MRI data from TEMSO study shows Aubagio (teriflunomide) slows brain atrophy in MS patients- Sanofi

Sanofi and its subsidiary Genzyme announced that magnetic resonance imaging (MRI) data from the Phase III TEMSO study demonstrate that Aubagio (teriflunomide) significantly reduced brain atrophy vs. placebo over two years in people with relapsing multiple sclerosis (RMS). In this analysis, MRI data from TEMSO were analyzed utilizing SIENA (structural image evaluation using normalization of atrophy), an alternative methodology than originally used. Change in brain volume from baseline was assessed in patients treated with teriflunomide 14 mg or 7 mg, or placebo. In the MS clinical studies of teriflunomide, including TEMSO, the incidence of serious adverse events was similar among teriflunomide and placebo-treated patients. These data will be presented on 10 October 2015 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

Results to be presented include:

1. By month 12, median percent reduction from baseline in brain volume was 0.39, 0.40, and 0.61 for teriflunomide 14 mg, 7 mg, and placebo, respectively (p=0.0001 for 14 mg vs placebo; p=0.0011 for 7 mg vs placebo).
2. The significant difference in reduction of brain atrophy for teriflunomide vs. placebo was maintained at month 24. Median percent reduction in brain volume from baseline was 0.90, 0.94, and 1.29 for teriflunomide 14 mg, 7 mg, and placebo, respectively (p=0.0001 for 14 mg vs placebo; p=0.0019 for 7 mg vs placebo).

Brain atrophy is the result of the destructive pathological processes that occur in MS. It is seen from the earliest stages of disease and leads to irreversible neurological and cognitive impairment.