title: Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
abstract: BACKGROUND
  In previous studies, teriflunomide significantly reduced the annualised relapse rate (ARR) and disability progression.
  
  
  OBJECTIVE
  This phase 3, rater-blinded study (NCT00883337) compared teriflunomide with interferon-beta-1a (IFNβ-1a).
  
  
  METHODS
  Patients with relapsing multiple sclerosis were randomised (1:1:1) to oral teriflunomide 7-or 14 mg, or subcutaneous IFNβ-1a 44 µg. The primary composite endpoint was time to failure, defined as first occurrence of confirmed relapse or permanent treatment discontinuation for any cause. Secondary endpoints included ARR, Fatigue Impact Scale (FIS) and Treatment Satisfaction Questionnaire for Medication (TSQM). The study was completed 48 weeks after the last patient was randomised.
  
  
  RESULTS
  Some 324 patients were randomised (IFNβ-1a: 104; teriflunomide 7 mg: 109; teriflunomide 14 mg: 111). No difference in time to failure was observed. There was no difference in ARR between teriflunomide 14 mg and IFNβ-1a, but ARR was significantly higher with teriflunomide 7 mg. FIS scores indicated more frequent fatigue with IFNβ-1a, though differences were only significant with teriflunomide 7 mg. TSQM scores were significantly higher with teriflunomide. There were no unexpected safety findings.
  
  
  CONCLUSIONS
  Effects on time to failure were comparable between teriflunomide and IFNβ-1a. There was no difference between teriflunomide 14 mg and IFNβ-1a on ARR, though ARR was higher with teriflunomide 7 mg. The teriflunomide safety profile was consistent with previous studies.
authors.affiliation: Neurology, University of Lille Nord de France, Lille, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Vermersch
authors.forename: Anna
authors.initials: A
authors.lastname: Czlonkowska
authors.forename: Luigi M E
authors.initials: LM
authors.lastname: Grimaldi
authors.forename: Christian
authors.initials: C
authors.lastname: Confavreux
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Tomas P
authors.initials: TP
authors.lastname: Olsson
authors.forename: Myriam
authors.initials: M
authors.lastname: Benamor
authors.forename: Deborah
authors.initials: D
authors.lastname: Bauer
authors.forename: Philippe
authors.initials: P
authors.lastname: Truffinet
authors.forename: Meg
authors.initials: M
authors.lastname: Church
authors.forename: Aaron E
authors.initials: AE
authors.lastname: Miller
authors.forename: Jerry S
authors.initials: JS
authors.lastname: Wolinsky
authors.forename: Mark S
authors.initials: MS
authors.lastname: Freedman
authors.forename: Paul
authors.initials: P
authors.lastname: O'Connor
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D003437:Crotonates / Q000008:administration & dosage / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D006885:Hydroxybutyrates; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D009570:Nitriles; D012008:Recurrence; D014052:Toluidines / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D003437:Crotonates; D006885:Hydroxybutyrates; D009570:Nitriles; D014052:Toluidines; C527525:teriflunomide; D016899:Interferon-beta; D000068556:Interferon beta-1a
keywords: Multiple sclerosis; acute relapsing; disease-modifying therapy; pharmacologic therapy; relapsing–remitting; teriflunomide