DMF Reduces Disease Activity Long-Term in Multiple Sclerosis

Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF) is effective at lowering disease activity long-term in patients with relapsing-remitting multiple sclerosis (RRMS), according to Eva Havrdova, MD, of Charles University of Prague. The findings are set to 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.

A duo of studies, DEFINE and CONFIRM, previously found that patients taking DMF were nearly two times as likely to show no disease activity (NEDA). The findings proved to hold true for five years and the research moved onto an eight-year extension study, ENDORSE. Long-term results, however, were lacking.

Havrdova and team randomized patients to receive either: DMF 240 mg twice per day, three times per day, a placebo, or glatiramer acetate. Overall NEDA was defined as patients with no relapses, no 12-week Expanded Disability Status Scale (EDSS)-confirmed progression, no gadolinium-enhanced lesions, and no new or enlarged T2 lesions.

After two years, 1,118 out of 1,736 ENDORSE patients had clinical NEDA and only 618 did not. Magnetic resonance imaging (MRI) results showed that out of the 799 patients who had data on all four components of NEDA, 171 had overall NEDA and 628 did not.

“At Year 3 in ENDORSE, the ARR [annualized relapse rate] was significantly lower in patients with clinical and overall NEDA vs those without: 0.099 vs 0.268 (risk ratio: 0.371; P< 0.0001) and 0.081 vs 0.198 (risk ratio: 0.409; P< 0.0001), respectively,” the authors confirmed. “Throughout the three years in ENDORSE, clinical and overall NEDA patients maintained significantly lower EDSS scores than those without.”

The outcomes suggest that compared to a placebo, DMF significantly reduces disease activity.