title: Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study.
abstract: BACKGROUND
  Interferon beta reduces activity in multiple sclerosis as measured clinically and by magnetic resonance imaging (MRI). We assessed the effect of interferon beta-1a on the occurrence of relapses in patients after first presentation with neurological events, who are at high risk of conversion to clinically definite multiple sclerosis.
  
  
  METHODS
  Eligible patients had had a first episode of neurological dysfunction suggesting multiple sclerosis within the previous 3 months and had strongly suggestive brain MRI findings. Patients were randomly assigned interferon beta-1a 22 microg or placebo subcutaneously once weekly for 2 years. Neurological and clinical assessments were done every 6 months and brain MRI every 12 months. Analyses excluded one patient assigned placebo who received no study injections.
  
  
  RESULTS
  241 (78%) of 308 randomised patients received study treatment for 2 years; 278 (90%) remained in the study until termination. 57 (85%) of 67 who stopped therapy did so after conversion to clinically definite multiple sclerosis. Fewer patients developed clinically definite multiple sclerosis in the interferon group than in the placebo group (52/154 [34%] vs 69/154 [45%]; p=0.047). The time at which 30% of patients had converted to clinically definite multiple sclerosis was 569 days in the interferon group and 252 in the placebo group (p=0.034). The annual relapse rates were 0.33 and 0.43 (p=0.045). The number of new T2-weighted MRI lesions and the increase in lesion burden were significantly lower with active treatment.
  
  
  CONCLUSIONS
  Interferon beta-1a treatment at an early stage of multiple sclerosis had significant positive effects on clinical and MRI outcomes.
authors.affiliation: Multiple Sclerosis Centre, Department of Neuroscience, IRCCS Ospedale S Raffaele, via Olgettina 60, 20132, Milan, Italy. g.comi@hsr.it
authors.forename: G
authors.initials: G
authors.lastname: Comi
authors.forename: M
authors.initials: M
authors.lastname: Filippi
authors.forename: F
authors.initials: F
authors.lastname: Barkhof
authors.forename: L
authors.initials: L
authors.lastname: Durelli
authors.forename: G
authors.initials: G
authors.lastname: Edan
authors.forename: O
authors.initials: O
authors.lastname: Fernández
authors.forename: H
authors.initials: H
authors.lastname: Hartung
authors.forename: P
authors.initials: P
authors.lastname: Seeldrayers
authors.forename: P S
authors.initials: PS
authors.lastname: Sørensen
authors.forename: M
authors.initials: M
authors.lastname: Rovaris
authors.forename: V
authors.initials: V
authors.lastname: Martinelli
authors.forename: O R
authors.initials: OR
authors.lastname: Hommes
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D016899:Interferon-beta / Q000008:administration & dosage*; D016015:Logistic Models; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D009103:Multiple Sclerosis / Q000175:diagnosis* / Q000188:drug therapy*; D015999:Multivariate Analysis; D010808:Physical Examination; D012008:Recurrence; D012016:Reference Values; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D016899:Interferon-beta