title: Oral BG-12 (dimethyl fumarate) for relapsing-remitting multiple sclerosis: a review of DEFINE and CONFIRM. Evaluation of: Gold R, Kappos L, Arnold D, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107; and Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97.
abstract: BACKGROUND
  Multiple sclerosis (MS) is an autoimmune neurodegenerative disease of the central nervous system involving inflammation, chronic demyelination and axonal loss. MS affects more than 2 million people worldwide.
  
  
  METHODS
  This article aims to summarize the findings from two pivotal 2-year, randomized, double-blind, placebo-controlled, Phase III studies of BG-12 (dimethyl fumarate) for relapsing-remitting MS (RRMS): DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in RRMS) and CONFIRM (Comparator and an Oral Fumarate in RRMS). Results from both studies demonstrated that BG-12 provides clinical and radiological efficacy over 2 years across a range of outcomes. These results were apparent as early as 12 weeks and sustained over the course of both studies. BG-12 was found to have an acceptable safety profile, with a similar overall incidence of adverse events across all treatment groups.
  
  
  CONCLUSIONS
  The combination of robust efficacy, ease of administration and established safety profile is unique to a new therapy in MS. Findings from the pivotal Phase III studies support BG-12 as a potential initial oral treatment for patients with RRMS or as an alternative to other currently available therapies.
authors: Charles University in Prague, First Faculty of Medicine, Department of Neurology , Prague , Czech Republic +420224966422 ; +420224917907 ; ehavr@lf1.cuni.cz.
authors: Eva
authors: E
authors: Havrdova
authors: Michael
authors: M
authors: Hutchinson
authors: Nuwan C
authors: NC
authors: Kurukulasuriya
authors: Kartik
authors: K
authors: Raghupathi
authors: Marianne T
authors: MT
authors: Sweetser
authors: Katherine T
authors: KT
authors: Dawson
authors: Ralf
authors: R
authors: Gold
mesh_terms: D005260:Female; D005650:Fumarates / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*
chemical_list: D005650:Fumarates; D007166:Immunosuppressive Agents; D010455:Peptides