Outcomes
exacerbations of symptoms, perianal fistulas, pain
ADVERSE EVENTS, SECONDARY, REMISSION, INFLAMMATORY BOWEL DISEASE 1
The primary endpoint was combined remission at weeks 24, defined as no draining in all treated external openings despite gentle finger compression, and the absence of collections larger than 2 cm of the treated perianal fistulas in at least two of three dimensions by MRI.There were two key secondary endpoints: clinical remission and clinical response. Clinical remission was defined as closure of all treated external openings that were draining at baseline by week 24. Clinical response was defined as closure of at least 50% of all treated external openings that were draining at baseline by week 24.Other secondary endpoints were Perianal Crohn’s Disease Activity Index (PDAI)/CDAI score, VAS score for pain, quality of life by the Inflammatory Bowel Disease Questionnaire (IBDQ), and MRI-based Van Assche score at weeks 12 and 24.We monitored adverse events, particularly exacerbations of symptoms, using a standard adverse-event case report form at each visit.