Ozanimod Comparable to Diroximel Fumarate for Relapsing-Remitting MS

According to results from a matching-adjusted indirect comparison study, ozanimod (Zeposia; Bristol Myers Squibb, New York, NY) had comparable efficacy and a favorable safety profile to diroximel fumarate (Vumerity; Biogen, Cambridge, MA) as treatment for relapsing-remitting multiple sclerosis (RRMS). Ozanimod was associated with lower risks of key safety outcomes as reported at the Americas Committee for Treatment & Research in Multiple Sclerosis (ACTRIMS) Forum 2023.

In this study, researchers evaluated annualized relapse rate (ARR), proportion relapsed, discontinuations, adverse events (AEs), serious AEs (SAEs), and treatment emergent AEs (TEAEs), including diarrhea, nasopharyngitis, and upper respiratory tract infection (URTI) obtained from previous clinical trials:

• SUNBEAM (NCT02294058) and RADIANCE (NCT02047734), two phase 3 trials which assessed the safety, tolerability, and efficacy of ozanimod 1.0 mg for RRMS, and
• EVOLVE-MS-1 (NCT02634307), a phase 3 trial which assessed diroximel fumarate 462 mg for the treatment of RRMS

Individual patient data from SUNBEAM and RADIANCE were weighted to match baseline patient characteristics obtained from EVOLVE-MS-1. Matching was conducted for Expanded Disability Status Scale score, prior relapse, gadolinium-enhancing lesions, prior disease modifying therapy use, age, sex, and weight.

After matching, ozanimod and diroximel fumarate had comparable efficacy outcomes: the risk ratio for ARR (0.924, 95% CI: 0.646–1.324) and odds ratio (OR) for proportion of patients relapsed (0.997; 95% CI: 0.671–1.483) were not significant between the treatment groups. Patients receiving ozanimod had significantly lower odds of discontinuation (OR: 0.089; 95% CI: 0.030–0.268), SAEs (OR: 0.290; 95% CI: 0.114–0.737), and for various TEAEs, including nasopharyngitis (OR: 0.466; 95% CI: 0.255–0.849), diarrhea (OR: 0.184; 95% CI: 0.072–0.473), and URTI (OR: 0.545; 95% CI: 0.297–0.999). Researchers noted several limitations to a matching-adjusted comparison study such as potential unobserved confounding and potentially reduced sample size owing to weighting.