OBJECTIVE: To describe the clinical evidence supporting the safety, efficacy, 
and clinical utility of oral dimethyl fumarate for the treatment of multiple 
sclerosis (MS).
DATA SOURCES: 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.
STUDY SELECTION AND DATA ABSTRACTION: 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.
DATA SYNTHESIS: 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.