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Needle-Knife Fistulotomy is Safe During ERCP, Even for Trainees
, based on results of a randomized trial.
Across procedures conducted predominantly by trainees, safety outcomes were similar between NKF and standard cannulation, and all patients were successfully cannulated, suggesting this is a broadly accessible technique, reported lead author Aleksey Novikov, MD, of the University of Florida College of Medicine, Gainesville, and colleagues, reported.
Writing in Techniques and Innovations in Gastrointestinal Endoscopy, the investigators noted that standard cannulation fails in 5-20% of cases, which has led to development of various alternative techniques, including NKF. To perform the technique, the endoscopist makes a small incision in the intraduodenal biliary segment 3-6mm above the papillary orifice, with cephalad extension until bili-ary access is achieved.
To date, four prospective studies have evaluated NKF in the hands of expert advanced endoscopists.
“These studies showed that NKF is a safe and useful technique that significantly reduces the risk of PEP in the hands of expert advanced endoscopists,” the investigators wrote. ‘The suggestion that NKF should be restricted to expert advanced endoscopists likely limits widespread use.”
To determine whether NKF is a suitable technique for less experienced endoscopists, the investigators conducted the present single-center, prospective randomized controlled trial at Thomas Jefferson University Hospital in Philadelphia.
Adults undergoing ERCP for biliary indications were randomly assigned in a 1:1 ratio to undergo primary cannulation via NKF or standard cannulation. Patients with prior sphincterotomy, ampullectomy, or unfavorable anatomy were excluded.
A total of 186 patients were randomized, with 137 ultimately included in the per-protocol analysis after exclusions for anatomic factors. Most procedures (72.3%) were performed by advanced endoscopy trainees under direct supervision, 26 procedures (19.0%) were performed by attending endoscopists without substantive prior NKF experience, and 12 (8.8%) by an attending endoscopist with NKF expertise.
“It is important to note that the majority of procedures performed in the context of this study were performed by an advanced endoscopy trainee with no NKF experience or an attending advanced endoscopist with minimal NKF experience,” the investigators wrote.
All patients received prophylactic rectal indomethacin, and cannulation attempts were capped at 20 minutes before crossover to another technique was permitted.
The primary endpoint was incidence of post-ERCP pancreatitis. Secondary endpoints included successful biliary access, time to access, and rates of bleeding and perforation.
Post-ERCP pancreatitis occurred at similar rate across groups: 6 cases (8.2%) in the standard cannulation arm and 5 cases (7.8%) in the NKF arm (P = .93). Rates of bleeding and perforation were also similar for both techniques.
Within the initial 20-minute window, biliary access rates were comparable between groups, at 75.3% and 82.2% for standard cannulation and NKF, respectively (P = .89). Allowing additional attempts or crossover, overall success rose to 100% in both arms.
Mean time to access was longer with NKF, averaging 380 seconds compared with 268 seconds for standard cannulation (P less than .05).
“NKF was essentially equivalent to standard cannulation in many aspects,” the investigators wrote, calling the two techniques “complementary.”
They also suggested that the relative equivalence between techniques “carries more weight” after considering the low level of NKF experience among participating endoscopists.
“Overall, our data support teaching advanced endoscopy trainees NKF as a primary method of biliary access in patients with favorable anatomy,” the investigators concluded.
The investigators disclosed relationships with Medtronic, Boston Scientific, and Olympus.
, based on results of a randomized trial.
Across procedures conducted predominantly by trainees, safety outcomes were similar between NKF and standard cannulation, and all patients were successfully cannulated, suggesting this is a broadly accessible technique, reported lead author Aleksey Novikov, MD, of the University of Florida College of Medicine, Gainesville, and colleagues, reported.
Writing in Techniques and Innovations in Gastrointestinal Endoscopy, the investigators noted that standard cannulation fails in 5-20% of cases, which has led to development of various alternative techniques, including NKF. To perform the technique, the endoscopist makes a small incision in the intraduodenal biliary segment 3-6mm above the papillary orifice, with cephalad extension until bili-ary access is achieved.
To date, four prospective studies have evaluated NKF in the hands of expert advanced endoscopists.
“These studies showed that NKF is a safe and useful technique that significantly reduces the risk of PEP in the hands of expert advanced endoscopists,” the investigators wrote. ‘The suggestion that NKF should be restricted to expert advanced endoscopists likely limits widespread use.”
To determine whether NKF is a suitable technique for less experienced endoscopists, the investigators conducted the present single-center, prospective randomized controlled trial at Thomas Jefferson University Hospital in Philadelphia.
Adults undergoing ERCP for biliary indications were randomly assigned in a 1:1 ratio to undergo primary cannulation via NKF or standard cannulation. Patients with prior sphincterotomy, ampullectomy, or unfavorable anatomy were excluded.
A total of 186 patients were randomized, with 137 ultimately included in the per-protocol analysis after exclusions for anatomic factors. Most procedures (72.3%) were performed by advanced endoscopy trainees under direct supervision, 26 procedures (19.0%) were performed by attending endoscopists without substantive prior NKF experience, and 12 (8.8%) by an attending endoscopist with NKF expertise.
“It is important to note that the majority of procedures performed in the context of this study were performed by an advanced endoscopy trainee with no NKF experience or an attending advanced endoscopist with minimal NKF experience,” the investigators wrote.
All patients received prophylactic rectal indomethacin, and cannulation attempts were capped at 20 minutes before crossover to another technique was permitted.
The primary endpoint was incidence of post-ERCP pancreatitis. Secondary endpoints included successful biliary access, time to access, and rates of bleeding and perforation.
Post-ERCP pancreatitis occurred at similar rate across groups: 6 cases (8.2%) in the standard cannulation arm and 5 cases (7.8%) in the NKF arm (P = .93). Rates of bleeding and perforation were also similar for both techniques.
Within the initial 20-minute window, biliary access rates were comparable between groups, at 75.3% and 82.2% for standard cannulation and NKF, respectively (P = .89). Allowing additional attempts or crossover, overall success rose to 100% in both arms.
Mean time to access was longer with NKF, averaging 380 seconds compared with 268 seconds for standard cannulation (P less than .05).
“NKF was essentially equivalent to standard cannulation in many aspects,” the investigators wrote, calling the two techniques “complementary.”
They also suggested that the relative equivalence between techniques “carries more weight” after considering the low level of NKF experience among participating endoscopists.
“Overall, our data support teaching advanced endoscopy trainees NKF as a primary method of biliary access in patients with favorable anatomy,” the investigators concluded.
The investigators disclosed relationships with Medtronic, Boston Scientific, and Olympus.
, based on results of a randomized trial.
Across procedures conducted predominantly by trainees, safety outcomes were similar between NKF and standard cannulation, and all patients were successfully cannulated, suggesting this is a broadly accessible technique, reported lead author Aleksey Novikov, MD, of the University of Florida College of Medicine, Gainesville, and colleagues, reported.
Writing in Techniques and Innovations in Gastrointestinal Endoscopy, the investigators noted that standard cannulation fails in 5-20% of cases, which has led to development of various alternative techniques, including NKF. To perform the technique, the endoscopist makes a small incision in the intraduodenal biliary segment 3-6mm above the papillary orifice, with cephalad extension until bili-ary access is achieved.
To date, four prospective studies have evaluated NKF in the hands of expert advanced endoscopists.
“These studies showed that NKF is a safe and useful technique that significantly reduces the risk of PEP in the hands of expert advanced endoscopists,” the investigators wrote. ‘The suggestion that NKF should be restricted to expert advanced endoscopists likely limits widespread use.”
To determine whether NKF is a suitable technique for less experienced endoscopists, the investigators conducted the present single-center, prospective randomized controlled trial at Thomas Jefferson University Hospital in Philadelphia.
Adults undergoing ERCP for biliary indications were randomly assigned in a 1:1 ratio to undergo primary cannulation via NKF or standard cannulation. Patients with prior sphincterotomy, ampullectomy, or unfavorable anatomy were excluded.
A total of 186 patients were randomized, with 137 ultimately included in the per-protocol analysis after exclusions for anatomic factors. Most procedures (72.3%) were performed by advanced endoscopy trainees under direct supervision, 26 procedures (19.0%) were performed by attending endoscopists without substantive prior NKF experience, and 12 (8.8%) by an attending endoscopist with NKF expertise.
“It is important to note that the majority of procedures performed in the context of this study were performed by an advanced endoscopy trainee with no NKF experience or an attending advanced endoscopist with minimal NKF experience,” the investigators wrote.
All patients received prophylactic rectal indomethacin, and cannulation attempts were capped at 20 minutes before crossover to another technique was permitted.
The primary endpoint was incidence of post-ERCP pancreatitis. Secondary endpoints included successful biliary access, time to access, and rates of bleeding and perforation.
Post-ERCP pancreatitis occurred at similar rate across groups: 6 cases (8.2%) in the standard cannulation arm and 5 cases (7.8%) in the NKF arm (P = .93). Rates of bleeding and perforation were also similar for both techniques.
Within the initial 20-minute window, biliary access rates were comparable between groups, at 75.3% and 82.2% for standard cannulation and NKF, respectively (P = .89). Allowing additional attempts or crossover, overall success rose to 100% in both arms.
Mean time to access was longer with NKF, averaging 380 seconds compared with 268 seconds for standard cannulation (P less than .05).
“NKF was essentially equivalent to standard cannulation in many aspects,” the investigators wrote, calling the two techniques “complementary.”
They also suggested that the relative equivalence between techniques “carries more weight” after considering the low level of NKF experience among participating endoscopists.
“Overall, our data support teaching advanced endoscopy trainees NKF as a primary method of biliary access in patients with favorable anatomy,” the investigators concluded.
The investigators disclosed relationships with Medtronic, Boston Scientific, and Olympus.
FROM TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY
Finding the Best Match for MASLD Management
, according to the authors of clinical reviews who offered guidance on the pros and cons of resmetirom and semaglutide.
MASLD has become one of the most common causes of chronic liver disease due to the increased prevalence of diabetes, obesity, and other metabolic disorders, Joanne Lin, DO, an internist in the Division of Gastroenterology and Hepatology at the University of California, San Francisco, and colleagues wrote, in a review published in the Journal of Clinical Gastroenterology.
Its complexity makes MASLD challenging to manage. Metabolic, genetic, and environmental factors are involved in the disease, so patients require multidisciplinary and individualized care, Lin told GI & Hepatology News.
Weight loss, dietary changes, and exercise had long been the only treatment approach clinicians could offer patients. But the approval of two drugs — the thyroid hormone receptor-beta agonist resmetirom and the GLP-1 receptor agonist (RA) semaglutide — for patients whose MASLD has advanced to metabolic dysfunction-associated steatohepatitis (MASH) gives physicians new options for patients with severe disease.
In the review, published online before the official approval of semaglutide, Lin and colleagues proposed an algorithm to guide clinicians in choosing a pharmacological therapy for MASLD. “Resmetirom should be primarily used to reverse fibrosis for patients with MASLD and F2-F3 stages, while GLP-1 RAs are beneficial in managing metabolic comorbidities and weight loss in patients with MASLD,” the researchers concluded.
GLP-1 Power and Potential
In August 2025, the FDA approved semaglutide for MASH and cited evidence from the ESSENCE trial in its decision.
The ESSENCE study, published in The New England Journal of Medicine, showed significantly higher rates of resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening steatohepatitis in patients with MASH and moderate or advanced liver fibrosis who received 2.4 mg of once-weekly semaglutide compared with patients who received placebo.
The most common adverse events reported with GLP-1 RAs are gastrointestinal-related, including nausea, diarrhea, vomiting, and constipation, and are mainly mild-to-moderate and dose dependent, Lin and colleagues noted in their review.
GLP-1s have some limitations, Lin said. “GLP-1s are great for weight loss and metabolic risk reduction, but studies are still ongoing to determine their effect on liver histology and reversing fibrosis/cirrhosis,” she said. Some patients seeking these medications also have trouble obtaining them because of their popularity for weight loss, she noted.
Resmetirom Shows Success
Resmetirom has demonstrated ability to target hepatocytes and increase the hepatic metabolism of lipids, Lin and colleagues wrote in their review.
Several trials have examined resmetirom as a treatment for MASH, notably the landmark MAESTRO-NASH study , a randomized, placebo-controlled trial of nearly 1000 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, which was the basis for the FDA’s approval of the drug in 2024. In the study, 25.9% of the patients treated with 80 mg of resmetirom and 29.9% treated with 100 mg resmetirom achieved MASH resolution with no increase in fibrosis compared with 9.7% of patients treated with placebo. In addition, 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group achieved fibrosis improvement by at least one stage without worsening of MASLD activity scores compared with 14.2% of patients treated with placebo.
The most common reported side effects from resmetirom are diarrhea or constipation, nausea or vomiting, and abdominal pain.
“The limitations of resmetirom include the absence of validated predictors for individual patient response, and no societal guidelines are available to determine when to stop the medication if ineffective,” Lin told GI & Hepatology News. In addition, resmetirom is currently only recommended for a subset of patients with F2-F3 fibrosis, based on the existing trial, she said.
Other limitations include its high cost, which restricts access to the drug for some patients, and lack of long-term safety and efficacy data, Lin added.
Weighing the Options
Comparing the emerging agents in the context of MASLD/MASH is important to help clinicians understand how different patient populations respond and guide evidence-based treatment decisions, said Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, in an interview.
“The choice of therapy should be individualized based on comorbidities,” said Ayesh, the lead author of a 2024 review published in Biomedicines that compared resmetirom, GLP-1 agonists, and fibroblast growth factor 21 analogs.
“For example, a GLP-1 receptor agonist may be more appropriate for patients with coexisting diabetes or obesity, while resmetirom may be better suited for patients with more advanced liver disease or minimal metabolic comorbidities,” he said.
GLP-1 RAs, such as semaglutide, offer benefits for diabetes, obesity, and metabolic dysfunction in patients with MASLD/MASH and may be more accessible and cost effective, Ayesh told GI & Hepatology News. However, some patients may experience gastrointestinal side effects or be unable to tolerate GLP-1 RAs, he noted.
By contrast, resmetirom may be preferable for patients with low BMI, advanced fibrosis, or an inability to tolerate GLP-1s, as resmetirom directly targets hepatic pathways involved in MASLD/MASH progression, Ayesh said.
Next Steps to Inform Practice
“More research is needed to validate noninvasive biomarkers to monitor response to these medications, determine predictors of efficacy, and evaluate the additive effects, safety, and drug-drug interactions of combination therapy,” Lin said.
Studies are needed to determine both medications’ effects on patients with advanced fibrosis/cirrhosis and special populations, such as individuals with advanced renal disease or posttransplant patients, she added. More studies are expected to inform clinical practice and proper guidelines for the treatment of MASLD, as has been the case with chronic diseases such as hypertension and diabetes, Lin said.
Long-term safety and efficacy data are critical, as most trials of the newly approved medications have had relatively short follow-up periods of approximately 1 year, Ayesh said. “We need real-world evidence and longitudinal studies spanning 3-5 years to confirm sustained efficacy and safety,” he said. Research on cost effectiveness and health-system impacts will be essential to guide policy and ensure equitable access to the medications, he added.
The study by Lin and colleagues received no outside funding. The researchers had no financial conflicts to disclose. Ayesh had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, according to the authors of clinical reviews who offered guidance on the pros and cons of resmetirom and semaglutide.
MASLD has become one of the most common causes of chronic liver disease due to the increased prevalence of diabetes, obesity, and other metabolic disorders, Joanne Lin, DO, an internist in the Division of Gastroenterology and Hepatology at the University of California, San Francisco, and colleagues wrote, in a review published in the Journal of Clinical Gastroenterology.
Its complexity makes MASLD challenging to manage. Metabolic, genetic, and environmental factors are involved in the disease, so patients require multidisciplinary and individualized care, Lin told GI & Hepatology News.
Weight loss, dietary changes, and exercise had long been the only treatment approach clinicians could offer patients. But the approval of two drugs — the thyroid hormone receptor-beta agonist resmetirom and the GLP-1 receptor agonist (RA) semaglutide — for patients whose MASLD has advanced to metabolic dysfunction-associated steatohepatitis (MASH) gives physicians new options for patients with severe disease.
In the review, published online before the official approval of semaglutide, Lin and colleagues proposed an algorithm to guide clinicians in choosing a pharmacological therapy for MASLD. “Resmetirom should be primarily used to reverse fibrosis for patients with MASLD and F2-F3 stages, while GLP-1 RAs are beneficial in managing metabolic comorbidities and weight loss in patients with MASLD,” the researchers concluded.
GLP-1 Power and Potential
In August 2025, the FDA approved semaglutide for MASH and cited evidence from the ESSENCE trial in its decision.
The ESSENCE study, published in The New England Journal of Medicine, showed significantly higher rates of resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening steatohepatitis in patients with MASH and moderate or advanced liver fibrosis who received 2.4 mg of once-weekly semaglutide compared with patients who received placebo.
The most common adverse events reported with GLP-1 RAs are gastrointestinal-related, including nausea, diarrhea, vomiting, and constipation, and are mainly mild-to-moderate and dose dependent, Lin and colleagues noted in their review.
GLP-1s have some limitations, Lin said. “GLP-1s are great for weight loss and metabolic risk reduction, but studies are still ongoing to determine their effect on liver histology and reversing fibrosis/cirrhosis,” she said. Some patients seeking these medications also have trouble obtaining them because of their popularity for weight loss, she noted.
Resmetirom Shows Success
Resmetirom has demonstrated ability to target hepatocytes and increase the hepatic metabolism of lipids, Lin and colleagues wrote in their review.
Several trials have examined resmetirom as a treatment for MASH, notably the landmark MAESTRO-NASH study , a randomized, placebo-controlled trial of nearly 1000 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, which was the basis for the FDA’s approval of the drug in 2024. In the study, 25.9% of the patients treated with 80 mg of resmetirom and 29.9% treated with 100 mg resmetirom achieved MASH resolution with no increase in fibrosis compared with 9.7% of patients treated with placebo. In addition, 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group achieved fibrosis improvement by at least one stage without worsening of MASLD activity scores compared with 14.2% of patients treated with placebo.
The most common reported side effects from resmetirom are diarrhea or constipation, nausea or vomiting, and abdominal pain.
“The limitations of resmetirom include the absence of validated predictors for individual patient response, and no societal guidelines are available to determine when to stop the medication if ineffective,” Lin told GI & Hepatology News. In addition, resmetirom is currently only recommended for a subset of patients with F2-F3 fibrosis, based on the existing trial, she said.
Other limitations include its high cost, which restricts access to the drug for some patients, and lack of long-term safety and efficacy data, Lin added.
Weighing the Options
Comparing the emerging agents in the context of MASLD/MASH is important to help clinicians understand how different patient populations respond and guide evidence-based treatment decisions, said Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, in an interview.
“The choice of therapy should be individualized based on comorbidities,” said Ayesh, the lead author of a 2024 review published in Biomedicines that compared resmetirom, GLP-1 agonists, and fibroblast growth factor 21 analogs.
“For example, a GLP-1 receptor agonist may be more appropriate for patients with coexisting diabetes or obesity, while resmetirom may be better suited for patients with more advanced liver disease or minimal metabolic comorbidities,” he said.
GLP-1 RAs, such as semaglutide, offer benefits for diabetes, obesity, and metabolic dysfunction in patients with MASLD/MASH and may be more accessible and cost effective, Ayesh told GI & Hepatology News. However, some patients may experience gastrointestinal side effects or be unable to tolerate GLP-1 RAs, he noted.
By contrast, resmetirom may be preferable for patients with low BMI, advanced fibrosis, or an inability to tolerate GLP-1s, as resmetirom directly targets hepatic pathways involved in MASLD/MASH progression, Ayesh said.
Next Steps to Inform Practice
“More research is needed to validate noninvasive biomarkers to monitor response to these medications, determine predictors of efficacy, and evaluate the additive effects, safety, and drug-drug interactions of combination therapy,” Lin said.
Studies are needed to determine both medications’ effects on patients with advanced fibrosis/cirrhosis and special populations, such as individuals with advanced renal disease or posttransplant patients, she added. More studies are expected to inform clinical practice and proper guidelines for the treatment of MASLD, as has been the case with chronic diseases such as hypertension and diabetes, Lin said.
Long-term safety and efficacy data are critical, as most trials of the newly approved medications have had relatively short follow-up periods of approximately 1 year, Ayesh said. “We need real-world evidence and longitudinal studies spanning 3-5 years to confirm sustained efficacy and safety,” he said. Research on cost effectiveness and health-system impacts will be essential to guide policy and ensure equitable access to the medications, he added.
The study by Lin and colleagues received no outside funding. The researchers had no financial conflicts to disclose. Ayesh had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
, according to the authors of clinical reviews who offered guidance on the pros and cons of resmetirom and semaglutide.
MASLD has become one of the most common causes of chronic liver disease due to the increased prevalence of diabetes, obesity, and other metabolic disorders, Joanne Lin, DO, an internist in the Division of Gastroenterology and Hepatology at the University of California, San Francisco, and colleagues wrote, in a review published in the Journal of Clinical Gastroenterology.
Its complexity makes MASLD challenging to manage. Metabolic, genetic, and environmental factors are involved in the disease, so patients require multidisciplinary and individualized care, Lin told GI & Hepatology News.
Weight loss, dietary changes, and exercise had long been the only treatment approach clinicians could offer patients. But the approval of two drugs — the thyroid hormone receptor-beta agonist resmetirom and the GLP-1 receptor agonist (RA) semaglutide — for patients whose MASLD has advanced to metabolic dysfunction-associated steatohepatitis (MASH) gives physicians new options for patients with severe disease.
In the review, published online before the official approval of semaglutide, Lin and colleagues proposed an algorithm to guide clinicians in choosing a pharmacological therapy for MASLD. “Resmetirom should be primarily used to reverse fibrosis for patients with MASLD and F2-F3 stages, while GLP-1 RAs are beneficial in managing metabolic comorbidities and weight loss in patients with MASLD,” the researchers concluded.
GLP-1 Power and Potential
In August 2025, the FDA approved semaglutide for MASH and cited evidence from the ESSENCE trial in its decision.
The ESSENCE study, published in The New England Journal of Medicine, showed significantly higher rates of resolution of steatohepatitis without worsening of fibrosis and reduction in liver fibrosis without worsening steatohepatitis in patients with MASH and moderate or advanced liver fibrosis who received 2.4 mg of once-weekly semaglutide compared with patients who received placebo.
The most common adverse events reported with GLP-1 RAs are gastrointestinal-related, including nausea, diarrhea, vomiting, and constipation, and are mainly mild-to-moderate and dose dependent, Lin and colleagues noted in their review.
GLP-1s have some limitations, Lin said. “GLP-1s are great for weight loss and metabolic risk reduction, but studies are still ongoing to determine their effect on liver histology and reversing fibrosis/cirrhosis,” she said. Some patients seeking these medications also have trouble obtaining them because of their popularity for weight loss, she noted.
Resmetirom Shows Success
Resmetirom has demonstrated ability to target hepatocytes and increase the hepatic metabolism of lipids, Lin and colleagues wrote in their review.
Several trials have examined resmetirom as a treatment for MASH, notably the landmark MAESTRO-NASH study , a randomized, placebo-controlled trial of nearly 1000 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, which was the basis for the FDA’s approval of the drug in 2024. In the study, 25.9% of the patients treated with 80 mg of resmetirom and 29.9% treated with 100 mg resmetirom achieved MASH resolution with no increase in fibrosis compared with 9.7% of patients treated with placebo. In addition, 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group achieved fibrosis improvement by at least one stage without worsening of MASLD activity scores compared with 14.2% of patients treated with placebo.
The most common reported side effects from resmetirom are diarrhea or constipation, nausea or vomiting, and abdominal pain.
“The limitations of resmetirom include the absence of validated predictors for individual patient response, and no societal guidelines are available to determine when to stop the medication if ineffective,” Lin told GI & Hepatology News. In addition, resmetirom is currently only recommended for a subset of patients with F2-F3 fibrosis, based on the existing trial, she said.
Other limitations include its high cost, which restricts access to the drug for some patients, and lack of long-term safety and efficacy data, Lin added.
Weighing the Options
Comparing the emerging agents in the context of MASLD/MASH is important to help clinicians understand how different patient populations respond and guide evidence-based treatment decisions, said Hazem Ayesh, MD, an endocrinologist at Deaconess Health System, Evansville, Indiana, in an interview.
“The choice of therapy should be individualized based on comorbidities,” said Ayesh, the lead author of a 2024 review published in Biomedicines that compared resmetirom, GLP-1 agonists, and fibroblast growth factor 21 analogs.
“For example, a GLP-1 receptor agonist may be more appropriate for patients with coexisting diabetes or obesity, while resmetirom may be better suited for patients with more advanced liver disease or minimal metabolic comorbidities,” he said.
GLP-1 RAs, such as semaglutide, offer benefits for diabetes, obesity, and metabolic dysfunction in patients with MASLD/MASH and may be more accessible and cost effective, Ayesh told GI & Hepatology News. However, some patients may experience gastrointestinal side effects or be unable to tolerate GLP-1 RAs, he noted.
By contrast, resmetirom may be preferable for patients with low BMI, advanced fibrosis, or an inability to tolerate GLP-1s, as resmetirom directly targets hepatic pathways involved in MASLD/MASH progression, Ayesh said.
Next Steps to Inform Practice
“More research is needed to validate noninvasive biomarkers to monitor response to these medications, determine predictors of efficacy, and evaluate the additive effects, safety, and drug-drug interactions of combination therapy,” Lin said.
Studies are needed to determine both medications’ effects on patients with advanced fibrosis/cirrhosis and special populations, such as individuals with advanced renal disease or posttransplant patients, she added. More studies are expected to inform clinical practice and proper guidelines for the treatment of MASLD, as has been the case with chronic diseases such as hypertension and diabetes, Lin said.
Long-term safety and efficacy data are critical, as most trials of the newly approved medications have had relatively short follow-up periods of approximately 1 year, Ayesh said. “We need real-world evidence and longitudinal studies spanning 3-5 years to confirm sustained efficacy and safety,” he said. Research on cost effectiveness and health-system impacts will be essential to guide policy and ensure equitable access to the medications, he added.
The study by Lin and colleagues received no outside funding. The researchers had no financial conflicts to disclose. Ayesh had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Vaping Increases Peptic Ulcer Disease Risk
PHOENIX — , 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 — , 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 — , 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.
FROM ACG 2025
Patients With a Positive FIT Fail to Get Follow-Up Colonoscopies
Patients With a Positive FIT Fail to Get Follow-Up Colonoscopies
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 this week 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, due to the higher risk.
Reasons patients may instead turn to FIT include cost or other factors.
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 2004.
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 nonpolypectomy group).
Among the FIT screenings, results were positive in 17.2% of postpolypectomy patients and 14.1% of patients who no prior polypectomy, indicating a history of polypectomy to be predictive of 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 emergency 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 nonpolypectomy 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 postcolonoscopy interval FIT.
The findings underscore that "positive results carried a high risk of advanced neoplasia or cancer, irrespective or prior polypectomy history," Wilson said.
Commenting on the study, William D. Chey, MD, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, Michigan, 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 suggest that the rate might even be significantly higher -- at 70% to 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 down 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 include consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestle, Phathom, Redhill, Salix/Valean, Takeda, and Vibrant.
A version of this article first 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 this week 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, due to the higher risk.
Reasons patients may instead turn to FIT include cost or other factors.
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 2004.
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 nonpolypectomy group).
Among the FIT screenings, results were positive in 17.2% of postpolypectomy patients and 14.1% of patients who no prior polypectomy, indicating a history of polypectomy to be predictive of 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 emergency 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 nonpolypectomy 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 postcolonoscopy interval FIT.
The findings underscore that "positive results carried a high risk of advanced neoplasia or cancer, irrespective or prior polypectomy history," Wilson said.
Commenting on the study, William D. Chey, MD, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, Michigan, 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 suggest that the rate might even be significantly higher -- at 70% to 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 down 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 include consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestle, Phathom, Redhill, Salix/Valean, Takeda, and Vibrant.
A version of this article first 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 this week 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, due to the higher risk.
Reasons patients may instead turn to FIT include cost or other factors.
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 2004.
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 nonpolypectomy group).
Among the FIT screenings, results were positive in 17.2% of postpolypectomy patients and 14.1% of patients who no prior polypectomy, indicating a history of polypectomy to be predictive of 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 emergency 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 nonpolypectomy 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 postcolonoscopy interval FIT.
The findings underscore that "positive results carried a high risk of advanced neoplasia or cancer, irrespective or prior polypectomy history," Wilson said.
Commenting on the study, William D. Chey, MD, chief of the Division of Gastroenterology & Hepatology at the University of Michigan in Ann Arbor, Michigan, 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 suggest that the rate might even be significantly higher -- at 70% to 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 down 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 include consulting and/or other relationships with Ardelyx, Atmo, Biomerica, Commonwealth Diagnostics International, Corprata, Dieta, Evinature, Food Marble, Gemelli, Kiwi BioScience, Modify Health, Nestle, Phathom, Redhill, Salix/Valean, Takeda, and Vibrant.
A version of this article first appeared on Medscape.com.
Patients With a Positive FIT Fail to Get Follow-Up Colonoscopies
Patients With a Positive FIT Fail to Get Follow-Up Colonoscopies
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
It's hardly news that the United States is experiencing a mental health crisis -- the CDC says as much. But experts in the field say that the current administration has severely compounded the problem by eliminating agency funding and national programs, slashing research grants and data resources, and creating new barriers to behavioral health care.
Philanthropic foundations aim to do what they can to address the shortfall. The numbers, however, just don't add up.
"Some big foundations and philanthropies have said they're going to increase what they give out in the next 4 years, but they'll never be able to fill the gap," said Morgan F. McDonald, MD, national director of population health at the Milbank Memorial Fund in New York City, which works with states on health policy. "Even if every one of them were to spend down their endowments, they still couldn't."
Given the financial limitations, some foundations are taking a different tack. While looking for ways to join forces with fellow nonprofits, they are providing emergency grants to bridge funding in the short term to keep research from grinding to a halt.
Budget Cuts Reach Far and Wide
Mental health research certainly didn't escape the extensive grant cancellations at the National Institutes of Health and the National Science Foundation.
"It's already affecting our ability to stay on the cutting edge of research, best practices, and treatment approaches," said Zainab Okolo, EdD, senior vice president of policy, advocacy, and government relations at The Jed Foundation in New York City, which focuses on the emotional health of teens and young adults.
The upheaval is evident in an array of government agencies. The Health Resources and Services Administration, which last year awarded $12 billion in grants to community health centers and addiction treatment services, has seen > one-fourth of its staff eliminated. The Substance Abuse and Mental Health Services Administration has lost more than a third of its staff as federal cuts took a $1 billion bite out of its operating budget. The Education Department has halted $1 billion in grants used to hire mental health workers in school districts nationwide.
"We're very, very concerned about cuts to behavioral health systems," said Alonzo Plough, PhD, chief science officer at the Robert Wood Johnson Foundation in Princeton, New Jersey. "Doctors and nurses working in safety-net clinics are seeing tremendous reductions."
All in all, the new tax and spending law means $1 trillion in cuts to health care programs including Medicaid -- the nation's largest payer for mental health services -- Medicare, and Affordable Care Act insurance. An estimated 10 million Americans are expected to lose their health coverage as a result.
"When accessibility to care goes down, there's a chance that more people will die by suicide," said Jill Harkavy-Friedman, PhD, senior vice president of research at the American Foundation for Suicide Prevention. "But it also means people will come into care later in the course of their difficulties. Health professionals will be dealing with worse problems."
Foundations Take Emergency Measures
Even if private dollars can't replace what's been lost, philanthropic and medical foundations are stepping up.
We're seeing a lot of foundations and funders that are shifting their funding," said Alyson Niemann, CEO of Mindful Philanthropy, an organization that works with > 1000 private funders to marshal resources for mental health. This year, in response to federal cuts, "many increased funding to health and well-being, doubling or even tripling it," Niemann noted.
"They're making a great deal of effort to respond with emergency funds, really getting in the trenches and being good partners to their grantees," she said. "We've seen them asking deliberate questions, thinking about where their funding can have the most impact."
The American Psychological Foundation (APF), a longtime supporter of research and innovation, is addressing the current crisis with 2 initiatives, Michelle Quist Ryder, PhD, the organization's CEO, explained in an email. The first is APF Director Action, which funds innovative interventions at the community level. The second, Direct Action Crisis Funding Grants, will help continue research that is at risk of stalling because of budget cuts.
"Studies that are 'paused' or lose funding often cannot simply pick back up where they left off. Having to halt progress on a project can invalidate the work already completed," Ryder wrote. "These Direct Action Crisis Grants help bridge funding gaps and keep research viable."
At the same time, collaboration between foundations is becoming more widespread as they seek to maximize their impact. Philanthropic organizations are sharing ideas and best practices as well as pooling fundings.
"The goal of philanthropy is to help people," Harkavy-Friedman said. "There's strength in numbers and more dollars in numbers."
Some See Hope in Raised Voices
Despite the emergency scrambling, many of those in the trenches remain surprisingly optimistic. Some point out that the current turmoil has put a helpful spotlight on behavioral health care. Practitioners, meanwhile, have an essential role to play.
"There's a reason that things were the way they were: People advocated for many years to get where we've gotten," Harkavy-Friedman said, citing veterans' mental health care, the national violent death reporting system, and 988 as examples. "We have to raise our voices louder -- professionals in particular, because they know the impact a person in the general public many not fully grasp."
As a growing numbers of health professionals call attention to the damage wrought by deep cuts in the federal budget, foundation executives see an opportunity.
"In the mental health field, there's a deficit in the narrative, where there's a lot of focus on crisis. What we're hoping to do is shift the narrative toward 'How do we flourish together?'" Niemann said. "Sometimes deficits are where the most incredible innovations appear."
Debbie Koenig is a health writer whose work has been published by WebMD, The New York Times, and The Washington Post.
A version of this article first appeared on Medscape.com.
It's hardly news that the United States is experiencing a mental health crisis -- the CDC says as much. But experts in the field say that the current administration has severely compounded the problem by eliminating agency funding and national programs, slashing research grants and data resources, and creating new barriers to behavioral health care.
Philanthropic foundations aim to do what they can to address the shortfall. The numbers, however, just don't add up.
"Some big foundations and philanthropies have said they're going to increase what they give out in the next 4 years, but they'll never be able to fill the gap," said Morgan F. McDonald, MD, national director of population health at the Milbank Memorial Fund in New York City, which works with states on health policy. "Even if every one of them were to spend down their endowments, they still couldn't."
Given the financial limitations, some foundations are taking a different tack. While looking for ways to join forces with fellow nonprofits, they are providing emergency grants to bridge funding in the short term to keep research from grinding to a halt.
Budget Cuts Reach Far and Wide
Mental health research certainly didn't escape the extensive grant cancellations at the National Institutes of Health and the National Science Foundation.
"It's already affecting our ability to stay on the cutting edge of research, best practices, and treatment approaches," said Zainab Okolo, EdD, senior vice president of policy, advocacy, and government relations at The Jed Foundation in New York City, which focuses on the emotional health of teens and young adults.
The upheaval is evident in an array of government agencies. The Health Resources and Services Administration, which last year awarded $12 billion in grants to community health centers and addiction treatment services, has seen > one-fourth of its staff eliminated. The Substance Abuse and Mental Health Services Administration has lost more than a third of its staff as federal cuts took a $1 billion bite out of its operating budget. The Education Department has halted $1 billion in grants used to hire mental health workers in school districts nationwide.
"We're very, very concerned about cuts to behavioral health systems," said Alonzo Plough, PhD, chief science officer at the Robert Wood Johnson Foundation in Princeton, New Jersey. "Doctors and nurses working in safety-net clinics are seeing tremendous reductions."
All in all, the new tax and spending law means $1 trillion in cuts to health care programs including Medicaid -- the nation's largest payer for mental health services -- Medicare, and Affordable Care Act insurance. An estimated 10 million Americans are expected to lose their health coverage as a result.
"When accessibility to care goes down, there's a chance that more people will die by suicide," said Jill Harkavy-Friedman, PhD, senior vice president of research at the American Foundation for Suicide Prevention. "But it also means people will come into care later in the course of their difficulties. Health professionals will be dealing with worse problems."
Foundations Take Emergency Measures
Even if private dollars can't replace what's been lost, philanthropic and medical foundations are stepping up.
We're seeing a lot of foundations and funders that are shifting their funding," said Alyson Niemann, CEO of Mindful Philanthropy, an organization that works with > 1000 private funders to marshal resources for mental health. This year, in response to federal cuts, "many increased funding to health and well-being, doubling or even tripling it," Niemann noted.
"They're making a great deal of effort to respond with emergency funds, really getting in the trenches and being good partners to their grantees," she said. "We've seen them asking deliberate questions, thinking about where their funding can have the most impact."
The American Psychological Foundation (APF), a longtime supporter of research and innovation, is addressing the current crisis with 2 initiatives, Michelle Quist Ryder, PhD, the organization's CEO, explained in an email. The first is APF Director Action, which funds innovative interventions at the community level. The second, Direct Action Crisis Funding Grants, will help continue research that is at risk of stalling because of budget cuts.
"Studies that are 'paused' or lose funding often cannot simply pick back up where they left off. Having to halt progress on a project can invalidate the work already completed," Ryder wrote. "These Direct Action Crisis Grants help bridge funding gaps and keep research viable."
At the same time, collaboration between foundations is becoming more widespread as they seek to maximize their impact. Philanthropic organizations are sharing ideas and best practices as well as pooling fundings.
"The goal of philanthropy is to help people," Harkavy-Friedman said. "There's strength in numbers and more dollars in numbers."
Some See Hope in Raised Voices
Despite the emergency scrambling, many of those in the trenches remain surprisingly optimistic. Some point out that the current turmoil has put a helpful spotlight on behavioral health care. Practitioners, meanwhile, have an essential role to play.
"There's a reason that things were the way they were: People advocated for many years to get where we've gotten," Harkavy-Friedman said, citing veterans' mental health care, the national violent death reporting system, and 988 as examples. "We have to raise our voices louder -- professionals in particular, because they know the impact a person in the general public many not fully grasp."
As a growing numbers of health professionals call attention to the damage wrought by deep cuts in the federal budget, foundation executives see an opportunity.
"In the mental health field, there's a deficit in the narrative, where there's a lot of focus on crisis. What we're hoping to do is shift the narrative toward 'How do we flourish together?'" Niemann said. "Sometimes deficits are where the most incredible innovations appear."
Debbie Koenig is a health writer whose work has been published by WebMD, The New York Times, and The Washington Post.
A version of this article first appeared on Medscape.com.
It's hardly news that the United States is experiencing a mental health crisis -- the CDC says as much. But experts in the field say that the current administration has severely compounded the problem by eliminating agency funding and national programs, slashing research grants and data resources, and creating new barriers to behavioral health care.
Philanthropic foundations aim to do what they can to address the shortfall. The numbers, however, just don't add up.
"Some big foundations and philanthropies have said they're going to increase what they give out in the next 4 years, but they'll never be able to fill the gap," said Morgan F. McDonald, MD, national director of population health at the Milbank Memorial Fund in New York City, which works with states on health policy. "Even if every one of them were to spend down their endowments, they still couldn't."
Given the financial limitations, some foundations are taking a different tack. While looking for ways to join forces with fellow nonprofits, they are providing emergency grants to bridge funding in the short term to keep research from grinding to a halt.
Budget Cuts Reach Far and Wide
Mental health research certainly didn't escape the extensive grant cancellations at the National Institutes of Health and the National Science Foundation.
"It's already affecting our ability to stay on the cutting edge of research, best practices, and treatment approaches," said Zainab Okolo, EdD, senior vice president of policy, advocacy, and government relations at The Jed Foundation in New York City, which focuses on the emotional health of teens and young adults.
The upheaval is evident in an array of government agencies. The Health Resources and Services Administration, which last year awarded $12 billion in grants to community health centers and addiction treatment services, has seen > one-fourth of its staff eliminated. The Substance Abuse and Mental Health Services Administration has lost more than a third of its staff as federal cuts took a $1 billion bite out of its operating budget. The Education Department has halted $1 billion in grants used to hire mental health workers in school districts nationwide.
"We're very, very concerned about cuts to behavioral health systems," said Alonzo Plough, PhD, chief science officer at the Robert Wood Johnson Foundation in Princeton, New Jersey. "Doctors and nurses working in safety-net clinics are seeing tremendous reductions."
All in all, the new tax and spending law means $1 trillion in cuts to health care programs including Medicaid -- the nation's largest payer for mental health services -- Medicare, and Affordable Care Act insurance. An estimated 10 million Americans are expected to lose their health coverage as a result.
"When accessibility to care goes down, there's a chance that more people will die by suicide," said Jill Harkavy-Friedman, PhD, senior vice president of research at the American Foundation for Suicide Prevention. "But it also means people will come into care later in the course of their difficulties. Health professionals will be dealing with worse problems."
Foundations Take Emergency Measures
Even if private dollars can't replace what's been lost, philanthropic and medical foundations are stepping up.
We're seeing a lot of foundations and funders that are shifting their funding," said Alyson Niemann, CEO of Mindful Philanthropy, an organization that works with > 1000 private funders to marshal resources for mental health. This year, in response to federal cuts, "many increased funding to health and well-being, doubling or even tripling it," Niemann noted.
"They're making a great deal of effort to respond with emergency funds, really getting in the trenches and being good partners to their grantees," she said. "We've seen them asking deliberate questions, thinking about where their funding can have the most impact."
The American Psychological Foundation (APF), a longtime supporter of research and innovation, is addressing the current crisis with 2 initiatives, Michelle Quist Ryder, PhD, the organization's CEO, explained in an email. The first is APF Director Action, which funds innovative interventions at the community level. The second, Direct Action Crisis Funding Grants, will help continue research that is at risk of stalling because of budget cuts.
"Studies that are 'paused' or lose funding often cannot simply pick back up where they left off. Having to halt progress on a project can invalidate the work already completed," Ryder wrote. "These Direct Action Crisis Grants help bridge funding gaps and keep research viable."
At the same time, collaboration between foundations is becoming more widespread as they seek to maximize their impact. Philanthropic organizations are sharing ideas and best practices as well as pooling fundings.
"The goal of philanthropy is to help people," Harkavy-Friedman said. "There's strength in numbers and more dollars in numbers."
Some See Hope in Raised Voices
Despite the emergency scrambling, many of those in the trenches remain surprisingly optimistic. Some point out that the current turmoil has put a helpful spotlight on behavioral health care. Practitioners, meanwhile, have an essential role to play.
"There's a reason that things were the way they were: People advocated for many years to get where we've gotten," Harkavy-Friedman said, citing veterans' mental health care, the national violent death reporting system, and 988 as examples. "We have to raise our voices louder -- professionals in particular, because they know the impact a person in the general public many not fully grasp."
As a growing numbers of health professionals call attention to the damage wrought by deep cuts in the federal budget, foundation executives see an opportunity.
"In the mental health field, there's a deficit in the narrative, where there's a lot of focus on crisis. What we're hoping to do is shift the narrative toward 'How do we flourish together?'" Niemann said. "Sometimes deficits are where the most incredible innovations appear."
Debbie Koenig is a health writer whose work has been published by WebMD, The New York Times, and The Washington Post.
A version of this article first appeared on Medscape.com.
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
Taking Therapy Home With Mobile Mental Health Apps
For Kelly, a retired Navy operations specialist, coping with depression and anxiety hindered her ability to enjoy everyday life. Then she elected to enter therapy, a decision she calls “transformative.”
“When I started doing therapy, it was like releasing the toxins, releasing the buildup of the fear or the rage or the overwhelming feelings of shame,” she says. “We can’t just hold on to it. Just telling the truth, it helps me every single day. It is so worth it.”
Kurt, an Army veteran, tried to power through his anxiety, depression, and survivor guilt. He didn’t have much faith in mental health therapy, thinking no one could relate to him. He was surprised, though, once he started treatment, how much his life improved. He now encourages other veterans to face their own mental health challenges, be it through virtual/mental health apps or in-person care.
“From getting help, every day of my life is better,” he says, “and I couldn’t be more grateful for it.”
Stories from Kelly and Kurt are 2 of 7 the US Department of Veterans Affairs (VA) highlighted during National Recovery Month, outlining how their lives were forever changed with the support of mental health care.
But for every Kelly and Kurt, there are thousands of individuals reluctant to seek mental health care. A analysis of 2019-2020 data from the National Health and Resilience in Veterans Study found that 924 (26%) of 4069 veterans met criteria for ≥ 1 psychological disorders, but only 12% reported engagement in mental health care. The researchers considered the role of protective psychosocial characteristics, such as grit (ie, “trait perseverance that extends to one’s decision or commitment to address mental health needs on one’s own; dispositional optimism; and purpose in life”). Veterans who reported mental dysfunction but scored highly on grit were less likely to be engaged in treatment. This pattern suggests higher levels of grit may reduce the likelihood of seeking treatment, “even in the presence of clinically meaningful distress.”
A 2004 study found only 23% to 40% of service members who screened positive for a mental disorder sought care. They often believed they would be seen as weak, or their unit leadership might treat them differently, and unit members would have less confidence in them.
Given that military members and veterans are at increased risk of posttraumatic stress disorder (PTSD) in addition to mood, anxiety, and substance use disorders, any alternatives that increase their access to support and services are crucial. For those who aren’t disposed to office visits and group therapy, the answer may lie in mobile apps.
In a recent randomized controlled trial, 201 veterans who screened positive for PTSD and alcohol use disorder were divided into 2 groups: a mobile mindfulness-based intervention group enhanced with brief alcohol intervention content (Mind Guide), and an active stress management program group. Mind Guide engagement was excellent, according to the study, with averages of > 31 logins and 5 hours of app use. At 16 weeks, the Mind Guide group showed significant reductions in PTSD symptoms (no differences emerged for alcohol use frequency). Mind Guide may be a valuable adjunct to more intensive in-person PTSD treatment by facilitating interest in services, integration into care, and/or sustainment of posttreatment improvements. The VA currently offers 16 apps, including MHA for Veterans, an app designed for patients to complete mental health assessments after their clinician assigned them. Other apps address a variety of issues, such as anger management, insomnia, chronic pain, and PTSD.
Two apps were created with an eye toward specific communities. One, Veterans Wellness Path, was designed for American Indians and Alaska Natives with input from those veterans, their family members, and health care practitioners. It supports the transition from military service to home and encourages balance and connection with self, family, community, and environment. Similarly, WellWithin Coach was designed by the VA National Center for PTSD with input from women veterans and subject matter experts in women’s mental health.
Whatever form it takes—in-person or virtual—finding support that works can make all the difference for veterans. Kelly founded and serves as the executive director of Acta Non Verba: Youth Urban Farm Project, an organization that brings together > 3000 low-income youth and families annually to learn about urban farming, aiming to fill a gap in an area known as a food desert: “We do have the power and the right to wake up the next day and try to do something different,” she said.
For Kelly, a retired Navy operations specialist, coping with depression and anxiety hindered her ability to enjoy everyday life. Then she elected to enter therapy, a decision she calls “transformative.”
“When I started doing therapy, it was like releasing the toxins, releasing the buildup of the fear or the rage or the overwhelming feelings of shame,” she says. “We can’t just hold on to it. Just telling the truth, it helps me every single day. It is so worth it.”
Kurt, an Army veteran, tried to power through his anxiety, depression, and survivor guilt. He didn’t have much faith in mental health therapy, thinking no one could relate to him. He was surprised, though, once he started treatment, how much his life improved. He now encourages other veterans to face their own mental health challenges, be it through virtual/mental health apps or in-person care.
“From getting help, every day of my life is better,” he says, “and I couldn’t be more grateful for it.”
Stories from Kelly and Kurt are 2 of 7 the US Department of Veterans Affairs (VA) highlighted during National Recovery Month, outlining how their lives were forever changed with the support of mental health care.
But for every Kelly and Kurt, there are thousands of individuals reluctant to seek mental health care. A analysis of 2019-2020 data from the National Health and Resilience in Veterans Study found that 924 (26%) of 4069 veterans met criteria for ≥ 1 psychological disorders, but only 12% reported engagement in mental health care. The researchers considered the role of protective psychosocial characteristics, such as grit (ie, “trait perseverance that extends to one’s decision or commitment to address mental health needs on one’s own; dispositional optimism; and purpose in life”). Veterans who reported mental dysfunction but scored highly on grit were less likely to be engaged in treatment. This pattern suggests higher levels of grit may reduce the likelihood of seeking treatment, “even in the presence of clinically meaningful distress.”
A 2004 study found only 23% to 40% of service members who screened positive for a mental disorder sought care. They often believed they would be seen as weak, or their unit leadership might treat them differently, and unit members would have less confidence in them.
Given that military members and veterans are at increased risk of posttraumatic stress disorder (PTSD) in addition to mood, anxiety, and substance use disorders, any alternatives that increase their access to support and services are crucial. For those who aren’t disposed to office visits and group therapy, the answer may lie in mobile apps.
In a recent randomized controlled trial, 201 veterans who screened positive for PTSD and alcohol use disorder were divided into 2 groups: a mobile mindfulness-based intervention group enhanced with brief alcohol intervention content (Mind Guide), and an active stress management program group. Mind Guide engagement was excellent, according to the study, with averages of > 31 logins and 5 hours of app use. At 16 weeks, the Mind Guide group showed significant reductions in PTSD symptoms (no differences emerged for alcohol use frequency). Mind Guide may be a valuable adjunct to more intensive in-person PTSD treatment by facilitating interest in services, integration into care, and/or sustainment of posttreatment improvements. The VA currently offers 16 apps, including MHA for Veterans, an app designed for patients to complete mental health assessments after their clinician assigned them. Other apps address a variety of issues, such as anger management, insomnia, chronic pain, and PTSD.
Two apps were created with an eye toward specific communities. One, Veterans Wellness Path, was designed for American Indians and Alaska Natives with input from those veterans, their family members, and health care practitioners. It supports the transition from military service to home and encourages balance and connection with self, family, community, and environment. Similarly, WellWithin Coach was designed by the VA National Center for PTSD with input from women veterans and subject matter experts in women’s mental health.
Whatever form it takes—in-person or virtual—finding support that works can make all the difference for veterans. Kelly founded and serves as the executive director of Acta Non Verba: Youth Urban Farm Project, an organization that brings together > 3000 low-income youth and families annually to learn about urban farming, aiming to fill a gap in an area known as a food desert: “We do have the power and the right to wake up the next day and try to do something different,” she said.
For Kelly, a retired Navy operations specialist, coping with depression and anxiety hindered her ability to enjoy everyday life. Then she elected to enter therapy, a decision she calls “transformative.”
“When I started doing therapy, it was like releasing the toxins, releasing the buildup of the fear or the rage or the overwhelming feelings of shame,” she says. “We can’t just hold on to it. Just telling the truth, it helps me every single day. It is so worth it.”
Kurt, an Army veteran, tried to power through his anxiety, depression, and survivor guilt. He didn’t have much faith in mental health therapy, thinking no one could relate to him. He was surprised, though, once he started treatment, how much his life improved. He now encourages other veterans to face their own mental health challenges, be it through virtual/mental health apps or in-person care.
“From getting help, every day of my life is better,” he says, “and I couldn’t be more grateful for it.”
Stories from Kelly and Kurt are 2 of 7 the US Department of Veterans Affairs (VA) highlighted during National Recovery Month, outlining how their lives were forever changed with the support of mental health care.
But for every Kelly and Kurt, there are thousands of individuals reluctant to seek mental health care. A analysis of 2019-2020 data from the National Health and Resilience in Veterans Study found that 924 (26%) of 4069 veterans met criteria for ≥ 1 psychological disorders, but only 12% reported engagement in mental health care. The researchers considered the role of protective psychosocial characteristics, such as grit (ie, “trait perseverance that extends to one’s decision or commitment to address mental health needs on one’s own; dispositional optimism; and purpose in life”). Veterans who reported mental dysfunction but scored highly on grit were less likely to be engaged in treatment. This pattern suggests higher levels of grit may reduce the likelihood of seeking treatment, “even in the presence of clinically meaningful distress.”
A 2004 study found only 23% to 40% of service members who screened positive for a mental disorder sought care. They often believed they would be seen as weak, or their unit leadership might treat them differently, and unit members would have less confidence in them.
Given that military members and veterans are at increased risk of posttraumatic stress disorder (PTSD) in addition to mood, anxiety, and substance use disorders, any alternatives that increase their access to support and services are crucial. For those who aren’t disposed to office visits and group therapy, the answer may lie in mobile apps.
In a recent randomized controlled trial, 201 veterans who screened positive for PTSD and alcohol use disorder were divided into 2 groups: a mobile mindfulness-based intervention group enhanced with brief alcohol intervention content (Mind Guide), and an active stress management program group. Mind Guide engagement was excellent, according to the study, with averages of > 31 logins and 5 hours of app use. At 16 weeks, the Mind Guide group showed significant reductions in PTSD symptoms (no differences emerged for alcohol use frequency). Mind Guide may be a valuable adjunct to more intensive in-person PTSD treatment by facilitating interest in services, integration into care, and/or sustainment of posttreatment improvements. The VA currently offers 16 apps, including MHA for Veterans, an app designed for patients to complete mental health assessments after their clinician assigned them. Other apps address a variety of issues, such as anger management, insomnia, chronic pain, and PTSD.
Two apps were created with an eye toward specific communities. One, Veterans Wellness Path, was designed for American Indians and Alaska Natives with input from those veterans, their family members, and health care practitioners. It supports the transition from military service to home and encourages balance and connection with self, family, community, and environment. Similarly, WellWithin Coach was designed by the VA National Center for PTSD with input from women veterans and subject matter experts in women’s mental health.
Whatever form it takes—in-person or virtual—finding support that works can make all the difference for veterans. Kelly founded and serves as the executive director of Acta Non Verba: Youth Urban Farm Project, an organization that brings together > 3000 low-income youth and families annually to learn about urban farming, aiming to fill a gap in an area known as a food desert: “We do have the power and the right to wake up the next day and try to do something different,” she said.
Novel Agent Promising for Refractory Ulcerative Colitis
The findings, from the ABTECT-1 and ABTECT-2 phase 3 induction trials, were presented in two separate late-breaking presentations at United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.
“These trials enrolled a broad spectrum of participants, including one of the most severe and refractory populations evaluated to date in a phase 3 UC trial, with about 60% of patients across the pooled dataset having a Mayo endoscopic subscore of 3 — the highest level of UC endoscopic disease activity,” study investigator Marla Dubinsky, MD, gastroenterologist and co-director of the IBD Center at Mount Sinai in New York City, told GI & Hepatology News.
“Even within this challenging population, obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints, including endoscopic improvement, after just 8 weeks of therapy,” Dubinsky said.
This suggests that obefazimod may serve as both an early advanced therapy option and a much-needed alternative for patients with moderately to severely active UC who have failed multiple biologics and JAK inhibitors, with few choices left short of colectomy, she added.
Study Details
Obefazimod is an investigational oral, potentially first-in-class drug that enhances expression of microRNA-124, resulting in regulation of the inflammatory response and restoring mucosal homeostasis in UC.
The ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC who had inadequate response, loss of response, or intolerance to at least one prior therapy (with no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators, and/or JAK inhibitors. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.
In ABTECT-1, obefazimod 50 mg and 25 mg met the primary endpoint of clinical remission, with 22% of patients in the 50-mg group and 24% in the 25-mg group achieving clinical remission at 8 weeks compared with 2.5% of the placebo group.
The effect sizes for clinical remission were 21% for the 25-mg dose and 19% for the 50-mg dose, reported Bruce E. Sands, MD, MS, AGAF, professor of medicine at Icahn School of Medicine at Mount Sinai and chief in the Division of Gastroenterology at Mount Sinai Health System in New York City.
In ABTECT-2, the 50-mg dose met the primary endpoint of clinical remission, with 20% of patients achieving remission compared with 11% in the 25-mg group and 6.3% in the placebo group.
The effect sizes for clinical remission in ABTECT-2 were “a bit smaller” (13% for the 50-mg dose and 5% for the 25-mg dose) “because the absolute efficacy of 50 mg in this study was a little bit lower, and the placebo response rate was a little bit higher at 6.3%, and so accordingly, the 25-mg dose did not achieve statistical significance,” Sands explained.
Both doses of obefazimod met all secondary endpoints in ABTECT-1 and the 50-mg dose achieved all secondary endpoints in ABTECT-2. Secondary endpoints included clinical response, endoscopic improvement, symptomatic remission, and histo-endoscopic mucosal improvement.
Pooled data across the two studies showed that both doses achieved “clinically meaningful improvements across all efficacy points,” Sands noted.
Notably, obefazimod 50 mg once daily achieved “consistent and clinically meaningful improvements” regardless of prior failure of advanced therapy, and both doses performed similarly well in the subgroup with no prior failure of advanced therapy, Silvio Danese, MD, PhD, with Vita-Salute San Raffaele University, Milan, Italy, reported in a separate presentation.
Adverse Events ‘Not a Barrier to Treatment’
Pooled data across the two studies showed no signal for serious, severe, or opportunistic infections or malignancies.
The most commonly reported treatment-emergent adverse event was headache, reported in 24% and 16% of patients taking obefazimod 50 mg and 25 mg, respectively, vs 6% of those taking placebo. Headaches were mild, transient, and short-lasting and “not a barrier to treatment, as evidenced by the low discontinuation (< 1%),” Sands noted.
“Because this is a safe agent and it’s an oral agent and convenient, I think the drug could be used early in the course of the disease, before advanced therapy or after failure of advanced therapies, even multiple advanced therapies,” Sands said.
“Of course, we’ll have to see what the maintenance data show. But we have a long experience from the phase 2a and 2b long-term extension treatments, and the durability seems to be quite good,” Sands cautioned.
Abivax CEO Marc de Garidel, MBA, told GI & Hepatology News that the company will share “top-line data” from the 44-week maintenance study evaluating obefazimod in UC in the second quarter of 2026.
“If positive, the data will support a potential NDA [New Drug Application] submission in the second half of 2026,” de Garidel said.
‘Promising Data’
Ashwin Ananthakrishnan, MBBS, MPH, AGAF, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, Boston, who wasn’t involved in the study, was impressed.
“I think this is very promising data from an important study. This is an entirely novel mechanism of action in ulcerative colitis,” Ananthakrishnan told GI & Hepatology News.
“While we have many treatments available, there are still a large number of patients who do not respond to existing treatment mechanisms,” he said. These trials “consisted of a large number of very refractory patients (severe endoscopic disease or multiple prior mechanism failures). That it works well in this population is very promising (and clinically impactful).”
It would be a “welcome addition to the armamentarium,” he added.
The study was funded by Abivax. Several study authors disclosed having financial relationships with the company. Ananthakrishnan reported having no disclosures.
A version of this article appeared on Medscape.com.
The findings, from the ABTECT-1 and ABTECT-2 phase 3 induction trials, were presented in two separate late-breaking presentations at United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.
“These trials enrolled a broad spectrum of participants, including one of the most severe and refractory populations evaluated to date in a phase 3 UC trial, with about 60% of patients across the pooled dataset having a Mayo endoscopic subscore of 3 — the highest level of UC endoscopic disease activity,” study investigator Marla Dubinsky, MD, gastroenterologist and co-director of the IBD Center at Mount Sinai in New York City, told GI & Hepatology News.
“Even within this challenging population, obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints, including endoscopic improvement, after just 8 weeks of therapy,” Dubinsky said.
This suggests that obefazimod may serve as both an early advanced therapy option and a much-needed alternative for patients with moderately to severely active UC who have failed multiple biologics and JAK inhibitors, with few choices left short of colectomy, she added.
Study Details
Obefazimod is an investigational oral, potentially first-in-class drug that enhances expression of microRNA-124, resulting in regulation of the inflammatory response and restoring mucosal homeostasis in UC.
The ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC who had inadequate response, loss of response, or intolerance to at least one prior therapy (with no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators, and/or JAK inhibitors. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.
In ABTECT-1, obefazimod 50 mg and 25 mg met the primary endpoint of clinical remission, with 22% of patients in the 50-mg group and 24% in the 25-mg group achieving clinical remission at 8 weeks compared with 2.5% of the placebo group.
The effect sizes for clinical remission were 21% for the 25-mg dose and 19% for the 50-mg dose, reported Bruce E. Sands, MD, MS, AGAF, professor of medicine at Icahn School of Medicine at Mount Sinai and chief in the Division of Gastroenterology at Mount Sinai Health System in New York City.
In ABTECT-2, the 50-mg dose met the primary endpoint of clinical remission, with 20% of patients achieving remission compared with 11% in the 25-mg group and 6.3% in the placebo group.
The effect sizes for clinical remission in ABTECT-2 were “a bit smaller” (13% for the 50-mg dose and 5% for the 25-mg dose) “because the absolute efficacy of 50 mg in this study was a little bit lower, and the placebo response rate was a little bit higher at 6.3%, and so accordingly, the 25-mg dose did not achieve statistical significance,” Sands explained.
Both doses of obefazimod met all secondary endpoints in ABTECT-1 and the 50-mg dose achieved all secondary endpoints in ABTECT-2. Secondary endpoints included clinical response, endoscopic improvement, symptomatic remission, and histo-endoscopic mucosal improvement.
Pooled data across the two studies showed that both doses achieved “clinically meaningful improvements across all efficacy points,” Sands noted.
Notably, obefazimod 50 mg once daily achieved “consistent and clinically meaningful improvements” regardless of prior failure of advanced therapy, and both doses performed similarly well in the subgroup with no prior failure of advanced therapy, Silvio Danese, MD, PhD, with Vita-Salute San Raffaele University, Milan, Italy, reported in a separate presentation.
Adverse Events ‘Not a Barrier to Treatment’
Pooled data across the two studies showed no signal for serious, severe, or opportunistic infections or malignancies.
The most commonly reported treatment-emergent adverse event was headache, reported in 24% and 16% of patients taking obefazimod 50 mg and 25 mg, respectively, vs 6% of those taking placebo. Headaches were mild, transient, and short-lasting and “not a barrier to treatment, as evidenced by the low discontinuation (< 1%),” Sands noted.
“Because this is a safe agent and it’s an oral agent and convenient, I think the drug could be used early in the course of the disease, before advanced therapy or after failure of advanced therapies, even multiple advanced therapies,” Sands said.
“Of course, we’ll have to see what the maintenance data show. But we have a long experience from the phase 2a and 2b long-term extension treatments, and the durability seems to be quite good,” Sands cautioned.
Abivax CEO Marc de Garidel, MBA, told GI & Hepatology News that the company will share “top-line data” from the 44-week maintenance study evaluating obefazimod in UC in the second quarter of 2026.
“If positive, the data will support a potential NDA [New Drug Application] submission in the second half of 2026,” de Garidel said.
‘Promising Data’
Ashwin Ananthakrishnan, MBBS, MPH, AGAF, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, Boston, who wasn’t involved in the study, was impressed.
“I think this is very promising data from an important study. This is an entirely novel mechanism of action in ulcerative colitis,” Ananthakrishnan told GI & Hepatology News.
“While we have many treatments available, there are still a large number of patients who do not respond to existing treatment mechanisms,” he said. These trials “consisted of a large number of very refractory patients (severe endoscopic disease or multiple prior mechanism failures). That it works well in this population is very promising (and clinically impactful).”
It would be a “welcome addition to the armamentarium,” he added.
The study was funded by Abivax. Several study authors disclosed having financial relationships with the company. Ananthakrishnan reported having no disclosures.
A version of this article appeared on Medscape.com.
The findings, from the ABTECT-1 and ABTECT-2 phase 3 induction trials, were presented in two separate late-breaking presentations at United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.
“These trials enrolled a broad spectrum of participants, including one of the most severe and refractory populations evaluated to date in a phase 3 UC trial, with about 60% of patients across the pooled dataset having a Mayo endoscopic subscore of 3 — the highest level of UC endoscopic disease activity,” study investigator Marla Dubinsky, MD, gastroenterologist and co-director of the IBD Center at Mount Sinai in New York City, told GI & Hepatology News.
“Even within this challenging population, obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints, including endoscopic improvement, after just 8 weeks of therapy,” Dubinsky said.
This suggests that obefazimod may serve as both an early advanced therapy option and a much-needed alternative for patients with moderately to severely active UC who have failed multiple biologics and JAK inhibitors, with few choices left short of colectomy, she added.
Study Details
Obefazimod is an investigational oral, potentially first-in-class drug that enhances expression of microRNA-124, resulting in regulation of the inflammatory response and restoring mucosal homeostasis in UC.
The ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC who had inadequate response, loss of response, or intolerance to at least one prior therapy (with no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators, and/or JAK inhibitors. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.
In ABTECT-1, obefazimod 50 mg and 25 mg met the primary endpoint of clinical remission, with 22% of patients in the 50-mg group and 24% in the 25-mg group achieving clinical remission at 8 weeks compared with 2.5% of the placebo group.
The effect sizes for clinical remission were 21% for the 25-mg dose and 19% for the 50-mg dose, reported Bruce E. Sands, MD, MS, AGAF, professor of medicine at Icahn School of Medicine at Mount Sinai and chief in the Division of Gastroenterology at Mount Sinai Health System in New York City.
In ABTECT-2, the 50-mg dose met the primary endpoint of clinical remission, with 20% of patients achieving remission compared with 11% in the 25-mg group and 6.3% in the placebo group.
The effect sizes for clinical remission in ABTECT-2 were “a bit smaller” (13% for the 50-mg dose and 5% for the 25-mg dose) “because the absolute efficacy of 50 mg in this study was a little bit lower, and the placebo response rate was a little bit higher at 6.3%, and so accordingly, the 25-mg dose did not achieve statistical significance,” Sands explained.
Both doses of obefazimod met all secondary endpoints in ABTECT-1 and the 50-mg dose achieved all secondary endpoints in ABTECT-2. Secondary endpoints included clinical response, endoscopic improvement, symptomatic remission, and histo-endoscopic mucosal improvement.
Pooled data across the two studies showed that both doses achieved “clinically meaningful improvements across all efficacy points,” Sands noted.
Notably, obefazimod 50 mg once daily achieved “consistent and clinically meaningful improvements” regardless of prior failure of advanced therapy, and both doses performed similarly well in the subgroup with no prior failure of advanced therapy, Silvio Danese, MD, PhD, with Vita-Salute San Raffaele University, Milan, Italy, reported in a separate presentation.
Adverse Events ‘Not a Barrier to Treatment’
Pooled data across the two studies showed no signal for serious, severe, or opportunistic infections or malignancies.
The most commonly reported treatment-emergent adverse event was headache, reported in 24% and 16% of patients taking obefazimod 50 mg and 25 mg, respectively, vs 6% of those taking placebo. Headaches were mild, transient, and short-lasting and “not a barrier to treatment, as evidenced by the low discontinuation (< 1%),” Sands noted.
“Because this is a safe agent and it’s an oral agent and convenient, I think the drug could be used early in the course of the disease, before advanced therapy or after failure of advanced therapies, even multiple advanced therapies,” Sands said.
“Of course, we’ll have to see what the maintenance data show. But we have a long experience from the phase 2a and 2b long-term extension treatments, and the durability seems to be quite good,” Sands cautioned.
Abivax CEO Marc de Garidel, MBA, told GI & Hepatology News that the company will share “top-line data” from the 44-week maintenance study evaluating obefazimod in UC in the second quarter of 2026.
“If positive, the data will support a potential NDA [New Drug Application] submission in the second half of 2026,” de Garidel said.
‘Promising Data’
Ashwin Ananthakrishnan, MBBS, MPH, AGAF, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, Boston, who wasn’t involved in the study, was impressed.
“I think this is very promising data from an important study. This is an entirely novel mechanism of action in ulcerative colitis,” Ananthakrishnan told GI & Hepatology News.
“While we have many treatments available, there are still a large number of patients who do not respond to existing treatment mechanisms,” he said. These trials “consisted of a large number of very refractory patients (severe endoscopic disease or multiple prior mechanism failures). That it works well in this population is very promising (and clinically impactful).”
It would be a “welcome addition to the armamentarium,” he added.
The study was funded by Abivax. Several study authors disclosed having financial relationships with the company. Ananthakrishnan reported having no disclosures.
A version of this article appeared on Medscape.com.