• Aaron E Miller, Paul O'Connor, Jerry S Wolinsky, Christian Confavreux, Ludwig Kappos, Tomas P Olsson, Philippe Truffinet, Lin Wang, Laura D'Castro, Giancarlo Comi, Mark S Freedman, and Teriflunomide Multiple Sclerosis Trial Group.
• Mount Sinai School of Medicine, USA. aaron.miller@mssm.edu
• Mult. Scler. 2012 Nov 1; 18 (11): 1625-32.

BackgroundThe Teriflunomide Multiple Sclerosis Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled phase III study, demonstrated that teriflunomide significantly reduced annualized relapse rate (ARR), disease progression and magnetic resonance imaging (MRI) activity, with a favorable safety profile in relapsing multiple sclerosis (RMS) patients.ObjectiveThe purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.MethodsRMS patients (n=1088) were randomized to placebo or teriflunomide, 7 mg or 14 mg, once daily, for 108 weeks. Subgroup analyses were performed for ARR and disability progression by baseline demographics (gender, race, age), disease characteristics (Expanded Disability Status Scale (EDSS) strata, relapse history, multiple sclerosis (MS) subtype), MRI parameters (gadolinium-enhancing lesions, total lesion volume) and prior use of MS drugs. A generalized estimating equation method and Cox regression model were used to assess consistency of the treatment effect across subgroups, utilizing a treatment-by-subgroup interaction test for each factor separately.ResultsReductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.ConclusionThe positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.

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