Introduction Delayed-release dimethyl fumarate (DMF) is an effective treatment for multiple sclerosis (MS). Some patients experience gastrointestinal (GI) adverse events (AEs) that may lead to premature DMF discontinuation. This study characterized the impact of site-specific GI management strategies on the occurrence of GI events and discontinuation patterns. Methods Data on GI events and DMF persistence were retrospectively abstracted from medical records of patients treated with DMF in routine medical practice in the EFFECT study (NCT02776072). GI management strategies were assessed via a study site questionnaire. Discontinuation rates were analyzed according to counseling patterns. Results Of 826 DMF-treated patients at 66 sites, 809 from 65 sites were eligible for the GI analysis; of these, 27% experienced GI AEs. Within 1 year of treatment, 14% (118/826) of patients discontinued DMF, 5% (44/809) due to GI events. Most sites (92%) reported that patients were very likely (> 75% of the time) to be counseled about GI events at/before DMF treatment initiation and/or to be recommended that DMF be taken with food (86%); 48% of sites reported to be very likely to recommend using symptomatic therapies for GI AEs. Lower discontinuation rates were reported at sites very likely versus not very likely (≤ 75% of the time) to (1) provide counseling; (2) provide specific details regarding GI events; or (3) recommend taking DMF with food, and/or using symptomatic GI therapies. Conclusion Counseling and other GI management strategies at initiation of DMF treatment appear to reduce the burden of GI events, and a variety of GI management strategies may improve DMF persistence. Trial Registration NCT02776072. Funding Biogen (Cambridge, MA, USA). Electronic supplementary material The online version of this article (10.1007/s40120-019-0127-2) contains supplementary material, which is available to authorized users.

IntroductionIn real world comparative effectiveness studies of relapsing-remitting multiple sclerosis (RRMS) patients, treatment with delayed-release dimethyl fumarate (DMF) compared with fingolimod (FTY) for ≤2 years was associated with no statistically significant differences in relapse outcomes. We assessed the real-world effectiveness of DMF compared with FTY in RRMS patients at 12 months.MethodsEFFECT (NCT02776072) was an observational, international, retrospective, single time point, medical record review study undertaken to evaluate the effectiveness of DMF and other disease-modifying therapies (DMTs). Patient eligibility criteria included age ≥18 years, diagnosis of RRMS, treatment naïve 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 Kaplan-Meier estimated proportion of patients relapsed at 12 months and annualised relapse rate (ARR). Substantive baseline covariates were used in estimating propensity score. The data were divided into 4 strata using propensity score. After assessing for balance in baseline covariates between treatment groups, Kaplan-Meier estimates and estimate of treatment effects were pooled across strata of propensity score.ResultsOf the 826 DMF and 785 FTY patients enrolled at sites in 17 countries, 816 and 781 patients respectively, were included in the full analysis set. Treatment groups were balanced after propensity score stratification. At 12 months, 86% of DMF-treated patients and 94% of FTY-treated patients remained on therapy. In the trimmed full analysis set, the estimated proportion of DMF patients that relapsed at 12 months was 12% compared with 13% for FTY patients; hazard ratio (95% CI) 1.07 (0.78, 1.46; p=0.6926). At 12 months after treatment initiation, the adjusted ARR ratio (95% CI) was 1.09 (0.80, 1.49; p=0.5754) for patients treated with DMF compared with FTY.ConclusionOver 12 months, treatment with DMF versus FTY was associated with no statistically significant difference on relapse outcomes.

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