Ozanimod is a selective S1P1-5 modulator recently approved in the US for the treatment of relapsing-remitting multiple sclerosis (RRMS). In the absence of head-to-head studies, a matching-adjusted indirect comparison (MAIC) can be used to compare ozanimod with other oral disease-modifying therapies in patients with MS.
The objective of this study was to compare the relative efficacy and safety of ozanimod 1.0 mg and teriflunomide (TEF) 14 mg.
A systematic literature review was performed to identify clinical trials that evaluated the efficacy and safety of ozanimod and TEF. Individual patient data (IPD) for ozanimod were obtained from the SUNBEAM and RADIANCE Part B trials, and aggregate level data for TEF were obtained from 6 clinical trials. Heterogeneity was observed between the ozanimod and TEF trials with respect to Expanded Disability Status Scale score, 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 while adjusting for imbalances between studies by weighting IPD from the ozanimod trials to match the mean baseline characteristics reported in the TEF trials. The following 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.