NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.
The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.
Dr. Aaron E. Miller
The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.
The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.
Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.
The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.
The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.
“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.
Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.
The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.