Real-world effectiveness of advanced therapies in microscopic colitis

Bram Verstockt; Thibault Taelman; Shahida Din; Stephan R Vavricka; Andreas Blesl; Yamile Zabana; Wouter Van Moerkercke; Vytautas Kiudelis; Juan de la Revilla Negro; Michel H Maillard; Edoardo Vincenzo Savarino; Niels Teich; Gilles Macaigne; Marie Truyens; Davide Giuseppe Ribaldone; Manuel Barreiro-de Acosta; Signe Wildt; Pauline Rivière; Mathurin Fumery; Aurélien Amiot; Jan Marsal; Gian Eugenio Tontini; Asaf Levartovsky; Sophie Vieujean; Michael Somers; Anneline Cremer; Ivan Lutakov; Nathaniel A Cohen; Sophie Dewit; Lukas Bajer; Jean-Francois Rahier; Ann-Sofie Backman; Stephane Nancey; Tenzin Choden; Jurgen Van Dongen; Gerhard Rogler; Matthias Lenfant; Mhairi Finlayson; Andreas Münch; Mette Julsgaard

doi:10.1016/j.cgh.2025.12.019

Real-world effectiveness of advanced therapies in microscopic colitis

Bram Verstockt^*, Thibault Taelman, Shahida Din, Stephan R Vavricka, Andreas Blesl, Yamile Zabana, Wouter Van Moerkercke, Vytautas Kiudelis, Juan de la Revilla Negro, Michel H Maillard, Edoardo Vincenzo Savarino, Niels Teich, Gilles Macaigne, Marie Truyens, Davide Giuseppe Ribaldone, Manuel Barreiro-de Acosta, Signe Wildt, Pauline Rivière, Mathurin Fumery, Aurélien AmiotJan Marsal, Gian Eugenio Tontini, Asaf Levartovsky, Sophie Vieujean, Michael Somers, Anneline Cremer, Ivan Lutakov, Nathaniel A Cohen, Sophie Dewit, Lukas Bajer, Jean-Francois Rahier, Ann-Sofie Backman, Stephane Nancey, Tenzin Choden, Jurgen Van Dongen, Gerhard Rogler, Matthias Lenfant, Mhairi Finlayson, Andreas Münch, Mette Julsgaard

^*Corresponding author af dette arbejde

Gastroenheden AHH

Abstract

BACKGROUND & AIMS: Microscopic colitis (MC) is a leading cause of chronic diarrhea, particularly in older adults. Although many patients respond to budesonide, refractory and dependent cases pose major therapeutic challenges. Although the off-label use of advanced inflammatory bowel disease therapies is expanding, robust real-world data remain scarce.

METHODS: Through the ECCO CONFER network, we conducted a multinational, retrospective study in patients with MC treated with biologics or small molecules following budesonide failure or intolerance. We systematically analyzed clinical outcomes, treatment durability, and predictors of therapeutic success.

RESULTS: Among 229 treatment cycles in 142 patients, anti-tumor necrosis factor (TNF) agents were most frequently initiated (55.9%), followed by vedolizumab (28.8%) and Janus kinase (JAK) inhibitors (9.2%). Short-term clinical response and remission rates were highest with JAK inhibitors (95.2% and 81.0%, respectively), significantly outperforming anti-TNFs, vedolizumab, and ustekinumab (P < .01). Long-term drug persistence mirrored these findings: JAK inhibitors demonstrated a markedly lower discontinuation rate (23.8%) compared with other agents (56.3%; odds ratio, 5.07; 95% confidence interval, 1.52-16.9; P = .008). Multivariate analysis confirmed drug class as the only independent predictor of therapy continuation. Despite advanced therapies, 4.2% of patients ultimately required surgical intervention.

CONCLUSIONS: This real-world study demonstrates the promising short- and long-term effectiveness of advanced therapies-particularly JAK inhibitors-in budesonide-refractory and budesonide-dependent MC. These findings pave the way for dedicated prospective trials and highlight evolving therapeutic strategies in MC.

Originalsprog	Engelsk
Tidsskrift	Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN	1542-3565
DOI	https://doi.org/10.1016/j.cgh.2025.12.019
Status	E-pub ahead of print - 26 dec. 2025

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10.1016/j.cgh.2025.12.019

Citationsformater

Verstockt, B., Taelman, T., Din, S., Vavricka, S. R., Blesl, A., Zabana, Y., Van Moerkercke, W., Kiudelis, V., de la Revilla Negro, J., Maillard, M. H., Savarino, E. V., Teich, N., Macaigne, G., Truyens, M., Ribaldone, D. G., Barreiro-de Acosta, M., Wildt, S., Rivière, P., Fumery, M., ... Julsgaard, M. (2025). Real-world effectiveness of advanced therapies in microscopic colitis. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. Advance online publication. https://doi.org/10.1016/j.cgh.2025.12.019

Verstockt, B, Taelman, T, Din, S, Vavricka, SR, Blesl, A, Zabana, Y, Van Moerkercke, W, Kiudelis, V, de la Revilla Negro, J, Maillard, MH, Savarino, EV, Teich, N, Macaigne, G, Truyens, M, Ribaldone, DG, Barreiro-de Acosta, M, Wildt, S, Rivière, P, Fumery, M, Amiot, A, Marsal, J, Tontini, GE, Levartovsky, A, Vieujean, S, Somers, M, Cremer, A, Lutakov, I, Cohen, NA, Dewit, S, Bajer, L, Rahier, J-F, Backman, A-S, Nancey, S, Choden, T, Van Dongen, J, Rogler, G, Lenfant, M, Finlayson, M, Münch, A & Julsgaard, M 2025, 'Real-world effectiveness of advanced therapies in microscopic colitis', Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. https://doi.org/10.1016/j.cgh.2025.12.019

@article{c7123ecbd33c4b828ffd1e22cbec8306,

title = "Real-world effectiveness of advanced therapies in microscopic colitis",

abstract = "BACKGROUND & AIMS: Microscopic colitis (MC) is a leading cause of chronic diarrhea, particularly in older adults. Although many patients respond to budesonide, refractory and dependent cases pose major therapeutic challenges. Although the off-label use of advanced inflammatory bowel disease therapies is expanding, robust real-world data remain scarce.METHODS: Through the ECCO CONFER network, we conducted a multinational, retrospective study in patients with MC treated with biologics or small molecules following budesonide failure or intolerance. We systematically analyzed clinical outcomes, treatment durability, and predictors of therapeutic success.RESULTS: Among 229 treatment cycles in 142 patients, anti-tumor necrosis factor (TNF) agents were most frequently initiated (55.9%), followed by vedolizumab (28.8%) and Janus kinase (JAK) inhibitors (9.2%). Short-term clinical response and remission rates were highest with JAK inhibitors (95.2% and 81.0%, respectively), significantly outperforming anti-TNFs, vedolizumab, and ustekinumab (P < .01). Long-term drug persistence mirrored these findings: JAK inhibitors demonstrated a markedly lower discontinuation rate (23.8%) compared with other agents (56.3%; odds ratio, 5.07; 95% confidence interval, 1.52-16.9; P = .008). Multivariate analysis confirmed drug class as the only independent predictor of therapy continuation. Despite advanced therapies, 4.2% of patients ultimately required surgical intervention.CONCLUSIONS: This real-world study demonstrates the promising short- and long-term effectiveness of advanced therapies-particularly JAK inhibitors-in budesonide-refractory and budesonide-dependent MC. These findings pave the way for dedicated prospective trials and highlight evolving therapeutic strategies in MC.",

author = "Bram Verstockt and Thibault Taelman and Shahida Din and Vavricka, {Stephan R} and Andreas Blesl and Yamile Zabana and {Van Moerkercke}, Wouter and Vytautas Kiudelis and {de la Revilla Negro}, Juan and Maillard, {Michel H} and Savarino, {Edoardo Vincenzo} and Niels Teich and Gilles Macaigne and Marie Truyens and Ribaldone, {Davide Giuseppe} and {Barreiro-de Acosta}, Manuel and Signe Wildt and Pauline Rivi{\`e}re and Mathurin Fumery and Aur{\'e}lien Amiot and Jan Marsal and Tontini, {Gian Eugenio} and Asaf Levartovsky and Sophie Vieujean and Michael Somers and Anneline Cremer and Ivan Lutakov and Cohen, {Nathaniel A} and Sophie Dewit and Lukas Bajer and Jean-Francois Rahier and Ann-Sofie Backman and Stephane Nancey and Tenzin Choden and {Van Dongen}, Jurgen and Gerhard Rogler and Matthias Lenfant and Mhairi Finlayson and Andreas M{\"u}nch and Mette Julsgaard",

note = "Copyright {\textcopyright} 2025. Published by Elsevier Inc.",

year = "2025",

month = dec,

day = "26",

doi = "10.1016/j.cgh.2025.12.019",

language = "English",

journal = "Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association",

issn = "1542-3565",

publisher = "W.B. Saunders",

}

TY - JOUR

T1 - Real-world effectiveness of advanced therapies in microscopic colitis

AU - Verstockt, Bram

AU - Taelman, Thibault

AU - Din, Shahida

AU - Vavricka, Stephan R

AU - Blesl, Andreas

AU - Zabana, Yamile

AU - Van Moerkercke, Wouter

AU - Kiudelis, Vytautas

AU - de la Revilla Negro, Juan

AU - Maillard, Michel H

AU - Savarino, Edoardo Vincenzo

AU - Teich, Niels

AU - Macaigne, Gilles

AU - Truyens, Marie

AU - Ribaldone, Davide Giuseppe

AU - Barreiro-de Acosta, Manuel

AU - Wildt, Signe

AU - Rivière, Pauline

AU - Fumery, Mathurin

AU - Amiot, Aurélien

AU - Marsal, Jan

AU - Tontini, Gian Eugenio

AU - Levartovsky, Asaf

AU - Vieujean, Sophie

AU - Somers, Michael

AU - Cremer, Anneline

AU - Lutakov, Ivan

AU - Cohen, Nathaniel A

AU - Dewit, Sophie

AU - Bajer, Lukas

AU - Rahier, Jean-Francois

AU - Backman, Ann-Sofie

AU - Nancey, Stephane

AU - Choden, Tenzin

AU - Van Dongen, Jurgen

AU - Rogler, Gerhard

AU - Lenfant, Matthias

AU - Finlayson, Mhairi

AU - Münch, Andreas

AU - Julsgaard, Mette

PY - 2025/12/26

Y1 - 2025/12/26

N2 - BACKGROUND & AIMS: Microscopic colitis (MC) is a leading cause of chronic diarrhea, particularly in older adults. Although many patients respond to budesonide, refractory and dependent cases pose major therapeutic challenges. Although the off-label use of advanced inflammatory bowel disease therapies is expanding, robust real-world data remain scarce.METHODS: Through the ECCO CONFER network, we conducted a multinational, retrospective study in patients with MC treated with biologics or small molecules following budesonide failure or intolerance. We systematically analyzed clinical outcomes, treatment durability, and predictors of therapeutic success.RESULTS: Among 229 treatment cycles in 142 patients, anti-tumor necrosis factor (TNF) agents were most frequently initiated (55.9%), followed by vedolizumab (28.8%) and Janus kinase (JAK) inhibitors (9.2%). Short-term clinical response and remission rates were highest with JAK inhibitors (95.2% and 81.0%, respectively), significantly outperforming anti-TNFs, vedolizumab, and ustekinumab (P < .01). Long-term drug persistence mirrored these findings: JAK inhibitors demonstrated a markedly lower discontinuation rate (23.8%) compared with other agents (56.3%; odds ratio, 5.07; 95% confidence interval, 1.52-16.9; P = .008). Multivariate analysis confirmed drug class as the only independent predictor of therapy continuation. Despite advanced therapies, 4.2% of patients ultimately required surgical intervention.CONCLUSIONS: This real-world study demonstrates the promising short- and long-term effectiveness of advanced therapies-particularly JAK inhibitors-in budesonide-refractory and budesonide-dependent MC. These findings pave the way for dedicated prospective trials and highlight evolving therapeutic strategies in MC.

AB - BACKGROUND & AIMS: Microscopic colitis (MC) is a leading cause of chronic diarrhea, particularly in older adults. Although many patients respond to budesonide, refractory and dependent cases pose major therapeutic challenges. Although the off-label use of advanced inflammatory bowel disease therapies is expanding, robust real-world data remain scarce.METHODS: Through the ECCO CONFER network, we conducted a multinational, retrospective study in patients with MC treated with biologics or small molecules following budesonide failure or intolerance. We systematically analyzed clinical outcomes, treatment durability, and predictors of therapeutic success.RESULTS: Among 229 treatment cycles in 142 patients, anti-tumor necrosis factor (TNF) agents were most frequently initiated (55.9%), followed by vedolizumab (28.8%) and Janus kinase (JAK) inhibitors (9.2%). Short-term clinical response and remission rates were highest with JAK inhibitors (95.2% and 81.0%, respectively), significantly outperforming anti-TNFs, vedolizumab, and ustekinumab (P < .01). Long-term drug persistence mirrored these findings: JAK inhibitors demonstrated a markedly lower discontinuation rate (23.8%) compared with other agents (56.3%; odds ratio, 5.07; 95% confidence interval, 1.52-16.9; P = .008). Multivariate analysis confirmed drug class as the only independent predictor of therapy continuation. Despite advanced therapies, 4.2% of patients ultimately required surgical intervention.CONCLUSIONS: This real-world study demonstrates the promising short- and long-term effectiveness of advanced therapies-particularly JAK inhibitors-in budesonide-refractory and budesonide-dependent MC. These findings pave the way for dedicated prospective trials and highlight evolving therapeutic strategies in MC.

U2 - 10.1016/j.cgh.2025.12.019

DO - 10.1016/j.cgh.2025.12.019

M3 - Journal article

C2 - 41456829

SN - 1542-3565

JO - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

ER -

Real-world effectiveness of advanced therapies in microscopic colitis

Abstract

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