Studies Confirm Long-term Safety, Efficacy of Ozanimod in Relapsing Forms of MS

Research on the long-term use of ozanimod in relapsing forms of multiple sclerosis (RMS) has shown the treatment is effective with no new safety concerns, according to 2 abstracts that were presented at MSVirtual 2020: 8th Joint ACTRIMS-ECTRIMS Meeting. Ozanimod is approved in the United States and European Union for the treatment of RMS. The therapy is an oral sphingosine 1-phosphate receptor 1 and 5 modulator.

DAYBREAK, an ongoing open-label extension (OLE) trial made up of patients with RMS who completed a phase 1, 2, or 3 ozanimod trial, found that the therapy was associated with a low annualized relapse rate (ARR), as well as low new or enlarging T2 and gadolinium-enhancing brain lesion counts.¹ In DAYBREAK, the participants were given ozanimod 0.91 mg per day.

A total of 2494 patients were included in this OLE, and they had mean ozanimod exposure of 35.4 months. By 24 months, 79% of participants were relapse free, and by 36 months, 75% were relapse free. The adjusted ARR was 0.112 (95% CI, 0.093-0.135).

The majority (81.8%) of the participants experienced any treatment-emergent adverse events (TEAEs), and the TEAEs were generally similar to what was observed in the parent trials. The most common TEAE was nasopharyngitis (17.9%), followed by headache (14.0%), upper respiratory tract infection (9.9%), and lymphopenia (9.6%).

“Most participants were relapse free and did not experience disability progression,” the researchers wrote. “Ozanimod was generally well tolerated and no new safety concerns emerged with long-term use.”

In the second abstract, the authors compared the relative efficacy and safety of ozanimod 1.0 mg with 14-mg teriflunomide, another oral treatment for RMS.² They completed a systematic literature review and identified clinical trials evaluating the 2 treatments. Data on ozanimod was obtained from the SUNBEAM and RADIANCE Part B trials, and data for teriflunomide was obtained from 6 clinical trials.

The trials were used to assess ARR, proportion of patients relapsed, confirmed disability progression (CDP) at 12 and 24 weeks, and adverse events (AEs).

The researchers found that ozanimod showed improvements in ARR over teriflunomide (rate ratio [RR], 0.73; 95% CI: 0.62-0.84). In addition, ozanimod demonstrated improvements for the proportion of patients who relapsed (odds ratio [OR], 0.56; 95% CI: 0.44-0.70), overall AEs (OR, 0.35; 95% CI: 0.29-0.43), serious AEs (OR, 0.53; 95% CI: 0.37-0.77), and discontinuations due to AEs (OR, 0.14; 95% CI: 0.09-0.12).

In addition, compared with teriflunomide, ozanimod showed similar CDP at 12 weeks (RR, 0.80; 95% CI: 0.61-1.05) and 24 weeks (RR, 0.80; 95% CI: 0.59-1.08).

References

1. Selmaj K, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1−3 trials. Presented at: MSVirtual 2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 11-13, 2020. Abstract P0217.

2. Cohan S, Kumar J, Arndorfer S, Zhu X, Zivkovix M, Tencer T. Comparative efficacy and safety of ozanimod versus teriflunomide for relapsing-remitting multiple sclerosis: a matching-adjusted indirect comparison. Presented at: MSVirtual 2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 11-13, 2020. Abstract P0047.