Safety and Efficacy of Ozanimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Age

1. Incidence rates of hypertension and opportunistic and serious infections increase with age in patients receiving ozanimod for ulcerative colitis (UC).

Evidence Rating Level: 1 (Excellent)

Treating older patients with UC is difficult due to an overreliance on corticosteroids and hesitancy in using more advanced therapies due to the increased risk of adverse events such as infection, major adverse cardiovascular events, thromboembolic complications, and malignancies. Ozanimod is a selective sphingosine 1-phosphate (S1P) receptor 1 and 5 modulator approved for the treatment of moderately to severely active UC. This article uses data from the True North study, a randomized, placebo-controlled phase 3 trial. In the 10-week induction period, patients in cohort 1 were assigned to receive ozanimod 0.92 mg or placebo, and patients in cohort 2 received open-label ozanimod at the same daily dose. At 10 weeks, patients with a clinical response to ozanimod in either cohort underwent randomization again to receive double-blind ozanimod or placebo for the maintenance period (through week 52). 1012 total patients were stratified by age: < 40 (n = 492; mean [range] age: 30.0 [18-39]; 56.3% male), 40-60 ((n = 404; mean [range] age: 49.4 [40-60]; 64.4% male), and > 60 (n = 116; mean [range] age: 65.2 [61-74]; 56.0%). Rates of treatment-emergent adverse events (TEAEs) were higher in patients receiving continuous ozanimod (47.7%-53.6%) than in those who switched to placebo (34.3%-39.2%) in all age groups. Exposure-adjusted incidence rates (EAIRs) of opportunistic infection (eg, herpes zoster), COVID-19, and serious infection increased with age. Patients ≥ 40 years of age had higher hypertension EAIRs than those < 40 years of age. These results suggest a need for greater monitoring of side effects in older patients receiving ozanimod for IBD. This may include herpes zoster vaccinations and increased monitoring of cardiac adverse reactions.

Click here to read the study in Inflammatory Bowel Diseases

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