EVOLVE-MS-2 (NCT03093324) is a randomized, double-blind, 5-week, phase 3 study evaluating gastrointestinal tolerability of DRF versus DMF in patients with RRMS. Patients who completed EVOLVE-MS-2 were eligible to roll over into EVOLVE-MS-1 (NCT02634307), an ongoing, open-label, phase 3 study evaluating DRF safety and exploratory efficacy over 96 weeks. Gd+ lesion counts were evaluated during the screening period before each study (~7 weeks apart), and again at Week 48 of EVOLVE-MS-1. A nonparametric signed rank test was used to determine if change in Gd+ lesion count between any 2 visits was significantly different from zero. EVOLVE-MS-2 patients remained blinded for treatment group as of this analysis.

Of the 289 patients who completed screening visits for both studies, 81 completed Week 48 to date in the ongoing EVOLVE-MS-1 study. Mean (SD) Gd+ lesion count was significantly reduced from screening in EVOLVE-MS-2 (1.1 [2.65]) to Week 48 in EVOLVE-MS-1 (0.2 [1.24]; 81.8% reduction; mean [SD] change: -0.9 [2.49], p<0.0001). Reductions were observed 7 weeks after DRF or DMF initiation (mean [SD] change: -0.3 [2.46]; p=0.0028).

DRF significantly reduced Gd+ lesions during the ~1-year treatment period. Significant reductions were observed as early as 7 weeks after initiating DRF and DMF treatment.

Study Support: Biogen/Alkermes