Ozanimod Reduces Severe Relapses in Multiple Sclerosis More Than Interferon Beta-1a
Treatments were evaluated for either 1 year (SUNBEAM) or 2 years (RADIANCE).
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The rate of relapse in relapsing multiple sclerosis is significantly reduced with ozanimod in comparison with interferon β-1a, according to a study recently presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, held October 10-12, 2018, in Berlin, Germany.
This study included 2659 individuals who were randomly assigned to one of 3 treatments: ozanimod HCl 1 mg (n=880), ozanimod HCl 0.5 mg (n=890), and interferon β-1a 30 µg (n=889). Treatments were evaluated for either 1 year (SUNBEAM) or 2 years (RADIANCE). The study researchers defined relapse as neurological symptoms that were either incident or worsened for more than 1 day as well as an increase of at least 0.5 in the Expanded Disability Status Scale, at least 1 on 2 Function System scores, or at least 2 on 1 Function System score. Steroid treatment or hospitalization constituted criteria for severe relapse. A Poisson regression model with adjustments for region, study, baseline age and gadolinium-enhancing lesions at baseline was used to compare annualized relapse rates. A log-rank test was used to compare the numbers of patients who relapsed.
Overall annualized relapse rate was reduced by 42% among those using ozanimod HCl 1 mg treatments (0.18; P =.0001) and by 26% among those using ozanimod HCl 0.5 mg (0.23; P =.0001), compared with interferon β-1a (0.30). Among those who relapsed, 96% were either hospitalized or given steroid treatment. Annualized relapse rate requiring steroids or hospitalization showed a 43% reduction with ozanimod HCl 1 mg (0.15; P =.0001) and 26% with 0.5 mg (0.20; P =.0001) when compared with interferon β-1a (0.27) in adjusted post-hoc analysis. The rate of relapse requiring either steroid treatment or hospitalization was significantly lower among those treated with ozanimod HCl 1 mg (20.1%; P =.0001) and ozanimod HCl 0.5 mg (23.3%; P =.008) compared with interferon β-1a (30.7%).
The study researchers concluded that “ozanimod significantly reduced the rate of relapses, including the present definition of severe relapses, vs [interferon β-1a] in patients with [relapsing multiple sclerosis]. These data support the potential of ozanimod as an effective oral treatment to reduce the rate of relapse, including severe relapse, in patients with [relapsing multiple sclerosis].”
Disclosures: Several authors report associations and financial disclosures with pharmaceutical companies. For a full list of author disclosures, visit the reference.
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Comi G, Kappos L, Hartung HP, et al. Ozanimod reduces rates of annualised relapse requiring steroids or hospitalisation versus interferon β-1a: pooled results from two multicentre, randomised, double-blind, phase 3 studies in relapsing multiple sclerosis (SUNBEAM and RADIANCE). Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. October 10-12, 2018; Berlin, Germany. Poster P869.