PND9 Comparative Efficacy and Safety of Ozanimod Versus Teriflunomide for Relapsing-Remitting Multiple Sclerosis: A Matching-Adjusted Indirect Comparison

Abstract

Ozanimod is a selective S1P1,5 modulator approved in the US for relapsing-remitting multiple sclerosis (RRMS). In the absence of head-to-head data, matching-adjusted indirect comparisons (MAICs) can be used to compare oral disease-modifying therapies (DMTs) in RRMS. The objective of this study was to compare the relative efficacy/safety of ozanimod 1.0 mg and teriflunomide (TEF) 14 mg. A systematic literature review identified clinical trials evaluating efficacy/safety of ozanimod and TEF. Individual patient data (IPD) were obtained from the ozanimod SUNBEAM and RADIANCE Part B trials, and aggregate-level data were obtained from 6 TEF trials. Heterogeneity was observed between ozanimod and TEF trials in Expanded Disability Status Scale scores, gadolinium-enhanced lesions, disease duration from symptom onset, prior relapse and DMT use, age, sex, region, and weight. An unanchored (no common comparator) MAIC was conducted adjusting for imbalances between studies by weighting the IPD for ozanimod to match mean baseline characteristics for TEF. Outcomes of interest were assessed: annualized relapse rate (ARR), proportion of patients relapsed, confirmed disability progression (CDP) sustained for 12 and 24 weeks, overall adverse events (AEs), serious AEs (SAEs), and discontinuations due to AEs. After matching, baseline patient characteristics were balanced between ozanimod and TEF. Compared with TEF, ozanimod demonstrated improvements in ARR (rate ratio [RR]: 0.73; 95% CI: 0.62–0.84), proportion of patients relapsed (odds ratio [OR]: 0.56; 95% CI: 0.44–0.70), overall AEs (OR: 0.35; 95% CI: 0.29–0.43), SAEs (OR: 0.53; 95% CI: 0.37–0.77), and discontinuations due to AEs (OR: 0.14; 95% CI: 0.09–0.21) and similar CDP at 12 (RR: 0.80; 95% CI: 0.61–1.05) and 24 (RR: 0.80; 95% CI: 0.59–1.08) weeks. Ozanimod was associated with improved relapse outcomes and lower risks of AEs over 1–2 years of follow-up compared with TEF, with no differences in CDP.