title: Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison.
abstract: The treatment of relapsing-remitting multiple sclerosis (RRMS) has become more effective over the last decade with the advent of the currently available disease-modifying therapies (DMTs). Pivotal clinical studies differ in many characteristics, such that cross-comparisons of relative risk reductions are of limited value and can be misleading. Our objective was to compare the clinical efficacy of currently approved first-line DMTs in patients with RRMS, applying an evidence-based medicine approach. We reviewed all phase III pivotal trials of DMTs. Six clinical trials of Avonex, Betaseron, Copaxone, Rebif and Tysabri in patients with RRMS were identified for analysis. Only randomized, placebo-controlled, double-blind studies were included. The clinical efficacy endpoints compared were: proportion of relapse-free patients at 1 and 2 years; annualized relapse rate at 2 years; proportion of progression-free patients at 2 years, and proportion of patients free of gadolinium-enhancing lesions at 1 year or 9 months. Based on these analyses, Betaseron, Rebif, and Tysabri show comparable effects, whereas for several endpoints Avonex or Copaxone did not significantly differ from placebo. In the absence of head-to-head studies for all products used to treat RRMS, it still may be possible to compare treatment effects by applying evidence-based medicine principles.
authors.affiliation: Department of Medicine (Neurology), University of Ottawa, Ottawa, Ontario, Canada. mfreedman@ottawahospital.on.ca
authors.forename: Mark S
authors.initials: MS
authors.lastname: Freedman
authors.forename: Bruce
authors.initials: B
authors.lastname: Hughes
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Mikol
authors.forename: Randy
authors.initials: R
authors.lastname: Bennett
authors.forename: Brian
authors.initials: B
authors.lastname: Cuffel
authors.forename: Vamil
authors.initials: V
authors.lastname: Divan
authors.forename: Nicole
authors.initials: N
authors.lastname: LaVallee
authors.forename: Ahmad
authors.initials: A
authors.lastname: Al-Sabbagh
mesh_terms: D002986:Clinical Trials as Topic; D003937:Diagnosis, Differential; D018450:Disease Progression; D006801:Humans; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000503:physiopathology / Q000628:therapy*; D010919:Placebos; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D010919:Placebos