Updates in Clinical, Endoscopic, and Histologic Composite and Co-primary Endpoints for Clinical Trials in Inflammatory Bowel Disease

AbstractPurpose of reviewThe evolution of endpoints used to assess disease activity and treatment efficacy in inflammatory bowel disease (IBD) has accompanied changes in clinical trial methodology and the therapeutic landscape.Recent findingsComposite and co-primary endpoints for patient-reported outcomes (without physician ’s global assessment) and endoscopic improvement (excluding friability) are used to define clinical remission and clinical response in contemporary clinical trials for ulcerative colitis and Crohn’s disease. Histologic-endoscopic mucosal healing has emerged as a therapeutic goal and validated hi stological indexes are increasingly integrated into clinical trials. Central reading of endoscopy is recognized as the gold standard for endoscopic assessment in clinical trials to minimize observer bias and inter-observer variability.SummaryDetermination of treatment efficacy in IBD has evolved to incorporate both patient-reported outcome measures and central reading of endoscopy +/- histology as composite endpoints in contemporary clinical trials.
Source: Current Treatment Options in Gastroenterology - Category: Gastroenterology Source Type: research