Delayed-release Dimethyl Fumarate Demonstrated No Difference in Clinical Outcomes Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Real-World EFFECT Study (P1.362)

Objective: To compare real-world effectiveness of delayed-release dimethyl fumarate (DMF) with fingolimod (FTY) in relapsing-remitting multiple sclerosis (RRMS) patients. Background: In real-world comparative effectiveness studies of RRMS patients, including claims data and registries, treatment with DMF compared with FTY for up to 2 years was associated with no statistically significant differences in relapse. Design/Methods: EFFECT (NCT02776072), a retrospective, multicenter, international, single-timepoint medical record review study, evaluated the effectiveness of DMF and other disease-modifying therapies (DMTs). Eligibility criteria included age ≥18 years, diagnosis of RRMS, treatment-naive or 1 prior DMT (interferon or glatiramer acetate), DMT treatment initiation after December 2010, and ≥12 months of medical record data following DMT initiation. Endpoints included proportion of patients relapsed and annualized relapse rate (ARR) at 12 months. Analyses were stratified by quartiles of propensity score (PS) created from baseline covariates. The trimmed full analysis set (FAS) excluded patients with PS outside of the overlapping range of DMF and FTY. Kaplan-Meier estimates were pooled across strata weighted by the number of patients at-risk. ARRs were estimated using Poisson regressions adjusted for PS strata in addition to baseline covariates Results: The trimmed FAS included 699 DMF and 664 FTY patients. Treatment groups were well-balanced after PS stratification. The estimated proportion of patients relapsed at 12 months was 12% (DMF) and 13% (FTY). Hazard ratio (95%, CI; DMF/FTY) was 1.07 (0.78, 1.46; P =0.693). Adjusted ARR (95% CI) was 0.13 (0.10, 0.17; DMF) and 0.12 (0.09, 0.16; FTY); rate ratio (95%; DMF/FTY): 1.09 (0.79, 1.49; P =0.617). At 12 months, 86% of DMF- and 94% of FTY-treated patients remained on therapy; the primary reason for discontinuation was tolerability for DMF, and safety and efficacy for FTY. Conclusions: Over 12 months, treatment with DMF versus FTY was not associated with statistically significant differences in relapse outcomes. Study Supported by: Biogen Disclosure: Dr. Sloane has nothing to disclose. Dr. Phillips has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with consulting fees from Acorda, Biogen, Genentech, Genzyme, Merck Serono, Sanofi-Aventis, and Xenoport. Dr. Calkwood has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Advisory, consultancy, and speaker activities for Acorda, Biogen, EMD Serono, Genzyme, Novartis, Roche, and Teva. Dr. Calkwood has received research support from Biogen, Celegene, Genzyme, Novartis, and Roche. Dr. Van Der Walt has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Advisory boards for Merck, Novartis and travel honoraria from Biogen, Novartis and Teva. Dr. Min has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant for Biogen. Dr. Wu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with employee of and holds stock/stock options in Biogen. Dr. Wu holds stock and/or stock options in employee of and holds stock/stock options in Biogen, which sponsored research in which Dr. Wu was involved as an investigator. Dr. Wu holds stock and/or stock options in employee of and holds stock/stock options in Biogen. Dr. Miller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with employee of and holds stock/stock options in Biogen. Dr. Miller holds stock and/or stock options in employee of and holds stock/stock options in Biogen, which sponsored research in which Dr. Miller was involved as an investigator. Dr. Miller holds stock and/or stock options in employee of and holds stock/stock options in Biogen.