Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes.

Min, Jinny; Cohan, Stanley; Alvarez, Enrique; Sloane, Jacob; Phillips, J Theodore; van der Walt, Anneke; Koulinska, Irene; Fang, Fang; Miller, Catherine; Chan, Andrew (2019). Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes. Neurology and therapy, 8(1), pp. 109-119. Springer 10.1007/s40120-019-0127-2

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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).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Chan, Andrew Hao-Kuang

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2193-8253

Publisher:

Springer

Language:

English

Submitter:

Chantal Kottler

Date Deposited:

24 Dec 2019 12:03

Last Modified:

24 Dec 2019 12:03

Publisher DOI:

10.1007/s40120-019-0127-2

PubMed ID:

30706431

Uncontrolled Keywords:

Gastrointestinal events Multiple sclerosis Retrospective study Tecfidera

BORIS DOI:

10.7892/boris.136478

URI:

https://boris.unibe.ch/id/eprint/136478

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