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

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 Disabili

SUBMITTER: Miller AE 

PROVIDER: S-EPMC3573676 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature