title: Effect of BG-12 on contrast-enhanced lesions in patients with relapsing--remitting multiple sclerosis: subgroup analyses from the phase 2b study.
abstract: BACKGROUND
  In a phase 2b study in patients with relapsing-remitting MS (RRMS), BG-12 240 mg three times daily significantly reduced the number of new gadolinium-enhanced (Gd+) lesions from weeks 12 to 24 (primary end point) by 69% compared with placebo.
  
  
  OBJECTIVE
  In this analysis, the effect of BG-12 240 mg three times daily on the number of Gd+ lesions from weeks 12 to 24 was evaluated in subgroups based on baseline disease characteristics and demographics.
  
  
  METHODS
  Two hundred and fifty-seven patients were randomized equally to receive BG-12 (120 mg once daily or three times daily or 240 mg three times daily) or placebo.
  
  
  RESULTS
  BG-12 240 mg three times daily significantly reduced the number of new Gd+ lesions compared with placebo in the following subgroups: Expanded Disability Status Scale (EDSS) score ≤ 2.5 (74%), EDSS score > 2.5 (63%), no Gd+ lesions (80%), ≥ 1 Gd+ lesion (55%), age < 40 years (49%), age ≥ 40 years (89%), female patients (81%), disease duration ≤ 6 years (81%) and disease duration > 6 years (54%) (all comparisons p < 0.05).
  
  
  CONCLUSIONS
  BG-12 demonstrated efficacy in patients with RRMS by decreasing new Gd+ lesion development across a range of subgroups defined by baseline disease characteristics or demographics.
authors: Department of Neurology, University Hospital Basel, Basel, Switzerland. lkappos@uhbs.ch
authors: Ludwig
authors: L
authors: Kappos
authors: Ralf
authors: R
authors: Gold
authors: David H
authors: DH
authors: Miller
authors: David G
authors: DG
authors: MacManus
authors: Eva
authors: E
authors: Havrdova
authors: Volker
authors: V
authors: Limmroth
authors: Chris H
authors: CH
authors: Polman
authors: Klaus
authors: K
authors: Schmierer
authors: Tarek A
authors: TA
authors: Yousry
authors: Mefkure
authors: M
authors: Eraksoy
authors: Eva
authors: E
authors: Meluzinova
authors: Michal
authors: M
authors: Dufek
authors: Minhua
authors: M
authors: Yang
authors: Kate
authors: K
authors: Dawson
authors: Gilmore N
authors: GN
authors: O'Neill
mesh_terms: D000293:Adolescent; D000328:Adult; D001921:Brain / Q000473:pathology*; D003287:Contrast Media; D000069462:Dimethyl Fumarate; D005260:Female; D005650:Fumarates / Q000627:therapeutic use*; D005682:Gadolinium; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003287:Contrast Media; D005650:Fumarates; D005682:Gadolinium; D000069462:Dimethyl Fumarate