Date: 2015-10-07
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain
Company: Genzyme (USA - MA), a Sanofi company (France)
Product: Aubagio® (teriflunomide)
Action
mechanism: immunomodulating agent. Teriflunomide, a once-daily, oral tablet, 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.
Disease: relapsing multiple sclerosis (RMS)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country:
Trial
details: The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).Secondary objectives were to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue and to evaluate the safety and tolerability of teriflunomide. (NCT00134563)
Latest
news: * On October 7, 2015, Genzyme, a Sanofi company, announced 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. 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.
