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 conduct a MAIC of the relative efficacy and safety of ozanimod 1.0 mg with dimethyl fumarate (DMF) 240 mg.
A systematic literature review was performed to identify clinical studies evaluating the efficacy and safety of ozanimod vs DMF. Individual patient data (IPD) for ozanimod were obtained from the SUNBEAM and RADIANCE Part B trials, and aggregate level data for DMF were obtained from CONFIRM and DEFINE. A MAIC was conducted while adjusting for imbalances between studies by reweighting IPD from ozanimod trials to match the mean baseline characteristics reported in the DMF trials. In the absence of a common comparator between ozanimod and DMF, an unanchored comparison was used. Thus, potential treatment effect modifiers and prognostic factors were included in matching.
After matching, baseline patient characteristics were balanced between ozanimod and DMF patients. Compared with DMF, ozanimod demonstrated improved annualized relapse rate (ARR; rate ratio [RR]: 0.80; 95% CI: 0.67–0.97), proportion of patients relapsed (odds ratio [OR]: 0.66; 95% CI: 0.52–0.83), overall adverse events (AEs; OR: 0.11; 95% CI: 0.08–0.16), serious AEs (OR: 0.27; 95% CI: 0.19–0.39), and discontinuations (OR: 0.11; 95% CI: 0.07–0.17) as well as nonsignificant differences for confirmed disability progression (CDP) at weeks 12 (RR: 0.79; 95% CI: 0.58–1.07) and 24 (RR: 0.89; 95% CI: 0.62–1.26).
After adjustment of baseline patient characteristics, ozanimod demonstrated improved relapse outcomes, lower risks of adverse outcomes, and low discontinuations compared with DMF. There were no significant differences in CDP.