Crohn's criteria: History of failure, contraindication, or intolerance to conventional therapies including short‑term oral corticosteroids for induction and an immunomodulatory agent (e.g., methotrexate, azathioprine, 6‑mercaptopurine) with a minimum trial of 12 weeks AND documentation of high‑risk disease features (e.g., persistent symptoms despite conventional therapy, obstruction, abscess, stricture, phlegmon, fistulas, resection, extensive bowel involvement, early age of onset, growth retardation, CDAI >450, or Harvey‑Bradshaw index >7). For continuation: documentation demonstrating disease stability or a positive clinical response (e.g., improved endoscopic activity, steroid tapering/discontinuation, reduced liquid stools, decreased abdominal pain, decreased CDAI or Harvey‑Bradshaw index) must be submitted.immunomodulator minimum 12 weeks
Conventional therapy requirements include short‑term corticosteroids and immunomodulator (12 weeks)