VANCOUVER, BC—Teriflunomide is associated with reduced risk of disability progression among patients experiencing multiple sclerosis (MS) relapse, compared to placebo, according to a post-hoc analysis of clinical trial data presented at the 68th AAN Annual Meeting.
“Treatment with teriflunomide resulted in significant reduction in the proportion of patients experiencing disability progression following relapse,” wrote lead study author Paul W. O’Connor, MD, of the University of Toronto in Canada, and coauthors, in a poster presentation.
The findings “further support the use of teriflunomide” in treating patients with RRMS, they wrote.
Previously-reported findings from the TEMSO (NCT00134563) and TOWER (NCT00751881) clinical trials showed that teriflunomide was associated with reduced disability progression and annualized relapse rates (ARR), compared to placebo.
In order to determine whether or not teriflunomide is associated with improved disability progression outcomes among patients who have relapsed, the authors conducted a post-hoc analysis of data from each of the trials, and of pooled datasets from both studies together. The pooled dataset included 751 patients administered placebo and 728 patients administered teriflunomide.
“Analysis of disability progression confirmed for 12 weeks were performed in the subgroup of patients who experienced a relapse while treated with placebo or teriflunomide 14mg in the TEMSO and TOWER studies, as well as the pooled TEMSO-TOWER dataset,” they explained.
More than 87% of participants in all datasets who did not experience a relapse, also experienced no 12-week confirmed disability progression, the researchers wrote.
Disability progression was significantly reduced among patients administered 14mg teriflunomide (pooled-dataset reduction in relative risk: 31.3%; P=0.0486). In most cases, disability progression following relapse “started within 30 days of relapse onset,” the authors reported.
“Teriflunomide 14mg significantly reduced ARR compared with placebo in the individual TEMSO and TOWER studies, as well as in the pooled dataset,” they reported (pooled-dataset reduction in ARR: 33.7%; P<0.001).
The analysis was funded by Sanofi Genzyme. Dr. O’Connor disclosed consulting fees from Sanofi, and coauthors disclosed consulting fees from, or employment at, Genzyme.