Aubagio teriflunomide: Phase III data
Top-line data from the open-label, international Phase III TENERE trial in 324 patients showed that once-daily 7 and 14 mg oral teriflunomide each missed the primary endpoint of significantly reducing the risk of treatment failure, defined as the occurrence of a confirmed relapse or permanent treatment discontinuation for any cause, vs. Rebif interferon beta-1a at week 48 (48.6% and 37.8%, respectively, vs. 42.3%, p-values not disclosed). On secondary endpoints, there was no difference between high-dose teriflunomide and Rebif in ARR from baseline to week 48 (0.259 vs. 0.216), while low-dose teriflunomide led to a higher ARR vs. Rebif (0.41). Sanofi's Genzyme Corp. subsidiary said the study was not powered to detect statistical significance on the ARR endpoint. Both doses of teriflunomide were well tolerated and most adverse events, including nasopharyngitis, diarrhea, hair thinning and back pain, were mild in severity. ...