WEDNESDAY, Oct. 5 (HealthDay News) -- For patients with relapsing multiple sclerosis (MS), oral teriflunomide significantly reduces relapse rates, disability progression, and magnetic resonance imaging (MRI) evidence of disease, according to a study published in the Oct. 6 issue of the New England Journal of Medicine.
Paul O'Connor, M.D., from the University of Toronto, and colleagues assessed whether oral teriflunomide affected the frequency of annualized relapses and the progression of physical disability at 12 weeks in 1,088 patients with relapsing MS. Participants were randomly assigned to placebo, 7 mg, or 14 mg of oral teriflunomide once a day for 108 weeks.
The investigators found that, compared to placebo, both the 7 mg and 14 mg doses of teriflunomide reduced annualized relapse rates, with relative risk reductions of 31.2 and 31.5 percent, respectively. Confirmed disability progression was seen in 27.3, 21.7, and 20.2 percent of patients in the placebo, 7 mg, and 14 mg of teriflunomide groups, respectively. Both teriflunomide doses were superior to placebo for MRI-measured end points. The teriflunomide groups more commonly had diarrhea, nausea, hair thinning, and raised alanine transferase (at least one times the upper limit of normal range). The incidence of raised alanine transferase to at least three times the upper limit of normal was similar for all groups. Though no deaths were reported, serious infections occurred in 1.6, 2.5, and 2.2 percent of patients in the 7 and 14 mg teriflunomide, and the placebo groups, respectively.
"Teriflunomide significantly reduced relapse rates, disability progression (at the higher
dose), and MRI evidence of disease activity, as compared with placebo," the authors write.
The study was funded by Sanofi-Aventis, the manufacturer of teriflunomide. Several authors disclosed financial relationships with various pharmaceutical companies, including Sanofi-Aventis.
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