Literature Highlight: Dimethyl Fumarate: an Investigational Drug for Relapsing/Remitting Multiple Sclerosis

Patients were 18-55 years old and were considered ambulatory (EDSS [Expanded Disability Status Scale] score ≤5). Patients were excluded if they had a progressive form of MS, another major disease, abnormal lab tests, or a recent exposure to contraindicated medication. The patients were randomly given either dimethyl fumarate 240 mg twice daily (BID), dimethyl fumarate 240 mg three times daily (TID), or placebo for two years. The primary endpoint was the proportion of patients who had a relapse by two years. Secondary endpoints included the annualized relapse rate (number of relapses divided by the number of patient-years in the study) and the time to disability progression. Nine hundred fifty-two patients completed the study, with similar proportions of patients in each group. Baseline characteristics were similar between groups. The proportion of patients who experienced at least one relapse at two years was significantly less in the dimethyl fumarate groups (27% in the BID group, 26% in the TID group, and 46% in the placebo group; p<0.001). Both dimethyl fumarate BID and TID significantly decreased the risk of relapse by 50% (HR for BID group 0.51; 95% CI 0.40-0.66; HR for TID group 0.50; 95% CI 0.39-0.65). The annualized relapse rates at two years were 0.36, 0.17, and 0.19 in the placebo group, BID group, and TID group, respectively. These annualized relapse rates represented 53% and 48% relative reductions in the BID and TID groups, respectively (p<0.001). Progression of disability occurred in 27% of the placebo group, 16% of the BID group, and 18% of the Volume 16, Issue 12 December 2012