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

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)1625-1632
Number of pages8
JournalMultiple Sclerosis Journal
Volume18
Issue number11
DOIs
Publication statusPublished - 2012

Keywords

  • disease-modifying therapy
  • multiple sclerosis
  • subgroup analysis
  • Teriflunomide

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology
  • Medicine(all)

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    Miller, A. E., O'Connor, P., Wolinsky, J. S., Confavreux, C., Kappos, L., Olsson, T. P., Truffinet, P., Wang, L., D'Castro, L., Comi, G., & Freedman, M. S. (2012). Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Multiple Sclerosis Journal, 18(11), 1625-1632. https://doi.org/10.1177/1352458512450354