Effects of BG-12 on Quality of Life in Patients with Relapsing-Remitting Multiple Sclerosis: Findings from the DEFINE Study (P07.102)

Abstract

Objective: To report the impact of BG-12 on patient quality of life (QoL) after 2 years9 treatment in the Phase 3 DEFINE study. Background In DEFINE, a randomized, double-blind, placebo-controlled, multicenter study that evaluated the efficacy and safety of BG-12 over 2 years in patients with relapsing-remitting multiple sclerosis (RRMS), BG-12 significantly reduced clinical relapses, disability progression, and magnetic resonance imaging measures of disease activity. Design/Methods: Patients aged 18-55 years with RRMS (McDonald criteria) and Expanded Disability Status Scale score of 0.0-5.0 were eligible for enrollment. Patients were randomized 1:1:1 to placebo or BG-12 240 mg twice (BID) or three times daily (TID). A Short Form (SF)-36 questionnaire measured patients9 health status and health-related QoL on 8 multi-item 100-point scales at baseline and 6, 12, and 24 months; higher scores indicated higher QoL. These scores were used to calculate the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Results: Overall, 1234 patients enrolled and received study treatment. At 2 years, patients reported higher mean SF-36 PCS scores with BG-12 BID (43.4) and TID (44.2) versus placebo (41.9; P Conclusions: Together with the significant effects on clinical measures (reduced relapse risk, annualized relapse rate, and disability progression), the demonstrated benefits on patient-reported health-related QoL further supports a potential role for BG-12 as a valuable oral treatment option in RRMS patients. Supported by: Biogen Idec Inc. Disclosure: Dr. Agarwal has received personal compensation for activities with Biogen Idec Inc as an employee. Dr. Kappos has received research support from Acorda Therapeutics, Actelion, Allozyne, BaroFold, Inc., Bayer Pharmaceuticals Corporation, Bayhill Therapeutics, Biogen Idec, Boehringer Ingelheim Pharmaceuticals, Inc, Elan Corporation, Genmab, GlaxoSmithKline, Inc., Glenmark Pharma, Merck Serono, MediciNova, Novartis, Sanofi-Aventis Pharmaceuticals, Santhera Pharmaceuticals, Shire, Roche Diagnostics, Teva Neuroscience, UCB Pharma, Pfizer Inc, Swiss MS Society, Swiss National Research Foundation, European Union, Gianni Rubatto Foundation, Novartis and Roche Research Foundations. Dr. Gold has received personal compensation for activities with Bayer Pharmaceuticals Corporation, Biogen Idec, Merck Serono, Teva Neuroscience. Dr. Gold has received personal compensation in an editorial capacity for Therapeutic Advances in Neurological Disorders. Dr. Gold has received (royalty or license fee or contractual rights) payments from Biogen Idec. Dr. Gold has received research support from Bayer Pharmaceuticals Corporation, Biogen Idec, Merck Serono, Novartis and Teva Neuroscience. Dr. Arnold has received personal compensation for activities with Bayer Healthcare, Biogen Idec, Genentech, Inc., NeuroRx Research, Roche Diagnostics Corporation, Schering, Serono, Inc., and Teva Neuroscience. Dr. Arnold Dr. Arnold has received research support from Bayer Healthcare, Biogen Idec, Genentech, Inc., NeuroRx Research, Roche Diagnostics Corporation, Schering, Serono, Inc., and Teva Neuroscience. Dr. Bar-Or has received personal compensation for activities with Aventis Pharmaceuticals, Bayhill Therapeutics, Biogen Idec, Berlex Laboratories, Eli Lilly & Company, Genentech, Inc., GlaxoSmithKline, Ono Pharmaceutical, Diogenix, Roche Diagnostics Corporation, Merck Serono, Novartis, Teva Neuroscience. Dr. Giovannoni has received personal compensation for activities with Bayer-Pharmaceuticals Corporation, Biogen Idec, Five Prime Therapeutics, Inc, Genzyme Corporation, Ironwood Pharmaceuticals, Merck Serono, Novartis, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals and Vertex Pharmaceuticals as a speaker, consultant and/or serving on data monitoring boards. Dr. Selmaj has received personal compensation for activities with Genzyme, Ono, and Biogen Idec. Dr. Kong has received personal compensation for activities with Biogen Idec as an employee. Dr. Sheikh has received personal compensation for activities with Biogen Idec as an employee. Dr. Dawson has received personal compensation for activities with Biogen Idec Inc. as an employee.