title: Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: the DEFINE study.
abstract: BACKGROUND
  Oral BG-12 (dimethyl fumarate), approved for the treatment of the relapsing forms of MS, has demonstrated clinical efficacy with an acceptable safety profile in the Phase III "Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (RRMS)" (DEFINE) and "Comparator and an Oral Fumarate in RRMS" (CONFIRM) studies.
  
  
  OBJECTIVE
  To evaluate the health-related quality of life (HRQoL) impairment that is associated with RRMS and to assess 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 and the EuroQol-5D.
  
  
  RESULTS
  In the 1237 patients from DEFINE, HRQoL impairment was greatest in patients who had higher disability scores 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 measures of 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 benefits of BG-12 on HRQoL measures, which coupled with significant clinical efficacy, further support its use as a new treatment for RRMS.
authors.affiliation: Departments of Neurology and Biomedicine, University Hospital Basel, Switzerland.
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Ralf
authors.initials: R
authors.lastname: Gold
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Arnold
authors.forename: Amit
authors.initials: A
authors.lastname: Bar-Or
authors.forename: Gavin
authors.initials: G
authors.lastname: Giovannoni
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Selmaj
authors.forename: Sujata P
authors.initials: SP
authors.lastname: Sarda
authors.forename: Sonalee
authors.initials: S
authors.lastname: Agarwal
authors.forename: Annie
authors.initials: A
authors.lastname: Zhang
authors.forename: Sarah I
authors.initials: SI
authors.lastname: Sheikh
authors.forename: Emily
authors.initials: E
authors.lastname: Seidman
authors.forename: Katherine T
authors.initials: KT
authors.lastname: Dawson
mesh_terms: D000328:Adult; D000069462:Dimethyl Fumarate; D004311:Double-Blind Method; D005260:Female; D005650:Fumarates / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D005650:Fumarates; D007166:Immunosuppressive Agents; D000069462:Dimethyl Fumarate
keywords: BG-12; DEFINE; dimethyl fumarate; multiple sclerosis; quality of life; randomized controlled trial; relapsing–remitting multiple sclerosis