The Effectiveness of Dimethyl Fumarate Monotherapy in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Systematic Review and Meta-Analysis

Background:

Dimethyl fumarate (BG-12, Tecfidera®) is a new oral drug approved by FDA and EMA in March2013 for relapsing – remitting multiple sclerosis (RRMS). The drug was much anticipated because of its possiblesuperiority over currently available medications: fingolimod and teriflunomide as the only MS treatments currentlyavailable in oral form.

Objective:

The aim of this systematic review with meta-analysis was to assess the efficacy and safety of BG-12 in thetreatment of RRMS.

Methods:

A systematic literature search was conducted in Medline/PubMed, EMBASE, and Cochrane Library up till 3^rdNovember, 2013. We sought all published randomized clinical trials evaluating the use of dimethyl fumarate for thetreatment of patients with RRMS. All included studies were critically appraised and analyzed with the use of ReviewManager 5.1.0. software according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) statement protocol.

Results:

Two trials, DEFINE and CONFIRM involved 2 651 patients and compared dimethyl fumarate taken either two orthree times daily with placebo in patients with RRMS. Additionally in CONFIRM trial third group of patients receivedglatiramer acetate. The overall results of the meta-analysis showed that BG-12 (at both dosages) given to patients withRRMS is safe and statistically significantly more effective than placebo in reducing the proportion of patients who hada relapse by 2 years, the rate of disability progression and the mean number of gadolinium-enhancing lesions at 2 years.The comparison between BG-12 and glatiramer acetate revealed that the analyzed agent could potentially be moreeffective in the treatment of RRMS.

Conclusions:

Despite limited RCTs data available, both analyzed BG-12 regimens showed their efficacy on clinicaldisease parameters and other measures of disease activity in RRMS. The safety profile of the study agent was acceptable.