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FDA Grants Rinvoq Updated Indication in IBD
The updated indication allows for starting upadacitinib before a TNF blocker in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy, the company said in a statement.
Previously, upadacitinib was indicated only in adults with moderately to severely active ulcerative colitis or Crohn’s disease who had an inadequate response or intolerance to one or more TNF blockers.
“Ulcerative colitis and Crohn’s disease can impact every aspect of a patient’s life. This label update gives healthcare providers the option to prescribe Rinvoq for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician,” Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in the statement.
Full prescribing information is available online.
Wallace is an employee of AbbVie.
A version of this article appeared on Medscape.com .
The updated indication allows for starting upadacitinib before a TNF blocker in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy, the company said in a statement.
Previously, upadacitinib was indicated only in adults with moderately to severely active ulcerative colitis or Crohn’s disease who had an inadequate response or intolerance to one or more TNF blockers.
“Ulcerative colitis and Crohn’s disease can impact every aspect of a patient’s life. This label update gives healthcare providers the option to prescribe Rinvoq for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician,” Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in the statement.
Full prescribing information is available online.
Wallace is an employee of AbbVie.
A version of this article appeared on Medscape.com .
The updated indication allows for starting upadacitinib before a TNF blocker in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy, the company said in a statement.
Previously, upadacitinib was indicated only in adults with moderately to severely active ulcerative colitis or Crohn’s disease who had an inadequate response or intolerance to one or more TNF blockers.
“Ulcerative colitis and Crohn’s disease can impact every aspect of a patient’s life. This label update gives healthcare providers the option to prescribe Rinvoq for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician,” Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in the statement.
Full prescribing information is available online.
Wallace is an employee of AbbVie.
A version of this article appeared on Medscape.com .
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.
Half of Patients Skip Repeat Stool Tests for CRC Screening
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
A large real-world study found that
Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.
“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.
In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.
“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.
Stool Tests Gaining Traction
Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.
Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.
They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.
“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.
Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.
Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).
“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.
Screening patterns shifted markedly during the pandemic.
Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.
“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.
A Multilevel Approach
Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.
Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”
“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.
Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”
She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.
As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.
The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.
The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
Diet Drinks Harder on the Liver Than Sugary Drinks?
BERLIN — Diet drinks may not be “healthier” than sugary drinks when it comes to liver health.
In fact, low- or artificially sweetened beverages were actually linked to a higher risk for MASLD than sugar-laden drinks, even at modest intake levels such as a single can per day.
“These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern,” lead author Lihe Liu, a graduate student in the Department of Gastroenterology at The First Affiliated Hospital of Soochow University in Suzhou, China, said in a news release.
She presented her research at the United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.
Stick With Water
MASLD affects 38% of the global population and has become a leading cause of cirrhosis, liver cancer, and liver-related death. Lifestyle modification remains “a cornerstone” of MASLD management. Current guidelines advise against SSBs, but the evidence regarding LNSSBs remains “limited,” Liu explained in her presentation.
To investigate, the researchers analyzed data of 123,788 UK Biobank participants without liver disease at baseline who were followed for an average of 10.3 years. Beverage consumption was assessed through repeated 24-hour dietary questionnaires using the question: “How many glasses, cans, or cartons containing 250 mL (roughly 250 g) of SSBs or LNSSBs did you drink yesterday?”
Intake was averaged across at least two recalls, and participants were grouped into three intake categories: none, more than 0 to one serving per day, or more than one serving per day.
The primary outcome was incident MASLD, and secondary outcomes included liver-related mortality and liver fat content measured using MRI-derived proton density fat fraction.
In the fully adjusted multivariable Cox model, compared with no consumption, consuming more than one serving of LNSSBs daily was associated with a 60% higher risk for MASLD (hazard ratio [HR], 1.599). The level of consumption of SSBs was associated with a 50% higher risk (HR, 1.469).
Consuming more than one serving of LNSSBs daily was also associated with a higher risk for severe liver outcomes (HR, 1.555), while SSBs showed no significant association after adjustment.
Neither SSBs nor LNSSBs showed significant associations with all-cause mortality in fully adjusted models.
Substituting either beverage with water reduced the risk for MASLD by 12.8% for SSBs and 15.2% for LNSSBs, Liu reported.
Both beverage types were positively associated with higher liver fat content. Consumption of more than one serving of SSBs and LNSSBs daily was associated with about 5% and 7% higher liver fat levels, respectively, than nonconsumption.
“The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain, and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings, and even stimulating insulin secretion,” Liu said.
“The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body,” she concluded.
More Study Needed
Reached for comment, Sujit V. Janardhan, MD, PhD, director of the steatotic liver disease program, Rush University Medical Center, Chicago, said the findings “certainly should cause one to take pause from the popular notion that diet or non-sugar-sweetened beverages are healthier than their sugar-sweetened alternatives.”
He cautioned, however, that it would be “important to confirm confounders are adequately addressed in this large population-based study.”
“We must better understand what other exposure and characteristics were present in patients who had increased intake of non-sugar-sweetened beverages,” Janardhan told GI & Hepatology News.
“For example, it’s possible people who drank more non-sugar-sweetened beverages had more cardiovascular or metabolic risk factors (which prompted them to switch to the ‘diet’ alternative) and that it is these comorbidities that drove an association with increased MASLD incidence and liver-related mortality,” Janardhan noted.
“If there is one finding that seems easy to take away from this study, it’s that people who drank more water in place of sweetened beverages had reduced risk of MASLD,” he told GI & Hepatology News.
Therefore, while awaiting results of mechanistic studies and careful confounder analysis, “plain old boring water is your best bet,” Janardhan said.
The study had no specific funding. Liu and Janardhan had no relevant disclosures.
A version of this article appeared on Medscape.com.
BERLIN — Diet drinks may not be “healthier” than sugary drinks when it comes to liver health.
In fact, low- or artificially sweetened beverages were actually linked to a higher risk for MASLD than sugar-laden drinks, even at modest intake levels such as a single can per day.
“These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern,” lead author Lihe Liu, a graduate student in the Department of Gastroenterology at The First Affiliated Hospital of Soochow University in Suzhou, China, said in a news release.
She presented her research at the United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.
Stick With Water
MASLD affects 38% of the global population and has become a leading cause of cirrhosis, liver cancer, and liver-related death. Lifestyle modification remains “a cornerstone” of MASLD management. Current guidelines advise against SSBs, but the evidence regarding LNSSBs remains “limited,” Liu explained in her presentation.
To investigate, the researchers analyzed data of 123,788 UK Biobank participants without liver disease at baseline who were followed for an average of 10.3 years. Beverage consumption was assessed through repeated 24-hour dietary questionnaires using the question: “How many glasses, cans, or cartons containing 250 mL (roughly 250 g) of SSBs or LNSSBs did you drink yesterday?”
Intake was averaged across at least two recalls, and participants were grouped into three intake categories: none, more than 0 to one serving per day, or more than one serving per day.
The primary outcome was incident MASLD, and secondary outcomes included liver-related mortality and liver fat content measured using MRI-derived proton density fat fraction.
In the fully adjusted multivariable Cox model, compared with no consumption, consuming more than one serving of LNSSBs daily was associated with a 60% higher risk for MASLD (hazard ratio [HR], 1.599). The level of consumption of SSBs was associated with a 50% higher risk (HR, 1.469).
Consuming more than one serving of LNSSBs daily was also associated with a higher risk for severe liver outcomes (HR, 1.555), while SSBs showed no significant association after adjustment.
Neither SSBs nor LNSSBs showed significant associations with all-cause mortality in fully adjusted models.
Substituting either beverage with water reduced the risk for MASLD by 12.8% for SSBs and 15.2% for LNSSBs, Liu reported.
Both beverage types were positively associated with higher liver fat content. Consumption of more than one serving of SSBs and LNSSBs daily was associated with about 5% and 7% higher liver fat levels, respectively, than nonconsumption.
“The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain, and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings, and even stimulating insulin secretion,” Liu said.
“The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body,” she concluded.
More Study Needed
Reached for comment, Sujit V. Janardhan, MD, PhD, director of the steatotic liver disease program, Rush University Medical Center, Chicago, said the findings “certainly should cause one to take pause from the popular notion that diet or non-sugar-sweetened beverages are healthier than their sugar-sweetened alternatives.”
He cautioned, however, that it would be “important to confirm confounders are adequately addressed in this large population-based study.”
“We must better understand what other exposure and characteristics were present in patients who had increased intake of non-sugar-sweetened beverages,” Janardhan told GI & Hepatology News.
“For example, it’s possible people who drank more non-sugar-sweetened beverages had more cardiovascular or metabolic risk factors (which prompted them to switch to the ‘diet’ alternative) and that it is these comorbidities that drove an association with increased MASLD incidence and liver-related mortality,” Janardhan noted.
“If there is one finding that seems easy to take away from this study, it’s that people who drank more water in place of sweetened beverages had reduced risk of MASLD,” he told GI & Hepatology News.
Therefore, while awaiting results of mechanistic studies and careful confounder analysis, “plain old boring water is your best bet,” Janardhan said.
The study had no specific funding. Liu and Janardhan had no relevant disclosures.
A version of this article appeared on Medscape.com.
BERLIN — Diet drinks may not be “healthier” than sugary drinks when it comes to liver health.
In fact, low- or artificially sweetened beverages were actually linked to a higher risk for MASLD than sugar-laden drinks, even at modest intake levels such as a single can per day.
“These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern,” lead author Lihe Liu, a graduate student in the Department of Gastroenterology at The First Affiliated Hospital of Soochow University in Suzhou, China, said in a news release.
She presented her research at the United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.
Stick With Water
MASLD affects 38% of the global population and has become a leading cause of cirrhosis, liver cancer, and liver-related death. Lifestyle modification remains “a cornerstone” of MASLD management. Current guidelines advise against SSBs, but the evidence regarding LNSSBs remains “limited,” Liu explained in her presentation.
To investigate, the researchers analyzed data of 123,788 UK Biobank participants without liver disease at baseline who were followed for an average of 10.3 years. Beverage consumption was assessed through repeated 24-hour dietary questionnaires using the question: “How many glasses, cans, or cartons containing 250 mL (roughly 250 g) of SSBs or LNSSBs did you drink yesterday?”
Intake was averaged across at least two recalls, and participants were grouped into three intake categories: none, more than 0 to one serving per day, or more than one serving per day.
The primary outcome was incident MASLD, and secondary outcomes included liver-related mortality and liver fat content measured using MRI-derived proton density fat fraction.
In the fully adjusted multivariable Cox model, compared with no consumption, consuming more than one serving of LNSSBs daily was associated with a 60% higher risk for MASLD (hazard ratio [HR], 1.599). The level of consumption of SSBs was associated with a 50% higher risk (HR, 1.469).
Consuming more than one serving of LNSSBs daily was also associated with a higher risk for severe liver outcomes (HR, 1.555), while SSBs showed no significant association after adjustment.
Neither SSBs nor LNSSBs showed significant associations with all-cause mortality in fully adjusted models.
Substituting either beverage with water reduced the risk for MASLD by 12.8% for SSBs and 15.2% for LNSSBs, Liu reported.
Both beverage types were positively associated with higher liver fat content. Consumption of more than one serving of SSBs and LNSSBs daily was associated with about 5% and 7% higher liver fat levels, respectively, than nonconsumption.
“The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain, and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings, and even stimulating insulin secretion,” Liu said.
“The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body,” she concluded.
More Study Needed
Reached for comment, Sujit V. Janardhan, MD, PhD, director of the steatotic liver disease program, Rush University Medical Center, Chicago, said the findings “certainly should cause one to take pause from the popular notion that diet or non-sugar-sweetened beverages are healthier than their sugar-sweetened alternatives.”
He cautioned, however, that it would be “important to confirm confounders are adequately addressed in this large population-based study.”
“We must better understand what other exposure and characteristics were present in patients who had increased intake of non-sugar-sweetened beverages,” Janardhan told GI & Hepatology News.
“For example, it’s possible people who drank more non-sugar-sweetened beverages had more cardiovascular or metabolic risk factors (which prompted them to switch to the ‘diet’ alternative) and that it is these comorbidities that drove an association with increased MASLD incidence and liver-related mortality,” Janardhan noted.
“If there is one finding that seems easy to take away from this study, it’s that people who drank more water in place of sweetened beverages had reduced risk of MASLD,” he told GI & Hepatology News.
Therefore, while awaiting results of mechanistic studies and careful confounder analysis, “plain old boring water is your best bet,” Janardhan said.
The study had no specific funding. Liu and Janardhan had no relevant disclosures.
A version of this article appeared on Medscape.com.
FDA OKs Simponi for Pediatric Ulcerative Colitis
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval.
The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC.
In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.
The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab.
Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.
Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said.
The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.
Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.
This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC.
Full prescribing information and medication guide is available online.
A version of this article first appeared on Medscape.com.
Withdrawing Anti-TNF in IBD Remission: New Data
In the Spanish EXIT study, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic, and radiological remission had no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who stopped treatment.
The discontinuation of anti-TNF treatment “could be considered as an option” for a selected group of patients, said the authors led by Javier Gisbert, MD, PhD, with Autonomous University of Madrid.
However, the higher proportion of patients with elevated fecal calprotectin and significant endoscopic lesions at the end of follow-up “calls for caution and should be considered when discontinuing treatment in patients,” Gisbert and colleagues concluded.
The EXIT study results were published in the journal Gut (2025 Feb. doi: 10.1136/gutjnl-2024-333385).
Risky Business?
Anti-TNF drugs have reshaped IBD treatment but bring infection risks and costs, prompting interest in planned withdrawal after stable remission.
Yet prior evidence has been mixed. A meta-analysis of 27 studies suggested higher relapse after stopping anti-TNF therapy. However, the results were heterogeneous and most of the studies were retrospective, with a low number of patients and without a control group to compare with.
Clinical trials that have assessed the risk for relapse after discontinuation of anti-TNF therapy generally favored maintenance but had notable limitations.
The EXIT trial was conducted at 33 IBD units across Spain. A total of 140 patients in steroid-free clinical remission for ≥ 6 months on standard-dose infliximab or adalimumab were randomized (1:1) to either continue anti-TNF or switch to placebo matched to the drug they had been taking. All patients continued on immunomodulator therapy.
At 1 year, the proportion of patients with sustained clinical remission (primary outcome) was similar between patients who continued anti-TNF therapy and peers who stopped the medication (76% and 84%, respectively).
However, the proportion of patients with significant endoscopic lesions at the end of follow-up was higher in those who withdrew anti-TNF therapy (19% vs 8.5%; P = .01). Elevated fecal calprotectin (> 250 µg/g) was more common after withdrawal (33% vs 13%; P = .01).
Fecal calprotectin > 250 µg/g at baseline predicted lower odds of sustained remission and higher risk for losing remission — and was the only factor associated with lower likelihood of sustained remission.
Common Clinical Question
“When a patient starts an advanced biologic therapy, they often ask — will I be able to stop it?” Jean-Frederic Colombel, MD, director of the Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, New York City, who wasn’t involved in the study, told GI & Hepatology News.
Generally speaking, Colombel said he tells patients, “If the drug is working well and you are in deep remission, they should try to avoid stopping because there is a risk of relapse. And with relapse, we never know if the drug will work again and maybe we’ll have to switch to another medication.”
“It’s an individualized discussion and decision and patients who do opt to stop [anti-TNF therapy] need to be monitored closely,” Colombel said.
Colombel cautioned that the study had a relatively short 1-year follow-up and those that stopped anti-TNF therapy had evidence of recurrent inflammation.
“Even though it didn’t translate yet to clinical relapse, there were more patients with subclinical active disease in the group that stopped as compared to the group that continued,” Colombel said.
He also noted that in the SPARE trial of patients with Crohn’s disease in clinical remission, patients who stopped infliximab had a higher risk for relapse compared with patients who stopped azathioprine and those who continued the combination therapy.
The EXIT study was supported by grants from Instituto de Salud Carlos III, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and AbbVie. Gisbert reported serving as speaker, consultant, and advisory member for or receiving research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma. Colombel had no relevant disclosures.
A version of this article appeared on Medscape.com.
In the Spanish EXIT study, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic, and radiological remission had no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who stopped treatment.
The discontinuation of anti-TNF treatment “could be considered as an option” for a selected group of patients, said the authors led by Javier Gisbert, MD, PhD, with Autonomous University of Madrid.
However, the higher proportion of patients with elevated fecal calprotectin and significant endoscopic lesions at the end of follow-up “calls for caution and should be considered when discontinuing treatment in patients,” Gisbert and colleagues concluded.
The EXIT study results were published in the journal Gut (2025 Feb. doi: 10.1136/gutjnl-2024-333385).
Risky Business?
Anti-TNF drugs have reshaped IBD treatment but bring infection risks and costs, prompting interest in planned withdrawal after stable remission.
Yet prior evidence has been mixed. A meta-analysis of 27 studies suggested higher relapse after stopping anti-TNF therapy. However, the results were heterogeneous and most of the studies were retrospective, with a low number of patients and without a control group to compare with.
Clinical trials that have assessed the risk for relapse after discontinuation of anti-TNF therapy generally favored maintenance but had notable limitations.
The EXIT trial was conducted at 33 IBD units across Spain. A total of 140 patients in steroid-free clinical remission for ≥ 6 months on standard-dose infliximab or adalimumab were randomized (1:1) to either continue anti-TNF or switch to placebo matched to the drug they had been taking. All patients continued on immunomodulator therapy.
At 1 year, the proportion of patients with sustained clinical remission (primary outcome) was similar between patients who continued anti-TNF therapy and peers who stopped the medication (76% and 84%, respectively).
However, the proportion of patients with significant endoscopic lesions at the end of follow-up was higher in those who withdrew anti-TNF therapy (19% vs 8.5%; P = .01). Elevated fecal calprotectin (> 250 µg/g) was more common after withdrawal (33% vs 13%; P = .01).
Fecal calprotectin > 250 µg/g at baseline predicted lower odds of sustained remission and higher risk for losing remission — and was the only factor associated with lower likelihood of sustained remission.
Common Clinical Question
“When a patient starts an advanced biologic therapy, they often ask — will I be able to stop it?” Jean-Frederic Colombel, MD, director of the Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, New York City, who wasn’t involved in the study, told GI & Hepatology News.
Generally speaking, Colombel said he tells patients, “If the drug is working well and you are in deep remission, they should try to avoid stopping because there is a risk of relapse. And with relapse, we never know if the drug will work again and maybe we’ll have to switch to another medication.”
“It’s an individualized discussion and decision and patients who do opt to stop [anti-TNF therapy] need to be monitored closely,” Colombel said.
Colombel cautioned that the study had a relatively short 1-year follow-up and those that stopped anti-TNF therapy had evidence of recurrent inflammation.
“Even though it didn’t translate yet to clinical relapse, there were more patients with subclinical active disease in the group that stopped as compared to the group that continued,” Colombel said.
He also noted that in the SPARE trial of patients with Crohn’s disease in clinical remission, patients who stopped infliximab had a higher risk for relapse compared with patients who stopped azathioprine and those who continued the combination therapy.
The EXIT study was supported by grants from Instituto de Salud Carlos III, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and AbbVie. Gisbert reported serving as speaker, consultant, and advisory member for or receiving research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma. Colombel had no relevant disclosures.
A version of this article appeared on Medscape.com.
In the Spanish EXIT study, anti-TNF withdrawal in selected patients with IBD in clinical, endoscopic, and radiological remission had no impact on sustained clinical remission at 1 year, although objective markers of activity were higher in patients who stopped treatment.
The discontinuation of anti-TNF treatment “could be considered as an option” for a selected group of patients, said the authors led by Javier Gisbert, MD, PhD, with Autonomous University of Madrid.
However, the higher proportion of patients with elevated fecal calprotectin and significant endoscopic lesions at the end of follow-up “calls for caution and should be considered when discontinuing treatment in patients,” Gisbert and colleagues concluded.
The EXIT study results were published in the journal Gut (2025 Feb. doi: 10.1136/gutjnl-2024-333385).
Risky Business?
Anti-TNF drugs have reshaped IBD treatment but bring infection risks and costs, prompting interest in planned withdrawal after stable remission.
Yet prior evidence has been mixed. A meta-analysis of 27 studies suggested higher relapse after stopping anti-TNF therapy. However, the results were heterogeneous and most of the studies were retrospective, with a low number of patients and without a control group to compare with.
Clinical trials that have assessed the risk for relapse after discontinuation of anti-TNF therapy generally favored maintenance but had notable limitations.
The EXIT trial was conducted at 33 IBD units across Spain. A total of 140 patients in steroid-free clinical remission for ≥ 6 months on standard-dose infliximab or adalimumab were randomized (1:1) to either continue anti-TNF or switch to placebo matched to the drug they had been taking. All patients continued on immunomodulator therapy.
At 1 year, the proportion of patients with sustained clinical remission (primary outcome) was similar between patients who continued anti-TNF therapy and peers who stopped the medication (76% and 84%, respectively).
However, the proportion of patients with significant endoscopic lesions at the end of follow-up was higher in those who withdrew anti-TNF therapy (19% vs 8.5%; P = .01). Elevated fecal calprotectin (> 250 µg/g) was more common after withdrawal (33% vs 13%; P = .01).
Fecal calprotectin > 250 µg/g at baseline predicted lower odds of sustained remission and higher risk for losing remission — and was the only factor associated with lower likelihood of sustained remission.
Common Clinical Question
“When a patient starts an advanced biologic therapy, they often ask — will I be able to stop it?” Jean-Frederic Colombel, MD, director of the Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai, New York City, who wasn’t involved in the study, told GI & Hepatology News.
Generally speaking, Colombel said he tells patients, “If the drug is working well and you are in deep remission, they should try to avoid stopping because there is a risk of relapse. And with relapse, we never know if the drug will work again and maybe we’ll have to switch to another medication.”
“It’s an individualized discussion and decision and patients who do opt to stop [anti-TNF therapy] need to be monitored closely,” Colombel said.
Colombel cautioned that the study had a relatively short 1-year follow-up and those that stopped anti-TNF therapy had evidence of recurrent inflammation.
“Even though it didn’t translate yet to clinical relapse, there were more patients with subclinical active disease in the group that stopped as compared to the group that continued,” Colombel said.
He also noted that in the SPARE trial of patients with Crohn’s disease in clinical remission, patients who stopped infliximab had a higher risk for relapse compared with patients who stopped azathioprine and those who continued the combination therapy.
The EXIT study was supported by grants from Instituto de Salud Carlos III, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and AbbVie. Gisbert reported serving as speaker, consultant, and advisory member for or receiving research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma. Colombel had no relevant disclosures.
A version of this article appeared on Medscape.com.
How Chronic Stress Disrupts the Gut Microbiome
Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.
Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.
Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.
“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.
What Does the Science Tell Us?
Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.
A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.
Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.
A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.
In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.
Stress during specific life stages also appears to alter the gut microbiome.
For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.
Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.
Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).
A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.
Mechanisms Behind the Link
Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.
“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.
Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.
“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.
Implications for Patient Care
The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.
In the meantime, what can clinicians tell patients?
Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.
“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.
A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.
“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.
“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.
Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.
“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.
Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”
Shaukat disclosed having no relevant disclosures.
A version of this article appeared on Medscape.com.
Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.
Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.
Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.
“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.
What Does the Science Tell Us?
Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.
A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.
Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.
A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.
In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.
Stress during specific life stages also appears to alter the gut microbiome.
For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.
Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.
Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).
A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.
Mechanisms Behind the Link
Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.
“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.
Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.
“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.
Implications for Patient Care
The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.
In the meantime, what can clinicians tell patients?
Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.
“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.
A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.
“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.
“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.
Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.
“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.
Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”
Shaukat disclosed having no relevant disclosures.
A version of this article appeared on Medscape.com.
Chronic psychological stress is common. A 2023 survey revealed that about one quarter of US adults reported high stress levels, and three quarters reported that chronic stress affects their daily lives.
Emerging evidence suggests that chronic stress not only exacts a high toll on mental health but also can wreak havoc on all levels of gastrointestinal (GI) functioning, all the way down to the microbiome.
Aasma Shaukat, MD, MPH, AGAF, gastroenterologist with NYU Langone Health and director of GI Outcomes Research, Gastroenterology at NYU Grossman School of Medicine in New York City, said in an interview with GI & Hepatology News.
“This basically means that the normal balance of microorganisms that essentially we think are beneficial gets reduced, and the colonies considered to be more harmful proliferate,” she explained.
What Does the Science Tell Us?
Numerous studies published in the past 5 years have linked chronic stress to modest but reproducible shifts in the composition of the microbiome.
A study of frontline healthcare workers during COVID-19 revealed that the pandemic was associated with significant depression, anxiety, and stress, as well as gut dysbiosis that persisted for at least half a year.
Notably, healthcare workers had low gut alpha diversity, indicating a less resilient and diverse microbiome, a state often associated with dysbiosis and increased risk for various diseases and negative health outcomes.
A two-cohort study of healthy adults found higher alpha diversity in those reporting low stress levels. It also found a link between stress and enriched levels of Escherichia/Shigella, an overgrowth of which has been linked to various conditions, including inflammatory bowel disease.
In addition, a 2023 systematic review of human studies concluded that stress is associated with changes in specific genera — namely reductions in gut-healthy Lachnospira/Lachnospiraceae and Phascolarctobacterium, which produce beneficial short-chain fatty acids that support the health of the intestinal lining and modulate the immune system.
Stress during specific life stages also appears to alter the gut microbiome.
For example, in a study of postpartum women, those at an increased risk for parenting stress showed lower alpha diversity on the Shannon diversity index.
Research involving mother-child pairs tied adversity — such as maltreatment of the mother during her childhood, prenatal anxiety, and hardship in the child’s early life — to distinct microbiome profiles in 2-year-olds, supporting a stress-microbiome pathway relevant to socioemotional outcomes, the authors said.
Emerging evidence indicates a link between the gut microbiome and posttraumatic stress disorder (PTSD).
A recent systematic review found differences in gut microbial taxa between individuals with PTSD and trauma-exposed controls without PTSD. A separate analysis pointed to a potential causal impact of gut microbiomes on the development of PTSD.
Mechanisms Behind the Link
Stress interferes with the brain’s production of neurotransmitters, such as serotonin, which controls anxiety, mood, sleep, and many other functions in the brain, Shaukat told GI & Hepatology News.
“But serotonin also crosses the blood-brain barrier, and actually, the gut has more serotonin receptors than the brain, so an imbalance of serotonin can actually affect the gut microbiome through signaling at the neurotransmitter level,” Shaukat explained.
Stress can also affect sleep, and sleep itself has regulatory properties for gut bacteria, Shaukat noted.
“Stress also lowers our immunity, and this can make the gut barrier susceptible or permeable to bacterial toxins that can pass through and breach the gut barrier and be released into the bloodstream, which can trigger inflammation,” Shaukat explained.
Implications for Patient Care
The gut-brain-microbiome axis remains an emerging field of study. “We’re learning more and more about this, and we need to because the microbial colonies are so diverse and we haven’t nailed it down yet,” Shaukat said.
In the meantime, what can clinicians tell patients?
Aside from managing stress, which “is easier said than done,” patients can improve their diet, Shaukat said.
“What we tell patients is to essentially increase their intake of gut-friendly foods that preferentially grow the bacterial colonies that are beneficial for us,” Shaukat said. This includes fermented foods, yogurt, kimchi, chia seeds, kombucha, pickled vegetables, and whole grains.
A recent randomized controlled trial of healthy adults found a “psychobiotic diet” — a diet high in prebiotic and fermented foods — was associated with less perceived stress and subtle beneficial shifts in microbial composition.
“These foods can help keep the gut in good health and may actually also reduce or mitigate some of the effects of stress,” Shaukat said.
“Eating well is something I think we should all think about and maybe prioritize when we’re going through a stressful situation or looking to kind of mitigate the effects of stress and the anxiety and depression it can cause,” she advised.
Shaukat said she also encourages patients to engage in regular physical activity, which benefits the gut microbiome by helping to regulate gut motility. Exercise can also boost mood and help relieve stress.
“A balanced Mediterranean diet and regular activity is truly the secret for gut health,” Shaukat said.
Patients may be tempted by the probiotic supplements lining drugstore shelves, but there “isn’t great evidence for probiotic supplements,” she said. “What we can get from dietary sources far outweighs what can be put in a pill.”
Shaukat disclosed having no relevant disclosures.
A version of this article appeared on Medscape.com.
FDA OKs Tremfya for Ulcerative Colitis
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor available as both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), the company noted in a news release.
The approval of SC guselkumab induction in UC was based on results from the phase 3 ASTRO trial, which randomly allocated 418 patients with moderately to severely active UC to receive either induction with 400 mg SC guselkumab at weeks 0, 4, and 8 or placebo.
Following induction, the treatment group either received a maintenance dose of 200 mg SC guselkumab at week 12 and then every 4 weeks or 100 mg every 8 weeks (starting at 16 weeks).
All patients had had an inadequate response or intolerance to conventional therapy.
All primary and secondary endpoints demonstrated statistically significant and clinically meaningful improvements with SC guselkumab compared to placebo across all clinical and endoscopic measures, the company said.
At 12 weeks, a significantly greater proportion of patients treated with 400 mg SC guselkumab every 4 weeks achieved clinical remission (26% vs 7% with placebo; P < .001) and endoscopic improvement (36% vs 12%; P < .001).
The results were consistent with the FDA-approved 200 mg IV induction regimen, which previously achieved clinical remission (23% vs 8% with placebo; P < .001) and endoscopic improvement (27% vs 11%; P < .001).
The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease and both routes demonstrated a similar time to onset of efficacy.
SC guselkumab induction followed by SC guselkumab maintenance therapy also demonstrated statistically significant and clinically meaningful improvements in clinical remission and endoscopic improvement compared to placebo.
“Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians,” study investigator David T. Rubin, MD, AGAF, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine, said in the news release.
“UC patients and providers now have the choice of starting Tremfya with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice,” Rubin said.
Full prescribing information and medication guide are available online.
A version of this article appeared on Medscape.com.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor available as both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), the company noted in a news release.
The approval of SC guselkumab induction in UC was based on results from the phase 3 ASTRO trial, which randomly allocated 418 patients with moderately to severely active UC to receive either induction with 400 mg SC guselkumab at weeks 0, 4, and 8 or placebo.
Following induction, the treatment group either received a maintenance dose of 200 mg SC guselkumab at week 12 and then every 4 weeks or 100 mg every 8 weeks (starting at 16 weeks).
All patients had had an inadequate response or intolerance to conventional therapy.
All primary and secondary endpoints demonstrated statistically significant and clinically meaningful improvements with SC guselkumab compared to placebo across all clinical and endoscopic measures, the company said.
At 12 weeks, a significantly greater proportion of patients treated with 400 mg SC guselkumab every 4 weeks achieved clinical remission (26% vs 7% with placebo; P < .001) and endoscopic improvement (36% vs 12%; P < .001).
The results were consistent with the FDA-approved 200 mg IV induction regimen, which previously achieved clinical remission (23% vs 8% with placebo; P < .001) and endoscopic improvement (27% vs 11%; P < .001).
The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease and both routes demonstrated a similar time to onset of efficacy.
SC guselkumab induction followed by SC guselkumab maintenance therapy also demonstrated statistically significant and clinically meaningful improvements in clinical remission and endoscopic improvement compared to placebo.
“Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians,” study investigator David T. Rubin, MD, AGAF, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine, said in the news release.
“UC patients and providers now have the choice of starting Tremfya with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice,” Rubin said.
Full prescribing information and medication guide are available online.
A version of this article appeared on Medscape.com.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor available as both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), the company noted in a news release.
The approval of SC guselkumab induction in UC was based on results from the phase 3 ASTRO trial, which randomly allocated 418 patients with moderately to severely active UC to receive either induction with 400 mg SC guselkumab at weeks 0, 4, and 8 or placebo.
Following induction, the treatment group either received a maintenance dose of 200 mg SC guselkumab at week 12 and then every 4 weeks or 100 mg every 8 weeks (starting at 16 weeks).
All patients had had an inadequate response or intolerance to conventional therapy.
All primary and secondary endpoints demonstrated statistically significant and clinically meaningful improvements with SC guselkumab compared to placebo across all clinical and endoscopic measures, the company said.
At 12 weeks, a significantly greater proportion of patients treated with 400 mg SC guselkumab every 4 weeks achieved clinical remission (26% vs 7% with placebo; P < .001) and endoscopic improvement (36% vs 12%; P < .001).
The results were consistent with the FDA-approved 200 mg IV induction regimen, which previously achieved clinical remission (23% vs 8% with placebo; P < .001) and endoscopic improvement (27% vs 11%; P < .001).
The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease and both routes demonstrated a similar time to onset of efficacy.
SC guselkumab induction followed by SC guselkumab maintenance therapy also demonstrated statistically significant and clinically meaningful improvements in clinical remission and endoscopic improvement compared to placebo.
“Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians,” study investigator David T. Rubin, MD, AGAF, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine, said in the news release.
“UC patients and providers now have the choice of starting Tremfya with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice,” Rubin said.
Full prescribing information and medication guide are available online.
A version of this article appeared on Medscape.com.
Are Probiotics for Pouchitis Prevention Worth the Cost?
, but its cost-effectiveness depends on relapse risk and may only be justified in patients who experience frequent relapses of pouchitis, a new analysis showed.
“Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall value for most patients,” lead author Gaurav Syal, MD, a gastroenterologist at UCLA Health, said in a statement.
“Our analysis can help guide shared decision-making between patients, clinicians, and payers to ensure resources are used where they can provide the most benefit,” Syal added.
The study was published online in Gastro Hep Advances.
Common Complication After Ulcerative Colitis Surgery
Pouchitis is a common complication in patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA, with a cumulative incidence of around 48% at 2 years and 80% at 30 years.
Many patients who experience pouchitis have a single episode and respond well to short antibiotic courses. However, others develop recurrent or relapsing pouchitis, and 17% progress to a chronic form that can become dependent on antibiotics or refractory to antibiotics.
An eight-strain probiotic was shown to be effective in primary and secondary prevention of pouchitis in randomized, placebo-controlled trials.
Syal and colleagues sought to determine whether it’s worth the cost.
They constructed decision-tree models with Markov simulations to compare the risk for initial development and recurrence of pouchitis over a 2-year period between no prophylaxis and daily use of the eight-strain probiotic.
In the primary prophylaxis model, the cycle length was 2 weeks and pouchitis treatment sequence was ciprofloxacin, metronidazole and ciprofloxacin-tinidazole. In the secondary prophylaxis model, the cycle length was 4 weeks and pouchitis treatment sequence was initially the same as the primary prophylaxis model with the addition of vedolizumab and infliximab.
Costs were calculated from a US third-party payer perspective, using a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).
For primary prevention, the probiotic slightly increased QALYs compared with no probiotic (0.927 vs 0.918) but at a far higher cost ($2223 vs $299), resulting in an incremental cost-effectiveness ratio (ICER) of $236,076 per QALY — well above the accepted threshold.
In patients with infrequent relapses, probiotic use was slightly more effective than no use of probiotic (cumulative QALYs, 1.26 vs 1.24) but more expensive ($3370 vs $557), yielding an ICER of $153,011 per QALY — again above the accepted threshold.
However, sensitivity analyses revealed that the probiotic was cost-effective in patients with frequent relapsing pouchitis — defined as two or more episodes per year.
In this subgroup, the ICER dropped below the willingness-to-pay threshold of $100,000 per QALY, and in some scenarios, the probiotic even became the dominant strategy, meaning it was both more effective and less costly than no prophylaxis, the researchers noted.
Current guidelines from AGA on managing pouchitis suggest using probiotics to prevent recurrent episodes of pouchitis with a caveat that those who experience infrequent episodes may choose to avoid secondary prevention strategies.
“Our findings supplement the guidelines by confirming that the eight-strain probiotics can be cost-effective in frequent relapsing not in infrequent relapsing pouchitis,” the authors wrote.
They also noted that the probiotic cost itself was the biggest driver of results, accounting for 95% of the total cost in the primary prevention model. According to their analysis, reducing its price by half could make it a cost-effective option more broadly.
They also noted that probiotic prophylaxis could be cost-effective for patients at higher-than-average risk, such as those with primary sclerosing cholangitis (PSC), who have 4.2 times higher odds of developing pouchitis than peers without PSC.
But they cautioned that “further research is warranted on the effectiveness of the eight-strain probiotic for primary prevention of pouchitis in patients with ulcerative colitis and IPAA and PSC.”
The study had no financial support. Syal reported receiving research support from Pfizer.
A version of this article appeared on Medscape.com.
, but its cost-effectiveness depends on relapse risk and may only be justified in patients who experience frequent relapses of pouchitis, a new analysis showed.
“Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall value for most patients,” lead author Gaurav Syal, MD, a gastroenterologist at UCLA Health, said in a statement.
“Our analysis can help guide shared decision-making between patients, clinicians, and payers to ensure resources are used where they can provide the most benefit,” Syal added.
The study was published online in Gastro Hep Advances.
Common Complication After Ulcerative Colitis Surgery
Pouchitis is a common complication in patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA, with a cumulative incidence of around 48% at 2 years and 80% at 30 years.
Many patients who experience pouchitis have a single episode and respond well to short antibiotic courses. However, others develop recurrent or relapsing pouchitis, and 17% progress to a chronic form that can become dependent on antibiotics or refractory to antibiotics.
An eight-strain probiotic was shown to be effective in primary and secondary prevention of pouchitis in randomized, placebo-controlled trials.
Syal and colleagues sought to determine whether it’s worth the cost.
They constructed decision-tree models with Markov simulations to compare the risk for initial development and recurrence of pouchitis over a 2-year period between no prophylaxis and daily use of the eight-strain probiotic.
In the primary prophylaxis model, the cycle length was 2 weeks and pouchitis treatment sequence was ciprofloxacin, metronidazole and ciprofloxacin-tinidazole. In the secondary prophylaxis model, the cycle length was 4 weeks and pouchitis treatment sequence was initially the same as the primary prophylaxis model with the addition of vedolizumab and infliximab.
Costs were calculated from a US third-party payer perspective, using a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).
For primary prevention, the probiotic slightly increased QALYs compared with no probiotic (0.927 vs 0.918) but at a far higher cost ($2223 vs $299), resulting in an incremental cost-effectiveness ratio (ICER) of $236,076 per QALY — well above the accepted threshold.
In patients with infrequent relapses, probiotic use was slightly more effective than no use of probiotic (cumulative QALYs, 1.26 vs 1.24) but more expensive ($3370 vs $557), yielding an ICER of $153,011 per QALY — again above the accepted threshold.
However, sensitivity analyses revealed that the probiotic was cost-effective in patients with frequent relapsing pouchitis — defined as two or more episodes per year.
In this subgroup, the ICER dropped below the willingness-to-pay threshold of $100,000 per QALY, and in some scenarios, the probiotic even became the dominant strategy, meaning it was both more effective and less costly than no prophylaxis, the researchers noted.
Current guidelines from AGA on managing pouchitis suggest using probiotics to prevent recurrent episodes of pouchitis with a caveat that those who experience infrequent episodes may choose to avoid secondary prevention strategies.
“Our findings supplement the guidelines by confirming that the eight-strain probiotics can be cost-effective in frequent relapsing not in infrequent relapsing pouchitis,” the authors wrote.
They also noted that the probiotic cost itself was the biggest driver of results, accounting for 95% of the total cost in the primary prevention model. According to their analysis, reducing its price by half could make it a cost-effective option more broadly.
They also noted that probiotic prophylaxis could be cost-effective for patients at higher-than-average risk, such as those with primary sclerosing cholangitis (PSC), who have 4.2 times higher odds of developing pouchitis than peers without PSC.
But they cautioned that “further research is warranted on the effectiveness of the eight-strain probiotic for primary prevention of pouchitis in patients with ulcerative colitis and IPAA and PSC.”
The study had no financial support. Syal reported receiving research support from Pfizer.
A version of this article appeared on Medscape.com.
, but its cost-effectiveness depends on relapse risk and may only be justified in patients who experience frequent relapses of pouchitis, a new analysis showed.
“Our findings highlight that while probiotic treatments can reduce the risk of this complication, their high costs limit their overall value for most patients,” lead author Gaurav Syal, MD, a gastroenterologist at UCLA Health, said in a statement.
“Our analysis can help guide shared decision-making between patients, clinicians, and payers to ensure resources are used where they can provide the most benefit,” Syal added.
The study was published online in Gastro Hep Advances.
Common Complication After Ulcerative Colitis Surgery
Pouchitis is a common complication in patients with ulcerative colitis who undergo restorative proctocolectomy with IPAA, with a cumulative incidence of around 48% at 2 years and 80% at 30 years.
Many patients who experience pouchitis have a single episode and respond well to short antibiotic courses. However, others develop recurrent or relapsing pouchitis, and 17% progress to a chronic form that can become dependent on antibiotics or refractory to antibiotics.
An eight-strain probiotic was shown to be effective in primary and secondary prevention of pouchitis in randomized, placebo-controlled trials.
Syal and colleagues sought to determine whether it’s worth the cost.
They constructed decision-tree models with Markov simulations to compare the risk for initial development and recurrence of pouchitis over a 2-year period between no prophylaxis and daily use of the eight-strain probiotic.
In the primary prophylaxis model, the cycle length was 2 weeks and pouchitis treatment sequence was ciprofloxacin, metronidazole and ciprofloxacin-tinidazole. In the secondary prophylaxis model, the cycle length was 4 weeks and pouchitis treatment sequence was initially the same as the primary prophylaxis model with the addition of vedolizumab and infliximab.
Costs were calculated from a US third-party payer perspective, using a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).
For primary prevention, the probiotic slightly increased QALYs compared with no probiotic (0.927 vs 0.918) but at a far higher cost ($2223 vs $299), resulting in an incremental cost-effectiveness ratio (ICER) of $236,076 per QALY — well above the accepted threshold.
In patients with infrequent relapses, probiotic use was slightly more effective than no use of probiotic (cumulative QALYs, 1.26 vs 1.24) but more expensive ($3370 vs $557), yielding an ICER of $153,011 per QALY — again above the accepted threshold.
However, sensitivity analyses revealed that the probiotic was cost-effective in patients with frequent relapsing pouchitis — defined as two or more episodes per year.
In this subgroup, the ICER dropped below the willingness-to-pay threshold of $100,000 per QALY, and in some scenarios, the probiotic even became the dominant strategy, meaning it was both more effective and less costly than no prophylaxis, the researchers noted.
Current guidelines from AGA on managing pouchitis suggest using probiotics to prevent recurrent episodes of pouchitis with a caveat that those who experience infrequent episodes may choose to avoid secondary prevention strategies.
“Our findings supplement the guidelines by confirming that the eight-strain probiotics can be cost-effective in frequent relapsing not in infrequent relapsing pouchitis,” the authors wrote.
They also noted that the probiotic cost itself was the biggest driver of results, accounting for 95% of the total cost in the primary prevention model. According to their analysis, reducing its price by half could make it a cost-effective option more broadly.
They also noted that probiotic prophylaxis could be cost-effective for patients at higher-than-average risk, such as those with primary sclerosing cholangitis (PSC), who have 4.2 times higher odds of developing pouchitis than peers without PSC.
But they cautioned that “further research is warranted on the effectiveness of the eight-strain probiotic for primary prevention of pouchitis in patients with ulcerative colitis and IPAA and PSC.”
The study had no financial support. Syal reported receiving research support from Pfizer.
A version of this article appeared on Medscape.com.
FROM GASTRO HEP ADVANCES
Ocaliva for Primary Biliary Cholangitis Withdrawn From US Market
The decision follows a request from the FDA. The FDA has also placed a clinical hold on all of Intercept’s clinical trials involving obeticholic acid.
PBC is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women older than 40 years of age. PBC causes a buildup of bile acid in the liver, resulting in inflammation and fibrosis, which — if not treated — can lead to cirrhosis, a liver transplant, or death.
Ocaliva, a farnesoid X receptor agonist, received accelerated FDA approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid.
Yet, in September 2024, staff reviewers at the FDA said a confirmatory trial did not show that the drug was effective for PBC.
Ocaliva has also been linked to an increased risk of serious liver injury in patients with PBC with and without cirrhosis.
The company has advised patients currently taking Ocaliva for PBC to consult their healthcare provider before making any changes.
Intercept will provide additional information to support healthcare professionals and patients as it works with the FDA on the transition process.
Healthcare professionals who have questions about this development can contact Intercept Medical Information at [email protected] or call 1-844-782-4278.
A version of this article appeared on Medscape.com.
The decision follows a request from the FDA. The FDA has also placed a clinical hold on all of Intercept’s clinical trials involving obeticholic acid.
PBC is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women older than 40 years of age. PBC causes a buildup of bile acid in the liver, resulting in inflammation and fibrosis, which — if not treated — can lead to cirrhosis, a liver transplant, or death.
Ocaliva, a farnesoid X receptor agonist, received accelerated FDA approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid.
Yet, in September 2024, staff reviewers at the FDA said a confirmatory trial did not show that the drug was effective for PBC.
Ocaliva has also been linked to an increased risk of serious liver injury in patients with PBC with and without cirrhosis.
The company has advised patients currently taking Ocaliva for PBC to consult their healthcare provider before making any changes.
Intercept will provide additional information to support healthcare professionals and patients as it works with the FDA on the transition process.
Healthcare professionals who have questions about this development can contact Intercept Medical Information at [email protected] or call 1-844-782-4278.
A version of this article appeared on Medscape.com.
The decision follows a request from the FDA. The FDA has also placed a clinical hold on all of Intercept’s clinical trials involving obeticholic acid.
PBC is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women older than 40 years of age. PBC causes a buildup of bile acid in the liver, resulting in inflammation and fibrosis, which — if not treated — can lead to cirrhosis, a liver transplant, or death.
Ocaliva, a farnesoid X receptor agonist, received accelerated FDA approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid.
Yet, in September 2024, staff reviewers at the FDA said a confirmatory trial did not show that the drug was effective for PBC.
Ocaliva has also been linked to an increased risk of serious liver injury in patients with PBC with and without cirrhosis.
The company has advised patients currently taking Ocaliva for PBC to consult their healthcare provider before making any changes.
Intercept will provide additional information to support healthcare professionals and patients as it works with the FDA on the transition process.
Healthcare professionals who have questions about this development can contact Intercept Medical Information at [email protected] or call 1-844-782-4278.
A version of this article appeared on Medscape.com.