Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD

Background and AimsInflammatory bowel diseases (IBD), encompassing Crohn’s disease (CD) ulcerative colitis (UC), are chronic disabling disorders. Prospective disease-modification trials to prevent progression eagerly awaited. However, is not clearly defined. The objective of the Selecting End PoInts foR Disease-ModIfication Trials (SPIRIT) initiative was achieve international expert consensus on endpoints be used in future IBD-disease modification trials.MethodsThis under auspices International Organization for Study Inflammatory Bowel Diseases (IOIBD) began with a systematic literature search evaluate current evidence definition IBD. On October 22, 2019, meeting took place during United European Gastroenterology Week (UEGW) Congress Barcelona, which predefined proposed statements were discussed plenary session voted anonymously. Agreement defined as at least 75% participants voting any one statement.ResultsThe group agreed that ultimate therapeutic goal both CD UC impact patient’s life (health-related quality life, disability, fecal incontinence), midterm complications (encompass damage CD, IBD-related surgery hospitalizations, extension UC, extraintestinal manifestations, permanent stoma, short syndrome), long-term (gastrointestinal dysplasia or cancer, mortality).ConclusionsRecommendations goals preventing patients IBD by SPIRIT consensus. these recommendations will require validation actual clinical studies before implementation trials. This statement. mortality). Recommendations