An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease.

Fiche publication

Date publication

mai 2025

Journal

Gastroenterology

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent

Tous les auteurs :
Hanžel J, Solitano V, Vuyyuru SK, Panaccione R, Sands BE, Peyrin-Biroulet L, Danese S, D'Haens GR, Atreya R, Allez M, Bernstein CN, Bossuyt P, Bressler B, Bryant RV, Cohen BL, Colombel JF, D'Amico F, Dignass A, Dubinsky M, Fleshner P, Gearry RB, Hanauer SB, Hart AL, Kayal M, Kucharzik T, Lakatos PL, Louis E, Magro F, Narula N, Leong RW, Panés J, Raine T, Ran Z, Regueiro MD, Reinisch W, Singh S, Steinhart AH, Travis S, Ungaro RC, Janneke van der Woude C, Yamamoto T, Ahuja V, Rubin DT, Dulai PS, Cornfield LJ, Hogan M, Sandborn WJ, Feagan BG, Jairath V, Ma C

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/40446946

Résumé

Approval of new therapies for inflammatory bowel disease (IBD) requires rigorously designed and well-executed randomized controlled trials (RCTs). Corticosteroids remain a cornerstone of IBD induction therapy and many patients in trials are enrolled while taking corticosteroids. Despite this, approaches to corticosteroid management in RCTs have been highly heterogeneous, often differing from clinical practice. This negatively impacts patients' willingness to participate due to prolonged corticosteroid exposure and may potentially bias outcomes in the clinical trial. Our aim is to provide comprehensive standardized recommendations on key aspects of corticosteroid use in IBD clinical trials through a multi-phase, international expert consensus, with a goal to help inform and standardize practice in future RCTs.