In EVOLVE-MS-2 (NCT03093324) trial of diroximel fumarate (Vumerity; Biogen, Cambridge, MA), recently approved for the treatment of relapsing forms of multiple sclerosis (MS), had significantly more gastrointestinal (GI) tolerability than dimethyl fumarate (Tecfidera, Biogen). In the ENDORSE study (NCT00835770), safety and efficacy of diroximel fumarate for up to 13 years was demonstrated.
GI tolerability was measured with the Individual GI Symptom and Impact Scale (IGISIS). Those treated with diroximel fumerate had a 46% reduction in relative risk of IGISIS score of 2 or more compared with those treated with dimethyl fumarate (P<.0003). Participants in the trial also reported that their quality of life improved because of reduced GI symptoms and they missed work less frequently because of GI symptoms.
Individuals using diroximel fumarate for 2 years (n=365), the percent brain volume loss (PBVL), a measure of atrophy, was similar to that seen in people without MS in the course of typical aging (-.36 [±0.60] and -.35 [±0.55] at years 1 and 2, respectively vs -.27). The estimated proportion of individuals without confirmed disability progression was 97.1% and 83.6% (305/365) were relapse free at 2 years. The estimated proportion of individuals with no evidence of disease activity (NEDA)-3 was 51.5% (186/365) at week 48 and 36% (130/361) at week 96.
The most common adverse events for dimethyl fumarate were flushing, abdominal pain, diarrhea and nausea
Tzu-Ying Chuang, MD, PhD, and Dhanashri Miskin, MD
Barbara C. Jobst, MD
Zehra Farzal, MD; Guillaume Lamotte MD, MSc; Elizabeth Mundel, MD; Laxman B. Bahroo, DO; and Fernando L. Pagan, MD