title: Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
abstract: BACKGROUND
  In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions.
  
  
  OBJECTIVE
  To examine detailed MRI findings from the first 2 years of this trial.
  
  
  METHODS
  Double-blind, placebo-controlled, randomized, parallel-group, multicenter, phase 3 study.
  
  
  METHODS
  Ninety-eight centers worldwide.
  
  
  METHODS
  A total of 404 individuals with a first demyelinating event suggestive of multiple sclerosis.
  
  
  METHODS
  Patients were randomized to receive interferon beta-1b, 250 microg subcutaneously every other day, or placebo. After 24 months of treatment or on conversion to clinically definite multiple sclerosis, open-label interferon beta-1b treatment was offered.
  
  
  METHODS
  Reported MRI data from patients completing 2 years of follow-up.
  
  
  RESULTS
  Data were analyzed from 248 patients taking interferon beta-1b and 156 taking placebo. Across 2 years the cumulative number of newly active lesions was lower in patients receiving interferon beta-1b vs placebo (median, 2.0 vs 5.0 [reduction of 60%]; P < .001). This corresponded to lower cumulative numbers of new T2 lesions (median, 1.0 vs 3.0 [reduction of 66%]; P < .001) and new gadolinium-enhancing lesions (median, 0.0 vs 1.0; P < .001) in patients receiving interferon beta-1b vs placebo. From screening to month 24, T2 lesion volume decreased and was more pronounced in patients receiving interferon beta-1b (P = .02).
  
  
  CONCLUSIONS
  Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group. Trial Registration clinicaltrials.gov Identifier: NCT00185211.
authors.affiliation: Department of Diagnostic Radiology and Image Analysis Center, Vrije Universiteit Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands. f.barkhof@vumc.nl
authors.forename: Frederik
authors.initials: F
authors.lastname: Barkhof
authors.forename: Chris H
authors.initials: CH
authors.lastname: Polman
authors.forename: Ernst-Wilhelm
authors.initials: EW
authors.lastname: Radue
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Mark S
authors.initials: MS
authors.lastname: Freedman
authors.forename: Gilles
authors.initials: G
authors.lastname: Edan
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hartung
authors.forename: David H
authors.initials: DH
authors.lastname: Miller
authors.forename: Xavier
authors.initials: X
authors.lastname: Montalbán
authors.forename: Peter
authors.initials: P
authors.lastname: Poppe
authors.forename: Marlieke
authors.initials: M
authors.lastname: de Vos
authors.forename: Fatiha
authors.initials: F
authors.lastname: Lasri
authors.forename: Lars
authors.initials: L
authors.lastname: Bauer
authors.forename: Susanne
authors.initials: S
authors.lastname: Dahms
authors.forename: Klaus
authors.initials: K
authors.lastname: Wagner
authors.forename: Christoph
authors.initials: C
authors.lastname: Pohl
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
mesh_terms: D000293:Adolescent; D000328:Adult; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005682:Gadolinium; D006801:Humans; D007279:Injections, Subcutaneous; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*
chemical_list: D003287:Contrast Media; D000068576:Interferon beta-1b; D016899:Interferon-beta; D005682:Gadolinium