Related Experiment Video
Updated: Jan 30, 2026
Comprehensive Autopsy Program for Individuals with Multiple Sclerosis
Published on: July 19, 2019
Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management
Jinny Min1, Stanley Cohan2, Enrique Alvarez3
1Biogen, Cambridge, MA, USA.
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).
Insights
Proactive gastrointestinal (GI) management, including patient counseling and recommending taking dimethyl fumarate (DMF) with food, can reduce GI adverse events and improve treatment persistence in multiple sclerosis (MS) patients.
Area of Science:
- Neurology
- Pharmacology
- Clinical Research
Background:
- Dimethyl fumarate (DMF) is a key treatment for multiple sclerosis (MS).
- Gastrointestinal (GI) adverse events (AEs) are common with DMF and can lead to treatment discontinuation.
- Effective GI management strategies are crucial for optimizing DMF therapy.
Purpose of the Study:
- To evaluate the impact of site-specific GI management strategies on GI events and DMF discontinuation.
- To analyze the relationship between patient counseling, GI management, and DMF persistence.
Main Methods:
- Retrospective analysis of patient medical records from the EFFECT study (NCT02776072).
- Assessment of GI management strategies through a study site questionnaire.
- Analysis of discontinuation rates based on counseling patterns and GI event management.
Main Results:
- 27% of patients experienced GI AEs, and 5% discontinued DMF due to GI events within one year.
- Most sites counseled patients on GI events and recommended taking DMF with food.
- Sites employing proactive GI management (counseling, dietary recommendations, symptomatic therapy) showed lower DMF discontinuation rates.
Conclusions:
- Initiating DMF treatment with comprehensive GI counseling and management strategies can mitigate GI AEs.
- Implementing diverse GI management approaches improves DMF persistence in MS patients.
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