Vumerity effective over 96 weeks in patients with relapsing-remitting MS
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Results from the EVOLVE-MS-1 study show Vumerity was effective and well-tolerated over 96 weeks in patients with relapsing-remitting MS compared with dimethyl fumarate, according to a presentation at ECTRIMS 2022.
Diroximel fumarate (Vumerity, Biogen), an oral fumarate for relapsing-remitting MS, has the same active metabolite as dimethyl fumarate (DMF) and a similar efficacy and safety profile. However, diroximel fumarate (DRF) has better gastrointestinal tolerability, according to the study.
Researchers evaluated the safety and efficacy of DRF in adults with relapsing-remitting MS in the 96-week, phase 3 open-label EVOLVE-MS-1 study, which was conducted from December 2015 to November 2021.
“MS is a complex and heterogenous disease, creating the need for a variety of treatment options to satisfy individual patient needs,” Monica Mann, vice president of medical affairs for global MS and pipeline at Biogen, told Healio. “The EVOLVE-MS-1 study offers providers and patients additional information about the safety, tolerability and efficacy of Vumerity as an oral treatment option for MS.”
Researchers enrolled 1,057 adults (mean age, 42.5 years; 72.1% women) with relapsing-remitting MS, of whom 464 rolled over after completing the EVOLVE-MS-2 trial, a randomized, blinded analysis of DRF or DMF over 5 weeks.
Results showed that 241 patients discontinued DRF, with 85 doing so because of adverse events. Adverse events occurred in 938 patients, with most instances mild or moderate. GI events occurred in 337 patients (mean duration, 10 days), seven of whom discontinued the study. Flushing was reported in 288 patients (median duration, 12.5 days), with five patients discontinuing. Serious adverse events occurred in 123 patients with four recorded deaths, none of which were considered related to study treatment.
In addition, adjusted annualized relapse rate at week 96 was 0.13, with an estimated 82.4% of patients relapse-free, and 41.1% with no evidence of disease activity, according to the study. The mean number of gadolinium-enhancing (Gd+) lesions decreased from 1.1 at baseline to 0.3 at week 96 (72.7%). Further, 91.1% of patients were Gd+ lesion-free at week 96 compared with 70.4% at baseline. The mean number of new or newly enlarging T2 lesions was 2.1 from baseline to week 48 and 1.3 from week 48 to week 96.
“The final outcomes from EVOLVE-MS-1 further support Vumerity as an effective and well-tolerated treatment option in MS patients, including those who are newly diagnosed,” Mann told Healio.