Quality of Life in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Delayed-Release Dimethyl Fumarate: A Three-Year Interim Analysis of ENDORSE (P7.236)

OBJECTIVE: Present an interim analysis of health-related quality of life (HRQoL) in relapsing-remitting multiple sclerosis (RRMS) patients treated with delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in ENDORSE, an 8-year extension of Phase 3 DEFINE and CONFIRM studies. BACKGROUND: In DEFINE/CONFIRM, patients receiving DMF showed better HRQoL compared to placebo (PBO), as assessed by the 36-item Short Form health survey version 1 (SF-36v1). DESIGN/METHODS: Patients randomized to DMF 240mg twice (BID) or three times daily (TID) in DEFINE/CONFIRM continued the same dosage. Patients receiving PBO or glatiramer acetate (GA) were re-randomized 1:1 to DMF BID or TID. SF-36v1 was administered at baseline and every 48 weeks thereafter: a positive change indicates improved HRQoL. Data (as of May 14, 2014) for approved dosage (BID) are reported and analyzed by parent/extension study arm; GA/BID results are not shown due to small sample size. Changes relative to DEFINE/CONFIRM baseline are presented for patients continuing DMF (BID/BID) and changes relative to ENDORSE baseline are presented for patients new to DMF (PBO/BID), as these convey effects since treatment initiation. RESULTS: The intent-to-treat population comprised 1,500 patients, including 501 BID/BID and 249 PBO/BID. At Year 3 of ENDORSE, BID/BID patients (n=348) showed mean changes of 0.8 (P=0.028) in physical component scale (PCS) and 0.4 (P=0.711) in mental component scale (MCS) scores. PBO/BID patients (n=167) demonstrated mean changes in PCS/MCS scores of -0.7/-1.1 (P=0.413/P=0.281). Proportions of patients with clinically-relevant improvements (蠅5-point increase) or stability (<5-point increase/decrease) in PCS and MCS scores were 78.4[percnt] and 73.0[percnt] (BID/BID) and 76.6[percnt] and 68.9[percnt] (PBO/BID). CONCLUSIONS: These data suggest a long-term improvement in physical aspects and stability over time in mental aspects of HRQoL with continuing DMF treatment. Data for patients who switched to DMF in ENDORSE suggest stability in physical and mental aspects. Study Supported by: Biogen Idec Disclosure: Dr. Kita9s employer has received personal compensation for activities as an advisor. Dr. Kappos has received personal compensation for activities with Actelion Pharmaceuticals. Dr. Fox has received personal compensation for activities with Biogen Idec, GlaxoSmithKline, Inc., Novartis, Questcor, Teva, and Xenoport. Dr. Fox has received research support from Novartis. Dr. Gold has received personal compensation for activities with Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Dr. Giovannoni has received personal compensation for activities with AbbVie, Biogen Idec, Canbex Therapeutics, Genzyme Sanofi, Ironwood Pharmaceuticals Inc., Novartis, Merck, Merck Serono, Roche, Synthon, Teva, Vertex, and Bayer Schering Pharma as a scie Dr. Phillips has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, Genzyme, Merck Serono, and Sanofi-Aventis Pharmaceuticals, Inc. as a consultant. Dr. Sarda has received personal compensation for activities with Biogen Idec as an employee. Dr. Okwuokenye has received personal compensation for activities with Biogen Idec as an employee. Dr. Kong has received personal compensation for activities with Biogen Idec as an employee. Dr. Kurukulasuriya has received personal compensation for activities with Biogen Idec as an employee.