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

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, van der Woude CJ, Yamamoto T, Ahuja V, Rubin DT, Dulai PS, Cornfield LJ, Hogan M, Sandborn WJ, Feagan BG, Jairath V, Ma C (2025)

Publication Type: Journal article

Publication year: 2025

Journal

DOI: 10.1053/j.gastro.2025.05.015

Abstract

Background & Aims: 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 multiphase, international expert consensus, with a goal to help inform and standardize practice in future RCTs. Methods: The consensus was informed by a systematic review of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, which determined the corticosteroid management rules used in placebo-controlled trials of advanced therapies in IBD. International expert consensus recommendations for all aspects of corticosteroid management in RCTs were then developed using a modified Delphi process with 2 rounds of survey questions and a ratification meeting. Results: These recommendations propose management of corticosteroids during screening, induction, and maintenance phases of pharmacologic trials in IBD and define corticosteroid-related end points. We emphasize the need for minimizing corticosteroid exposure through expedited tapering and shorter fixed-dosing periods that more closely reflect clinical care and provide recommendations for standardized definitions of corticosteroid-free remission. Conclusions: These recommendations will serve to optimize trial design and facilitate appropriate, acceptable, and standardized RCT corticosteroid handling practices.

Authors with CRIS profile

Involved external institutions

Cedars-Sinai Medical Center United States (USA) (US) Northwestern University United States (USA) (US) University of Otago New Zealand (NZ) Alimentiv United Kingdom (GB) University of California, San Diego (UC San Diego, UCSD) United States (USA) (US) St. Mark's Hospital United Kingdom (GB) Icahn School of Medicine at Mount Sinai United States (USA) (US) Städtisches Klinikum Lüneburg Germany (DE) McGill University Canada (CA) Centre Hospitalier Universitaire de Liège (CHU Liège) Belgium (BE) University of Oxford United Kingdom (GB) Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal France (FR) Cambridge University Hospitals United Kingdom (GB) University of Manitoba Canada (CA) Shanghai University of Medicine & Health Sciences (SUHMS) / 上海健康医学院 China (CN) Imelda vzw Belgium (BE) Cleveland Clinic United States (USA) (US) University of British Columbia Canada (CA) The Queen Elizabeth Hospital Australia (AU) Medizinische Universität Wien Austria (AT) Ospedale San Raffaele (früher: Centro San Raffaele del Monte Tabor Foundation) Italy (IT) Goethe-Universität Frankfurt am Main Germany (DE) All India Institute of Medical Sciences India (IN) University of Chicago United States (USA) (US) Western University Canada (CA) Erasmus University Medical Center (MC) Netherlands (NL) University of Calgary Canada (CA) Centre Hospitalier Régional et Universitaire de Nancy (CHRU de Nancy / CHU de Nancy) France (FR) Universidade do Porto Portugal (PT) Università Vita-Salute San Raffaele (UniSR) Italy (IT) McMaster University Canada (CA) Macquarie University Hospital Australia (AU) Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra Netherlands (NL) Centro de Investigación Biomédica en Red - Enfermedades Hepáticas y Digestivas (CIBERHD) Spain (ES) University of Ljubljana (UL) / Univerza v Ljubljani Slovenia (SI)

How to cite

APA:

Hanžel, J., Solitano, V., Vuyyuru, S.K., Panaccione, R., Sands, B.E., Peyrin-Biroulet, L.,... Ma, C. (2025). An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease. Gastroenterology. https://doi.org/10.1053/j.gastro.2025.05.015

MLA:

Hanžel, Jurij, et al. "An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease." Gastroenterology (2025).

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