Clinical Efficacy of BG-12 in Relapsing-Remitting Multiple Sclerosis (RRMS): Data from the Phase 3 CONFIRM Study (S01.003)

Abstract

Objective: To describe the efficacy of BG-12 (dimethyl fumarate) in patients with RRMS in the Phase 3 CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis) study. Background BG-12 demonstrated significant reductions in the proportion of patients relapsed, annualized relapse rate (ARR), and disability progression versus placebo in RRMS patients in DEFINE, the first of two Phase 3 studies. Design/Methods: CONFIRM was a multicenter, randomized, placebo-controlled, reference comparator study that evaluated the efficacy and safety of BG-12 over 2 years in RRMS patients. Patients (18–55 years) with a diagnosis of RRMS per McDonald criteria and an Expanded Disability Status Scale (EDSS) score of 0.0–5.0 were enrolled. CONFIRM evaluated BG-12 240 mg twice (BID) and three times daily (TID) versus placebo and included an active reference comparator arm with subcutaneous glatiramer acetate (GA) 20 mg/day. The primary endpoint was ARR at 2 years. Secondary clinical endpoints included the proportion of patients who relapsed and disability progression as measured by EDSS at 2 years. Results: A total of 1417 patients received treatment. Baseline demographic and clinical characteristics were similar across treatment groups. BG-12 BID (n=359) and TID (n=345) significantly reduced ARR by 44% (p Conclusions: Efficacy results from CONFIRM further support those from DEFINE and suggest that BG-12 has the potential to be a valuable treatment option for RRMS patients. Supported by: Biogen Idec Inc. Disclosure: Dr. Fox has received personal compensation for activities with Avanir, Biogen Idec, EMD Serono, and Novartis. Dr. Fox has received research support from Biogen Idec and Genentech, Inc. Dr. Miller has received personal compensation for activities with UCL Institute of Neurology, Biogen Idec, GlaxoSmithKline, and Bayer Schering Pharma. Dr. Miller has received personal compensation in an editorial capacity for Journal of Neurology. Dr. Miller has received research support from GlaxoSmithKline, Biogen Idec, and Novartis. Dr. Phillips has received personal compensation for activities with Avanir, Biogen Idec, Genzyme, Novartis, and Teva as a speaker or consultant.Dr. Phillips has received research support from Biogen Idec and Roche. Dr. Kita has received personal compensation for activities with Biogen Idec as a speaker. Dr. Kita has received research support from Biogen Idec. Dr. Hutchinson has received personal compensation for activities with Biogen Idec as a speaker. Dr. Havrodova has received personal compensation for activities with Bayer Pharmaceuticals Corporation, Biogen Idec, Genzyme Corporation, GlaxoSmithKline, Inc., Novartis, Merck, Sanofi-Aventis Pharmaceuticals, Serono, Inc., and Teva as consultant, speaker and/or advisory board participant. Ms. Yang has received personal compensation for activities with Biogen Idec as an employee. Dr. Zhang has received personal compensation for activities with Biogen Idec as an employee. Dr. Viglietta has received personal compensation for activities with Biogen Idec. Dr. Dawson has received personal compensation for activities with Biogen Idec Inc. as an employee.