title: Dimethyl fumarate (Tecfidera): a new oral agent for multiple sclerosis.
abstract: OBJECTIVE
  To describe the clinical evidence supporting the safety, efficacy, and clinical utility of oral dimethyl fumarate for the treatment of multiple sclerosis (MS).
  
  
  METHODS
  A comprehensive PubMed search was conducted in July 2013 using the search terms dimethyl fumarate and Tecfidera. Reference lists of abstracted publications were reviewed to identify relevant works that were not retrieved via the electronic search. Additional information was obtained from the FDA Web site, manufacturer prescribing information, and Clinicaltrials.gov.
  
  
  METHODS
  Clinical trials and review articles that included the use of dimethyl fumarate in the treatment of MS and were available in English were abstracted for review.
  
  
  RESULTS
  The safety and efficacy of dimethyl fumarate for the treatment of relapsing remitting MS was confirmed in 2 phase III trials, DEFINE and CONFIRM. Relative to placebo, twice-daily dimethyl fumarate was found to reduce the proportion of patients with relapses at 2 years by 34% to 49% and the annualized relapse rate by 44% to 53%. Although the incidence of serious adverse effects did not differ from that of placebo, intolerable flushing and gastrointestinal adverse effects prompted discontinuation in 3% and 4% of patients, respectively.
  
  
  CONCLUSIONS
  In March 2013, dimethyl fumarate was approved as a third oral option for patients with relapsing forms of MS. Although no head-to-head trials have been conducted, a comparison of data from phase III trials suggests that the efficacy of dimethyl fumarate is comparable to that of existing oral agents and may offer a preferable safety profile.
authors.affiliation: University of Rochester Medical Center/Strong Memorial Hospital, Rochester, NY, USA.
authors.forename: Jineane V
authors.initials: JV
authors.lastname: Venci
authors.forename: Mona A
authors.initials: MA
authors.lastname: Gandhi
mesh_terms: D000284:Administration, Oral; D000069462:Dimethyl Fumarate; D004347:Drug Interactions; D005650:Fumarates / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D005650:Fumarates; D007166:Immunosuppressive Agents; D000069462:Dimethyl Fumarate
keywords: ambulatory care; clinical pharmacy; drug information; evidence-based practice; multiple sclerosis; neurology