Sanofi and its subsidiary Genzyme announced have that magnetic resonance imaging (MRI) data from the Phase III TEMSO study demonstrate that Aubagio (teriflunomide) significantly slowed brain volume loss (or 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.
Companies inforemed that change in brain volume from baseline was assessed in patients treated with Aubagio 14 mg or 7 mg, or placebo. In the MS clinical studies of Aubagio, including TEMSO, the incidence of serious adverse events was similar among Aubagio and placebo-treated patients. These data will be presented on October 10, 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:
By month 12, median percent reduction from baseline in brain volume was 0.39, 0.40, and 0.61 for Aubagio 14 mg, 7 mg, and placebo, respectively. This change was lower for both Aubagio groups vs. placebo: 14 mg by 36.9 percent, p=0.0001; 7 mg by 34.4 percent, p=0.0011.
The significant difference in reduction of brain atrophy for Aubagio vs. placebo was maintained at month 24. Median percent reduction in brain volume from baseline was 0.90, 0.94, and 1.29 for Aubagio 14 mg, 7 mg, and placebo, respectively. This change was lower for both Aubagio groups vs. placebo: 14 mg by 30.6 percent, p=0.0001; 7 mg by 27.6 percent, p=0.0019.
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.
“Control or prevention of brain atrophy is an important target for MS treatment,” said Prof. Dr. Ludwig Kappos, Neurology Chair, University Hospital Basel, Switzerland. “These data help provide further insight into teriflunomide’s potential effects in people with RMS.”
“These results showing the reduction in brain atrophy over two years add to the growing body of data for Aubagio,” said Bill Sibold, Head of Genzyme’s Multiple Sclerosis business. “We remain committed to furthering the understanding of Aubagio and the potential benefits it could deliver to relapsing MS patients.”