IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis: The PROCTRIAL Consensus.
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Caron Bénédicte, Abreu Maria T, Siegel Corey A, Panaccione Remo, Sands Bruce E, Dignass Axel, Turner Dan, Dotan Iris, Hart Ailsa L, Ahuja Vineet, Allez Matthieu, Ananthakrishnan Ashwin N, Ghosh Subrata, Griffiths Anne M, Halfvarson Jonas, Kaser Arthur, Kotze Paulo G, Koutroubakis Ioannis E, Lakatos Peter L, Levine Arie, Lewis James D, Magro Fernando, Mantzaris Gerassimos J, O'Morain Colm, Ran Zhihua, Reinisch Walter, Rogler Gerhard, Sachar David B, Siegmund Britta, Silverberg Mark S, Sood Ajit, Spinelli Antonino, Steinwurz Flavio, Tysk Curt, Yamamoto-Furusho Jesus K, Schreiber Stefan, Rubin David T, Sandborn William J, Danese Silvio, Peyrin-Biroulet Laurent
Аннотация
METHODS: Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters.
RESULTS: The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity was proposed. Secondary endpoints that should be evaluated include endoscopic remission, histologic remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life.
CONCLUSIONS: In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the Definition and end points for ulcerative PROCtitis in clinical TRIALs consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials.