Background: Adherence to therapy in multiple sclerosis (MS) leads to improved clinical outcomes. Persistence to therapy and discontinuation rates contribute to adherence. Diroximel fumarate (DRF) is a novel oral fumarate recently approved in the United States for relapsing forms of MS, administered as 2 capsules twice daily. Objectives: To compare adherence with DRF vs dimethyl fumarate (DMF) in EVOLVE-MS-2 and describe long-term adherence and efficacy outcomes with DRF in EVOLVEMS-1. Methods: Adherence was assessed in patients with relapsing- remitting MS who received DRF or DMF in the 5-week, randomized EVOLVE-MS-2 study (trial registration: NCT03093324) and in those who received DRF in the ongoing, 96-week, open-label EVOLVE-MS-1 study (NCT02634307). All EVOLVE-MS-2 patients received 2 capsules twice daily. Adherence was determined by pill count (number taken divided by the number prescribed x 100). In patients who discontinued treatment, adherence was based on duration of treatment and not the full study period. Efficacy outcomes were assessed in EVOLVE-MS-1. Results: In the completed EVOLVE-MS-2 study, mean adherence was high (DRF 97.1%, n = 252; DMF 97.0%, n = 251); 97.4% of patients were ≥80% adherent to therapy. Discontinuation rates were lower with DRF (3.2%) than DMF (7.2%), primarily due to differences in gastrointestinal tolerability. In EVOLVE-MS-1 as of November 30, 2018 (median [range] exposure, 84 [0-100] weeks; n = 888), mean adherence was 93.4% (n = 877); 92.0% of patients were ≥80% adherent. Overall, 16.3% of patients discontinued treatment. Median (range) exposure for patients with ≥80% vs <80% adherence was 84 (1-100) and 22 (0-97) weeks, respectively. In patients with ≥80% adherence, adjusted annualized relapse rate was 0.15 (95% CI 0.13-0.19), representing a 79.4% (95% CI 75.0-83.0; P < .0001) reduction from the 12 months before study entry. Mean (SD) change in Expanded Disability Status Scale score from baseline to week 96 in patients with ≥80% adherence was 0.07 (0.59; n = 310). The small sample size (n = 70 at baseline, n = 2 at week 96) of patients with <80% adherence limits the ability to draw conclusions on the correlation between adherence and efficacy outcomes. Conclusions: High adherence and low discontinuation rates demonstrate documented treatment adherence and persistence to DRF. Adherence rates with DRF and DMF in EVOLVE-MS-2 were sustained in DRF-treated patients from EVOLVE-MS-1 for up to 96 weeks, demonstrating little impact of a 2-capsules-twice-daily dosing regimen. DRF-treated patients in EVOLVE-MS-1 had improved effi- cacy outcomes from baseline. [ABSTRACT FROM AUTHOR]
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