To assess anti-fibrosis agents in trials of patients with Crohn’s disease (CD), the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) reached an expert consensus on a set of endpoints that can be used to assess these agents. The systematic review identified clinical, radiologic, biochemical, endoscopic, and composite endpoints used in assessing activity of fibrostenosing CD and response to treatment, and determined their operational properties. Among the details:

• A total of 36 potentially relevant endpoints for intestinal fibrosis were selected and assessed.
• 48 physicians with expertise in IBD from 5 regions participated in the Delphi consensus process.
• A core set of 13 endpoints were rated as critical: complete clinical response, long-term efficacy, sustained clinical benefit, treatment failure, radiological remission, normal quality of life, clinical remission without steroids, therapeutic failure, deep remission, compete absence of occlusive symptoms, symptom-free survival, bowel damage progression, and no disability.