Phase III TOPIC study of Aubagio shows slowed brain atrophy in multiple sclerosis.- Sanofi.

A post hoc analysis of the Phase III TOPIC study of Aubagio (teriflunomide), from Sanofi, shows the therapy can significantly slow whole brain volume loss (atrophy) compared with placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS). Additionally, in this study, the reduction of annual whole brain volume loss was associated with a delay in conversion to clinically definite MS.

Aubagio 14 mg significantly reduced the median percentage of whole brain volume (WBV) change versus placebo at all time points evaluated (months 6, 12, 18 and 24). At month six, treatment with Aubagio (n=165) correlated with an 87.4 percent median reduction in WBV loss relative to placebo (n=154). At month 12, treatment with Aubagio (n=135) correlated with a 28.6 percent median reduction in WBV loss relative to placebo (n=122). At month 18, treatment with Aubagio (n=109) correlated with a 36.1 percent median reduction in WBV loss relative to placebo (n=92; P=0.0003). At the last evaluation (24 months), treatment with Aubagio (n=89) correlated with a 43 percent median reduction in WBV loss relative to placebo (n=69). In addition, annual WBV loss observed in patients had a significant impact on conversion to clinically definite MS, with a 51.7 percent increase in risk of clinically definite MS conversion for every 1 percent decrease in WBV (P<0.0001).>

In the MS clinical studies of Aubagio, including TOPIC, the incidence of serious adverse events was similar among Aubagio and placebo-treated patients. These results will be presented during the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany.

Comment: Aubagio is approved in more than 80 countries, with additional marketing applications under review by regulatory authorities globally. Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries, as well as a Phase IV study with more than 3,600 patients currently enrolled.