Phase 3 Study of Aubagio for Relapsing Multiple Sclerosis
Genzyme, a Sanofi company, announced top-line results from the Phase 3 TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trial that assessed the efficacy and safety of Aubagio (teriflunomide), a once-daily, oral treatment for patients with relapsing forms of multiple sclerosis (MS). In the study, patients receiving teriflunomide 14mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability. Analysis of the full TOWER data is ongoing.
This double-blind, multi-center trial enrolled 1,169 patients and compared once-daily treatment with either 7mg or 14mg oral teriflunomide against placebo. Results from the primary and secondary endpoints for the 14mg dose include the following:
- A 36.3% reduction in annualized relapse rate, the primary endpoint of the trial, was observed in patients who received teriflunomide compared to placebo (P<0.0001)
- A 31.5% reduction in the risk of 12-week sustained accumulation of disability, the main secondary endpoint, as measured by the Expanded Disability Status Scale (EDSS) was observed with teriflunomide compared to placebo (P=0.0442)
A 22.3% reduction in annualized relapse rate was observed in patients treated with teriflunomide 7mg compared to placebo (P=0.02); there was no statistically significant difference observed between teriflunomide 7mg and placebo for the risk of 12-week sustained accumulation of disability.
Patients who completed the trial were followed for a period between 48 and 173 weeks. The average duration of teriflunomide exposure in TOWER was 18 months.
Teriflunomide is an immunomodulator with a unique mechanism of action. Although the mechanism of action for teriflunomide is not fully understood, research supports that teriflunomide inhibits the proliferation of stimulated T and B lymphocytes in the periphery thought to be responsible for the damaging inflammatory process in MS, while generally maintaining normal immune function.For more information call (800) 745-4447 or visit www.genzyme.com.