Shorter Crohn’s Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies

Background and Aims Early biologic therapy treatment has demonstrated better outcomes in Crohn’s disease (CD). We evaluated the impact of CD duration in patients with moderately to severely active CD treated with risankizumab therapy. Methods This post hoc analysis evaluated clinical, endoscopic, and safety outcomes by baseline CD duration (< 2, 2–5, > 5–10, and > 10 years) in patients from ADVANCE, MOTIVATE, and FORTIFY. Pooled induction analyses included patients who received intravenous risankizumab 600 mg or placebo for 12 weeks. Maintenance analyses included patients who responded to induction risankizumab and received subcutaneous risankizumab 180 mg or 360 mg for 52 weeks. Duration subgroups were compared using Cochrane-Armitage trend tests with nominal P values. Results Among 527 patients who received risankizumab 600-mg induction therapy, higher outcome rates were observed at week 12 among patients with shorter vs longer baseline disease duration (for < 2, 2–5, > 5–10, and > 10 years, clinical remission: 42.7%, 46.9%, 43.5%, and 33.2% [P =.046]; endoscopic response: 48.3%, 36.3%, 32.0%, and 33.4% [P =.025]). Among 298 patients receiving risankizumab 180-mg or 360-mg maintenance therapy, shorter vs longer baseline disease duration was generally associated with numerically higher endoscopic outcome rates at week 52. Higher clinical remission and endoscopic outcome rates were generally observed with shorter disease duration with risankizumab 180 mg only. Adverse event rates were generally similar across duration subgroups. Conclusion Clinical benefits of risankizumab are observed across disease duration subgroups; clinical and endoscopic outcome rates are higher with risankizumab initiation earlier in the disease course; ClinicalTrials.gov numbers, NCT03105128, NCT03104413, NCT03105102.