapy.

“This pooled analysis demonstrated that seladelpar treatment for up to 6 months reduced pruritus to a greater extent vs placebo in patients with PBC who had moderate-to-severe pruritus at baseline,” said senior author Marlyn J. Mayo, MD, AGAF, of the Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, in presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

In PBC, a rare, chronic liver disease that can progressively destroy the intrahepatic bile ducts, ursodeoxycholic acid (UDCA) has remained a highly effective standard of care; however, up to 40% of patients either fail to achieve a biochemical response or develop intolerances to the therapy.

Seladelpar, in addition to improving measures of PBC disease including liver function tests and markers of cholestasis, has been shown in clinical trials to reduce the symptoms of pruritus and related sleep disturbances.

The drug is approved by the FDA for the treatment of PBC in combination with UDCA when patients fail to have an adequate response to UDCA alone, or as monotherapy when patients are intolerant to UDCA.

With pruritus, or itching, representing a key detrimental symptom of PBC and affecting as many as 70% of patients, Mayo and her colleagues conducted a pooled analysis of two phase 3, placebo-controlled trials, the ENHANCE and RESPONSE trials, in order to delve deeper into the specifics of how seladelpar improves itching.

The studies both involved patients with PBC and moderate-to-severe pruritus at baseline who had an inadequate response to UDCA and received seladelpar as add-on therapy to the drug, if tolerant of UDCA.

In the ENHANCE trial, patients were randomized 1:1:1 to daily oral seladelpar 5 mg, 10 mg, or placebo for 52 weeks, and in the RESPONSE trial, they were randomized 2:1 to daily oral seladelpar 10 mg or placebo for 52 weeks.

The ENHANCE trial was terminated early with key endpoints amended to 3 months.

In total, the analysis included 126 patients with a pruritus numerical rating scale (NRS) score of at least 4 at baseline (indicative of moderate-to-severe itch), with 76 patients receiving seladelpar 10 mg and 50 receiving placebo.

Patients in the two groups had a mean age of 53 years; 96% were female; their mean age at PBC diagnosis was 47 years; and itch scores — including the NRS, PBC-40 itch domain, and 5-D itch scale scores — were similar across the treatment and placebo groups at baseline.

After 6 months, patients treated with seladelpar reported greater improvements than those receiving placebo across all measures.

For changes in pruritus NRS through month 6, greater decreases were observed with seladelpar 10 mg at months 1, 3, and 6, with a 6-month decrease from baseline of 3.33 in the seladelpar group vs 1.77 with placebo (P < .01).

For PBC-40 itch domain scores, the mean reduction from baseline at 6 months was 2.41 vs 0.98, although significance was lost at month 6 due to a reduction in numbers.

For the 5-D itch total scores, the mean reduction from baseline to 6 months was 5.09 vs 1.70 (P < .0001).

And for the 5-D itch degree, the domain scores were also improved with seladelpar (mean reduction from baseline to 6 months of 1.08 vs 0.47; P = .01).

Patients treated with seladelpar also showed greater improvement in the sleep disturbances that can accompany pruritus, including on the 5-D itch Sleep Item scale (P < .01 at 6 months) and the PBC-40 Sleep Disturbance Item (P < .0001 at 1 month vs placebo; not significant at 6 months).

There were no significant differences between the groups in safety or tolerability profiles overall, with any adverse events occurring in 57 of the 76 (75%) patients receiving seladelpar and 40 of 50 (80%) receiving placebo.

Grade 3 or higher adverse events occurred in 8% of seladelpar and 12% of placebo patients, and pruritus-specific adverse events occurred in 8% and 14%, respectively.

“We found that improvement versus placebo was evident at month 1 of treatment and was sustained through month 6 using three different measures of pruritus,” Mayo said.

“And improvements in sleep disturbance were also seen in patients receiving seladelpar vs placebo through month 6 using two different measures of (5-D itch and PBC-40).”

Mayo noted that seladelpar is currently the only FDA-approved second-line therapy for people who have not had an adequate biochemical response or cannot tolerate UDCA.

While the drug is not likely at a point where it could be positioned as a first-line itch therapy, Mayo suggested that, for those who have had a poor response to UDCA, “I think it makes sense to start with something like this and then see how patients’ itching is affected by the drug.”

“It’s possible it could help avoid having to add yet another drug to treat the itch, and the hope is that this will help reduce the issue of polypharmacy.”

Commenting on the study, Luis F. Lara, MD, Division Chief of Digestive Diseases at the University of Cincinnati in Cincinnati, who co-moderated the session, underscored the need for treatment among patients who fail to respond to standard therapy.

“I think this is very important research,” he told GI & Hepatology News. “First, the fact that so many patients suffer their pruritus without any therapy is actually disturbing.”

“And the fact that this medication seems to be extremely effective in treating this, likely tremendously affecting patients’ quality of life, is something to really highlight.”

Lara noted that the findings raise the question of “whether this should be considered earlier in the disease process, rather than waiting to use it as a second-line therapy, when pruritus has already become significant.”

Akwi W. Asombang, MD, interventional enterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School in Boston, who was also a co-moderator, agreed that “having a disease process that results in itching all the time can represent profound discomfort and a significant quality of life issue.”

“So, to have a drug that could minimize or alleviate that process could be huge,” Asombang told GI & Hepatology News.

The ENHANCE and RESPONSE trials were funded by Gilead Sciences. Mayo’s disclosures included consulting and/or other relationships with CymaBay Therapeutics, GSK, Intra-Sana, Ipsen, Mirum Pharma, and Target PharmaSolutions. Lara disclosed having a relationship with AbbVie. Asombang reported having no disclosures.

A version of this article appeared on Medscape.com . 

PHOENIX — Seladelpar, a first-in-class, selective peroxisome proliferator-activated receptor delta agonist, shows significant improvement across key pruritus outcomes in patients with primary biliary cholangitis (PBC), supporting the drug’s benefits for the large percentage of patients who may fail to improve with or become intolerant of standard PBC therapy.

“This pooled analysis demonstrated that seladelpar treatment for up to 6 months reduced pruritus to a greater extent vs placebo in patients with PBC who had moderate-to-severe pruritus at baseline,” said senior author Marlyn J. Mayo, MD, AGAF, of the Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, in presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

In PBC, a rare, chronic liver disease that can progressively destroy the intrahepatic bile ducts, ursodeoxycholic acid (UDCA) has remained a highly effective standard of care; however, up to 40% of patients either fail to achieve a biochemical response or develop intolerances to the therapy.

Seladelpar, in addition to improving measures of PBC disease including liver function tests and markers of cholestasis, has been shown in clinical trials to reduce the symptoms of pruritus and related sleep disturbances.

The drug is approved by the FDA for the treatment of PBC in combination with UDCA when patients fail to have an adequate response to UDCA alone, or as monotherapy when patients are intolerant to UDCA.

With pruritus, or itching, representing a key detrimental symptom of PBC and affecting as many as 70% of patients, Mayo and her colleagues conducted a pooled analysis of two phase 3, placebo-controlled trials, the ENHANCE and RESPONSE trials, in order to delve deeper into the specifics of how seladelpar improves itching.

The studies both involved patients with PBC and moderate-to-severe pruritus at baseline who had an inadequate response to UDCA and received seladelpar as add-on therapy to the drug, if tolerant of UDCA.

In the ENHANCE trial, patients were randomized 1:1:1 to daily oral seladelpar 5 mg, 10 mg, or placebo for 52 weeks, and in the RESPONSE trial, they were randomized 2:1 to daily oral seladelpar 10 mg or placebo for 52 weeks.

The ENHANCE trial was terminated early with key endpoints amended to 3 months.

In total, the analysis included 126 patients with a pruritus numerical rating scale (NRS) score of at least 4 at baseline (indicative of moderate-to-severe itch), with 76 patients receiving seladelpar 10 mg and 50 receiving placebo.

Patients in the two groups had a mean age of 53 years; 96% were female; their mean age at PBC diagnosis was 47 years; and itch scores — including the NRS, PBC-40 itch domain, and 5-D itch scale scores — were similar across the treatment and placebo groups at baseline.

After 6 months, patients treated with seladelpar reported greater improvements than those receiving placebo across all measures.

For changes in pruritus NRS through month 6, greater decreases were observed with seladelpar 10 mg at months 1, 3, and 6, with a 6-month decrease from baseline of 3.33 in the seladelpar group vs 1.77 with placebo (P < .01).

For PBC-40 itch domain scores, the mean reduction from baseline at 6 months was 2.41 vs 0.98, although significance was lost at month 6 due to a reduction in numbers.

For the 5-D itch total scores, the mean reduction from baseline to 6 months was 5.09 vs 1.70 (P < .0001).

And for the 5-D itch degree, the domain scores were also improved with seladelpar (mean reduction from baseline to 6 months of 1.08 vs 0.47; P = .01).

Patients treated with seladelpar also showed greater improvement in the sleep disturbances that can accompany pruritus, including on the 5-D itch Sleep Item scale (P < .01 at 6 months) and the PBC-40 Sleep Disturbance Item (P < .0001 at 1 month vs placebo; not significant at 6 months).

There were no significant differences between the groups in safety or tolerability profiles overall, with any adverse events occurring in 57 of the 76 (75%) patients receiving seladelpar and 40 of 50 (80%) receiving placebo.

Grade 3 or higher adverse events occurred in 8% of seladelpar and 12% of placebo patients, and pruritus-specific adverse events occurred in 8% and 14%, respectively.

“We found that improvement versus placebo was evident at month 1 of treatment and was sustained through month 6 using three different measures of pruritus,” Mayo said.

“And improvements in sleep disturbance were also seen in patients receiving seladelpar vs placebo through month 6 using two different measures of (5-D itch and PBC-40).”

Mayo noted that seladelpar is currently the only FDA-approved second-line therapy for people who have not had an adequate biochemical response or cannot tolerate UDCA.

While the drug is not likely at a point where it could be positioned as a first-line itch therapy, Mayo suggested that, for those who have had a poor response to UDCA, “I think it makes sense to start with something like this and then see how patients’ itching is affected by the drug.”

“It’s possible it could help avoid having to add yet another drug to treat the itch, and the hope is that this will help reduce the issue of polypharmacy.”

Commenting on the study, Luis F. Lara, MD, Division Chief of Digestive Diseases at the University of Cincinnati in Cincinnati, who co-moderated the session, underscored the need for treatment among patients who fail to respond to standard therapy.

“I think this is very important research,” he told GI & Hepatology News. “First, the fact that so many patients suffer their pruritus without any therapy is actually disturbing.”

“And the fact that this medication seems to be extremely effective in treating this, likely tremendously affecting patients’ quality of life, is something to really highlight.”

Lara noted that the findings raise the question of “whether this should be considered earlier in the disease process, rather than waiting to use it as a second-line therapy, when pruritus has already become significant.”

Akwi W. Asombang, MD, interventional enterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School in Boston, who was also a co-moderator, agreed that “having a disease process that results in itching all the time can represent profound discomfort and a significant quality of life issue.”

“So, to have a drug that could minimize or alleviate that process could be huge,” Asombang told GI & Hepatology News.

The ENHANCE and RESPONSE trials were funded by Gilead Sciences. Mayo’s disclosures included consulting and/or other relationships with CymaBay Therapeutics, GSK, Intra-Sana, Ipsen, Mirum Pharma, and Target PharmaSolutions. Lara disclosed having a relationship with AbbVie. Asombang reported having no disclosures.

A version of this article appeared on Medscape.com . 

PHOENIX — Seladelpar, a first-in-class, selective peroxisome proliferator-activated receptor delta agonist, shows significant improvement across key pruritus outcomes in patients with primary biliary cholangitis (PBC), supporting the drug’s benefits for the large percentage of patients who may fail to improve with or become intolerant of standard PBC therapy.

“This pooled analysis demonstrated that seladelpar treatment for up to 6 months reduced pruritus to a greater extent vs placebo in patients with PBC who had moderate-to-severe pruritus at baseline,” said senior author Marlyn J. Mayo, MD, AGAF, of the Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, in presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

In PBC, a rare, chronic liver disease that can progressively destroy the intrahepatic bile ducts, ursodeoxycholic acid (UDCA) has remained a highly effective standard of care; however, up to 40% of patients either fail to achieve a biochemical response or develop intolerances to the therapy.

Seladelpar, in addition to improving measures of PBC disease including liver function tests and markers of cholestasis, has been shown in clinical trials to reduce the symptoms of pruritus and related sleep disturbances.

The drug is approved by the FDA for the treatment of PBC in combination with UDCA when patients fail to have an adequate response to UDCA alone, or as monotherapy when patients are intolerant to UDCA.

With pruritus, or itching, representing a key detrimental symptom of PBC and affecting as many as 70% of patients, Mayo and her colleagues conducted a pooled analysis of two phase 3, placebo-controlled trials, the ENHANCE and RESPONSE trials, in order to delve deeper into the specifics of how seladelpar improves itching.

The studies both involved patients with PBC and moderate-to-severe pruritus at baseline who had an inadequate response to UDCA and received seladelpar as add-on therapy to the drug, if tolerant of UDCA.

In the ENHANCE trial, patients were randomized 1:1:1 to daily oral seladelpar 5 mg, 10 mg, or placebo for 52 weeks, and in the RESPONSE trial, they were randomized 2:1 to daily oral seladelpar 10 mg or placebo for 52 weeks.

The ENHANCE trial was terminated early with key endpoints amended to 3 months.

In total, the analysis included 126 patients with a pruritus numerical rating scale (NRS) score of at least 4 at baseline (indicative of moderate-to-severe itch), with 76 patients receiving seladelpar 10 mg and 50 receiving placebo.

Patients in the two groups had a mean age of 53 years; 96% were female; their mean age at PBC diagnosis was 47 years; and itch scores — including the NRS, PBC-40 itch domain, and 5-D itch scale scores — were similar across the treatment and placebo groups at baseline.

After 6 months, patients treated with seladelpar reported greater improvements than those receiving placebo across all measures.

For changes in pruritus NRS through month 6, greater decreases were observed with seladelpar 10 mg at months 1, 3, and 6, with a 6-month decrease from baseline of 3.33 in the seladelpar group vs 1.77 with placebo (P < .01).

For PBC-40 itch domain scores, the mean reduction from baseline at 6 months was 2.41 vs 0.98, although significance was lost at month 6 due to a reduction in numbers.

For the 5-D itch total scores, the mean reduction from baseline to 6 months was 5.09 vs 1.70 (P < .0001).

And for the 5-D itch degree, the domain scores were also improved with seladelpar (mean reduction from baseline to 6 months of 1.08 vs 0.47; P = .01).

Patients treated with seladelpar also showed greater improvement in the sleep disturbances that can accompany pruritus, including on the 5-D itch Sleep Item scale (P < .01 at 6 months) and the PBC-40 Sleep Disturbance Item (P < .0001 at 1 month vs placebo; not significant at 6 months).

There were no significant differences between the groups in safety or tolerability profiles overall, with any adverse events occurring in 57 of the 76 (75%) patients receiving seladelpar and 40 of 50 (80%) receiving placebo.

Grade 3 or higher adverse events occurred in 8% of seladelpar and 12% of placebo patients, and pruritus-specific adverse events occurred in 8% and 14%, respectively.

“We found that improvement versus placebo was evident at month 1 of treatment and was sustained through month 6 using three different measures of pruritus,” Mayo said.

“And improvements in sleep disturbance were also seen in patients receiving seladelpar vs placebo through month 6 using two different measures of (5-D itch and PBC-40).”

Mayo noted that seladelpar is currently the only FDA-approved second-line therapy for people who have not had an adequate biochemical response or cannot tolerate UDCA.

While the drug is not likely at a point where it could be positioned as a first-line itch therapy, Mayo suggested that, for those who have had a poor response to UDCA, “I think it makes sense to start with something like this and then see how patients’ itching is affected by the drug.”

“It’s possible it could help avoid having to add yet another drug to treat the itch, and the hope is that this will help reduce the issue of polypharmacy.”

Commenting on the study, Luis F. Lara, MD, Division Chief of Digestive Diseases at the University of Cincinnati in Cincinnati, who co-moderated the session, underscored the need for treatment among patients who fail to respond to standard therapy.

“I think this is very important research,” he told GI & Hepatology News. “First, the fact that so many patients suffer their pruritus without any therapy is actually disturbing.”

“And the fact that this medication seems to be extremely effective in treating this, likely tremendously affecting patients’ quality of life, is something to really highlight.”

Lara noted that the findings raise the question of “whether this should be considered earlier in the disease process, rather than waiting to use it as a second-line therapy, when pruritus has already become significant.”

Akwi W. Asombang, MD, interventional enterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School in Boston, who was also a co-moderator, agreed that “having a disease process that results in itching all the time can represent profound discomfort and a significant quality of life issue.”

“So, to have a drug that could minimize or alleviate that process could be huge,” Asombang told GI & Hepatology News.

The ENHANCE and RESPONSE trials were funded by Gilead Sciences. Mayo’s disclosures included consulting and/or other relationships with CymaBay Therapeutics, GSK, Intra-Sana, Ipsen, Mirum Pharma, and Target PharmaSolutions. Lara disclosed having a relationship with AbbVie. Asombang reported having no disclosures.

A version of this article appeared on Medscape.com .