Teriflunomide: Additional Phase III data

Additional data from the double-blind, international Phase III TEMSO trial in 1,088 patients showed that once-daily 7 and 14 mg oral teriflunomide significantly reduced ARR from baseline to 2 years by 31.2% and 31.5%, respectively, vs. placebo. Specifically, low- and high-dose teriflunomide led to ARRs of 0.37 and 0.36, respectively, vs. 0.539 for placebo (p=0.0002 and p=0.0005, respectively). Additionally, high-dose teriflunomide significantly reduced the risk of disability progression vs. placebo (20.2% vs. 27.3%, p=0.0279), while low-dose teriflunomide non-significantly reduced the endpoint (21.7%, p=0.0835). Low- and high-dose teriflunomide also significantly reduced total lesion volume relative to placebo by 39.4% and 67.4%, respectively (p=0.0317 and p=0.0003, respectively). Both doses of teriflunomide were well tolerated, with diarrhea, nausea, elevations in liver alanine transaminase (ALT) levels, and mild hair thinning and hair loss occurring more frequently in teriflunomide-treated patients vs. placebo. Data were presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Gothenburg. ...