Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis

Mult Scler. 2012 Nov;18(11):1625-32. doi: 10.1177/1352458512450354. Epub 2012 Jun 21.


Background: The 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.

Objective: The purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.

Methods: RMS 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.

Results: Reductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.

Conclusion: The positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.

Trial registration: NCT00134563.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Canada
  • Crotonates / administration & dosage*
  • Crotonates / adverse effects
  • Disability Evaluation
  • Disease Progression
  • Double-Blind Method
  • Europe
  • Humans
  • Kaplan-Meier Estimate
  • Magnetic Resonance Imaging
  • Multiple Sclerosis, Relapsing-Remitting / diagnosis
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Predictive Value of Tests
  • Proportional Hazards Models
  • Time Factors
  • Toluidines / administration & dosage*
  • Toluidines / adverse effects
  • Treatment Outcome
  • United States


  • Anti-Inflammatory Agents
  • Crotonates
  • Toluidines
  • teriflunomide

Associated data