In-Depth Look at DMF Efficacy for Patients with Multiple Sclerosis

Delayed-release dimethyl fumarate (DMF) proved to be safe and effective in two phase 3 studies, DEFINE and CONFIRM, for patients with relapsing-remitting multiple sclerosis (RRMS). Gavin Giovannoni, MBBCh, PhD, FRCP, FRCPath, of the Queen Mary University of London and colleagues took a more detailed look to verify the data.

The studies included six phase 3 RRMS clinical trials which consisted of more than 6,500 patients. The information on DMF, also called a gastro-resistant DMF, was compiled into a database and analyzed by the team. The research will be presented in a poster session at the 31^st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2015) in Barcelona, Spain.

The analysis included patients with early RRMS from ages 18 to 55 with an Expanded Disability Status Scale (EDSS) score of 0-5-0. For up to two years they were randomly assigned to either receive: DMF 240 mg (BID) twice per day, three times per day, a placebo, or subcutaneous glatiramer acetate. Outcomes were measured using EDSS, Multiple Sclerosis Functional Composite (MSFC), and Visual Function Test (VFT). The PASAT-3 test was also used to evaluate cognitive function on a scale of 0 to 60 (the higher the score, the higher cognitive reserve).

At baseline, the amount of patients with a PASAT-3 score more than 39 was 616 out of 769 patients in the DMF BID group and 593 out of 771 patients taking the placebo. After two years, PASAT-3 score significant decreased in those taking DMF BID when compared to the placebo group. In addition, annualized relapse rate (ARR) decreased with DMF BID by 51%, and the risk of disability progression after 12 weeks reduced by 44%.

“Compared with placebo, DMF BID demonstrated beneficial effects on clinical outcomes in RRMS patients early in their disease course according to extent of cognitive impairment,” the authors confirmed.