[en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Hanžel, Jurij; Department of Gastroenterology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia, Alimentiv Inc, London, Ontario, Canada.
Solitano, Virginia; 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.
Vuyyuru, Sudheer Kumar; Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
Panaccione, Remo; Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Sands, Bruce E; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Peyrin-Biroulet, Laurent; 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.
Danese, Silvio; Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy, Vita-Salute, San Raffaele University, Milan, Italy.
D'Haens, Geert R; Department of Gastroenterology, Amsterdam UMC campus AMC, Amsterdam, the Netherlands.
Atreya, Raja; Erlangen University Hospital, Medical Clinic 1, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
Allez, Matthieu; Department of Gastroenterology & Hepatology, Hôpital Saint-Louis, APHP, Paris, France.
Bernstein, Charles N; Section of Gastroenterology, IBD Clinical and Research Centre, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Bossuyt, Peter; Imelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
Bressler, Brian; Division of Gastroenterology, University of British Columbia, Vancouver, British Columbia, Canada.
Bryant, Robert V; Inflammatory Bowel Disease Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
Cohen, Benjamin L; Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic, Cleveland, Ohio.
Colombel, Jean-Frederic; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
D'Amico, Ferdinando; Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, Milan, Italy.
Dignass, Axel; Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.
Dubinsky, Marla; Division of Pediatric Gastroenterology and Nutrition, Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Fleshner, Phillip; Division of Colorectal Surgery, Cedars Sinai Medical Center, Los Angeles, California.
Gearry, Richard B; Department of Medicine, University of Otago, Christchurch, New Zealand.
Hanauer, Stephen B; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Hart, Ailsa L; St. Mark's Hospital and Academic Institute, Imperial College London, Middlesex, United Kingdom.
Kayal, Maia; Icahn School of Medicine at Mount Sinai, New York, New York.
Kucharzik, Torsten; Department of Gastroenterology, Lüneburg Hospital, Lüneburg, Germany.
Lakatos, Peter L; McGill University Health Centre, Montreal General Hospital, McGill University, Montreal, Quebec, Canada, Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary.
Louis, Edouard ; Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
Magro, Fernando; Department of Pharmacology and Therapeutics, CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal.
Narula, Neeraj; Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Leong, Rupert W; Concord Hospital and Macquarie University Hospital, Sydney, New South Wales, Australia.
Panés, Julián; Department of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Raine, Tim; Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
Ran, Zhihua; Department of Gastroenterology, Zhou Pu Hospital affiliated to Shanghai University of Medicine & Health Sciences, Shanghai, China.
Regueiro, Miguel D; Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic, Cleveland, Ohio.
Reinisch, Walter; Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Singh, Siddharth; Division of Gastroenterology, University of California San Diego, La Jolla, California.
Steinhart, A Hillary; Division of Gastroenterology and Hepatology, Mount Sinai Hospital, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Travis, Simon; Kennedy Institute and Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.
Ungaro, Ryan C; Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
van der Woude, C Janneke; Department of Gastroenterology & Hepatology, Erasmus Medical Center, Rotterdam, the Netherlands.
Yamamoto, Takayuki; Yokkaichi Hazu Medical Center, Department of Surgery & IBD Center, Yokkaichi, Japan.
Ahuja, Vineet; Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Rubin, David T; The University of Chicago Medicine, Chicago, Illinois.
Dulai, Parambir S; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Cornfield, Linda J; Alimentiv Inc, London, Ontario, Canada.
Sandborn, William J; Division of Gastroenterology, University of California San Diego, La Jolla, California.
Feagan, Brian G; 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.
Jairath, Vipul; 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.
Ma, Christopher; 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.
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