CMSC 2012: Dimethyl Fumarate Improves Annualized Relapse Rate and Risk of Relapse in Patients With RRMS

SAN DIEGO — Treatment with the investigational oral treatment for relapsing-remitting multiple sclerosis (RRMS), dimethyl fumarate (also known as BG-12), yielded significant reductions in the annualized relapse rate (ARR) and risk of relapse, according to research presented at the Fourth Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and America’s Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

Dimethyl fumarate, currently under review by US and European regulators as a monotherapy treatment for RRMS, is thought to have both anti-inflammatory and neuroprotective effects. Its efficacy has been studied in two phase 3 trials—the DEFINE and CONFIRM studies.

Robert J. Fox, MD, of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic in Ohio, and colleagues reported results from the multicenter, randomized placebo-controlled phase III CONFIRM study involving 1,417 patients aged 18 to 55 years with RRMS and an Expanded Disability Status Scale (EDSS) score less than 5 who received either placebo, dimethyl fumarate 240 mg twice daily (BID), or 240 mg three times per day (TID). An active comparator arm was also included, in which patients received subcutaneous glatiramer acetate, 20 mg/day.

At 2 years, ARR was statistically significantly reduced by 44 percent, 51 percent, and 29 percent for dimethyl fumarate BID, TID, and glatiramer acetate, respectively, compared with placebo.

Similarly, risk of relapse was also statistically significantly reduced by 34 percent, 45 percent, and 29 percent for dimethyl fumarate BID, TID, and glatiramer acetate, respectively, compared with placebo.

The 12-week confirmed disability progression was also reduced by 21 percent, 24 percent and 7percent for dimethyl fumarate BID, TID, and glatiramer acetate, respectively, compared with placebo.

The adverse event profile and incidence of serious adverse events was similar across all treatment groups. The most common adverse events associated with dimethyl fumarate were flushing or reddening of the skin, nausea, and diarrhea, especially during the first month of treatment but much less frequently thereafter. The incidence of serious infections were low and similar between groups, and no malignancies were reported.

"Clinical efficacy results from CONFIRM are consistent with and further support those from DEFINE and suggest that BG-12 has the potential to be a valuable treatment option for patients with RRMS," the authors concluded.

This research was supported by Biogen Idec Inc.