Conference Coverage

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 . 

PHOENIX — The opportunity to diagnose eosinophilic esophagitis (EoE) when patients present to the emergency department (ED) with the classic symptom of esophageal food impaction (EFI) is commonly missed, with necessary biopsies provided at strikingly low rates, despite guideline recommendations, new research showed.

“This is the first study to assess the rate of biopsies at time of esophageal food impaction in a large, real-world dataset of community practices,” the authors explained in research presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The findings underscore that “clinicians should remember to perform esophageal biopsies during endoscopy for esophageal food impaction.”

Research shows patients with EoE, a chronic and progressive type 2 inflammatory disease, have an average delay of 4 years before being diagnosed, with a delay of up to 10 years in about a third of cases. With those delays comes the likelihood of disease progression.

The latest guidelines from the ACG indicate that for diagnosis, “from a practical standpoint,” the preferred approach is to obtain at least two to four biopsies from at least two distinct esophageal areas, while targeting areas of visual inflammation.

However, prior evidence suggests that the biopsies are commonly not performed when patients present with the symptoms of EFI.

To further investigate the management of EFI during and after ED visits in a real-world setting, first author Walker D. Redd, MD, Center for Gastrointestinal Biology and Disease, UNC School of Medicine, Chapel Hill, North Carolina, and colleagues conducted a retrospective cohort study of 2566 patients in a multistate gastrointestinal practice group at 143 care centers in seven US states.

The patients were treated for esophageal food or foreign body removal between 2018 and 2024.

Among them, 1434 patients received evaluation with esophagogastroduodenoscopy (EGD), with 754 having no EGD and 378 receiving EGD for non-EFI.

The patients had a mean age of 63, with nearly 60% being older than 60 years, and 44.9% were women.

At the index EGD, only 19% had records of having esophageal biopsies. Among them, nearly half, 47%, were determined to have biopsy-confirmed EoE.

Of those who did not receive biopsies, only 7% had records of having received a follow-up EGD with an esophageal biopsy within 1 year, with 40% of those having EoE confirmed from a biopsy.

Among the remaining 93% of patients who had no record of such follow-up care within 1 year, 41% were lost to follow-up.

“We found that only about one fifth of patients had esophageal biopsies collected at the time of esophageal food impaction, which is similar to previous reports,” Redd said.

Overall, “esophageal biopsy rates at the time of esophageal food impaction remain low, and follow-up EGD with biopsy rates are also very low.”

Responding to a comment from the audience, Redd agreed that a limitation of the study was the scenario of patients from out of town being treated at an ED and then going back home, where their follow-up status may not be known.

Nevertheless, awareness of the low rates “represent an important opportunity to reduce the diagnostic delay and improve quality of care in EoE,” he said.

Commenting on the study, Danny Issa, MD, an interventional gastroenterologist at UCLA Health, agreed that the low rates of follow-up were troubling.

“Only 1 in 10 is a very low rate of follow-up endoscopy,” he told GI & Hepatology News.

“These results show we need to encourage quality improvement initiatives to make sure those patients are followed up,” he said.

Furthermore, “additional studies are needed to better understand the barriers behind the lack of follow-up, which were not addressed fully in the study.”

Co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist at Valley Medical Group, in Paramus, New Jersey, added that “the point that needs to be made is that these patients need biopsies so you can diagnose and subsequently treat them.”

Redd reported having a consulting relationship with Sanofi. Issa reported having relationships with Boston Scientific and Eli Lilly. Chokhavatia had no disclosures to report.

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

PHOENIX — The opportunity to diagnose eosinophilic esophagitis (EoE) when patients present to the emergency department (ED) with the classic symptom of esophageal food impaction (EFI) is commonly missed, with necessary biopsies provided at strikingly low rates, despite guideline recommendations, new research showed.

“This is the first study to assess the rate of biopsies at time of esophageal food impaction in a large, real-world dataset of community practices,” the authors explained in research presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The findings underscore that “clinicians should remember to perform esophageal biopsies during endoscopy for esophageal food impaction.”

Research shows patients with EoE, a chronic and progressive type 2 inflammatory disease, have an average delay of 4 years before being diagnosed, with a delay of up to 10 years in about a third of cases. With those delays comes the likelihood of disease progression.

The latest guidelines from the ACG indicate that for diagnosis, “from a practical standpoint,” the preferred approach is to obtain at least two to four biopsies from at least two distinct esophageal areas, while targeting areas of visual inflammation.

However, prior evidence suggests that the biopsies are commonly not performed when patients present with the symptoms of EFI.

To further investigate the management of EFI during and after ED visits in a real-world setting, first author Walker D. Redd, MD, Center for Gastrointestinal Biology and Disease, UNC School of Medicine, Chapel Hill, North Carolina, and colleagues conducted a retrospective cohort study of 2566 patients in a multistate gastrointestinal practice group at 143 care centers in seven US states.

The patients were treated for esophageal food or foreign body removal between 2018 and 2024.

Among them, 1434 patients received evaluation with esophagogastroduodenoscopy (EGD), with 754 having no EGD and 378 receiving EGD for non-EFI.

The patients had a mean age of 63, with nearly 60% being older than 60 years, and 44.9% were women.

At the index EGD, only 19% had records of having esophageal biopsies. Among them, nearly half, 47%, were determined to have biopsy-confirmed EoE.

Of those who did not receive biopsies, only 7% had records of having received a follow-up EGD with an esophageal biopsy within 1 year, with 40% of those having EoE confirmed from a biopsy.

Among the remaining 93% of patients who had no record of such follow-up care within 1 year, 41% were lost to follow-up.

“We found that only about one fifth of patients had esophageal biopsies collected at the time of esophageal food impaction, which is similar to previous reports,” Redd said.

Overall, “esophageal biopsy rates at the time of esophageal food impaction remain low, and follow-up EGD with biopsy rates are also very low.”

Responding to a comment from the audience, Redd agreed that a limitation of the study was the scenario of patients from out of town being treated at an ED and then going back home, where their follow-up status may not be known.

Nevertheless, awareness of the low rates “represent an important opportunity to reduce the diagnostic delay and improve quality of care in EoE,” he said.

Commenting on the study, Danny Issa, MD, an interventional gastroenterologist at UCLA Health, agreed that the low rates of follow-up were troubling.

“Only 1 in 10 is a very low rate of follow-up endoscopy,” he told GI & Hepatology News.

“These results show we need to encourage quality improvement initiatives to make sure those patients are followed up,” he said.

Furthermore, “additional studies are needed to better understand the barriers behind the lack of follow-up, which were not addressed fully in the study.”

Co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist at Valley Medical Group, in Paramus, New Jersey, added that “the point that needs to be made is that these patients need biopsies so you can diagnose and subsequently treat them.”

Redd reported having a consulting relationship with Sanofi. Issa reported having relationships with Boston Scientific and Eli Lilly. Chokhavatia had no disclosures to report.

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

PHOENIX — The opportunity to diagnose eosinophilic esophagitis (EoE) when patients present to the emergency department (ED) with the classic symptom of esophageal food impaction (EFI) is commonly missed, with necessary biopsies provided at strikingly low rates, despite guideline recommendations, new research showed.

“This is the first study to assess the rate of biopsies at time of esophageal food impaction in a large, real-world dataset of community practices,” the authors explained in research presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The findings underscore that “clinicians should remember to perform esophageal biopsies during endoscopy for esophageal food impaction.”

Research shows patients with EoE, a chronic and progressive type 2 inflammatory disease, have an average delay of 4 years before being diagnosed, with a delay of up to 10 years in about a third of cases. With those delays comes the likelihood of disease progression.

The latest guidelines from the ACG indicate that for diagnosis, “from a practical standpoint,” the preferred approach is to obtain at least two to four biopsies from at least two distinct esophageal areas, while targeting areas of visual inflammation.

However, prior evidence suggests that the biopsies are commonly not performed when patients present with the symptoms of EFI.

To further investigate the management of EFI during and after ED visits in a real-world setting, first author Walker D. Redd, MD, Center for Gastrointestinal Biology and Disease, UNC School of Medicine, Chapel Hill, North Carolina, and colleagues conducted a retrospective cohort study of 2566 patients in a multistate gastrointestinal practice group at 143 care centers in seven US states.

The patients were treated for esophageal food or foreign body removal between 2018 and 2024.

Among them, 1434 patients received evaluation with esophagogastroduodenoscopy (EGD), with 754 having no EGD and 378 receiving EGD for non-EFI.

The patients had a mean age of 63, with nearly 60% being older than 60 years, and 44.9% were women.

At the index EGD, only 19% had records of having esophageal biopsies. Among them, nearly half, 47%, were determined to have biopsy-confirmed EoE.

Of those who did not receive biopsies, only 7% had records of having received a follow-up EGD with an esophageal biopsy within 1 year, with 40% of those having EoE confirmed from a biopsy.

Among the remaining 93% of patients who had no record of such follow-up care within 1 year, 41% were lost to follow-up.

“We found that only about one fifth of patients had esophageal biopsies collected at the time of esophageal food impaction, which is similar to previous reports,” Redd said.

Overall, “esophageal biopsy rates at the time of esophageal food impaction remain low, and follow-up EGD with biopsy rates are also very low.”

Responding to a comment from the audience, Redd agreed that a limitation of the study was the scenario of patients from out of town being treated at an ED and then going back home, where their follow-up status may not be known.

Nevertheless, awareness of the low rates “represent an important opportunity to reduce the diagnostic delay and improve quality of care in EoE,” he said.

Commenting on the study, Danny Issa, MD, an interventional gastroenterologist at UCLA Health, agreed that the low rates of follow-up were troubling.

“Only 1 in 10 is a very low rate of follow-up endoscopy,” he told GI & Hepatology News.

“These results show we need to encourage quality improvement initiatives to make sure those patients are followed up,” he said.

Furthermore, “additional studies are needed to better understand the barriers behind the lack of follow-up, which were not addressed fully in the study.”

Co-moderator Sita S. Chokhavatia, MD, AGAF, a gastroenterologist at Valley Medical Group, in Paramus, New Jersey, added that “the point that needs to be made is that these patients need biopsies so you can diagnose and subsequently treat them.”

Redd reported having a consulting relationship with Sanofi. Issa reported having relationships with Boston Scientific and Eli Lilly. Chokhavatia had no disclosures to report.

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

Patients with gallstone disease blocking the bile duct (choledochlithiasis) who do not have gall bladder removal in the same hospital admission as endoscopic retrograde pancreatography (ERCP) have as much as a 17-fold increase in the risk for biliary complications, regardless of the receipt of sphincterotomy or stenting, new research showed.

“These findings suggest an opportunity for systemic interventions, including prioritization algorithms and better perioperative coordination, to address preventable delays,” reported the authors in the study, presented at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

Choledocholithiasis can occur in up to 20% of symptomatic gallstone cases, and while guidelines recommend having a cholecystectomy concurrently with ERCP, data on the best timing is inconsistent and delays in gall bladder removal are consequently common.

One large study, for instance, the PONCHO trial conducted at 23 hospitals in Netherlands, showed complications to be significantly lower with same-admission vs interval cholecystectomy (4.7% vs 16.9%; P = .02).

Meanwhile, other research has suggested that delayed cholecystectomy is a preferred approach, allowing for removal when there is less inflammation.

Real world data meanwhile shows, despite the guidelines, the procedures are performed at the same time as ERCP only in about 41% of cases, first author Jessica El Halabi, MD, of the Johns Hopkins Hospital, Baltimore, said.

To further investigate outcomes associated with those delays, El Halabi and colleagues conducted a retrospective cohort study involving 507 patients admitted with choledocholithiasis at the hospital and community hospitals between 2005 and 2023 who had 12 months or more follow-up.

The patients had a mean age of 59 years and 59.4% were women.

Of the patients, 265 (52.3%) underwent early cholecystectomy, defined as surgery during the index admission, while 242 (47.7%) underwent delayed cholecystectomy, defined as postdischarge cholecystectomy or if cholecystectomy was not performed.

Overall, biliary complications occurred in as many as 23% of those who had delayed cholecystectomy compared with just 0.8% among those having the early cholecystectomy (P < .001).

Of patients who had delayed cholecystectomy and developed complications, 15.5% did so within 3 months, 6.5% by 6 months, and 1% by 12 months.

Among those who had ERCP with sphincterotomy, there were no significant differences in rates of biliary complications vs those who did not have sphincterotomy (26% vs 21%; P = .74), while stenting also did not reduce the risk (25% vs 27%; P = .81).

The leading reasons for delayed cholecystectomy included patients having a high surgical risk (27.3%), concurrent biliary pathology (19.2%), and physician preference (14%).

The findings underscore that “concurrent cholecystectomy is associated with the lowest risk of biliary complications,” El Halabi said.

“Delayed cholecystectomy is associated with an approximately 23% incidence of biliary complications with 1 year of initial admission, with the highest incidence occurring within 3 months,” she added. “Neither sphincterotomy nor stenting during ERCP mitigates this risk.”

“Early cholecystectomy during the index admission remains the most reliable strategy to reduce recurrent events.”

 

Findings Underscore Importance of Timing

Commenting on the study, Luis F. Lara, MD, division chief of digestive diseases at the University of Cincinnati, who co-moderated the session, agreed that evidence soundly supports early cholecystectomy.

“We also did a large study looking at this and there’s no doubt that doing it during the index admission has a tremendous effect on long-term outcomes,” Lara told GI & Hepatology News.

Lara noted that “part of it is people don’t show up again until they get sick again, so we don’t want to lose that opportunity the first time, during the index admission,” he said.

Lara’s previous studies have specifically documented how early cholecystectomy for acute biliary pancreatitis improves outcomes of hospitalization for cirrhosis and factors associated with early unplanned readmissions following same-admission cholecystectomy for acute biliary pancreatitis.

Akwi W. Asombang, MD, an interventional gastroenterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, both in Boston, agreed that the findings are important.

“We know that if a cholecystectomy is not performed in the same admission as ERCP, the stones in the gallbladder remain and may migrate out into the bile duct, resulting in further complications as described in the study,” Asombang, also a session co-moderator, told GI & Hepatology News.

She noted that the practice can vary between institutions based on factors including the availability of physicians to perform the cholecystectomy.

Potential complications in delaying the procedure can range from inflammation and pancreatitis to obstruction of the bile duct, “which then can result in cholangitis and eventually sepsis or even death,” Asombang cautioned.

“So the timing of the procedure with ERCP is definitely significant,” she said.

El Halabi and Asombang had no disclosures to report. Lara reported a relationship with AbbVie.

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

Patients with gallstone disease blocking the bile duct (choledochlithiasis) who do not have gall bladder removal in the same hospital admission as endoscopic retrograde pancreatography (ERCP) have as much as a 17-fold increase in the risk for biliary complications, regardless of the receipt of sphincterotomy or stenting, new research showed.

“These findings suggest an opportunity for systemic interventions, including prioritization algorithms and better perioperative coordination, to address preventable delays,” reported the authors in the study, presented at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

Choledocholithiasis can occur in up to 20% of symptomatic gallstone cases, and while guidelines recommend having a cholecystectomy concurrently with ERCP, data on the best timing is inconsistent and delays in gall bladder removal are consequently common.

One large study, for instance, the PONCHO trial conducted at 23 hospitals in Netherlands, showed complications to be significantly lower with same-admission vs interval cholecystectomy (4.7% vs 16.9%; P = .02).

Meanwhile, other research has suggested that delayed cholecystectomy is a preferred approach, allowing for removal when there is less inflammation.

Real world data meanwhile shows, despite the guidelines, the procedures are performed at the same time as ERCP only in about 41% of cases, first author Jessica El Halabi, MD, of the Johns Hopkins Hospital, Baltimore, said.

To further investigate outcomes associated with those delays, El Halabi and colleagues conducted a retrospective cohort study involving 507 patients admitted with choledocholithiasis at the hospital and community hospitals between 2005 and 2023 who had 12 months or more follow-up.

The patients had a mean age of 59 years and 59.4% were women.

Of the patients, 265 (52.3%) underwent early cholecystectomy, defined as surgery during the index admission, while 242 (47.7%) underwent delayed cholecystectomy, defined as postdischarge cholecystectomy or if cholecystectomy was not performed.

Overall, biliary complications occurred in as many as 23% of those who had delayed cholecystectomy compared with just 0.8% among those having the early cholecystectomy (P < .001).

Of patients who had delayed cholecystectomy and developed complications, 15.5% did so within 3 months, 6.5% by 6 months, and 1% by 12 months.

Among those who had ERCP with sphincterotomy, there were no significant differences in rates of biliary complications vs those who did not have sphincterotomy (26% vs 21%; P = .74), while stenting also did not reduce the risk (25% vs 27%; P = .81).

The leading reasons for delayed cholecystectomy included patients having a high surgical risk (27.3%), concurrent biliary pathology (19.2%), and physician preference (14%).

The findings underscore that “concurrent cholecystectomy is associated with the lowest risk of biliary complications,” El Halabi said.

“Delayed cholecystectomy is associated with an approximately 23% incidence of biliary complications with 1 year of initial admission, with the highest incidence occurring within 3 months,” she added. “Neither sphincterotomy nor stenting during ERCP mitigates this risk.”

“Early cholecystectomy during the index admission remains the most reliable strategy to reduce recurrent events.”

 

Findings Underscore Importance of Timing

Commenting on the study, Luis F. Lara, MD, division chief of digestive diseases at the University of Cincinnati, who co-moderated the session, agreed that evidence soundly supports early cholecystectomy.

“We also did a large study looking at this and there’s no doubt that doing it during the index admission has a tremendous effect on long-term outcomes,” Lara told GI & Hepatology News.

Lara noted that “part of it is people don’t show up again until they get sick again, so we don’t want to lose that opportunity the first time, during the index admission,” he said.

Lara’s previous studies have specifically documented how early cholecystectomy for acute biliary pancreatitis improves outcomes of hospitalization for cirrhosis and factors associated with early unplanned readmissions following same-admission cholecystectomy for acute biliary pancreatitis.

Akwi W. Asombang, MD, an interventional gastroenterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, both in Boston, agreed that the findings are important.

“We know that if a cholecystectomy is not performed in the same admission as ERCP, the stones in the gallbladder remain and may migrate out into the bile duct, resulting in further complications as described in the study,” Asombang, also a session co-moderator, told GI & Hepatology News.

She noted that the practice can vary between institutions based on factors including the availability of physicians to perform the cholecystectomy.

Potential complications in delaying the procedure can range from inflammation and pancreatitis to obstruction of the bile duct, “which then can result in cholangitis and eventually sepsis or even death,” Asombang cautioned.

“So the timing of the procedure with ERCP is definitely significant,” she said.

El Halabi and Asombang had no disclosures to report. Lara reported a relationship with AbbVie.

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

Patients with gallstone disease blocking the bile duct (choledochlithiasis) who do not have gall bladder removal in the same hospital admission as endoscopic retrograde pancreatography (ERCP) have as much as a 17-fold increase in the risk for biliary complications, regardless of the receipt of sphincterotomy or stenting, new research showed.

“These findings suggest an opportunity for systemic interventions, including prioritization algorithms and better perioperative coordination, to address preventable delays,” reported the authors in the study, presented at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

Choledocholithiasis can occur in up to 20% of symptomatic gallstone cases, and while guidelines recommend having a cholecystectomy concurrently with ERCP, data on the best timing is inconsistent and delays in gall bladder removal are consequently common.

One large study, for instance, the PONCHO trial conducted at 23 hospitals in Netherlands, showed complications to be significantly lower with same-admission vs interval cholecystectomy (4.7% vs 16.9%; P = .02).

Meanwhile, other research has suggested that delayed cholecystectomy is a preferred approach, allowing for removal when there is less inflammation.

Real world data meanwhile shows, despite the guidelines, the procedures are performed at the same time as ERCP only in about 41% of cases, first author Jessica El Halabi, MD, of the Johns Hopkins Hospital, Baltimore, said.

To further investigate outcomes associated with those delays, El Halabi and colleagues conducted a retrospective cohort study involving 507 patients admitted with choledocholithiasis at the hospital and community hospitals between 2005 and 2023 who had 12 months or more follow-up.

The patients had a mean age of 59 years and 59.4% were women.

Of the patients, 265 (52.3%) underwent early cholecystectomy, defined as surgery during the index admission, while 242 (47.7%) underwent delayed cholecystectomy, defined as postdischarge cholecystectomy or if cholecystectomy was not performed.

Overall, biliary complications occurred in as many as 23% of those who had delayed cholecystectomy compared with just 0.8% among those having the early cholecystectomy (P < .001).

Of patients who had delayed cholecystectomy and developed complications, 15.5% did so within 3 months, 6.5% by 6 months, and 1% by 12 months.

Among those who had ERCP with sphincterotomy, there were no significant differences in rates of biliary complications vs those who did not have sphincterotomy (26% vs 21%; P = .74), while stenting also did not reduce the risk (25% vs 27%; P = .81).

The leading reasons for delayed cholecystectomy included patients having a high surgical risk (27.3%), concurrent biliary pathology (19.2%), and physician preference (14%).

The findings underscore that “concurrent cholecystectomy is associated with the lowest risk of biliary complications,” El Halabi said.

“Delayed cholecystectomy is associated with an approximately 23% incidence of biliary complications with 1 year of initial admission, with the highest incidence occurring within 3 months,” she added. “Neither sphincterotomy nor stenting during ERCP mitigates this risk.”

“Early cholecystectomy during the index admission remains the most reliable strategy to reduce recurrent events.”

 

Findings Underscore Importance of Timing

Commenting on the study, Luis F. Lara, MD, division chief of digestive diseases at the University of Cincinnati, who co-moderated the session, agreed that evidence soundly supports early cholecystectomy.

“We also did a large study looking at this and there’s no doubt that doing it during the index admission has a tremendous effect on long-term outcomes,” Lara told GI & Hepatology News.

Lara noted that “part of it is people don’t show up again until they get sick again, so we don’t want to lose that opportunity the first time, during the index admission,” he said.

Lara’s previous studies have specifically documented how early cholecystectomy for acute biliary pancreatitis improves outcomes of hospitalization for cirrhosis and factors associated with early unplanned readmissions following same-admission cholecystectomy for acute biliary pancreatitis.

Akwi W. Asombang, MD, an interventional gastroenterologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, both in Boston, agreed that the findings are important.

“We know that if a cholecystectomy is not performed in the same admission as ERCP, the stones in the gallbladder remain and may migrate out into the bile duct, resulting in further complications as described in the study,” Asombang, also a session co-moderator, told GI & Hepatology News.

She noted that the practice can vary between institutions based on factors including the availability of physicians to perform the cholecystectomy.

Potential complications in delaying the procedure can range from inflammation and pancreatitis to obstruction of the bile duct, “which then can result in cholangitis and eventually sepsis or even death,” Asombang cautioned.

“So the timing of the procedure with ERCP is definitely significant,” she said.

El Halabi and Asombang had no disclosures to report. Lara reported a relationship with AbbVie.

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

PHOENIX — The oral medication resmetirom significantly improved liver stiffness and reduced portal hypertension in metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis, according to the results of a new study.

As well as showing sustained reduction in liver stiffness on vibration-controlled transient elastography (VCTE) after 2 years of treatment with resmetirom, the study suggested that up to 35% of patients could “potentially reverse their cirrhosis,” said lead author Naim Alkhouri, MD, chief medical officer and director of the steatotic liver program at Arizona Liver Health in Phoenix.

Alkhouri presented data on patients with compensated cirrhosis from a 1-year open-label extension of the already-completed MAESTRO-NAFLD-1 study at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The FDA approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals) in 2024 for MASH and moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease), to be used in conjunction with diet and exercise. The agency granted the once-daily, oral thyroid hormone receptor beta-selective agonist breakthrough therapy designation and priority review.

According to the American Liver Foundation, about 5% of adults in the US have MASH — one of the leading causes of liver transplantation in the country. There is currently no FDA-approved therapy for compensated cirrhosis caused by MASH, said Alkhouri. Patients with MASH cirrhosis with clinically significant portal hypertension (CSPH) experience major adverse liver outcomes.

In an analysis of 122 patients with Child Pugh A MASH cirrhosis who completed both a year in an open-label arm of MAESTRO-NAFLD-1 and a 1-year extension, 113 (93%) completed 2 years of treatment with resmetirom (80 mg). Of the 122 patients, only 114 received MRI proton density fat fraction (MRI-PDFF) testing — 93 (82%) had a baseline of > 5% indicating cirrhosis, while 21 (18%) had an MRI-PDFF of < 5%.

Patients were assessed for baseline portal hypertension (Baveno VII) with FibroScan VCTE and platelet count, which was confirmed using magnetic resonance elastography (MRE). Noninvasive biomarkers and imaging were analyzed at baseline and out to 2 years.

At baseline, 63% of patients were categorized as probable/definitive CSPH (Baveno VII). At 1 year of treatment with resmetirom, 20% of patients who were CSPH positive no longer met the criteria, and at 2 years this number had increased to 28%.

After 2 years of treatment, more than half of the patients had a sustained reduction in liver stiffness of more than 25%, as measured by VCTE; and 35% of patients with confirmed F4 at baseline (liver biopsy F4 and/or platelets < 140/MRE ≥ 5 with VCTE ≥ 15) had a conversion to F3.

Patients taking resmetirom also had significant improvements in MRI-PDFF and MRE at 2 years. Almost a third of those with a baseline MRI-PDFF > 5% improved, while 43% of those with a baseline of < 5% improved.

Although 113 patients had an adverse event — primarily gastrointestinal — the observed events were consistent with previous studies. Twenty-seven patients had a serious adverse event, but none were related to the study drug, said Alkhouri. The researchers reported that only 8% of patients discontinued the medication.

 

Changing the Treatment Landscape for MASH-Related Cirrhosis

When asked to comment by GI & Hepatology News, Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, said that “reversal of cirrhosis from F4 to F3 and reduction of portal hypertension are quite surprising, since cirrhosis typically progresses slowly.”

Ayesh said it was notable that the researchers had used imaging to confirm both functional and hemodynamic improvements in liver architecture not just biochemical changes. Given the results, “clinicians may reasonably consider off-label use in selected compensated patients until more outcome data become available,” he said.

A phase 3 study is underway to examine those outcomes, MAESTRO-NASH OUTCOMES, with 845 patients with MASH cirrhosis, and should be completed in 2027.

“Resmetirom could change the treatment landscape for MASH-related cirrhosis,” said Ayesh, adding, “this drug offers a chance to target the disease process itself,” while other therapies focus on preventing complications.

“For patients without access to liver transplant, a therapy that can slow or reverse disease progression could be transformative,” he told GI & Hepatology News.

Alkhouri disclosed that he is a consultant and speaker for Madrigal Pharmaceuticals. Three coauthors are Madrigal employees and own stock options in the company. Two coauthors are Madrigal consultants and advisers. Ayesh reported no conflicts.

A version of this article appeared on Medscape.com.

PHOENIX — The oral medication resmetirom significantly improved liver stiffness and reduced portal hypertension in metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis, according to the results of a new study.

As well as showing sustained reduction in liver stiffness on vibration-controlled transient elastography (VCTE) after 2 years of treatment with resmetirom, the study suggested that up to 35% of patients could “potentially reverse their cirrhosis,” said lead author Naim Alkhouri, MD, chief medical officer and director of the steatotic liver program at Arizona Liver Health in Phoenix.

Alkhouri presented data on patients with compensated cirrhosis from a 1-year open-label extension of the already-completed MAESTRO-NAFLD-1 study at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The FDA approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals) in 2024 for MASH and moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease), to be used in conjunction with diet and exercise. The agency granted the once-daily, oral thyroid hormone receptor beta-selective agonist breakthrough therapy designation and priority review.

According to the American Liver Foundation, about 5% of adults in the US have MASH — one of the leading causes of liver transplantation in the country. There is currently no FDA-approved therapy for compensated cirrhosis caused by MASH, said Alkhouri. Patients with MASH cirrhosis with clinically significant portal hypertension (CSPH) experience major adverse liver outcomes.

In an analysis of 122 patients with Child Pugh A MASH cirrhosis who completed both a year in an open-label arm of MAESTRO-NAFLD-1 and a 1-year extension, 113 (93%) completed 2 years of treatment with resmetirom (80 mg). Of the 122 patients, only 114 received MRI proton density fat fraction (MRI-PDFF) testing — 93 (82%) had a baseline of > 5% indicating cirrhosis, while 21 (18%) had an MRI-PDFF of < 5%.

Patients were assessed for baseline portal hypertension (Baveno VII) with FibroScan VCTE and platelet count, which was confirmed using magnetic resonance elastography (MRE). Noninvasive biomarkers and imaging were analyzed at baseline and out to 2 years.

At baseline, 63% of patients were categorized as probable/definitive CSPH (Baveno VII). At 1 year of treatment with resmetirom, 20% of patients who were CSPH positive no longer met the criteria, and at 2 years this number had increased to 28%.

After 2 years of treatment, more than half of the patients had a sustained reduction in liver stiffness of more than 25%, as measured by VCTE; and 35% of patients with confirmed F4 at baseline (liver biopsy F4 and/or platelets < 140/MRE ≥ 5 with VCTE ≥ 15) had a conversion to F3.

Patients taking resmetirom also had significant improvements in MRI-PDFF and MRE at 2 years. Almost a third of those with a baseline MRI-PDFF > 5% improved, while 43% of those with a baseline of < 5% improved.

Although 113 patients had an adverse event — primarily gastrointestinal — the observed events were consistent with previous studies. Twenty-seven patients had a serious adverse event, but none were related to the study drug, said Alkhouri. The researchers reported that only 8% of patients discontinued the medication.

 

Changing the Treatment Landscape for MASH-Related Cirrhosis

When asked to comment by GI & Hepatology News, Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, said that “reversal of cirrhosis from F4 to F3 and reduction of portal hypertension are quite surprising, since cirrhosis typically progresses slowly.”

Ayesh said it was notable that the researchers had used imaging to confirm both functional and hemodynamic improvements in liver architecture not just biochemical changes. Given the results, “clinicians may reasonably consider off-label use in selected compensated patients until more outcome data become available,” he said.

A phase 3 study is underway to examine those outcomes, MAESTRO-NASH OUTCOMES, with 845 patients with MASH cirrhosis, and should be completed in 2027.

“Resmetirom could change the treatment landscape for MASH-related cirrhosis,” said Ayesh, adding, “this drug offers a chance to target the disease process itself,” while other therapies focus on preventing complications.

“For patients without access to liver transplant, a therapy that can slow or reverse disease progression could be transformative,” he told GI & Hepatology News.

Alkhouri disclosed that he is a consultant and speaker for Madrigal Pharmaceuticals. Three coauthors are Madrigal employees and own stock options in the company. Two coauthors are Madrigal consultants and advisers. Ayesh reported no conflicts.

A version of this article appeared on Medscape.com.

PHOENIX — The oral medication resmetirom significantly improved liver stiffness and reduced portal hypertension in metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis, according to the results of a new study.

As well as showing sustained reduction in liver stiffness on vibration-controlled transient elastography (VCTE) after 2 years of treatment with resmetirom, the study suggested that up to 35% of patients could “potentially reverse their cirrhosis,” said lead author Naim Alkhouri, MD, chief medical officer and director of the steatotic liver program at Arizona Liver Health in Phoenix.

Alkhouri presented data on patients with compensated cirrhosis from a 1-year open-label extension of the already-completed MAESTRO-NAFLD-1 study at American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The FDA approved resmetirom (Rezdiffra, Madrigal Pharmaceuticals) in 2024 for MASH and moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease), to be used in conjunction with diet and exercise. The agency granted the once-daily, oral thyroid hormone receptor beta-selective agonist breakthrough therapy designation and priority review.

According to the American Liver Foundation, about 5% of adults in the US have MASH — one of the leading causes of liver transplantation in the country. There is currently no FDA-approved therapy for compensated cirrhosis caused by MASH, said Alkhouri. Patients with MASH cirrhosis with clinically significant portal hypertension (CSPH) experience major adverse liver outcomes.

In an analysis of 122 patients with Child Pugh A MASH cirrhosis who completed both a year in an open-label arm of MAESTRO-NAFLD-1 and a 1-year extension, 113 (93%) completed 2 years of treatment with resmetirom (80 mg). Of the 122 patients, only 114 received MRI proton density fat fraction (MRI-PDFF) testing — 93 (82%) had a baseline of > 5% indicating cirrhosis, while 21 (18%) had an MRI-PDFF of < 5%.

Patients were assessed for baseline portal hypertension (Baveno VII) with FibroScan VCTE and platelet count, which was confirmed using magnetic resonance elastography (MRE). Noninvasive biomarkers and imaging were analyzed at baseline and out to 2 years.

At baseline, 63% of patients were categorized as probable/definitive CSPH (Baveno VII). At 1 year of treatment with resmetirom, 20% of patients who were CSPH positive no longer met the criteria, and at 2 years this number had increased to 28%.

After 2 years of treatment, more than half of the patients had a sustained reduction in liver stiffness of more than 25%, as measured by VCTE; and 35% of patients with confirmed F4 at baseline (liver biopsy F4 and/or platelets < 140/MRE ≥ 5 with VCTE ≥ 15) had a conversion to F3.

Patients taking resmetirom also had significant improvements in MRI-PDFF and MRE at 2 years. Almost a third of those with a baseline MRI-PDFF > 5% improved, while 43% of those with a baseline of < 5% improved.

Although 113 patients had an adverse event — primarily gastrointestinal — the observed events were consistent with previous studies. Twenty-seven patients had a serious adverse event, but none were related to the study drug, said Alkhouri. The researchers reported that only 8% of patients discontinued the medication.

 

Changing the Treatment Landscape for MASH-Related Cirrhosis

When asked to comment by GI & Hepatology News, Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, said that “reversal of cirrhosis from F4 to F3 and reduction of portal hypertension are quite surprising, since cirrhosis typically progresses slowly.”

Ayesh said it was notable that the researchers had used imaging to confirm both functional and hemodynamic improvements in liver architecture not just biochemical changes. Given the results, “clinicians may reasonably consider off-label use in selected compensated patients until more outcome data become available,” he said.

A phase 3 study is underway to examine those outcomes, MAESTRO-NASH OUTCOMES, with 845 patients with MASH cirrhosis, and should be completed in 2027.

“Resmetirom could change the treatment landscape for MASH-related cirrhosis,” said Ayesh, adding, “this drug offers a chance to target the disease process itself,” while other therapies focus on preventing complications.

“For patients without access to liver transplant, a therapy that can slow or reverse disease progression could be transformative,” he told GI & Hepatology News.

Alkhouri disclosed that he is a consultant and speaker for Madrigal Pharmaceuticals. Three coauthors are Madrigal employees and own stock options in the company. Two coauthors are Madrigal consultants and advisers. Ayesh reported no conflicts.

A version of this article appeared on Medscape.com.

PHOENIX — Patients with or without polyp removal in an index colonoscopy commonly receive follow-up surveillance with a fecal immunochemical test (FIT), yet many of these patients do not receive a recommended colonoscopy after a positive FIT.

“In this large US study, we found interval FITs are frequently performed in patients with and without prior polypectomy,” said first author Natalie J. Wilson, MD, of the University of Minnesota in Minneapolis, while presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

“These findings reinforce the importance of colonoscopy following positive interval FIT, given the high risk of advanced neoplasia and colorectal cancer, regardless of polypectomy history,” Wilson said.

Guideline recommendations stress the need for follow-up surveillance with a colonoscopy, particularly in patients who have had a prior polypectomy, because of the higher risk.

Reasons patients may instead turn to FIT may include cost or other factors, she said.

To determine just how often that happens, how having a previous polypectomy affects FIT results, and how adherent patients are to follow up if a FIT result is positive, Wilson and her colleagues evaluated data from nearly 4.8 million individuals in the Veterans Health Administration Corporate Data Warehouse who underwent colonoscopy between 2000 and 2024.

Of the patients, 10.9% were found to have subsequently received interval FIT within 10 years of the index colonoscopy, and of those patients, nearly half (49.9%) had received a polypectomy at the index colonoscopy.

The average time from the colonoscopy/polypectomy to the interval FIT was 5.9 years (5.6 years in the polypectomy group vs 6.2 years in the non-polypectomy group).

Among the FIT screenings, results were positive in 17.2% of post-polypectomy patients and 14.1% of patients with no prior polypectomy, indicating a history of polypectomy to be predictive of a positive interval FIT (odds ratio [OR], 1.12; P < .0001).

Notably, while a follow-up colonoscopy is considered essential following a positive FIT result — and having a previous polypectomy should add further urgency to the matter — the study showed only 50.4% of those who had an earlier polypectomy went on to receive the recommended follow-up colonoscopy after a positive follow-up FIT, and the rate was 49.3% among those who had not received a polypectomy (P = .001).

For those who did receive a follow-up colonoscopy after a positive FIT, the duration of time to receiving the colonoscopy was longer among those who had a prior polypectomy, at 2.9 months compared with 2.5 months in the non-polypectomy group (P < .001).

Colonoscopy results following a positive FIT showed higher rates of detections among patients who had prior polypectomies than among those with no prior polypectomy, including tubular adenomas (54.7% vs 45.8%), tubulovillous adenomas (5.6% vs 4.7%), adenomas with high-grade dysplasia (0.8% vs 0.7%), sessile serrated lesions (3.52% vs 2.4%), advanced colorectal neoplasia (9.2% vs 7.9%), and colorectal cancer (3.3% vs 3.0%).

However, a prior polypectomy was not independently predictive of colorectal cancer (OR, 0.96; P = .65) or advanced colorectal neoplasia (OR, 0.97; P = .57) in the post-colonoscopy interval FIT.

The findings underscore that “positive results carried a high risk of advanced neoplasia or cancer, irrespective of prior polypectomy history,” Wilson said.

 

Clinicians Must ‘Do a Better Job’

Commenting on the study, William D. Chey, MD, AGAF, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, noted that the study “addresses one of the biggest challenges we face as a profession, which is making sure that patients who have a positive stool test get a colonoscopy.”

He noted that the low rate of just 50% of recipients of positive FITs going on to receive a colonoscopy is consistent with what is observed in other trials.

“Other data suggests that the rate might even be significantly higher — at 70%-80%, depending upon the population and the test,” Chey told Medscape Medical News.

Reasons for the failure to receive the follow-up testing range from income restrictions (due to the high cost of a colonoscopy, especially if not covered by insurance), education, speaking a foreign language, and other factors, he said.

The relatively high rates of colon cancers detected by FIT in the study, in those with and without a prior polypectomy, along with findings from other studies “should raise questions about whether there might be a role for FIT testing in addition to colonoscopy.” However, much stronger evidence would be needed, Chey noted.

In the meantime, a key issue is “how do we do a better job of making sure that individuals who have a positive FIT test get a colonoscopy,” he said.

“I think a lot of this is going to come down to how it’s done at the primary care level.”

Chey added that in that, and any other setting, “the main message that needs to get out to people who are undergoing stool-based screening is that the stool test is only the first part of the screening process, and if it’s positive, a follow-up colonoscopy must be performed.”

“Otherwise, the stool-based test is of no value.”

Wilson had no disclosures to report. Chey’s disclosures included consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestlé, Phathom, Redhill, Salix/Valeant, Takeda, and Vibrant.

 

A version of this article appeared on Medscape.com . 

PHOENIX — Patients with or without polyp removal in an index colonoscopy commonly receive follow-up surveillance with a fecal immunochemical test (FIT), yet many of these patients do not receive a recommended colonoscopy after a positive FIT.

“In this large US study, we found interval FITs are frequently performed in patients with and without prior polypectomy,” said first author Natalie J. Wilson, MD, of the University of Minnesota in Minneapolis, while presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

“These findings reinforce the importance of colonoscopy following positive interval FIT, given the high risk of advanced neoplasia and colorectal cancer, regardless of polypectomy history,” Wilson said.

Guideline recommendations stress the need for follow-up surveillance with a colonoscopy, particularly in patients who have had a prior polypectomy, because of the higher risk.

Reasons patients may instead turn to FIT may include cost or other factors, she said.

To determine just how often that happens, how having a previous polypectomy affects FIT results, and how adherent patients are to follow up if a FIT result is positive, Wilson and her colleagues evaluated data from nearly 4.8 million individuals in the Veterans Health Administration Corporate Data Warehouse who underwent colonoscopy between 2000 and 2024.

Of the patients, 10.9% were found to have subsequently received interval FIT within 10 years of the index colonoscopy, and of those patients, nearly half (49.9%) had received a polypectomy at the index colonoscopy.

The average time from the colonoscopy/polypectomy to the interval FIT was 5.9 years (5.6 years in the polypectomy group vs 6.2 years in the non-polypectomy group).

Among the FIT screenings, results were positive in 17.2% of post-polypectomy patients and 14.1% of patients with no prior polypectomy, indicating a history of polypectomy to be predictive of a positive interval FIT (odds ratio [OR], 1.12; P < .0001).

Notably, while a follow-up colonoscopy is considered essential following a positive FIT result — and having a previous polypectomy should add further urgency to the matter — the study showed only 50.4% of those who had an earlier polypectomy went on to receive the recommended follow-up colonoscopy after a positive follow-up FIT, and the rate was 49.3% among those who had not received a polypectomy (P = .001).

For those who did receive a follow-up colonoscopy after a positive FIT, the duration of time to receiving the colonoscopy was longer among those who had a prior polypectomy, at 2.9 months compared with 2.5 months in the non-polypectomy group (P < .001).

Colonoscopy results following a positive FIT showed higher rates of detections among patients who had prior polypectomies than among those with no prior polypectomy, including tubular adenomas (54.7% vs 45.8%), tubulovillous adenomas (5.6% vs 4.7%), adenomas with high-grade dysplasia (0.8% vs 0.7%), sessile serrated lesions (3.52% vs 2.4%), advanced colorectal neoplasia (9.2% vs 7.9%), and colorectal cancer (3.3% vs 3.0%).

However, a prior polypectomy was not independently predictive of colorectal cancer (OR, 0.96; P = .65) or advanced colorectal neoplasia (OR, 0.97; P = .57) in the post-colonoscopy interval FIT.

The findings underscore that “positive results carried a high risk of advanced neoplasia or cancer, irrespective of prior polypectomy history,” Wilson said.

 

Clinicians Must ‘Do a Better Job’

Commenting on the study, William D. Chey, MD, AGAF, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, noted that the study “addresses one of the biggest challenges we face as a profession, which is making sure that patients who have a positive stool test get a colonoscopy.”

He noted that the low rate of just 50% of recipients of positive FITs going on to receive a colonoscopy is consistent with what is observed in other trials.

“Other data suggests that the rate might even be significantly higher — at 70%-80%, depending upon the population and the test,” Chey told Medscape Medical News.

Reasons for the failure to receive the follow-up testing range from income restrictions (due to the high cost of a colonoscopy, especially if not covered by insurance), education, speaking a foreign language, and other factors, he said.

The relatively high rates of colon cancers detected by FIT in the study, in those with and without a prior polypectomy, along with findings from other studies “should raise questions about whether there might be a role for FIT testing in addition to colonoscopy.” However, much stronger evidence would be needed, Chey noted.

In the meantime, a key issue is “how do we do a better job of making sure that individuals who have a positive FIT test get a colonoscopy,” he said.

“I think a lot of this is going to come down to how it’s done at the primary care level.”

Chey added that in that, and any other setting, “the main message that needs to get out to people who are undergoing stool-based screening is that the stool test is only the first part of the screening process, and if it’s positive, a follow-up colonoscopy must be performed.”

“Otherwise, the stool-based test is of no value.”

Wilson had no disclosures to report. Chey’s disclosures included consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestlé, Phathom, Redhill, Salix/Valeant, Takeda, and Vibrant.

 

A version of this article appeared on Medscape.com . 

PHOENIX — Patients with or without polyp removal in an index colonoscopy commonly receive follow-up surveillance with a fecal immunochemical test (FIT), yet many of these patients do not receive a recommended colonoscopy after a positive FIT.

“In this large US study, we found interval FITs are frequently performed in patients with and without prior polypectomy,” said first author Natalie J. Wilson, MD, of the University of Minnesota in Minneapolis, while presenting the findings at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

“These findings reinforce the importance of colonoscopy following positive interval FIT, given the high risk of advanced neoplasia and colorectal cancer, regardless of polypectomy history,” Wilson said.

Guideline recommendations stress the need for follow-up surveillance with a colonoscopy, particularly in patients who have had a prior polypectomy, because of the higher risk.

Reasons patients may instead turn to FIT may include cost or other factors, she said.

To determine just how often that happens, how having a previous polypectomy affects FIT results, and how adherent patients are to follow up if a FIT result is positive, Wilson and her colleagues evaluated data from nearly 4.8 million individuals in the Veterans Health Administration Corporate Data Warehouse who underwent colonoscopy between 2000 and 2024.

Of the patients, 10.9% were found to have subsequently received interval FIT within 10 years of the index colonoscopy, and of those patients, nearly half (49.9%) had received a polypectomy at the index colonoscopy.

The average time from the colonoscopy/polypectomy to the interval FIT was 5.9 years (5.6 years in the polypectomy group vs 6.2 years in the non-polypectomy group).

Among the FIT screenings, results were positive in 17.2% of post-polypectomy patients and 14.1% of patients with no prior polypectomy, indicating a history of polypectomy to be predictive of a positive interval FIT (odds ratio [OR], 1.12; P < .0001).

Notably, while a follow-up colonoscopy is considered essential following a positive FIT result — and having a previous polypectomy should add further urgency to the matter — the study showed only 50.4% of those who had an earlier polypectomy went on to receive the recommended follow-up colonoscopy after a positive follow-up FIT, and the rate was 49.3% among those who had not received a polypectomy (P = .001).

For those who did receive a follow-up colonoscopy after a positive FIT, the duration of time to receiving the colonoscopy was longer among those who had a prior polypectomy, at 2.9 months compared with 2.5 months in the non-polypectomy group (P < .001).

Colonoscopy results following a positive FIT showed higher rates of detections among patients who had prior polypectomies than among those with no prior polypectomy, including tubular adenomas (54.7% vs 45.8%), tubulovillous adenomas (5.6% vs 4.7%), adenomas with high-grade dysplasia (0.8% vs 0.7%), sessile serrated lesions (3.52% vs 2.4%), advanced colorectal neoplasia (9.2% vs 7.9%), and colorectal cancer (3.3% vs 3.0%).

However, a prior polypectomy was not independently predictive of colorectal cancer (OR, 0.96; P = .65) or advanced colorectal neoplasia (OR, 0.97; P = .57) in the post-colonoscopy interval FIT.

The findings underscore that “positive results carried a high risk of advanced neoplasia or cancer, irrespective of prior polypectomy history,” Wilson said.

 

Clinicians Must ‘Do a Better Job’

Commenting on the study, William D. Chey, MD, AGAF, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, noted that the study “addresses one of the biggest challenges we face as a profession, which is making sure that patients who have a positive stool test get a colonoscopy.”

He noted that the low rate of just 50% of recipients of positive FITs going on to receive a colonoscopy is consistent with what is observed in other trials.

“Other data suggests that the rate might even be significantly higher — at 70%-80%, depending upon the population and the test,” Chey told Medscape Medical News.

Reasons for the failure to receive the follow-up testing range from income restrictions (due to the high cost of a colonoscopy, especially if not covered by insurance), education, speaking a foreign language, and other factors, he said.

The relatively high rates of colon cancers detected by FIT in the study, in those with and without a prior polypectomy, along with findings from other studies “should raise questions about whether there might be a role for FIT testing in addition to colonoscopy.” However, much stronger evidence would be needed, Chey noted.

In the meantime, a key issue is “how do we do a better job of making sure that individuals who have a positive FIT test get a colonoscopy,” he said.

“I think a lot of this is going to come down to how it’s done at the primary care level.”

Chey added that in that, and any other setting, “the main message that needs to get out to people who are undergoing stool-based screening is that the stool test is only the first part of the screening process, and if it’s positive, a follow-up colonoscopy must be performed.”

“Otherwise, the stool-based test is of no value.”

Wilson had no disclosures to report. Chey’s disclosures included consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestlé, Phathom, Redhill, Salix/Valeant, Takeda, and Vibrant.

 

A version of this article appeared on Medscape.com . 

PHOENIX — Users of e-cigarettes had increased odds of peptic ulcer disease (PUD) compared to those who have never used them, a cross-sectional study found.

The study also found increased risk of PUD among former users of e-cigarettes, reported Albert E. Ohrin, MBChB, MHS, of Ascension Saint Agnes Hospital, Baltimore, Maryland, who presented the study here at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting. 

While cigarette smoking is a known risk factor for PUD, there was little in the literature investigating whether vaping has a similar risk profile, said Ohrin, a first-year internal medicine resident. He told GI & Hepatology News he found e-cigarette users on Reddit discussing worsening PUD and decided to investigate further, especially since vaping is so popular among young people.

E-cigarettes are the most-used tobacco product among middle and high school students. The National Youth Tobacco Survey in the US reported that 1.6 million students (5.9%) vaped in 2024, a decline from 7.7% in 2023. And the number of adults using e-cigarettes is increasing, according to the US CDC. In 2023, 6.5% of adults over age 18 used e-cigarettes, up from 3.7% in 2020. 

Ohrin and colleagues conducted a cross-sectional analysis of adults enrolled in the National Institutes of Health All of Us Research Program. Participants self-reported e-cigarette use. PUD was defined using validated electronic health record diagnosis codes.

Among the 371,398 participants, 29,373 (8%) reported using e-cigarettes, including 21,277 current users and 8096 former users. E-cigarette users were significantly younger (mean age 45.3 vs 59.3 years; P < .001), more likely to be female, and more likely to report lower education and income (P < .001). 

Current e-cigarette users had 27% higher odds of PUD (adjusted odds ratio [aOR], 1.27; 95% CI, 1.12-1.45), compared to never-users. This was greater than the risk with traditional combustible cigarettes (aOR, 1.19) that was seen in the study.

Former e-cig users had 13% higher odds (aOR, 1.13; 95% CI, 1.04-1.24) compared to never-users, and any e-cigarette use was associated with higher odds of PUD (aOR, 1.17; 95% CI, 1.09-1.26) compared to never-use. 

Use of non-steroidal anti-inflammatories (aOR, 2.15) and having gastroesophageal reflux disease (aOR, 4.45) presented the most significant PUD risk.

Ohrin said he and his colleagues were surprised to see that people who had stopped using e-cigarettes still had higher odds of PUD, although he pointed out that the researchers did not know the frequency of use or how long users had stopped. 

“Now that we know there’s an association, we are going to do more studies on e-cigarettes” to see what the potential harms are, especially on the gastrointestinal system, he told GI & Hepatology News. 

“One of the things we are looking to elicit is — is there a dose response?” he said, noting it would take a prospective trial to determine that effect.

 

‘Opens a Door’ to Looking at the GI System

Laura Crotty Alexander, MD, a professor of medicine and associate division chief of pulmonary, critical care, sleep medicine, and physiology at the University of California, San Diego, said she found the study novel and interesting. 

“It’s the first I’ve heard of an association between e-cigarette vaping and peptic ulcer disease,” said Crotty Alexander, who has studied the health effects of e-cigarettes for a decade. 

Previous studies have shown that nicotine itself can drive an increase in gastric acid production and decrease healing, which can contribute to PUD, Crotty Alexander told GI & Hepatology News. With combustible cigarettes, it is thought that “the larger drivers of that association are the other things in tobacco smoke, such as tar and carbon monoxide and a million other horrible chemicals,” she said. 

Crotty Alexander and her colleagues have conducted studies in vitro and in mice that show that e-cigarette aerosols are irritants and cause oxidative stress, which can drive PUD. 

While many studies have shown vaping impacts various organs, Ohrin’s study “opens a door” to start looking at the gastrointestinal system, she said. 

The study is also a signal to clinicians to “take an accurate inhalant history,” which means asking about vaping, she added.

Ohrin and Crotty Alexander reported no conflicts.

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

PHOENIX — Users of e-cigarettes had increased odds of peptic ulcer disease (PUD) compared to those who have never used them, a cross-sectional study found.

The study also found increased risk of PUD among former users of e-cigarettes, reported Albert E. Ohrin, MBChB, MHS, of Ascension Saint Agnes Hospital, Baltimore, Maryland, who presented the study here at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting. 

While cigarette smoking is a known risk factor for PUD, there was little in the literature investigating whether vaping has a similar risk profile, said Ohrin, a first-year internal medicine resident. He told GI & Hepatology News he found e-cigarette users on Reddit discussing worsening PUD and decided to investigate further, especially since vaping is so popular among young people.

E-cigarettes are the most-used tobacco product among middle and high school students. The National Youth Tobacco Survey in the US reported that 1.6 million students (5.9%) vaped in 2024, a decline from 7.7% in 2023. And the number of adults using e-cigarettes is increasing, according to the US CDC. In 2023, 6.5% of adults over age 18 used e-cigarettes, up from 3.7% in 2020. 

Ohrin and colleagues conducted a cross-sectional analysis of adults enrolled in the National Institutes of Health All of Us Research Program. Participants self-reported e-cigarette use. PUD was defined using validated electronic health record diagnosis codes.

Among the 371,398 participants, 29,373 (8%) reported using e-cigarettes, including 21,277 current users and 8096 former users. E-cigarette users were significantly younger (mean age 45.3 vs 59.3 years; P < .001), more likely to be female, and more likely to report lower education and income (P < .001). 

Current e-cigarette users had 27% higher odds of PUD (adjusted odds ratio [aOR], 1.27; 95% CI, 1.12-1.45), compared to never-users. This was greater than the risk with traditional combustible cigarettes (aOR, 1.19) that was seen in the study.

Former e-cig users had 13% higher odds (aOR, 1.13; 95% CI, 1.04-1.24) compared to never-users, and any e-cigarette use was associated with higher odds of PUD (aOR, 1.17; 95% CI, 1.09-1.26) compared to never-use. 

Use of non-steroidal anti-inflammatories (aOR, 2.15) and having gastroesophageal reflux disease (aOR, 4.45) presented the most significant PUD risk.

Ohrin said he and his colleagues were surprised to see that people who had stopped using e-cigarettes still had higher odds of PUD, although he pointed out that the researchers did not know the frequency of use or how long users had stopped. 

“Now that we know there’s an association, we are going to do more studies on e-cigarettes” to see what the potential harms are, especially on the gastrointestinal system, he told GI & Hepatology News. 

“One of the things we are looking to elicit is — is there a dose response?” he said, noting it would take a prospective trial to determine that effect.

 

‘Opens a Door’ to Looking at the GI System

Laura Crotty Alexander, MD, a professor of medicine and associate division chief of pulmonary, critical care, sleep medicine, and physiology at the University of California, San Diego, said she found the study novel and interesting. 

“It’s the first I’ve heard of an association between e-cigarette vaping and peptic ulcer disease,” said Crotty Alexander, who has studied the health effects of e-cigarettes for a decade. 

Previous studies have shown that nicotine itself can drive an increase in gastric acid production and decrease healing, which can contribute to PUD, Crotty Alexander told GI & Hepatology News. With combustible cigarettes, it is thought that “the larger drivers of that association are the other things in tobacco smoke, such as tar and carbon monoxide and a million other horrible chemicals,” she said. 

Crotty Alexander and her colleagues have conducted studies in vitro and in mice that show that e-cigarette aerosols are irritants and cause oxidative stress, which can drive PUD. 

While many studies have shown vaping impacts various organs, Ohrin’s study “opens a door” to start looking at the gastrointestinal system, she said. 

The study is also a signal to clinicians to “take an accurate inhalant history,” which means asking about vaping, she added.

Ohrin and Crotty Alexander reported no conflicts.

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

PHOENIX — Users of e-cigarettes had increased odds of peptic ulcer disease (PUD) compared to those who have never used them, a cross-sectional study found.

The study also found increased risk of PUD among former users of e-cigarettes, reported Albert E. Ohrin, MBChB, MHS, of Ascension Saint Agnes Hospital, Baltimore, Maryland, who presented the study here at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting. 

While cigarette smoking is a known risk factor for PUD, there was little in the literature investigating whether vaping has a similar risk profile, said Ohrin, a first-year internal medicine resident. He told GI & Hepatology News he found e-cigarette users on Reddit discussing worsening PUD and decided to investigate further, especially since vaping is so popular among young people.

E-cigarettes are the most-used tobacco product among middle and high school students. The National Youth Tobacco Survey in the US reported that 1.6 million students (5.9%) vaped in 2024, a decline from 7.7% in 2023. And the number of adults using e-cigarettes is increasing, according to the US CDC. In 2023, 6.5% of adults over age 18 used e-cigarettes, up from 3.7% in 2020. 

Ohrin and colleagues conducted a cross-sectional analysis of adults enrolled in the National Institutes of Health All of Us Research Program. Participants self-reported e-cigarette use. PUD was defined using validated electronic health record diagnosis codes.

Among the 371,398 participants, 29,373 (8%) reported using e-cigarettes, including 21,277 current users and 8096 former users. E-cigarette users were significantly younger (mean age 45.3 vs 59.3 years; P < .001), more likely to be female, and more likely to report lower education and income (P < .001). 

Current e-cigarette users had 27% higher odds of PUD (adjusted odds ratio [aOR], 1.27; 95% CI, 1.12-1.45), compared to never-users. This was greater than the risk with traditional combustible cigarettes (aOR, 1.19) that was seen in the study.

Former e-cig users had 13% higher odds (aOR, 1.13; 95% CI, 1.04-1.24) compared to never-users, and any e-cigarette use was associated with higher odds of PUD (aOR, 1.17; 95% CI, 1.09-1.26) compared to never-use. 

Use of non-steroidal anti-inflammatories (aOR, 2.15) and having gastroesophageal reflux disease (aOR, 4.45) presented the most significant PUD risk.

Ohrin said he and his colleagues were surprised to see that people who had stopped using e-cigarettes still had higher odds of PUD, although he pointed out that the researchers did not know the frequency of use or how long users had stopped. 

“Now that we know there’s an association, we are going to do more studies on e-cigarettes” to see what the potential harms are, especially on the gastrointestinal system, he told GI & Hepatology News. 

“One of the things we are looking to elicit is — is there a dose response?” he said, noting it would take a prospective trial to determine that effect.

 

‘Opens a Door’ to Looking at the GI System

Laura Crotty Alexander, MD, a professor of medicine and associate division chief of pulmonary, critical care, sleep medicine, and physiology at the University of California, San Diego, said she found the study novel and interesting. 

“It’s the first I’ve heard of an association between e-cigarette vaping and peptic ulcer disease,” said Crotty Alexander, who has studied the health effects of e-cigarettes for a decade. 

Previous studies have shown that nicotine itself can drive an increase in gastric acid production and decrease healing, which can contribute to PUD, Crotty Alexander told GI & Hepatology News. With combustible cigarettes, it is thought that “the larger drivers of that association are the other things in tobacco smoke, such as tar and carbon monoxide and a million other horrible chemicals,” she said. 

Crotty Alexander and her colleagues have conducted studies in vitro and in mice that show that e-cigarette aerosols are irritants and cause oxidative stress, which can drive PUD. 

While many studies have shown vaping impacts various organs, Ohrin’s study “opens a door” to start looking at the gastrointestinal system, she said. 

The study is also a signal to clinicians to “take an accurate inhalant history,” which means asking about vaping, she added.

Ohrin and Crotty Alexander reported no conflicts.

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