title: Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
abstract: OBJECTIVE
  To assess efficacy, safety, and tolerability of every-other-day interferon beta-1b treatment in patients with a first clinical event suggestive of multiple sclerosis (MS) (clinically isolated syndrome).
  
  
  METHODS
  We conducted a multicenter, randomized, double-blind, placebo-controlled trial. Patients with a first clinical demyelinating event and at least two clinically silent brain MRI lesions were randomized to interferon beta-1b (IFNB-1b) 250 mug subcutaneously (SC) every other day (EOD) (n = 292) or placebo (n = 176), until clinically definite MS (CDMS) was diagnosed or they had been followed for 24 months.
  
  
  RESULTS
  After 2 years, 45% of placebo patients had converted to CDMS (Kaplan-Meier estimate; primary outcome measure) and 85% fulfilled the McDonald criteria (co-primary outcome measure). Overall interferon beta-1b delayed the time to diagnosis of CDMS (p < 0.0001) and McDonald MS (p < 0.00001). Hazard ratios (95% CI) were 0.50 (0.36 to 0.70) for CDMS and 0.54 (0.43 to 0.67) for McDonald MS favoring treatment with IFNB-1b. Treatment was well tolerated, as indicated by the low rate of patients dropping out of the study before CDMS was reached (6.6% overall, 7.2% in the IFNB-1b group).
  
  
  CONCLUSIONS
  Interferon beta-1b 250 mug subcutaneously every other day delayed conversion to clinically definite multiple sclerosis, and should be considered as a therapeutic option in patients presenting with a first clinical event suggestive of multiple sclerosis.
authors.affiliation: University Hospital, Basel, Switzerland. lkappos@uhbs.ch
authors.forename: L
authors.initials: L
authors.lastname: Kappos
authors.forename: C H
authors.initials: CH
authors.lastname: Polman
authors.forename: M S
authors.initials: MS
authors.lastname: Freedman
authors.forename: G
authors.initials: G
authors.lastname: Edan
authors.forename: H P
authors.initials: HP
authors.lastname: Hartung
authors.forename: D H
authors.initials: DH
authors.lastname: Miller
authors.forename: X
authors.initials: X
authors.lastname: Montalban
authors.forename: F
authors.initials: F
authors.lastname: Barkhof
authors.forename: L
authors.initials: L
authors.lastname: Bauer
authors.forename: P
authors.initials: P
authors.lastname: Jakobs
authors.forename: C
authors.initials: C
authors.lastname: Pohl
authors.forename: R
authors.initials: R
authors.lastname: Sandbrink
mesh_terms: D000328:Adult; D002170:Canada / Q000453:epidemiology; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000627:therapeutic use*; D007557:Israel / Q000453:epidemiology; D008297:Male; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology* / Q000517:prevention & control*; D015990:Placebo Effect; D015995:Prevalence; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068576:Interferon beta-1b; D016899:Interferon-beta