title: Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome.
abstract: BACKGROUND
  Multiple sclerosis (MS) is characterised by inflammatory lesions of the central nervous system. Interferon beta-1b (IFNB-1b) has been shown to improve clinical and magnetic resonance imaging (MRI) measures for patients with MS.
  
  
  OBJECTIVE
  To evaluate whether IFNB-1b in patients presenting with clinically isolated syndromes (CIS) prevented persisting T1 hypointensities on MRI (persistent black holes (PBHs)).
  
  
  METHODS
  In the placebo-controlled phase, patients (n = 468) were initially randomised to IFNB-1b (n = 292) or placebo (n = 176) for two years or clinically definite MS (CDMS). In the open-label phase (n = 418), both groups were offered IFNB-1b for up to five years. Lesions were classified as PBHs if T1 hypointensity persisted throughout the last available scan (minimum time one year).
  
  
  RESULTS
  A total of 435 patients were evaluable for analysis. The number of PBHs/patient was lower in the early rather than the delayed treatment arm during both phases (.42 vs .71, p = .0102 and .70 vs 1.17, p = .0121). Exploratory analyses identified baseline characteristics that affected rate of conversion.
  
  
  CONCLUSIONS
  Although the rate of lesions that converted to PBH showed no significant differences between groups, the numbers of PBHs per patient out of new lesions was significantly lower in IFNB-1b patients compared to patients on placebo.
  
  
  BACKGROUND
  NCT00544037.
authors.affiliation: Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands.
authors.forename: Gijsbert J A
authors.initials: GJ
authors.lastname: Nagtegaal
authors.forename: Christoph
authors.initials: C
authors.lastname: Pohl
authors.forename: Mike P
authors.initials: MP
authors.lastname: Wattjes
authors.forename: Hanneke E
authors.initials: HE
authors.lastname: Hulst
authors.forename: Mark S
authors.initials: MS
authors.lastname: Freedman
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hartung
authors.forename: David
authors.initials: D
authors.lastname: Miller
authors.forename: Xavier
authors.initials: X
authors.lastname: Montalban
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Gilles
authors.initials: G
authors.lastname: Edan
authors.forename: Dirk
authors.initials: D
authors.lastname: Pleimes
authors.forename: Karola
authors.initials: K
authors.lastname: Beckman
authors.forename: Brigitte
authors.initials: B
authors.lastname: Stemper
authors.forename: Christoph H
authors.initials: CH
authors.lastname: Polman
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
authors.forename: Frederik
authors.initials: F
authors.lastname: Barkhof
mesh_terms: D000293:Adolescent; D000328:Adult; D002490:Central Nervous System / Q000473:pathology*; D003711:Demyelinating Diseases / Q000188:drug therapy* / Q000473:pathology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068576:Interferon beta-1b; D016899:Interferon-beta
keywords: Interferon beta-1b; MRI; T1 hypointensity; black holes