Key clinical point: Phase 3 EVOLVE-MS-2 study demonstrates that diroximel fumarate (DRF) has an improved gastrointestinal (GI) tolerability profile compared with dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (MS).
Major finding: Patients treated with DRF self-reported 46% fewer days with an Individual Gastrointestinal Symptom and Impact Scale (IGISIS) symptom intensity score of ≥2 vs those treated with DMF (rate ratio, 0.54; 95% confidence interval, 0.39-0.75). The rates of GI adverse events (AEs) were lower with DRF than DMF (34.8% vs. 49.0%). DRF-treated patients had a lower discontinuation rate because of GI AEs (0.8% vs. 4.8%) and overall AEs (1.6% vs. 5.6%).
Study details: EVOLVE-MS-2 was a 5-week randomized trial that directly compared the GI tolerability of DRF 462 mg (n = 253) with that of DMF 240 mg (n = 249); primary endpoint was the number of days with an IGISIS intensity score of 2 or greater relative to exposure.
Disclosures: This study was funded by Alkermes Inc. and Biogen. The authors reported receiving grants and personal fees from multiple pharmaceutical companies.
Citation: Naismith RT et al. CNS Drugs. 2020 Jan 17. doi: 10.1007/s40263-020-00700-0.