title: IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event.
abstract: BACKGROUND
  The Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) showed that IM interferon beta-1a (IFNbeta-1a) significantly slows the rate of development of clinically definite multiple sclerosis (CDMS) over 2 years in high-risk patients who experience a first clinical demyelinating event. This report highlights the primary results of a 5-year, open-label extension of CHAMPS (the Controlled High Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance [CHAMPIONS Study]).
  
  
  OBJECTIVE
  To determine if the benefits of IFNbeta-1a observed in CHAMPS are sustained for up to 5 years.
  
  
  METHODS
  CHAMPS patients at participating CHAMPIONS sites were enrolled in the study. All patients were offered, but not required to take, IFNbeta-1a 30 microg IM once weekly for up to 5 years (from CHAMPS randomization). Patients who received placebo in CHAMPS were considered the delayed treatment (DT) group, and patients who received IFNbeta-1a in CHAMPS were considered the immediate treatment (IT) group. The primary outcome measure was the rate of development of CDMS. Additional outcomes included disease state classification at 5 years, annualized relapse rates, disability level at 5 years (Expanded Disability Status Scale), and MRI measures at 5 years.
  
  
  RESULTS
  Fifty-three percent (203/383) of patients enrolled in CHAMPIONS (n = 100, IT group; n = 103, DT group) and 64% (32/50) of CHAMPS study sites participated in CHAMPIONS. The median time to initiation of IFNbeta-1a therapy in the DT group was 29 months. The cumulative probability of development of CDMS was significantly lower in the IT group compared with the DT group (5-year incidence 36 +/- 9 vs 49 +/- 10%; p = 0.03). Multivariate analysis suggested that the only factors independently associated with an increased rate of development of CDMS were randomization to the DT group and younger age at onset of neurologic symptoms. Few patients in either group developed major disability within 5 years.
  
  
  CONCLUSIONS
  These results support the use of IM interferon beta-1a after a first clinical demyelinating event and indicate that there may be modest beneficial effects of immediate treatment compared with delayed initiation of treatment.
authors.forename: R Philip
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authors.lastname: Felton
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authors.lastname: Fox
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authors.lastname: Freedman
authors.forename: Steven
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authors.lastname: Galetta
authors.forename: Andrew
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authors.lastname: Goodman
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authors.lastname: Guarnaccia
authors.forename: Stanley
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authors.lastname: Hashimoto
authors.forename: Steven
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authors.lastname: Horowitz
authors.forename: Jeffrey
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authors.lastname: Javerbaum
authors.forename: Lloyd
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authors.lastname: Kasper
authors.forename: Michael
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authors.lastname: Kaufman
authors.forename: Lloyd
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authors.lastname: Kerson
authors.forename: Michelle
authors.initials: M
authors.lastname: Mass
authors.forename: Kottil
authors.initials: K
authors.lastname: Rammohan
authors.forename: Merrell
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authors.lastname: Reiss
authors.forename: Loren
authors.initials: L
authors.lastname: Rolak
authors.forename: John
authors.initials: J
authors.lastname: Rose
authors.forename: Thomas
authors.initials: T
authors.lastname: Scott
authors.forename: John
authors.initials: J
authors.lastname: Selhorst
authors.forename: Robert
authors.initials: R
authors.lastname: Shin
authors.forename: Craig
authors.initials: C
authors.lastname: Smith
authors.forename: William
authors.initials: W
authors.lastname: Stuart
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authors.lastname: Thurston
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mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D003711:Demyelinating Diseases / Q000188:drug therapy* / Q000276:immunology*; D005500:Follow-Up Studies; D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000145:classification / Q000453:epidemiology / Q000517:prevention & control*; D012008:Recurrence; D012044:Regression Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D016899:Interferon-beta; D000068556:Interferon beta-1a