News

Fecal microbiota transplantation (FMT), shown to be effective in the treatment of recurrent Clostridioides difficile infection (CDI), also shows significant benefit in the treatment of primary CDI, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.

“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.

FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.

In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.

FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.

With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.

For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.

The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.

With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.

The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).

The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.

The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.

In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.

Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.

Importantly, there were also no significant differences in adverse events between the groups.

“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.

 

FMT Faces Challenges in the US

FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.

While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.

The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.

And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.

“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.

 

Acceptance Higher in Europe

In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.

“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.

Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”

 

Quality of Life

Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.

“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”

She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”

“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.

In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.

“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.

Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”

This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.

 

A version of this article appeared on Medscape.com.

Fecal microbiota transplantation (FMT), shown to be effective in the treatment of recurrent Clostridioides difficile infection (CDI), also shows significant benefit in the treatment of primary CDI, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.

“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.

FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.

In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.

FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.

With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.

For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.

The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.

With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.

The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).

The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.

The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.

In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.

Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.

Importantly, there were also no significant differences in adverse events between the groups.

“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.

 

FMT Faces Challenges in the US

FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.

While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.

The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.

And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.

“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.

 

Acceptance Higher in Europe

In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.

“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.

Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”

 

Quality of Life

Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.

“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”

She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”

“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.

In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.

“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.

Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”

This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.

 

A version of this article appeared on Medscape.com.

Fecal microbiota transplantation (FMT), shown to be effective in the treatment of recurrent Clostridioides difficile infection (CDI), also shows significant benefit in the treatment of primary CDI, with efficacy that is comparable to the standard treatment of vancomycin, and in some measures, showing even stronger efficacy, new research showed.

“FMT, prepared and administered according to international guidelines, is an effective and safe treatment option for C difficile infections, which should be considered for all patients with the infection,” first author Frederik Emil Juul, MD, PhD, of the Clinical Effectiveness Research Group, University of Oslo, in Oslo, Norway, told GI & Hepatology News.

FMT even showed a numerical superiority to vancomycin, which, though not statistically significant, “indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors further asserted in the study, published recently in the Annals of Internal Medicine.

In the treatment of antibiotic-associated colitis due to CDI, vancomycin or fidaxomicin are the standard therapies, yet up to 20% of patients experience one or more symptom recurrences following successful initial antibiotic treatment, prompting the need for continued antibiotic regimens, resulting in increased costs and potential adverse events, while contributing to antibiotic resistance.

FMT, designed to restore a normal functional colonic microenvironment with the transfer of a healthy person’s stool, though still somewhat controversial, has gained acceptance and favor in recent years in the treatment of recurrent CDI, however, research has been lacking on its efficacy in the treatment of primary CDI.

With a previous proof-of-concept trial and observational study showing promising results in primary CDI, Juul and colleagues conducted the current randomized, open-label noninferiority trial.

For the multi-center study, 100 adult patients with CDI, defined as C diff toxin in stool and at least three loose stools daily, and no previous CDI within 1 year prior to enrollment, were randomized at 20 hospitals in Norway to receive either FMT, administered as an enema, without antibiotic pretreatment, or oral vancomycin at a dose of 125 mg, four times daily for 10 days.

The patients had a median age of about 70 years; more than 40% of patients had a Charlson Comorbidity Index score of ≥ 4, indicating severe comorbidity, and a third had severe CDI.

With the trial showing favorable results, a data and safety monitoring board recommended stopping the trial for efficacy and noninferiority after about half of the planned enrollment was reached.

The primary endpoint of a clinical cure, defined as firm stools or less than three bowel movements daily and no disease recurrence within 60 days without additional treatment, was observed in 34 of 51 patients who received FMT (66.7%) compared with 30 of 49 of those receiving vancomycin (61.2%; difference, 5.4 percentage points; P for noninferiority < .001).

The results contradict the theory that response to FMT is 25 percentage points lower than response to vancomycin, the authors noted.

The proportion of patients with clinical cure at day 14 was 70.6% in the FMT group and 77.6% in the vancomycin group, and among those patients, two (5.6%) in the FMT group had disease recurrence compared with eight (21.1%) in the vancomycin group between days 15 and 60.

In the FMT group, 11 patients received additional treatment compared with four in the vancomycin group, predominantly oral vancomycin in both groups.

Despite the high rates of severe comorbidity among the patients at baseline, a subgroup analyses showed no significant differences in treatment effects based on factors including sex, age group, Charlson Comorbidity Index score, or CDI severity.

Importantly, there were also no significant differences in adverse events between the groups.

“Our results indicate that it is reasonable to treat patients with primary CDI with FMT and provide antibiotics only to patients with ongoing symptoms or recurrence after FMT,” the authors concluded.

 

FMT Faces Challenges in the US

FMT specifically consists of direct instillation of fecal matter to the upper gastrointestinal tract, via capsules or duodenal infusion, or the lower gastrointestinal tract via colonoscopy or enema.

While an AGA guideline issued in 2024 endorsed FMT for the prevention of recurrent, refractory, or fulminant CDI in select adults not responding to standard antibiotics, the association underscored important caveats, including a low quality of evidence, and concluded that FMT could not yet be recommended for other gastrointestinal conditions.

The treatment meanwhile has faced an uphill battle in the US. The provision of screened FMT inocula through the nonprofit OpenBiome, previously the country’s largest stool bank, was recently suspended amid FDA policy changes.

And while other commercial-grade biotherapeutic products Rebyota and Vowst, have received FDA approval, cost and insurance coverage can be significant barriers, said Elizabeth Hohmann, MD, of the Infectious Disease Division at Massachusetts General Hospital, Boston, in an editorial published with the study.

“Currently approved options are expensive and are not available to many who might benefit for various reasons, primarily cost,” she said.

 

Acceptance Higher in Europe

In Europe, and particularly Norway, acceptance of FMT for CDI and other indications has been more favorable, and while regulation of the treatment has varied among European countries, a new regulation to be implemented by the European Union in 2027 will improve standardization of the production, handling, storage, and other factors of FMT, Juul told GI & Hepatology News.

“I believe the new regulations will make the treatment more available to patients, and a standardization of the FMT production will make future trials more comparable and useful across countries,” he said.

Juul said he further expects that “our results will lower the threshold for choosing FMT as treatment in primary infections. I know that Denmark also gives FMT to patients with primary CDI.”

 

Quality of Life

Hohmann, who has treated many patients with recurrent CDI with FMT, noted that a key factor that should be underscored is how much better patients can feel after the treatment.

“Although there are no quality of life surveys in [the current study], had they been done, I suspect quality of life might have been higher in the FMT group; in my experience, people feel better after microbiome restoration.”

She added that her patients “report feeling much better, and that’s why I keep doing it,” she said. “I’ve had an 80-year-old patient tell me he’s going back to snow shoveling; another saying she can return to yoga classes.”

“When you have had bad gut microbiome dysbiosis that becomes normal, you feel a lot better,” Hohmann said.

In the treatment of primary CDI, however, Hohmann said the prospects, at least in the US, are likely slim.

“I do not believe that we in the United States will see FMT as a primary treatment of C difficile infection anytime soon,” she wrote in the editorial.

Nevertheless, Hohmann asserted that “FMT should remain available, with appropriate sources of carefully screened inocula for care and for further research into the many illnesses and therapies that are influenced by the health of the gut microbiome.”

This study received funding from the South-East Norway Health Trust. Hohmann had no disclosures to report.

 

A version of this article appeared on Medscape.com.

Whether it’s safe to stop anti-TNF treatment in patients with inflammatory bowel disease (IBD) in remission remains unclear.

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.

Whether it’s safe to stop anti-TNF treatment in patients with inflammatory bowel disease (IBD) in remission remains unclear.

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.

Whether it’s safe to stop anti-TNF treatment in patients with inflammatory bowel disease (IBD) in remission remains unclear.

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.

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.

“Chronic stress can change the diversity and composition of the gut microbiome and essentially tips us toward an imbalance or dysbiosis,” 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.

“Chronic stress can change the diversity and composition of the gut microbiome and essentially tips us toward an imbalance or dysbiosis,” 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.

“Chronic stress can change the diversity and composition of the gut microbiome and essentially tips us toward an imbalance or dysbiosis,” 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.

Posttraumatic stress disorder (PTSD) guidelines increasingly are recommending prolonged exposure therapy (PET) and cognitive processing therapy (CPT) as first-line treatments, including the 2023 US Department of Veterans Affairs (VA) and US Department of Defense clinical practice guideline.

Since 2006, > 6000 VA therapists have been trained in PET and CPT; the VA requires all veterans to have access to these treatments. However, despite strong clinical trial evidence supporting PET and CPT for the treatment of PTSD, a 2023 study found that only 11.6% of veterans who received a PTSD diagnosis between 2017 and 2019 initiated Trauma-Focused Evidence-Based Psychotherapy (TF-EBP) in their first year of treatment. Of those who initiated TF-EBP, 67% dropped out. Recent VA programs have attempted to expand the reach of PET with video telehealth to reach rural and remote veterans through virtual group programs.

Recent research has suggested ways to maximize the effectiveness of the programs and assist veterans in receiving the full benefits. Studies have found that swapping traditional longer-term treatments (usually spanning 8 to 15 weeks) for intensified, shorter versions (eg, 6 sessions) may enhance engagement and retention. 

Intensive PET for PTSD is safe and highly effective. A study involving patients with chronic PTSD and complex trauma showed significant reductions in PTSD symptom severity, with large effect sizes and sustained improvements at 3 and 6 months. Multiple 90-minute sessions over consecutive days, supplemented with in vivo exposure or followed by weekly booster sessions, were found to minimize treatment disruptions.

PET is among the most extensively studied treatments for PTSD and is supported by dozens of clinical trials involving thousands of patients. The intervention was originally developed and validated in civilian samples and includes psychoeducation, relaxation through breathing retraining, and in vivo and imaginal exposure to traumatic memories.

A recent study compared treatment outcomes among military veterans and civilian patients receiving treatment in a community setting. Although some studies have compared PET outcomes for military veterans and civilian participants in community settings, none have directly compared outcomes across trauma type (combat, terror, or civilian trauma) and veteran status (military vs civilian) within the same framework. The study notes that combat-related trauma significantly differs from other forms of trauma exposure, as it is typically more prolonged and severe and therefore is more often resistant to treatment. Military personnel also often find themselves both victims and aggressors, a duality that can intensify guilt, shame, anger, disgust, and emotional reactions to moral injury, complicating treatment. 

The study assessed the effects of 8 to 15 PET sessions on PTSD symptoms in 55 civilians and 43 veterans using the PTSD Symptom Scale–Interview Version (PSS-I). Participants showed significant symptom reductions across all trauma types and veteran statuses.

Although veterans and participants in the combat trauma subgroup showed higher levels of baseline symptom severity compared with civilians, all groups experienced similar symptom reductions. These findings differ from some meta-analyses, which have found that PET often produces smaller effect sizes in combat-related PTSD compared to civilian trauma samples.

The study compared treatment outcomes across different groups within the same treatment centers and under consistent supervision. The PET intervention was delivered in community mental health centers to all patients regardless of background. Only 2 prior studies have compared civilian and military veterans within the same locations.

Although the “traditional” number of PET sessions produce evidence-based outcomes, high dropout rates and relapses have catalyzed interest in approaches that boost the power of therapy, such as delivering PET in ever-shorter sequences. 

A study in a Swedish psychiatric outpatient clinic compared the effect of an 8-day intensified treatment program with traditionally spaced treatments on 101 participants with PTSD or complex PTSD. The study reported a significant reduction in PTSD symptoms at posttreatment, with large effect sizes in both conditions. Moreover, symptom reduction was maintained at follow-up. Dropout rates were significantly different between treatment groups: 4.3% in the intensified treatment program and 24.1% in the traditional group.

Another study used VA administrative data to assess the impact of sequenced psychotherapy (≥ 8 sessions of not trauma-focused individual or group psychotherapy delivered before trauma-focused care) on initiation and retention in CPT and PET over 2 years. Roughly 13% of 490,097 veterans who entered care for PTSD between 2014 and 2020 initiated VA-disseminated evidence-based treatment within 21 months (9.5% CPT, 3.4% PE). Among those who initiated treatment, retention was 46% and 42%, respectively. Individual therapy was associated with increased CPT and PET retention of 8.0% and 8.2%. For group therapy, retention increases were 3.4% and 8.7%. 

Another recent study examined the RESET (Reconsolidation, Exposure, and Short-term Emotional Transformation) clinical protocol, an intensive, structured trauma-focused intervention designed to treat PTSD within 6 daily sessions. The protocol includes psychoeducation, targeted exposure, dynamic case formulation, and guided trauma processing. This novel framework ensures therapy moves beyond symptom reduction, fostering a deep understanding of the patient’s core struggles and their broader psychological patterns, and integrates it with the reconsolidation of the index trauma narrative to form a more cohesive sense of self.” 

Clinical studies are ongoing to refine and enhance PET and CPT. They may serve to make therapy more useful and effective in easing—maybe erasing—veterans’ traumatic memories.

Posttraumatic stress disorder (PTSD) guidelines increasingly are recommending prolonged exposure therapy (PET) and cognitive processing therapy (CPT) as first-line treatments, including the 2023 US Department of Veterans Affairs (VA) and US Department of Defense clinical practice guideline.

Since 2006, > 6000 VA therapists have been trained in PET and CPT; the VA requires all veterans to have access to these treatments. However, despite strong clinical trial evidence supporting PET and CPT for the treatment of PTSD, a 2023 study found that only 11.6% of veterans who received a PTSD diagnosis between 2017 and 2019 initiated Trauma-Focused Evidence-Based Psychotherapy (TF-EBP) in their first year of treatment. Of those who initiated TF-EBP, 67% dropped out. Recent VA programs have attempted to expand the reach of PET with video telehealth to reach rural and remote veterans through virtual group programs.

Recent research has suggested ways to maximize the effectiveness of the programs and assist veterans in receiving the full benefits. Studies have found that swapping traditional longer-term treatments (usually spanning 8 to 15 weeks) for intensified, shorter versions (eg, 6 sessions) may enhance engagement and retention. 

Intensive PET for PTSD is safe and highly effective. A study involving patients with chronic PTSD and complex trauma showed significant reductions in PTSD symptom severity, with large effect sizes and sustained improvements at 3 and 6 months. Multiple 90-minute sessions over consecutive days, supplemented with in vivo exposure or followed by weekly booster sessions, were found to minimize treatment disruptions.

PET is among the most extensively studied treatments for PTSD and is supported by dozens of clinical trials involving thousands of patients. The intervention was originally developed and validated in civilian samples and includes psychoeducation, relaxation through breathing retraining, and in vivo and imaginal exposure to traumatic memories.

A recent study compared treatment outcomes among military veterans and civilian patients receiving treatment in a community setting. Although some studies have compared PET outcomes for military veterans and civilian participants in community settings, none have directly compared outcomes across trauma type (combat, terror, or civilian trauma) and veteran status (military vs civilian) within the same framework. The study notes that combat-related trauma significantly differs from other forms of trauma exposure, as it is typically more prolonged and severe and therefore is more often resistant to treatment. Military personnel also often find themselves both victims and aggressors, a duality that can intensify guilt, shame, anger, disgust, and emotional reactions to moral injury, complicating treatment. 

The study assessed the effects of 8 to 15 PET sessions on PTSD symptoms in 55 civilians and 43 veterans using the PTSD Symptom Scale–Interview Version (PSS-I). Participants showed significant symptom reductions across all trauma types and veteran statuses.

Although veterans and participants in the combat trauma subgroup showed higher levels of baseline symptom severity compared with civilians, all groups experienced similar symptom reductions. These findings differ from some meta-analyses, which have found that PET often produces smaller effect sizes in combat-related PTSD compared to civilian trauma samples.

The study compared treatment outcomes across different groups within the same treatment centers and under consistent supervision. The PET intervention was delivered in community mental health centers to all patients regardless of background. Only 2 prior studies have compared civilian and military veterans within the same locations.

Although the “traditional” number of PET sessions produce evidence-based outcomes, high dropout rates and relapses have catalyzed interest in approaches that boost the power of therapy, such as delivering PET in ever-shorter sequences. 

A study in a Swedish psychiatric outpatient clinic compared the effect of an 8-day intensified treatment program with traditionally spaced treatments on 101 participants with PTSD or complex PTSD. The study reported a significant reduction in PTSD symptoms at posttreatment, with large effect sizes in both conditions. Moreover, symptom reduction was maintained at follow-up. Dropout rates were significantly different between treatment groups: 4.3% in the intensified treatment program and 24.1% in the traditional group.

Another study used VA administrative data to assess the impact of sequenced psychotherapy (≥ 8 sessions of not trauma-focused individual or group psychotherapy delivered before trauma-focused care) on initiation and retention in CPT and PET over 2 years. Roughly 13% of 490,097 veterans who entered care for PTSD between 2014 and 2020 initiated VA-disseminated evidence-based treatment within 21 months (9.5% CPT, 3.4% PE). Among those who initiated treatment, retention was 46% and 42%, respectively. Individual therapy was associated with increased CPT and PET retention of 8.0% and 8.2%. For group therapy, retention increases were 3.4% and 8.7%. 

Another recent study examined the RESET (Reconsolidation, Exposure, and Short-term Emotional Transformation) clinical protocol, an intensive, structured trauma-focused intervention designed to treat PTSD within 6 daily sessions. The protocol includes psychoeducation, targeted exposure, dynamic case formulation, and guided trauma processing. This novel framework ensures therapy moves beyond symptom reduction, fostering a deep understanding of the patient’s core struggles and their broader psychological patterns, and integrates it with the reconsolidation of the index trauma narrative to form a more cohesive sense of self.” 

Clinical studies are ongoing to refine and enhance PET and CPT. They may serve to make therapy more useful and effective in easing—maybe erasing—veterans’ traumatic memories.

Posttraumatic stress disorder (PTSD) guidelines increasingly are recommending prolonged exposure therapy (PET) and cognitive processing therapy (CPT) as first-line treatments, including the 2023 US Department of Veterans Affairs (VA) and US Department of Defense clinical practice guideline.

Since 2006, > 6000 VA therapists have been trained in PET and CPT; the VA requires all veterans to have access to these treatments. However, despite strong clinical trial evidence supporting PET and CPT for the treatment of PTSD, a 2023 study found that only 11.6% of veterans who received a PTSD diagnosis between 2017 and 2019 initiated Trauma-Focused Evidence-Based Psychotherapy (TF-EBP) in their first year of treatment. Of those who initiated TF-EBP, 67% dropped out. Recent VA programs have attempted to expand the reach of PET with video telehealth to reach rural and remote veterans through virtual group programs.

Recent research has suggested ways to maximize the effectiveness of the programs and assist veterans in receiving the full benefits. Studies have found that swapping traditional longer-term treatments (usually spanning 8 to 15 weeks) for intensified, shorter versions (eg, 6 sessions) may enhance engagement and retention. 

Intensive PET for PTSD is safe and highly effective. A study involving patients with chronic PTSD and complex trauma showed significant reductions in PTSD symptom severity, with large effect sizes and sustained improvements at 3 and 6 months. Multiple 90-minute sessions over consecutive days, supplemented with in vivo exposure or followed by weekly booster sessions, were found to minimize treatment disruptions.

PET is among the most extensively studied treatments for PTSD and is supported by dozens of clinical trials involving thousands of patients. The intervention was originally developed and validated in civilian samples and includes psychoeducation, relaxation through breathing retraining, and in vivo and imaginal exposure to traumatic memories.

A recent study compared treatment outcomes among military veterans and civilian patients receiving treatment in a community setting. Although some studies have compared PET outcomes for military veterans and civilian participants in community settings, none have directly compared outcomes across trauma type (combat, terror, or civilian trauma) and veteran status (military vs civilian) within the same framework. The study notes that combat-related trauma significantly differs from other forms of trauma exposure, as it is typically more prolonged and severe and therefore is more often resistant to treatment. Military personnel also often find themselves both victims and aggressors, a duality that can intensify guilt, shame, anger, disgust, and emotional reactions to moral injury, complicating treatment. 

The study assessed the effects of 8 to 15 PET sessions on PTSD symptoms in 55 civilians and 43 veterans using the PTSD Symptom Scale–Interview Version (PSS-I). Participants showed significant symptom reductions across all trauma types and veteran statuses.

Although veterans and participants in the combat trauma subgroup showed higher levels of baseline symptom severity compared with civilians, all groups experienced similar symptom reductions. These findings differ from some meta-analyses, which have found that PET often produces smaller effect sizes in combat-related PTSD compared to civilian trauma samples.

The study compared treatment outcomes across different groups within the same treatment centers and under consistent supervision. The PET intervention was delivered in community mental health centers to all patients regardless of background. Only 2 prior studies have compared civilian and military veterans within the same locations.

Although the “traditional” number of PET sessions produce evidence-based outcomes, high dropout rates and relapses have catalyzed interest in approaches that boost the power of therapy, such as delivering PET in ever-shorter sequences. 

A study in a Swedish psychiatric outpatient clinic compared the effect of an 8-day intensified treatment program with traditionally spaced treatments on 101 participants with PTSD or complex PTSD. The study reported a significant reduction in PTSD symptoms at posttreatment, with large effect sizes in both conditions. Moreover, symptom reduction was maintained at follow-up. Dropout rates were significantly different between treatment groups: 4.3% in the intensified treatment program and 24.1% in the traditional group.

Another study used VA administrative data to assess the impact of sequenced psychotherapy (≥ 8 sessions of not trauma-focused individual or group psychotherapy delivered before trauma-focused care) on initiation and retention in CPT and PET over 2 years. Roughly 13% of 490,097 veterans who entered care for PTSD between 2014 and 2020 initiated VA-disseminated evidence-based treatment within 21 months (9.5% CPT, 3.4% PE). Among those who initiated treatment, retention was 46% and 42%, respectively. Individual therapy was associated with increased CPT and PET retention of 8.0% and 8.2%. For group therapy, retention increases were 3.4% and 8.7%. 

Another recent study examined the RESET (Reconsolidation, Exposure, and Short-term Emotional Transformation) clinical protocol, an intensive, structured trauma-focused intervention designed to treat PTSD within 6 daily sessions. The protocol includes psychoeducation, targeted exposure, dynamic case formulation, and guided trauma processing. This novel framework ensures therapy moves beyond symptom reduction, fostering a deep understanding of the patient’s core struggles and their broader psychological patterns, and integrates it with the reconsolidation of the index trauma narrative to form a more cohesive sense of self.” 

Clinical studies are ongoing to refine and enhance PET and CPT. They may serve to make therapy more useful and effective in easing—maybe erasing—veterans’ traumatic memories.

“Moral and mortal stressors may be intertwined in their contribution to the complex symptomatic outcomes” of combat exposure according to a recent study in the European Journal of Psychotraumatology. The study examined the effect moral injury has on Israel Defense Forces (IDF) combat veterans. The resulting trauma may be consolidated in a single category, such as posttraumatic stress disorder (PTSD), but stressors leading to that diagnosis may have been quite different. Properly defining the stressors to assist in better targeted treatment is a challenge.

Moral injury is the emotional distress of being involved in or witnessing actions that conflict with deeply held beliefs. Such experiences could be committing or failing to prevent a transgressive act or learning about or surviving a transgressive act.

The study defines moral injury outcomes as the psychological and emotional consequences that result from exposure to potentially morally injurious events (PMIEs): “This terminology is intended to distinguish the outcomes of moral injury from the broader and sometimes ambiguous use of ‘moral injury’ in the literature, which can refer to either the event, the experience, or the resulting symptoms.”

The study followed 374 male combat veterans for 5 years. Veterans served in the Israel Defense Forces (IDF) in 4 primary combat roles: infantry, armored corps, special forces, and combat engineering. Psychological characteristics were measured 12 months prior to enlistment. PMIE exposure was measured during the final month of military service using the Moral Injury Events Scale. Moral injury outcomes were assessed 6 months postdischarge using the Expressions of Moral Injury Scale-Military Version-Short Form. Posttraumatic stress symptom (PTSS) clusters were evaluated 1 year postdischarge using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 

Nearly half (49%) of participants reported exposure to PMIEs, while 8% met criteria for probable PTSD. The researchers say elevated PMIE rates observed in their sample may be attributed, in part, to participants’ extended deployments in densely populated urban areas, carrying out operations in close proximity to civilians, where it is difficult to distinguish between combatants and noncombatants. PTSD rates were somewhat lower than those reported in US studies (10% to 30%) among veterans; this may be attributed to the cohort not being engaged in a full-scale war, but deployed mostly in peacekeeping missions.

Longitudinal studies have described the effects of wartime atrocities on PTSD symptom severity. Studies have also linked moral injury outcomes and PTSS clusters (including negative alterations in cognition and mood [NACM]), depression, anxiety, and substance abuse. PMIEs can also include perceptions of betrayal from leaders, colleagues, or trusted others. The study of 374 male combat veterans found a direct effect of PMIE-betrayal on arousal and reactivity as well as NACM clusters. Results also showed indirect associations between exposure to all PMIE dimensions and PTSS clusters via moral injury outcomes. Combat exposure and experiencing PMIEs during military service significantly contributed to the emergence of PTSS during the first year after discharge. The study found 2 distinct paths PMIEs may lead to PTSS among veterans: experiencing acts of transgression and encountering betrayal. 

Betrayal has been linked to feelings of anger and humiliation, emotions thought to have evolved to trigger adaptive behavioral responses, such as aggression and revenge, to threats or transgressions by others. PMIE-betrayal also demonstrated direct effects on the arousal and reactivity and NACM symptom clusters, suggesting partial mediation. Another study (also on IDF veterans) found significant positive correlations between PMIE-betrayal and the NACM cluster, suggesting PMIE-betrayal as a link between PTSD and moral injury. While the link between betrayal and NACM is readily apparent, its connection to arousal and reactivity, a fear-based physiological symptom, is less evident. 

The findings of the study point to the need for assessment tools that separately measure exposure to PMIEs and individual reactions to them. A recent Federal Practitioner study of 100 veterans with a history of incarceration completed the Moral Injury Events Scale and an adapted version for legal-involved persons (MIES-LIP). The authors found that MIES-LIP demonstrated strong psychometric properties, including good reliability and convergent validity for legal-related moral injury.

The study cites a recent review of cognitive-behavioral psychotherapies for individuals experiencing moral injury that challenges the adequacy of existing evidence-based treatments for PTSD for addressing moral injury and its associated symptoms. It is important to evaluate individuals who express feelings of betrayal with tailored, evidence-based interventions such as adaptive disclosure or cognitive-processing therapy. Acceptance and commitment therapy may also help individuals experiencing emotions such as shame, humiliation, guilt, and anger following morally injurious events.

Newer therapy models like Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation allow clinicians to use personalized trauma cues to facilitate memory processing, reduce avoidance, and aid in emotional reconsolidation. Clinical research has demonstrated this model’s efficacy in reducing PTSD symptoms, depression, and anxiety, with high acceptability and low dropout rates among military personnel, veterans, and first responders.

Regardless of the treatment, the researchers encourage mental health professionals to approach veterans seeking help with the “utmost sensitivity and attentiveness to any expressions of (moral injury) outcomes.”

“Moral and mortal stressors may be intertwined in their contribution to the complex symptomatic outcomes” of combat exposure according to a recent study in the European Journal of Psychotraumatology. The study examined the effect moral injury has on Israel Defense Forces (IDF) combat veterans. The resulting trauma may be consolidated in a single category, such as posttraumatic stress disorder (PTSD), but stressors leading to that diagnosis may have been quite different. Properly defining the stressors to assist in better targeted treatment is a challenge.

Moral injury is the emotional distress of being involved in or witnessing actions that conflict with deeply held beliefs. Such experiences could be committing or failing to prevent a transgressive act or learning about or surviving a transgressive act.

The study defines moral injury outcomes as the psychological and emotional consequences that result from exposure to potentially morally injurious events (PMIEs): “This terminology is intended to distinguish the outcomes of moral injury from the broader and sometimes ambiguous use of ‘moral injury’ in the literature, which can refer to either the event, the experience, or the resulting symptoms.”

The study followed 374 male combat veterans for 5 years. Veterans served in the Israel Defense Forces (IDF) in 4 primary combat roles: infantry, armored corps, special forces, and combat engineering. Psychological characteristics were measured 12 months prior to enlistment. PMIE exposure was measured during the final month of military service using the Moral Injury Events Scale. Moral injury outcomes were assessed 6 months postdischarge using the Expressions of Moral Injury Scale-Military Version-Short Form. Posttraumatic stress symptom (PTSS) clusters were evaluated 1 year postdischarge using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 

Nearly half (49%) of participants reported exposure to PMIEs, while 8% met criteria for probable PTSD. The researchers say elevated PMIE rates observed in their sample may be attributed, in part, to participants’ extended deployments in densely populated urban areas, carrying out operations in close proximity to civilians, where it is difficult to distinguish between combatants and noncombatants. PTSD rates were somewhat lower than those reported in US studies (10% to 30%) among veterans; this may be attributed to the cohort not being engaged in a full-scale war, but deployed mostly in peacekeeping missions.

Longitudinal studies have described the effects of wartime atrocities on PTSD symptom severity. Studies have also linked moral injury outcomes and PTSS clusters (including negative alterations in cognition and mood [NACM]), depression, anxiety, and substance abuse. PMIEs can also include perceptions of betrayal from leaders, colleagues, or trusted others. The study of 374 male combat veterans found a direct effect of PMIE-betrayal on arousal and reactivity as well as NACM clusters. Results also showed indirect associations between exposure to all PMIE dimensions and PTSS clusters via moral injury outcomes. Combat exposure and experiencing PMIEs during military service significantly contributed to the emergence of PTSS during the first year after discharge. The study found 2 distinct paths PMIEs may lead to PTSS among veterans: experiencing acts of transgression and encountering betrayal. 

Betrayal has been linked to feelings of anger and humiliation, emotions thought to have evolved to trigger adaptive behavioral responses, such as aggression and revenge, to threats or transgressions by others. PMIE-betrayal also demonstrated direct effects on the arousal and reactivity and NACM symptom clusters, suggesting partial mediation. Another study (also on IDF veterans) found significant positive correlations between PMIE-betrayal and the NACM cluster, suggesting PMIE-betrayal as a link between PTSD and moral injury. While the link between betrayal and NACM is readily apparent, its connection to arousal and reactivity, a fear-based physiological symptom, is less evident. 

The findings of the study point to the need for assessment tools that separately measure exposure to PMIEs and individual reactions to them. A recent Federal Practitioner study of 100 veterans with a history of incarceration completed the Moral Injury Events Scale and an adapted version for legal-involved persons (MIES-LIP). The authors found that MIES-LIP demonstrated strong psychometric properties, including good reliability and convergent validity for legal-related moral injury.

The study cites a recent review of cognitive-behavioral psychotherapies for individuals experiencing moral injury that challenges the adequacy of existing evidence-based treatments for PTSD for addressing moral injury and its associated symptoms. It is important to evaluate individuals who express feelings of betrayal with tailored, evidence-based interventions such as adaptive disclosure or cognitive-processing therapy. Acceptance and commitment therapy may also help individuals experiencing emotions such as shame, humiliation, guilt, and anger following morally injurious events.

Newer therapy models like Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation allow clinicians to use personalized trauma cues to facilitate memory processing, reduce avoidance, and aid in emotional reconsolidation. Clinical research has demonstrated this model’s efficacy in reducing PTSD symptoms, depression, and anxiety, with high acceptability and low dropout rates among military personnel, veterans, and first responders.

Regardless of the treatment, the researchers encourage mental health professionals to approach veterans seeking help with the “utmost sensitivity and attentiveness to any expressions of (moral injury) outcomes.”

“Moral and mortal stressors may be intertwined in their contribution to the complex symptomatic outcomes” of combat exposure according to a recent study in the European Journal of Psychotraumatology. The study examined the effect moral injury has on Israel Defense Forces (IDF) combat veterans. The resulting trauma may be consolidated in a single category, such as posttraumatic stress disorder (PTSD), but stressors leading to that diagnosis may have been quite different. Properly defining the stressors to assist in better targeted treatment is a challenge.

Moral injury is the emotional distress of being involved in or witnessing actions that conflict with deeply held beliefs. Such experiences could be committing or failing to prevent a transgressive act or learning about or surviving a transgressive act.

The study defines moral injury outcomes as the psychological and emotional consequences that result from exposure to potentially morally injurious events (PMIEs): “This terminology is intended to distinguish the outcomes of moral injury from the broader and sometimes ambiguous use of ‘moral injury’ in the literature, which can refer to either the event, the experience, or the resulting symptoms.”

The study followed 374 male combat veterans for 5 years. Veterans served in the Israel Defense Forces (IDF) in 4 primary combat roles: infantry, armored corps, special forces, and combat engineering. Psychological characteristics were measured 12 months prior to enlistment. PMIE exposure was measured during the final month of military service using the Moral Injury Events Scale. Moral injury outcomes were assessed 6 months postdischarge using the Expressions of Moral Injury Scale-Military Version-Short Form. Posttraumatic stress symptom (PTSS) clusters were evaluated 1 year postdischarge using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 

Nearly half (49%) of participants reported exposure to PMIEs, while 8% met criteria for probable PTSD. The researchers say elevated PMIE rates observed in their sample may be attributed, in part, to participants’ extended deployments in densely populated urban areas, carrying out operations in close proximity to civilians, where it is difficult to distinguish between combatants and noncombatants. PTSD rates were somewhat lower than those reported in US studies (10% to 30%) among veterans; this may be attributed to the cohort not being engaged in a full-scale war, but deployed mostly in peacekeeping missions.

Longitudinal studies have described the effects of wartime atrocities on PTSD symptom severity. Studies have also linked moral injury outcomes and PTSS clusters (including negative alterations in cognition and mood [NACM]), depression, anxiety, and substance abuse. PMIEs can also include perceptions of betrayal from leaders, colleagues, or trusted others. The study of 374 male combat veterans found a direct effect of PMIE-betrayal on arousal and reactivity as well as NACM clusters. Results also showed indirect associations between exposure to all PMIE dimensions and PTSS clusters via moral injury outcomes. Combat exposure and experiencing PMIEs during military service significantly contributed to the emergence of PTSS during the first year after discharge. The study found 2 distinct paths PMIEs may lead to PTSS among veterans: experiencing acts of transgression and encountering betrayal. 

Betrayal has been linked to feelings of anger and humiliation, emotions thought to have evolved to trigger adaptive behavioral responses, such as aggression and revenge, to threats or transgressions by others. PMIE-betrayal also demonstrated direct effects on the arousal and reactivity and NACM symptom clusters, suggesting partial mediation. Another study (also on IDF veterans) found significant positive correlations between PMIE-betrayal and the NACM cluster, suggesting PMIE-betrayal as a link between PTSD and moral injury. While the link between betrayal and NACM is readily apparent, its connection to arousal and reactivity, a fear-based physiological symptom, is less evident. 

The findings of the study point to the need for assessment tools that separately measure exposure to PMIEs and individual reactions to them. A recent Federal Practitioner study of 100 veterans with a history of incarceration completed the Moral Injury Events Scale and an adapted version for legal-involved persons (MIES-LIP). The authors found that MIES-LIP demonstrated strong psychometric properties, including good reliability and convergent validity for legal-related moral injury.

The study cites a recent review of cognitive-behavioral psychotherapies for individuals experiencing moral injury that challenges the adequacy of existing evidence-based treatments for PTSD for addressing moral injury and its associated symptoms. It is important to evaluate individuals who express feelings of betrayal with tailored, evidence-based interventions such as adaptive disclosure or cognitive-processing therapy. Acceptance and commitment therapy may also help individuals experiencing emotions such as shame, humiliation, guilt, and anger following morally injurious events.

Newer therapy models like Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation allow clinicians to use personalized trauma cues to facilitate memory processing, reduce avoidance, and aid in emotional reconsolidation. Clinical research has demonstrated this model’s efficacy in reducing PTSD symptoms, depression, and anxiety, with high acceptability and low dropout rates among military personnel, veterans, and first responders.

Regardless of the treatment, the researchers encourage mental health professionals to approach veterans seeking help with the “utmost sensitivity and attentiveness to any expressions of (moral injury) outcomes.”

An intensive 1-day overview course in inflammatory bowel disease (IBD) continues to attract large numbers of first-year gastrointestinal(GI) fellows across the country.

Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.

The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.

“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.

“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”

 

The Program

The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.

The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.

The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.

In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.

In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.

Among the specific survey findings: 

• 100% said the course had improved their ability to effectively treat and manage patients
• A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08) 
• A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
• 98% reported increased interest in exploring IBD during fellowship
• 100% noted improved understanding of supplemental opportunities to learn about IBD
• 96% would strongly recommend this course to future GI fellows

Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.

Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”

And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”

In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.

This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.

A version of this article appeared on Medscape.com.

An intensive 1-day overview course in inflammatory bowel disease (IBD) continues to attract large numbers of first-year gastrointestinal(GI) fellows across the country.

Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.

The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.

“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.

“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”

 

The Program

The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.

The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.

The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.

In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.

In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.

Among the specific survey findings: 

• 100% said the course had improved their ability to effectively treat and manage patients
• A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08) 
• A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
• 98% reported increased interest in exploring IBD during fellowship
• 100% noted improved understanding of supplemental opportunities to learn about IBD
• 96% would strongly recommend this course to future GI fellows

Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.

Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”

And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”

In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.

This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.

A version of this article appeared on Medscape.com.

An intensive 1-day overview course in inflammatory bowel disease (IBD) continues to attract large numbers of first-year gastrointestinal(GI) fellows across the country.

Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.

The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.

“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.

“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”

 

The Program

The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.

The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.

The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.

In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.

In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.

Among the specific survey findings: 

• 100% said the course had improved their ability to effectively treat and manage patients
• A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08) 
• A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
• 98% reported increased interest in exploring IBD during fellowship
• 100% noted improved understanding of supplemental opportunities to learn about IBD
• 96% would strongly recommend this course to future GI fellows

Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.

Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”

And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”

In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.

This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.

A version of this article appeared on Medscape.com.

The FDA approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya, Johnson & Johnson) for adults with moderately to severely active ulcerative colitis (UC).

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.

The FDA approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya, Johnson & Johnson) for adults with moderately to severely active ulcerative colitis (UC).

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.

The FDA approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya, Johnson & Johnson) for adults with moderately to severely active ulcerative colitis (UC).

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.

An eight-strain probiotic has been shown to reduce the risk for pouchitis in patients with ulcerative colitis who undergo ileal pouch anal anastomosis (IPAA), 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.

An eight-strain probiotic has been shown to reduce the risk for pouchitis in patients with ulcerative colitis who undergo ileal pouch anal anastomosis (IPAA), 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.

An eight-strain probiotic has been shown to reduce the risk for pouchitis in patients with ulcerative colitis who undergo ileal pouch anal anastomosis (IPAA), 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.