Teriflunomide significantly reduced the annualized relapse rate in patients with relapsing-remitting multiple sclerosis (MS) by more than one-third, compared with placebo, in the second of two large, randomized, phase III trials that have been conducted with the drug.
The latest study—Teriflunomide Oral in People With Relapsing Multiple Sclerosis (TOWER)—demonstrated that the 14-mg dose of teriflunomide produced a 36% relative risk reduction in the annualized relapse rate, compared with placebo. A 7-mg dose of the oral MS agent yielded a 22% relative risk reduction. Teriflunomide 14 mg, but not 7 mg, was also associated with a significantly lower sustained disability accumulation than placebo.
“These data support the use of teriflunomide as an initial therapy for patients with relapsing-remitting MS and as an option for patients who are unable to tolerate other disease-modifying therapies,” Christian Confavreux, MD, of the Université Claude Bernard Lyon 1 in France, and associates wrote online ahead of print January 22 in Lancet Neurology.
The TOWER trial involved 1,169 patients with relapsing-remitting MS who were randomized to treatment—408 were assigned to teriflunomide 14 mg, 372 to teriflunomide 7 mg, and 389 to placebo. The mean age of patients at study entry was approximately 38—slightly more than 80% were white, 15% were Asian, and 2% were black.
The annualized relapse rates were 0.50 for patients treated with placebo, 0.32 for patients treated with teriflunomide 14 mg, and 0.39 for those treated with teriflunomide 7 mg. Absolute risk reductions for teriflunomide 14 mg and 7 mg versus placebo were –0.11 and –0.18, respectively.
A key secondary end point was sustained accumulation of disability. This outcome was defined as an increase of at least 1 point on the Expanded Disability Status Scale from baseline that persisted for at least 12 weeks. The hazard ratios for the time to sustained accumulation of disability were 0.68 for the 14-mg dose of teriflunomide and 0.95 for the 7-mg dose versus placebo.
“The safety and tolerability profile of teriflunomide ... was similar for both the 7-mg and 14-mg doses, including long-term treatment observations,” the investigators wrote. Common side effects in patients treated with teriflunomide were hair thinning and headache.
—Sara Freeman