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Link to original content: http://pubmed.ncbi.nlm.nih.gov/21878455/
Effect of BG-12 on contrast-enhanced lesions in patients with relapsing--remitting multiple sclerosis: subgroup analyses from the phase 2b study - PubMed Skip to main page content
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Clinical Trial
. 2012 Mar;18(3):314-21.
doi: 10.1177/1352458511421054. Epub 2011 Aug 30.

Effect of BG-12 on contrast-enhanced lesions in patients with relapsing--remitting multiple sclerosis: subgroup analyses from the phase 2b study

Ludwig Kappos  1 , Ralf Gold, David H Miller, David G MacManus, Eva Havrdova, Volker Limmroth, Chris H Polman, Klaus Schmierer, Tarek A Yousry, Mefkure Eraksoy, Eva Meluzinova, Michal Dufek, Minhua Yang, Kate Dawson, Gilmore N O'Neill
Affiliations
Clinical Trial

Effect of BG-12 on contrast-enhanced lesions in patients with relapsing--remitting multiple sclerosis: subgroup analyses from the phase 2b study

Ludwig Kappos et al. Mult Scler. 2012 Mar.

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).

Conclusion: 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.

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