BARCELONA — A reanalysis of phase III data on teriflunomide (Aubagio) shows that both doses of the drug result in significant reduction of brain volume loss vs. placebo in patients with relapsing multiple sclerosis (RMS).
Ludwig Kappos, MD, of the University Hospital of Basel in Basel, Switzerland, and fellow researchers presented the data at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress in Barcelona.
For this study, Professor Kappos and colleagues analyzed changes in brain volume from MRI data from the TEMSO study using the SIENA methodology in patients treated with Aubagio 14 mg or 7 mg or placebo. Previously, Aubagio 14 mg was found to significantly reduce the risk of disability progression in patients with RMS.
A total of 969 patients were included in the blinded analysis, with a mean baseline normalized brain volume (NBV) of 1502, 1508, and 1509 for teriflunomide 14 mg (n=322), 7 mg (n=324), and placebo (n=323), respectively. At 12-month follow-up, median percent reduction in brain volume from baseline was 0.39 for 14 mg, 0.40 for 7 mg, and 0.61 for placebo. Overall brain volume loss (BVL) was lower for both teriflunomide groups compared to placebo: 36.9% for 14 mg (P= 0.0001), and 34.4% for 7 mg (P= 0.0011). At 24-month follow-up, reduction in brain volume from baseline was 0.90 for 14 mg, 0.94 for 7 mg, and 1.29 for placebo, with BVL change for 14 mg 30.6% (P= 0.0001) and 27.6% for 7 mg (P= -.0019) vs. placebo.
Overall, both doses of teriflunomide were associated with significant reductions in BVL compared to placebo, with differences maintained over two years. The findings correlate with previously reported effects of teriflunomide on the delaying of disability progression in RMS.
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- Radue EW et al. Abstract 229. Presented at: The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress; Oct. 7-10, 2015; Barcelona.