Real-World Strategies for Managing Gastrointestinal Events and Increasing Adherence with Delayed-Release Dimethyl Fumarate: Interim Analysis of a Sub-Study of Effect

Background: Adverse events associated with gastrointestinal (GI) tolerability can result in discontinuation of delayed-release dimethyl fumarate (DMF) treatment. In an attempt to improve adherence with DMF, some clinical practice centers are initiating patient education/engagement efforts.

Objectives: In a sub-study of EFFECT (NCT02776072), we examined DMF discontinuation rates due to selected GI events and site mitigation strategies to characterize real-world management of GI events during DMF treatment.

Methods: EFFECT is a retrospective medical record review in patients treated with DMF or other selected disease-modifying therapies (DMTs). Eligibility criteria include: age ≥18 years, diagnosis of RRMS, treatment-naïve or 1 prior DMT (interferon or glatiramer acetate), and ≥12 months of medical record data following index treatment initiation. In the sub-study, discontinuations due to selected GI events among DMF-treated patients were evaluated through a single medical record abstraction. At study sites with DMF-treated patients, structured questionnaires were administered to healthcare providers (HCP) to evaluate GI management practices. Sites estimated the likelihood of counseling patients using a scale of 0%, >0-25%, >25%-75%, and >75%-100%. 

Results: As of 15 Dec 2016, 820 DMF-treated patients (safety population) were enrolled at 61 sites (619 [75%] female; mean [SD] age, 44 [12] years). At 1 year, 115/820 (14%) patients discontinued DMF treatment; 41/820 (5%) discontinued due to GI events. A total of 213/820 (26%) patients experienced ≥1 GI event; nausea (10%) and diarrhea (9%) were most commonly reported. Questionnaire respondents were physicians (49%), registered nurses (16%), nurse practitioners (11%), physician assistants (2%), or other (21%). The majority of sites (89%, 54 sites) reported that patients were counseled verbally about GI events associated with DMF >75% of the time at or before DMF initiation; 66% (40 sites) reported counseling >75% of the time after DMF initiation. A sizable proportion of sites also reported that patients were counseled >25% of the time by an alternate HCP, in lieu of the prescriber, at or before DMF initiation (41%, 25 sites), or after DMF initiation (49%, 30 sites). Site-level discontinuation rates according to counseling patterns will be presented.

Conclusions: In this interim analysis, few patients discontinued DMF treatment due to GI events. Most sites provided counseling regarding GI events associated with DMF.