title: Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance.
abstract: OBJECTIVE
  To determine whether immediate initiation of treatment at the time of a clinically isolated syndrome in patients at high risk for clinically definite multiple sclerosis alters disease course over 10 years.
  
  
  METHODS
  Prospective follow-up study.
  
  
  METHODS
  Twenty-four Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) sites in the United States and Canada.
  
  
  METHODS
  A total of 81 patients originally randomly assigned to receive intramuscular interferon beta-1a (the immediate-treatment group) and 74 patients originally randomly assigned to receive placebo (the delayed-treatment group). All patients were from CHAMPS.
  
  
  METHODS
  For the immediate-treatment group, treatment was initiated within a month after the onset of a clinically isolated syndrome, and for the delayed-treatment group, treatment was initiated a median of 30 months (interquartile range, 24-35 months) after CHAMPS randomization.
  
  
  METHODS
  Rate of developing clinically definite multiple sclerosis, annualized relapse rate, disease course classification, disability measures, and magnetic resonance imaging measures.
  
  
  RESULTS
  The immediate-treatment group showed a lower 10-year rate of clinically definite multiple sclerosis (unadjusted hazard ratio, 0.64 [95% CI, 0.48-0.87]; P = .004) and a lower annualized relapse rate between years 5 and 10 (P = .03). There was no differential effect on disability, magnetic resonance imaging T2-weighted lesions, or the proportion of patients developing progressive disease at 10 years. Few patients reached the Expanded Disability Status Scale milestone scores of 4.0 or greater (9% of patients) or 6.0 or greater (6% of patients).
  
  
  CONCLUSIONS
  Immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome in high-risk patients reduces relapse rates over 10 years but does not improve disability outcomes compared with a control group that also initiated therapy relatively early in the disease course.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00179478.
authors: Multiple Sclerosis Center, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, KS 211, Boston, MA 02215, USA. rkinkel@bidmc.harvard.edu
authors: R Philip
authors: RP
authors: Kinkel
authors: Mariya
authors: M
authors: Dontchev
authors: Craig
authors: C
authors: Kollman
authors: Thomai T
authors: TT
authors: Skaramagas
authors: Paul W
authors: PW
authors: O'Connor
authors: Jack H
authors: JH
authors: Simon
mesh_terms: D000328:Adult; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007273:Injections, Intramuscular; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D009103:Multiple Sclerosis / Q000473:pathology / Q000517:prevention & control*; D011446:Prospective Studies; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D016899:Interferon-beta; D000068556:Interferon beta-1a