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- Title
Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing–remitting multiple sclerosis: The DEFINE study.
- Authors
Kappos, Ludwig; Gold, Ralf; Arnold, Douglas L; Bar-Or, Amit; Giovannoni, Gavin; Selmaj, Krzysztof; Sarda, Sujata P; Agarwal, Sonalee; Zhang, Annie; Sheikh, Sarah I; Seidman, Emily; Dawson, Katherine T
- Abstract
Background: Oral BG-12 (dimethyl fumarate), approved for the treatment of the relapsing forms of MS, has demonstratedclinical efficacy with an acceptable safety profile in the Phase III "Determination of the Efficacy and Safety ofOral Fumarate in Relapsing–Remitting Multiple Sclerosis (RRMS)†(DEFINE) and “Comparator and an Oral Fumarate inRRMS" (CONFIRM) studies.Objectives: To evaluate the health-related quality of life (HRQoL) impairment that is associated with RRMS and toassess the effects of BG-12 on HRQoL in the DEFINE study.Methods: Patients with RRMS were randomized to BG-12 240 mg twice (BID) or three times (TID) daily, or placebo,for 2 years. HRQoL was assessed by the Short Form-36 (SF-36), global assessment of well-being visual analog scale andthe EuroQol-5D.Results: In the 1237 patients from DEFINE, HRQoL impairment was greatest in patients who had higher disabilityscores and in those who had experienced relapse. Change in SF-36 physical component summary scores during 2 years’treatment significantly favored BG-12 over placebo (both doses: p < 0.001). We saw similar benefits in other measuresof functioning and general well-being as early as Week 24. These benefits were maintained during the study.Conclusions: Our results add to evidence for a negative impact of RRMS on HRQoL and they demonstrate the benefitsof BG-12 on HRQoL measures, which coupled with significant clinical efficacy, further support its use as a new treatmentfor RRMS.
- Subjects
QUALITY of life; MULTIPLE sclerosis research; MYELIN sheath diseases; BISOPROLOL; ADRENERGIC beta blockers
- Publication
Multiple Sclerosis Journal, 2014, Vol 20, Issue 2, p243
- ISSN
1352-4585
- Publication type
Article
- DOI
10.1177/1352458513507817