Gastrointestinal Tolerability of Diroximel Fumarate May Shorten Time to Reach Optimal Dose

In the phase 3 EVOLVE-MS-2 study (NCT03093324), individuals with relapsing multiple sclerosis (MS) treated with diroximel fumarate (Vumerity; Biogen, Cambridge, MA) (n=253) had improved gastrointestinal (GI) tolerability compared with those treated with dimethyl fumarate (n=251). Further data analyses show that the lower incidence of adverse GI effects occurred during both titration and maintenance dosing of diroximel fumarate. In contrast, with dimethyl fumarate, adverse GI effects increased after titatrion to the full dose and peaked in weaks 3 and 4. 

Discontinuation of treatment because of GI adverse events was 0.8% with diroximel fumarate vs 58.3% with dimethyl fumarate.

“These findings suggest GI tolerability is consistent across the doses with Vumerity, which may enable patients to potentially reach the maintenance dose with less dose interruptions,” said Robert Naismith, MD, Washington University School of Medicine. “Reducing the need for physicians to utilize real-world GI mitigation strategies has the potential to have a positive impact on treatment compliance and adherence.”
 
Serious adverse events observed after treatment with diroximel fumarate and dimethyl fumarate, which have the same active metabolite, include anaphylaxis, angioedema, and progressive multifocal leukoencephalopathy. The most common adverse events with dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea.