Real-world Strategies for Management of Gastrointestinal Events in Patients Treated with Delayed-release Dimethyl Fumarate: EFFECT Gastrointestinal Sub-study Results

Abstract

Introduction Gastrointestinal (GI) adverse events (AEs) associated with DMF can result in premature treatment discontinuation. Objectives To characterize effective real-world patient education and management strategies at sites initiating treatment with delayed-release dimethyl fumarate (DMF), as well as the impact of GI events on treatment persistence. Patients and methods EFFECT ( NCT02776072 ) is a retrospective study of patients age ≥ 18 treated with DMF in the clinical practice setting. Data were captured via retrospective medical record review at a single time point. Sites completed a structured questionnaire regarding typical GI management practices at the center using a scale of 0%, > 0–25%, > 25%–75%, and > 75%–100%. Results Overall, 826 DMF-treated patients were enrolled at 65 sites; 809 were eligible for analysis. Over Year 1, incidence of GI events was 27% (216/809). Sites reporting that counseling was likely to occur by both the prescriber and an additional health care provider had lower discontinuation rates vs. sites that did not (2% [6/286] vs. 7% [33/495]). Discussion Sites with lower vs. higher discontinuation rates were also likely to provide patients specific details regarding GI events (5% [33/693] vs. 10% [11/116]), recommend taking DMF with food (5% [39/750] vs. 9% [5/59]), or recommend using symptomatic GI therapies (3% [15/469] vs. 9% [29/340]). Conclusion Overall, treatment persistence was high in this study, potentially due to most sites reporting a high likelihood of counseling and mitigation strategy recommendations for potential DMF-related GI events.