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AN INTERNATIONAL CONSENSUS ON APPROPRIATE MANAGEMENT OF CORTICOSTEROIDS IN CLINICAL TRIALS IN INFLAMMATORY BOWEL DISEASE

Jurij Hanžel 1, Virginia Solitano 2, Sudheer K. Vuyyuru 3, Remo Panaccione 4, Bruce E. Sands 5, Laurent Peyrin-Biroulet 6, Silvio Danese 7, Geert R. D'Haens 8, Raja Atreya 9, Matthieu Allez 10, Charles N. Bernstein 11, Peter Bossuyt 12, Brian Bressler 13, Robert Bryant 14, Benjamin L. Cohen 15, Jean-Frédéric Colombel 5, Ferdinando D'Amico 16, Axel Dignass 17, Marla C. Dubinsky 18, Phillip Fleshner 19, Richard Gearry 20, Steve Hanauer 21, Ailsa L Hart 22, Maia Kayal 5, Torsten Kucharzik 23, Peter L Lakatos 24, Edouard Louis 25, Fernando Magro 26, Neeraj Narula 27, Rupert W Leong 28, Julian Panés 29, Tim Raine 30, Zhihua Ran 31, Miguel Regueiro 32, Walter Reinisch 33, Siddharth Singh 34, Hillary Steinhart 35, Simon Travis 36, Ryan C. Ungaro 5, C. Janneke van der Woude 37, Takayuki Yamamoto 38, V A 39, David T. Rubin 40, Parambir Dulai 21, Linda J. Cornfield 41, Malcolm Hogan 41, William Sandborn 34, Brian G. Feagan 42, Vipul Jairath 42, Christopher Ma 43

Affiliations

1 University of Ljubljana, Ljubljana, Slovenia|||Alimentiv Inc., London, Canada

2 IRCCS Ospedale San Raffaele, Universita Vita-Salute San Raffaele, Milan, Italy|||Western University, London, Canada

3 Western University, London, Canada

4 University of Calgary, Calgary, Canada

5 Icahn School of Medicine at Mount Sinai, New York, United States

6 Nancy University Hospital, Dept of Gastroenterology, INFINY Institute, FHU-CURE, INSERM NGERE, F-54500 Vandoeuvre-lès-Nancy, France, 92200 Neuilly sur Seine, France|||McGill University Health Centre, Montreal, Canada

7 IRCCS Ospedale San Raffaele, Milan, Italy|||San Raffaele University, Milan, Italy

8 Amsterdam UMC campus AMC, Amsterdam, Netherlands

9 Erlangen University Hospital, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany

10 Hopital Saint-Louis, APHP, Université Paris Cité, Paris, France|||McGill University Health Centre, Montreal General Hospital, McGill University, Montreal, Canada

11 University of Manitoba, Winnipeg, Canada

12 Imelda General Hospital, Bonheiden, Belgium

13 University of British Columbia, Vancouver, Canada

14 The Queen Elizabeth Hospital, Woodville, South Australia, Australia

15 Digestive Diseases Institute, Cleveland Clinic, Cleveland, United States

16 IRCCS San Raffaele Hospital, Milan, Italy

17 Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany

18 Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, United States

19 Cedars Sinai Medical Center, Los Angeles, United States

20 University of Otago, Christchurch, New Zealand

21 Feinberg School of Medicine, Northwestern University, Chicago, United States

22 St. Mark’s Hospital and Academic Institute, Imperial College London, Middlesex, United Kingdom

23 Lüneburg Hospital, Lüneburg, Germany

24 McGill University Health Centre, Montreal General Hospital, McGill University, Montreal, Canada|||Semmelweis University, Budapest, Hungary

25 University Hospital CHU Liege, Liege, Belgium

26 University of Porto, Porto, Portugal

27 Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Canada

28 Concord Hospital and Macquarie University Hospital, Sydney, New South Wales, Australia

29 Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

30 Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

31 Zhou Pu Hospital affiliated to Shanghai University of Medicine and Health Sciences, Shanghai, China

32 Cleveland Clinic Foundation, Cleveland, United States

33 Medical University of Vienna, Vienna, Austria

34 University of California San Diego, La Jolla, United States

35 Mount Sinai Hospital, Division of Gastroenterology and Hepatology, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada

36 University of Oxford, Oxford, United Kingdom

37 Erasmus Medical Center, Rotterdam, Netherlands

38 Yokkaichi Hazu Medical Center, Yokkaichi, Japan

39 All India Institute of Medical Sciences, New Delhi, India

40 The University of Chicago Medicine, Chicago, United States

41 Alimentiv Inc., London, Canada

42 Alimentiv Inc., London, Canada|||Western University, London, Canada

43 Alimentiv Inc., London, Canada|||University of Calgary, Cumming School of Medicine, Division of Gastroenterology and Hepatology; Department of Community Health Sciences, Calgary, Canada

Summary

AI Generated

An international Delphi consensus of 45 IBD RCT experts developed standardised recommendations for corticosteroid management across screening, induction, and maintenance phases of clinical trials in moderately-to-severely active inflammatory bowel disease.

Key recommendations include a 2-week stable corticosteroid dosing period before screening, maximum baseline dosages of 20 mg/day prednisone equivalents (or 9 mg/day budesonide), and exclusion of patients who received intravenous corticosteroids during screening.
During induction, corticosteroid dosages should be fixed for at least 2 weeks after randomisation, with tapering beginning at ≤2 weeks of induction and mandated by trial protocol rather than investigator discretion.
The consensus recommends a unified tapering protocol of 5 mg prednisone equivalents per week, while enteric- and colonic-release budesonide should be discontinued without tapering.
Patients who deviate from the tapering schedule by receiving dosage escalation during maintenance should be regarded as having failed treatment, and only patients using corticosteroids at maintenance start should form the denominator for corticosteroid-free remission rates.
These recommendations aim to minimise inappropriate prolonged corticosteroid exposure, standardise practices across trials, improve comparability between studies, and reduce steroid-related harm to participants.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Most inflammatory bowel disease (IBD) randomised controlled trials (RCTs) only permit tapering of corticosteroids after initiating the maintenance period, either as adaptive or forced tapering, resulting in different corticosteroid exposure among participants.¹ These practices result in inappropriately, prolonged, and excessive exposure to corticosteroids that is not consistent with optimal clinical care and may inflate placebo response rates.^2-7

Aims & Methods

We aimed to provide comprehensive standardised recommendations on key aspects of corticosteroid use in RCTs for adults with moderately-to-severely active IBD, through a multi-phase, international expert consensus. 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. Expert consensus recommendations for all aspects of corticosteroid management in RCTs were then developed using a modified Delphi process with two rounds of survey questions and a ratification meeting. For the surveys, corticosteroid management practices were divided into several domains describing the key stages of an IBD RCT and were directly reflected in clinical trial protocols: corticosteroid management during screening, induction, and maintenance; and corticosteroid-related endpoints.

Results

The international Delphi panel consisted of 45 IBD RCT experts. The recommendations propose management of corticosteroid intake during screening, induction, and maintenance phases of pharmacologic RCTs in IBD, and define corticosteroid-related endpoints. The need for minimising corticosteroid exposure through expedited tapering and shorter fixed-dosing periods that more closely reflect routine clinical care was emphasised, and recommendations for standardised definitions of corticosteroid-free remission were provided (Table). The panellists recommended a 2-week stable dosing period before screening, and favoured beginning dosage tapering at ≤2 weeks of induction. Panellists supported a unified tapering protocol of 5 mg prednisone equivalents/week, and voted that enteric- and colonic-release corticosteroids do not require tapering. A point of consensus was that both the beginning of tapering and its rate should be mandated by the trial protocol, rather than the investigators’ discretion. Consensus was not reached on the duration of corticosteroid withdrawal prior to the final study visit for defining corticosteroid-free remission. During the ratification meeting, the panellists highlighted the need for meticulous documentation of corticosteroid use during RCTs to avoid underreporting.

Table. Statements reaching consensus on corticosteroid handling in randomised controlled trials in inflammatory bowel disease
Corticosteroids during screening and prior to the screening endoscopy/randomisation	Corticosteroids during induction	Corticosteroids during maintenance
Patients with Crohn’s disease should: - be permitted to receive the following corticosteroid formulations at any time during screening: oral systemic corticosteroids; oral enteric-release corticosteroids. - discontinue rectally administered corticosteroids at least 2 weeks prior to screening endoscopy/randomisation.	During the induction phase of a trial, the dosage of oral systemic corticosteroids, or oral enteric- or colonic-release corticosteroids, should be fixed for at least 2 weeks after randomisation.	The tapering of the oral systemic corticosteroid dosage should be initiated at the beginning of the maintenance phase of a trial (if not already done in induction).
Patients with ulcerative colitis should: - be permitted to receive the following corticosteroid formulations at any time during screening: oral systemic corticosteroids; oral colonic-release corticosteroids. - discontinue rectally administered corticosteroids at least 2 weeks prior to screening endoscopy/randomisation.	During the induction phase of a trial, the decision to require tapering the dosage of corticosteroids should depend on the following factors: duration of the induction trial; expected efficacy of the investigational agent; expected speed of onset of the investigational agent.	During the maintenance phase of a trial, the onset and rate of oral systemic corticosteroid tapering should be mandated by the trial protocol.
Any period of intravenous corticosteroid use during screening should be exclusionary for trial participation.	During the induction phase of a trial, the dosage of oral systemic corticosteroids should be tapered in patients receiving the same treatment regimen, regardless of an early symptomatic response, to avoid complications in interpreting induction trial results.	In a trial that requires tapering of corticosteroids during the maintenance phase: - dosages of 20 mg/day prednisone equivalents should be tapered by 5 mg/day, per week, until discontinuation. - patients who received corticosteroid dosage escalation should reinitiate tapering within 2 weeks after dosage escalation
Patients who have received oral systemic corticosteroids, or oral enteric- or colonic-release corticosteroids, prior to screening endoscopy/randomisation should be required to have used a stable dosage for at least 2 weeks.	During the induction phase of a trial, the onset and rate of oral systemic corticosteroid tapering, or oral enteric- or colonic-release corticosteroid tapering, should be mandated by the trial protocol.	Enteric- and colonic-release budesonide dosages should be discontinued without tapering during the maintenance phase.
Patients who have received oral systemic corticosteroids prior to the screening endoscopy/randomisation should not be permitted to have exceeded 20 mg of prednisone equivalent per day as the maximum pre-randomisation dosage.	During the induction phase of a trial, the dosage of oral enteric- or colonic-release corticosteroids should be tapered in patients receiving the same treatment regimen, regardless of an early symptomatic response, to avoid complications in interpreting induction trial results.	Patients should be permitted to transiently receive increased doses of corticosteroids to treat indications beyond inflammatory bowel disease (e.g., asthma, adrenocortical insufficiency, stress doses for surgery) for ≤2 weeks.
Patients who have received budesonide prior to the screening endoscopy/randomisation should not be permitted to have exceeded 9 mg daily as the maximum pre-randomisation dosage.	In a trial that requires tapering of corticosteroids during the induction phase, dosages of 20 mg/day prednisone equivalents should be tapered by 5 mg/day per week until discontinuation.	Patients who: - deviated from recommended oral systemic corticosteroid, or oral enteric- or colonic-release corticosteroid, tapering schedule by receiving dosage escalation in the maintenance phase of a trial should be regarded as having failed treatment. - received oral systemic corticosteroid or oral enteric- or colonic-release corticosteroid dosage escalation to the baseline dosage of the maintenance trial during tapering should be regarded as having failed treatment.
	Enteric- and colonic-release budesonide dosages should be discontinued without tapering during the induction phase.	Only patients who used any formulation of corticosteroids at the start of the maintenance trial (or induction if that is when tapering began) should be used as the denominator for calculating the rate of corticosteroid-free remission.
	Patients starting oral systemic corticosteroids de novo, oral enteric- or colonic-release corticosteroids de novo, rectally administered corticosteroids de novo, or intravenous steroids during induction should be regarded as having failed treatment.

Conclusion

This set of internationally guided recommendations will serve to improve optimisation of RCT design and facilitate appropriate, acceptable, and standardised corticosteroid handling practices in RCTs, as well as maximise comparability between trials and minimise steroid-related harm to trial participants.

References

¹George et al. Inflamm Bowel Dis. 2020;26:515-523. DOI:10.1093/ibd/izz193
²Candy et al. Gut. 1995;37:674-678. DOI:10.1136/gut.37.5.674
³D’Haens et al. N Engl J Med. 2023;388:2444-2455. DOI:10.1056/NEJMoa2207940
⁴D’Haens et al. Lancet. 2022;399:2015-2030. DOI:10.1016/S0140-6736(22)00467-6
⁵Feagan et al. Lancet. 2021;397:2372-2384. DOI:10.1016/S0140-6736(21)00666-8
⁶Danese et al. Lancet. 2022;399:2113-2128. DOI:10.1016/S0140-6736(22)00581-5
⁷Almradi et al. J Crohns Colitis. 2022;16:717-736. DOI:10.1093/ecco-jcc/jjab194

Disclosure

JH has received consulting fees from Alimentiv Inc.
SKV has received consulting fees from Alimentiv Inc.
VS, ZR, and VA report no disclosures.
RA, MA, CNB, PB, RVB, BLC, JFC, FDA, AD, MD, RG, PF, SBH, ALH, MK, TK, PL, EL, FM, NN, RWL, TR, MR, WR, SS, AHS, RCU, CJW, TY, DTR, and PD report no disclosures related to Alimentiv Inc.
RP reports being a consultant and on the Advisory Board for Alimentiv Inc.
BES reports consulting fees from Alimentiv Inc.
LPB reports consulting for Alimentiv Inc.
SD reports consultancy fees from Alimentiv Inc.
GRDH reports advisor fees from Alimentiv Inc.
BB reports advisor/speaker fees from Alimentiv Inc.
JP has received consultancy fees/honorarium from Alimentiv Inc., and has served on a data safety monitoring board for Alimentiv Inc.
ST reports receiving consulting fees from Alimentiv Inc.
LJC and MH are employees of Alimentiv Inc.
WJS is a consultant for Alimentiv Inc.
BGF is the Senior Scientific Officer of Alimentiv Inc.
VJ has received consulting/advisory board fees from Alimentiv Inc.
CM has received consulting fees from Alimentiv Inc.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

New treatments on the horizon for Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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	Frequency, n (%)	Time of onset: during the ESD, n (%)	Serious complication, n (%)	Resolution with endoscopy, n (%)	Resolution with no sequelae, n (%)
Perforation	9 (15)	8 (13)	2 (3.3)	6 (10)	8 (13)
Bleeding	3 (5)	1 (1.6)	0 (0)	3 (5)	3 (5)
Post polypectomy syndrome	4 (6.7)	0 (0)	0 (0)	0 (0)	4 (6.7)
Other complication	1 (1.6)	0 (0)	0 (0)	0 (0)	1 (1.6)

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