Health-Related Quality of Life in Relapsing-Remitting Multiple Sclerosis (RRMS): Comparison with Other Medical Conditions and Effect of Delayed-Release Dimethyl Fumarate Treatment (P4.182)

OBJECTIVE: Descriptively compare the impact of MS vs other chronic conditions on patient-reported health-related quality of life (HRQoL) and report the effect of oral delayed-release dimethyl fumarate (DMF) on HRQoL in a pre-specified, integrated analysis of the Phase 3 DEFINE and CONFIRM studies. BACKGROUND: DEFINE and CONFIRM evaluated the efficacy and safety of delayed-release DMF 240mg twice (BID) and three times daily (TID) in RRMS. DESIGN/METHODS: HRQoL was assessed at baseline and Weeks 24, 48, and 96 using the Short Form-36 version 1 [SF-36v1]). The SF-36v1 consists of 8 multi-item domains (physical functioning [PF], role-physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]). PF, RP, BP, and GH assess physical aspects of HRQoL (Physical Component Summary [PCS]) and VT, SF, RE, and MH assess mental aspects (Mental Component Summary [MCS]). Normative mean domain scores for hypertension, congestive heart failure, diabetes type II, recent acute myocardial infarction, and clinical depression were obtained from the SF-36v1 manual. RESULTS: The US general population normal score for PCS and MCS is 50. Mean baseline domain score ranges across the placebo and delayed-release DMF groups were 67.1-68.9 (PF), 55.0-55.8 (RP), 68.5-68.6 (BP), 53.2-53.9 (GH), 49.2-49.8 (VT), 69.5-70.4 (SF), 63.3-64.4 (RE), and 65.0-65.1 (MH), and across the five other medical conditions were 47.5-73.4 (PF), 34.4-62.0 (RP), 58.8-72.8 (BP), 47.1-63.3 (GH), 40.1-58.3 (VT), 57.2-86.7 (SF), 38.9-76.7 (RE), and 46.3-77.9 (MH). At 2 years, compared with placebo, mean changes relative to baseline in PCS and MCS scores were statistically significantly improved in the delayed-release DMF BID (P<0.0001 and P=0.0246, respectively) and TID (P<0.0001 and P=0.0107, respectively) groups. CONCLUSIONS: The disease burden of MS appears to be higher than the US general population and less than or comparable to other medical conditions. Delayed-release DMF demonstrates benefits on patient-reported HRQoL. Study supported by: Biogen Idec, Inc. Disclosure: Dr. Sarda has received personal compensation for activities with Biogen Idec. Dr. Phillips has received personal compensation for activities with Biogen Idec as an employee. Dr. Phillips holds stock and/or stock options in Biogen Idec which sponsored research in which Dr. Phillips was involved as an investigator. Dr. Gaebler 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.