S98 Ozanimod Efficacy and Safety in Older Patients With Ulcerative Colitis: A Post Hoc Analysis From True North

Abstract

Background: Ozanimod is approved for the treatment of moderately to severely active ulcerative colitis (UC) in the US and EU. Older patients are understudied in IBD. This post hoc analysis from the phase 3 True North (TN) trial examined the efficacy and safety of ozanimod in patients aged < 60 y and ≥60 y. Methods: Patients were randomized to double-blind ozanimod 0.92 mg or placebo (Cohort 1) or received open-label ozanimod (Cohort 2) during the 10-week induction period. Clinical responders to ozanimod at Week (W) 10 were rerandomized to ozanimod or placebo for maintenance through W52. Efficacy endpoints were assessed at W10 and W52; adjusted treatment differences for ozanimod vs placebo were calculated using the Cochran-Mantel-Haenszel test. Treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) were also assessed. Results: Overall, 562 patients 2 x ULN. One death from acute respiratory distress syndrome due to viral pneumonia occurred during induction in an older patient (64 y) on ozanimod but was unrelated to treatment. Conclusion(s): Ozanimod is a safe, tolerable oral treatment option for older patients with UC without concerning serious AEs. Efficacy in older patients was comparable to younger patients. A key limitation of this study is the small sample size, warranting future studies with larger, real-world cohorts.