Abstract: Effect Of BG-12 (Dimethyl Fumarate) On Quality Of Life In Patients With MS (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Mariko Kita, MD , Virginia Mason Medical Center, Seattle, WA, USA, Seattle, WA

Robert J. Fox, MD, FAAN , Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH

Ralf Gold, MD , St Josef Hospital, Ruhr University, Bochum, Germany, Bochum, Germany

Gavin Giovannoni, PhD , Queen Mary University of London, Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK, London, United Kingdom

J. Theodore Phillips, MD PhD FAAN , Multiple Sclerosis Program, Baylor Institute for Immunology Research, Dallas, TX, USA, Dallas, TX

Sujata P. Sarda, PhD , Biogen Idec Inc., Weston, MA, USA, Weston, MA

Jessica Kong, PhD , Biogen Idec Inc., Weston, MA, USA, Cambridge, MA

Vissia Viglietta, MD , Biogen Idec Inc., Weston, MA, USA, Cambridge, MA

Sarah I. Sheikh, MD, MRCP, MSc , Biogen Idec Inc., Weston, MA, USA, Cambridge, MA

Katherine T. Dawson, MD , Biogen Idec Inc., Weston, MA, USA, Cambridge, MA

Ludwig Kappos, MD , University Hospital, Basel Neurology, Basel, Switzerland, Basel, Switzerland

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Background: In the Phase 3 DEFINE and CONFIRM studies, BG-12 (dimethyl fumarate) demonstrated both clinical and radiological efficacy in patients with relapsing-remitting multiple sclerosis (RRMS).

Objectives: To describe the effects of BG-12 over 2 years on health-related quality of life (HRQoL) endpoints from a pre-specified integrated analysis in RRMS patients over 2 years. This analysis was conducted to estimate more precisely the therapeutic effect of BG-12 versus placebo.

Methods: The pre-specified integrated analysis plan was to be conducted only if baseline characteristics and treatment effects were consistent across studies. Patients randomized to oral BG-12 240 mg twice (BID) or three times daily (TID) or placebo were included in the pre-specified integrated analysis. HRQoL endpoints assessed in both studies were the Short Form-36 (SF-36) Physical and Mental Component Summary (PCS/MCS) scales, global assessment of well-being visual analog scale (VAS), and the EuroQOL-5D (EQ-5D) VAS and the EQ-5D. Higher scores indicated better HRQoL.

Results: Baseline characteristics and treatment effects were similar across studies. The pre-specified integrated analysis included 769, 761, and 771 patients assigned to BG-12 BID, TID, and placebo, respectively. Both physical and mental health and functioning were significantly improved with BG-12 versus placebo. Mean SF-36 PCS scores increased from baseline by 0.47 (BID) and 0.43 (TID) versus a reduction of −1.05 (placebo) at 2 years (both p<0.0001). SF-36 MCS scores increased by 0.31 (BID) and 0.63 (TID) versus a reduction of −0.60 (placebo) (p=0.0246 and p=0.0107, respectively). Patients in BG-12 groups reported a significantly better sense of well-being and perception of health status versus the placebo group. Mean changes from baseline to 2 years with BID and TID versus placebo were −0.3 and 0.1 versus −4.0 for global well-being VAS (both p<0.0001); and –0.90 and –0.31 versus –3.37 for EQ-5D VAS (p=0.0011 and p=0.0002, respectively). Similar to EQ-5D VAS, mean changes in EQ-5D from baseline to 2 years with BID and TID versus placebo were 0.01 and 0.01 versus –1.0 (p=0.0239 and p=0.0141, respectively).

Conclusions: BG-12 treatment resulted in significant improvements in physical and mental aspects of health and functioning, general well-being, and overall health status compared with placebo in patients with RRMS.

SX18 Effect Of BG-12 (Dimethyl Fumarate) On Quality Of Life In Patients With MS