Teriflunomide results now published
Teriflunomide is a novel oral multiple sclerosis (MS) drug in development that is expected to be available in 2012-2013. The results of the drug’s pivotal trial, previously presented at MS meetings, are now available in print (O’Connor and colleagues. N Engl J Med 2011;365:1293-1303).
The study involved 1,088 people with relapsing MS. All received one of two doses of teriflunomide (7 or 14 mg per day) or a placebo. At the end of two years, the annualized relapse rate was 0.37 for teriflunomide (i.e. about 1 relapse every 3 years) compared to 0.54 with placebo (about 1 relapse every 2 years). This represented a one-third reduction in relapses compared to placebo – very similar to the reductions seen with injectable MS medications (interferons, glatiramer acetate). Using a higher dose of teriflunomide was not significantly more effective. About 20-22% experienced disability progression while on teriflunomide compared to about 27% on placebo.
Side effects with teriflunomide included diarrhea, nausea, hair thinning and elevated liver enzymes. The risk of serious infections was somewhat higher with active treatment.
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