An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease.
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Hanžel Jurij, Solitano Virginia, Vuyyuru Sudheer Kumar, Panaccione Remo, Sands Bruce E, Peyrin-Biroulet Laurent, Danese Silvio, D'Haens Geert R, Atreya Raja, Allez Matthieu, Bernstein Charles N, Bossuyt Peter, Bressler Brian, Bryant Robert V, Cohen Benjamin L, Colombel Jean-Frederic, D'Amico Ferdinando, Dignass Axel, Dubinsky Marla, Fleshner Phillip, Gearry Richard B, Hanauer Stephen B, Hart Ailsa L, Kayal Maia, Kucharzik Torsten, Lakatos Peter L, Louis Edouard, Magro Fernando, Narula Neeraj, Leong Rupert W, Panés Julián, Raine Tim, Ran Zhihua, Regueiro Miguel D, Reinisch Walter, Singh Siddharth, Steinhart A Hillary, Travis Simon, Ungaro Ryan C, van der Woude C Janneke, Yamamoto Takayuki, Ahuja Vineet, Rubin David T, Dulai Parambir S, Cornfield Linda J, Hogan Malcolm, Sandborn William J, Feagan Brian G, Jairath Vipul, Ma Christopher
Аннотация
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.