Patients with relapsing-remitting multiple sclerosis (MS) who received oral teriflunomide 14 mg had a 36.3% reduction in annualized relapse rate and a 31.5% reduction in the risk of 12-week sustained accumulation of disability, compared with patients receiving placebo, according to results from the phase III Teriflunomide Oral in people With relapsing remitting multiplE scleRosis (TOWER) trial.
Patients treated with teriflunomide 7 mg had a 22.3% reduction in annualized relapse rate, compared with placebo. No statistically significant difference was observed between teriflunomide 7 mg and placebo for the risk of 12-week sustained accumulation of disability.
Teriflunomide Versus Placebo
TOWER was a multi-center, double-blind, parallel-group trial that evaluated the efficacy and safety of teriflunomide in 1,169 patients ages 18 to 55 with relapsing forms of MS. Once-daily treatment with either 7 mg or 14 mg oral teriflunomide was compared against placebo.
Safety variables were defined as adverse events reported by the patients or noted by the investigator during the study period. Patients who completed the trial were followed for a period of 48 to 173 weeks, with an average 18-month duration of teriflunomide exposure.