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

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.