Real-world Effectiveness of Delayed-release Dimethyl Fumarate in Relapsing-remitting Multiple Sclerosis Patients Who Are Treatment-naïve or Treated With Only One Prior Therapy: Final Results from the EFFECT Study (P6.373)

Objective: The EFFECT study (NCT02776072) retrospectively evaluated the effectiveness of delayed-release dimethyl fumarate (DMF) in relapsing-remitting multiple sclerosis (RRMS) patients in a clinical practice setting who were treatment-naive or treated with only one prior therapy. Background: DMF has demonstrated a favorable benefit–risk profile in RRMS patients in clinical trials. However, there is an increasing demand to validate these findings through real-world effectiveness (RWE) data to guide physicians and patients in treatment decision making. Design/Methods: In this international, multicenter study, data were collected at a single time point via retrospective medical record review of patients treated in clinical practice. Inclusion criteria: DMF treatment initiated after December 2010; ≥12 months of follow-up data after DMF initiation; treatment-naive or one (IFN or GA) prior treatment. The proportion of patients relapsed was estimated using the Kaplan-Meier method. Unadjusted ARR was total relapses divided by total patient-years of exposure. Results: A total of 816 DMF patients (620 [76%] female; mean [SD] age, 44 [12] years) were included in the analysis. At 12 months, the proportion of patients who experienced a relapse was 11.5%. ARR was significantly lower at 12 months after DMF treatment initiation compared with12 months prior (0.14 [95% CI: 0.12, 0.18] vs 0.49 [0.45, 0.54]; rate ratio (95% CI) 0.29 [0.23, 0.36]; P Conclusions: In this RWE analysis of patients who were treatment-naive or had received only one treatment prior to DMF, most patients did not have a relapse after 12 months of treatment. DMF was associated with a significant reduction in relapse rate after 12 months of treatment compared to 12 months prior, consistent with clinical trial findings that DMF is an effective treatment option for RRMS patients. Study Supported by: Biogen Disclosure: 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. Cohan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment, consulting, scientific advisory board, speaking, or other activities (Sanofi Genzyme, Biogen, Acorda, Genentech, Novartis). Advisory Boards, Research Steering Committees, Research Support and Speaking Honoraria, (Biogen, Mallinckrodt, Novartis. Dr. Cohan has received research support from Biogen, Mallinckrodt, Novartis, Roche Genentech, Sanofi Genzyme. Dr. Chan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, Genzyme, Merck, Novartis, Roche, Sanofi-Aventis, Teva Neuroscience, UCB. Dr. Chan has received research support from Genzyme and UCB. Dr. Lathi has nothing to disclose. 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. 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. Min has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant for 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.