Studies Support Use of Oral Ozanimod to Treat Relapsing Multiple Sclerosis

In 2 studies published in The Lancet Neurology, ozanimod was well tolerated and had a lower relapse rate in patients with relapsing multiple sclerosis (MS). These data were originally presented at the 2017 meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Additional data on ozanimod will be presented at the 2019 ECTRIMS meeting, taking place September 11-13.

The first study followed 1346 patients for at least 12 months¹ and sought to assess the safety and efficacy of ozanimod compared with interferon β-1a. This randomized, double-blind, double-dummy, active-controlled phase 3 trial was held at 152 academic medical centers and clinical practices in 20 countries.

Patients included in the study had relapsing MS, a baseline expanded disability status scale score of 0.0 to 5.0, and either 1 or more relapse in the 12 months prior to screening or 1 or more relapse in the previous 24 months plus at least 1 gadolinium-enhancing lesion in the 12 months before screening.

Patients were randomly assigned 1:1:1 to be treated for at least 12 months with either once-daily oral ozanimod 1.0 mg (n = 447) or 0.5 mg (n = 451) or weekly interferon β-1a 30 μg (n = 448).

The annualized relapse rate (ARR) was 0.35 for the interferon β-1a group, 0.18 for the group taking ozanimod 1.0 mg group, and 0.24 for the group taking ozanimod 0.5 mg. Patients taking ozanimod were less likely to stop taking the treatment because of adverse events (AEs). Only 13 (2.9%) patients taking ozanimod 1.0 mg and 7 (1.5%) patients taking ozanimod 0.5 mg discontinued due to AEs compared with 16 (3.6%) patients who received interferon β-1a.

The second study² was a 24-month, multicenter, double-blind, double-dummy phase 3 trial with 1320 patients with relapsing MS at 147 medical centers and clinical practices in 21 countries. A total of 1313 patients received a study drug, and they were randomly assigned 1:1:1 to be treated with either once-daily oral ozanimod 1.0 mg (n = 433) or 0.5 mg (n = 439) or weekly interferon β -1a 30 μg (n = 441). Overall, 1138 (86.7%) completed the 24 months of treatment.

The adjusted ARR was 0.17 for patients taking ozanimod 1.0 mg, 0.22 for patients taking ozanimod 0.5 mg, and 0.28 for patients taking interferon β -1a. The interferon group had a higher incidence of treatment-emergent AEs (83.0%) versus the ozanimod 1.0 mg group (74.7%) and the ozanimod 0.5 mg group (74.3%).

“These findings show the potential of ozanimod as an effective oral therapy for individuals with relapsing multiple sclerosis,” the researchers wrote.

1. Comi G, Kappos L, Selmaj KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial [published online September 3, 2019]. Lancet Neurol. doi: 10.1016/S1474-4422(19)30239-X.

2. Cohen JA, Comi G, Selmaj KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial [published online September 3, 2019]. Lancet Neurol. doi: 10.1016/S1474-4422(19)30238-8.

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