Annualized relapse rates lower for ofatumumab versus teriflunomide in two identical phase 3 trials
THURSDAY, Aug. 6, 2020 (HealthDay News) — Among patients with relapsing multiple sclerosis, annualized relapse rates are lower for those receiving anti-CD20 monoclonal antibody ofatumumab compared with teriflunomide, according to a study published in the Aug. 6 issue of the New England Journal of Medicine.
Stephen L. Hauser, M.D., from the University of California in San Francisco, and colleagues conducted two phase 3, randomized, double-blind, double-dummy, active-controlled trials, identical in design, involving patients with relapsing multiple sclerosis. Participants were randomly assigned to receive either subcutaneous ofatumumab or oral teriflunomide for up to 30 months (946 and 936, respectively) and were followed for a median of 1.6 years.
The researchers found annualized relapse rates of 0.11 and 0.22 in the ofatumumab and teriflunomide groups, respectively (difference, −0.11; 95 percent confidence interval [CI], −0.16 to −0.06; P < 0.001), in trial 1 and 0.10 and 0.25, respectively (difference, −0.15; 95 percent CI, −0.20 to −0.09; P < 0.001), in trial 2. The percentages of patients with disability worsening confirmed at three months were 10.9 and 15.0 percent with ofatumumab and teriflunomide, respectively, in the pooled trials (hazard ratio, 0.66; 95 percent CI, 0.50 to 0.86; P = 0.002); at six months, the percentages with disability worsening were 8.1 and 12.0 percent, respectively (hazard ratio, 0.68; 95 percent CI, 0.50 to 0.92; P = 0.01), while the percentages with disability improvement confirmed at six months were 11.0 and 8.1 percent, respectively (hazard ratio, 1.35; 95 percent CI, 0.95 to 1.92; P = 0.09).
“Ofatumumab was associated with lower annualized relapse rates than teriflunomide and showed benefit with respect to most secondary clinical and magnetic resonance imaging end points but not confirmed disability improvement,” the authors write.
The study was funded by Novartis, the manufacturer of ofatumumab.
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