BG-12 reduces evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosis

J Neurol. 2011 Mar;258(3):449-56. doi: 10.1007/s00415-010-5777-z. Epub 2010 Oct 21.

Abstract

BG-12, an immunomodulatory agent, reduces frequency of new gadolinium-enhancing (Gd+) lesions in relapsing multiple sclerosis (MS). This study reports the effect of 240 mg BG-12 orally three times daily (tid) for 24 weeks on the evolution of new Gd+ lesions to T1-hypointense lesions. Brain magnetic resonance imaging (MRI) scans from patients in placebo and 240 mg BG-12 tid arms of a phase 2b study were examined retrospectively. Included patients had at least one new Gd+ lesion from weeks 4 to 12. Week 24 scans were analyzed for number and proportion of new Gd+ lesions that evolved to T1-hypointense lesions. Eighteen patients receiving BG-12 and 38 patients receiving placebo were included in the analysis. The analysis tracked 147 new Gd+ lesions in patients from the BG-12 group and 221 Gd+ lesions in patients from the placebo group. The percentage of Gd+ lesions that evolved to T1-hypointense lesions was 34% lower with BG-12 treatment versus placebo (29%, BG-12; 44%, placebo; odds ratio 0.51; 95% confidence interval 0.43, 0.61; p < 0.0001). In addition to reducing frequency of new Gd+ lesions, BG-12 significantly reduced probability of their evolution to T1-hypointense lesions in patients with MS compared with placebo.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Controlled Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Dimethyl Fumarate
  • Double-Blind Method
  • Female
  • Fumarates / therapeutic use*
  • Humans
  • Magnetic Resonance Imaging* / trends
  • Male
  • Middle Aged
  • Multiple Sclerosis / pathology*
  • Multiple Sclerosis / prevention & control*
  • Retrospective Studies
  • Young Adult

Substances

  • Fumarates
  • Dimethyl Fumarate