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

Jurij Hanžel¹, Virginia Solitano², Sudheer Kumar Vuyyuru³, Remo Panaccione⁴, Bruce E Sands⁵, Laurent Peyrin-Biroulet⁶, Silvio Danese⁷, Geert R D'Haens⁸, Raja Atreya⁹, Matthieu Allez¹⁰, Charles N Bernstein¹¹, Peter Bossuyt¹², Brian Bressler¹³, Robert V Bryant¹⁴, Benjamin L Cohen¹⁵, Jean-Frederic Colombel⁵, Ferdinando D'Amico¹⁶, Axel Dignass¹⁷, Marla Dubinsky¹⁸, Phillip Fleshner¹⁹, Richard B Gearry²⁰, Stephen B Hanauer²¹, Ailsa L Hart²², Maia Kayal²³, Torsten Kucharzik²⁴, Peter L Lakatos²⁵, Edouard Louis²⁶, Fernando Magro²⁷, Neeraj Narula²⁸, Rupert W Leong²⁹, Julián Panés³⁰, Tim Raine³¹, Zhihua Ran³², Miguel D Regueiro¹⁵, Walter Reinisch³³, Siddharth Singh³⁴, A Hillary Steinhart³⁵, Simon Travis³⁶, Ryan C Ungaro⁵, C Janneke van der Woude³⁷, Takayuki Yamamoto³⁸, Vineet Ahuja³⁹, David T Rubin⁴⁰, Parambir S Dulai²¹, Linda J Cornfield⁴¹, Malcolm Hogan⁴¹, William J Sandborn³⁴, Brian G Feagan⁴², Vipul Jairath⁴², Christopher Ma⁴³

Affiliations

¹ Department of Gastroenterology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Alimentiv Inc, London, Ontario, Canada.
² Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
³ Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
⁴ Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
⁵ Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
⁶ Department of Gastroenterology, INFINY Institute, FHU-CURE, INSERM NGERE, Nancy University Hospital, F-54500, Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, 92200, Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
⁷ Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy; Vita-Salute, San Raffaele University, Milan, Italy.
⁸ Department of Gastroenterology, Amsterdam UMC campus AMC, Amsterdam, the Netherlands.
⁹ Erlangen University Hospital, Medical Clinic 1, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
¹⁰ Department of Gastroenterology & Hepatology, Hôpital Saint-Louis, APHP, Paris, France.
¹¹ Section of Gastroenterology, IBD Clinical and Research Centre, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
¹² Imelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
¹³ Division of Gastroenterology, University of British Columbia, Vancouver, British Columbia, Canada.
¹⁴ Inflammatory Bowel Disease Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
¹⁵ Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic, Cleveland, Ohio.
¹⁶ Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, Milan, Italy.
¹⁷ Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.
¹⁸ Division of Pediatric Gastroenterology and Nutrition, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁹ Division of Colorectal Surgery, Cedars Sinai Medical Center, Los Angeles, California.
²⁰ Department of Medicine, University of Otago, Christchurch, New Zealand.
²¹ Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
²² St. Mark's Hospital and Academic Institute, Imperial College London, Middlesex, United Kingdom.
²³ Icahn School of Medicine at Mount Sinai, New York, New York.
²⁴ Department of Gastroenterology, Lüneburg Hospital, Lüneburg, Germany.
²⁵ McGill University Health Centre, Montreal General Hospital, McGill University, Montreal, Quebec, Canada; Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary.
²⁶ Department of Gastroenterology, University Hospital CHU Liege, Liege, Belgium.
²⁷ Department of Pharmacology and Therapeutics, CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal.
²⁸ Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
²⁹ Concord Hospital and Macquarie University Hospital, Sydney, New South Wales, Australia.
³⁰ Department of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
³¹ Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
³² Department of Gastroenterology, Zhou Pu Hospital affiliated to Shanghai University of Medicine & Health Sciences, Shanghai, China.
³³ Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
³⁴ Division of Gastroenterology, University of California San Diego, La Jolla, California.
³⁵ Division of Gastroenterology and Hepatology, Mount Sinai Hospital, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
³⁶ Kennedy Institute and Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.
³⁷ Department of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands.
³⁸ Yokkaichi Hazu Medical Center, Department of Surgery & IBD Center, Yokkaichi, Japan.
³⁹ Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
⁴⁰ The University of Chicago Medicine, Chicago, Illinois.
⁴¹ Alimentiv Inc, London, Ontario, Canada.
⁴² Alimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁴³ Alimentiv Inc, London, Ontario, Canada; Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. Electronic address: christopher.ma@ucalgary.ca.

PMID: 40446946
PMCID: PMC12354294 (available on 2026-05-28)
DOI: 10.1053/j.gastro.2025.05.015

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

Jurij Hanžel et al. Gastroenterology. 2025.

. 2025 May 28:S0016-5085(25)00825-X.

doi: 10.1053/j.gastro.2025.05.015. Online ahead of print.

Authors

Affiliations

¹ Department of Gastroenterology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Alimentiv Inc, London, Ontario, Canada.
² Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
³ Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
⁴ Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
⁵ Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
⁶ Department of Gastroenterology, INFINY Institute, FHU-CURE, INSERM NGERE, Nancy University Hospital, F-54500, Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, 92200, Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
⁷ Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy; Vita-Salute, San Raffaele University, Milan, Italy.
⁸ Department of Gastroenterology, Amsterdam UMC campus AMC, Amsterdam, the Netherlands.
⁹ Erlangen University Hospital, Medical Clinic 1, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
¹⁰ Department of Gastroenterology & Hepatology, Hôpital Saint-Louis, APHP, Paris, France.
¹¹ Section of Gastroenterology, IBD Clinical and Research Centre, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
¹² Imelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
¹³ Division of Gastroenterology, University of British Columbia, Vancouver, British Columbia, Canada.
¹⁴ Inflammatory Bowel Disease Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
¹⁵ Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic, Cleveland, Ohio.
¹⁶ Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, Milan, Italy.
¹⁷ Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.
¹⁸ Division of Pediatric Gastroenterology and Nutrition, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁹ Division of Colorectal Surgery, Cedars Sinai Medical Center, Los Angeles, California.
²⁰ Department of Medicine, University of Otago, Christchurch, New Zealand.
²¹ Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
²² St. Mark's Hospital and Academic Institute, Imperial College London, Middlesex, United Kingdom.
²³ Icahn School of Medicine at Mount Sinai, New York, New York.
²⁴ Department of Gastroenterology, Lüneburg Hospital, Lüneburg, Germany.
²⁵ McGill University Health Centre, Montreal General Hospital, McGill University, Montreal, Quebec, Canada; Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary.
²⁶ Department of Gastroenterology, University Hospital CHU Liege, Liege, Belgium.
²⁷ Department of Pharmacology and Therapeutics, CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal.
²⁸ Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
²⁹ Concord Hospital and Macquarie University Hospital, Sydney, New South Wales, Australia.
³⁰ Department of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
³¹ Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
³² Department of Gastroenterology, Zhou Pu Hospital affiliated to Shanghai University of Medicine & Health Sciences, Shanghai, China.
³³ Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
³⁴ Division of Gastroenterology, University of California San Diego, La Jolla, California.
³⁵ Division of Gastroenterology and Hepatology, Mount Sinai Hospital, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
³⁶ Kennedy Institute and Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.
³⁷ Department of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands.
³⁸ Yokkaichi Hazu Medical Center, Department of Surgery & IBD Center, Yokkaichi, Japan.
³⁹ Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
⁴⁰ The University of Chicago Medicine, Chicago, Illinois.
⁴¹ Alimentiv Inc, London, Ontario, Canada.
⁴² Alimentiv Inc, London, Ontario, Canada; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁴³ Alimentiv Inc, London, Ontario, Canada; Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. Electronic address: christopher.ma@ucalgary.ca.

PMID: 40446946
PMCID: PMC12354294 (available on 2026-05-28)
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.

Keywords: Crohn’s Disease; Delphi; Steroids; Ulcerative Colitis.

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References

1. Collaborators C-I, Ma C, Hanzel J, et al. CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease. Gastroenterology 2022;163:950–964. - PubMed
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An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease

Affiliations

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

Authors

Affiliations

Abstract

References

Grants and funding

LinkOut - more resources

Full Text Sources