Journal ArticleDOI
Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis
Paul O'Connor,Jerry S. Wolinsky,Christian Confavreux,Giancarlo Comi,Ludwig Kappos,Tomas Olsson,Hadj Benzerdjeb,Philippe Truffinet,Lin Wang,Aaron E. Miller,Mark S. Freedman +10 more
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TLDR
Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo.Abstract:
Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teri flunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P<0.001 for both comparisons with placebo). The proportion of patients with confirmed disability progression was 27.3% with placebo, 21.7% with teriflunomide at 7 mg (P = 0.08), and 20.2% with teriflunomide at 14 mg (P = 0.03). Both teriflunomide doses were superior to placebo on a range of end points measured by magnetic resonance imaging (MRI). Diarrhea, nausea, and hair thinning were more common with teriflunomide than with placebo. The incidence of elevated alanine aminotransferase levels (≥1 times the upper limit of the normal range) was higher with teriflunomide at 7 mg and 14 mg (54.0% and 57.3%, respectively) than with placebo (35.9%); the incidence of levels that were at least 3 times the upper limit of the normal range was similar in the lower- and higher-dose teriflunomide groups and the placebo group (6.3%, 6.7%, and 6.7%, respectively). Serious infections were reported in 1.6%, 2.5%, and 2.2% of patients in the three groups, respectively. No deaths occurred. Conclusions Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo. (Funded by Sanofi-Aventis; TEMSO ClinicalTrials.gov number, NCT00134563.)read more
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Multiple Sclerosis: Mechanisms and Immunotherapy
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Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.
Christian Confavreux,Paul O'Connor,Giancarlo Comi,Mark S. Freedman,Aaron E. Miller,Tomas Olsson,Jerry S. Wolinsky,Teresa Bagulho,Jean Luc Delhay,Deborah Dukovic,Philippe Truffinet,Ludwig Kappos +11 more
TL;DR: Teriflunomide 14 mg was associated with a lower relapse rate and less disability accumulation compared with placebo, with a similar safety and tolerability profile to that reported in previous studies.
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Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies
TL;DR: The available evidence supporting risk-benefit profiles for available and emerging DMTs is reviewed, including those currently in use (sequential monotherapy, escalation therapy, and induction and maintenance therapy) and others that may soon become feasible (combination approaches and "personalized medicine").
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