Discontinuation of dimethyl fumarate in multiple sclerosis - a nationwide study

Malte Roar, Amalie Rhode Høgh Nielsen, Jonas Munksgaard Berg, Georgi Sirakov, Morten Stilund, Jakob Schäfer, Rikke Ratzer, Jette Frederiksen, Nasrin Asgari, Said Nasim Ashna, Henrik Boye Jensen, Matthias Kant, Ásta Theódorsdóttir, Zsolt Illes, Finn Sellebjerg, Melinda Magyari, Louise Mose Schlosser, Hilde Nordborg, Stig Wergeland, Tobias Sejbaek*

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstract

Background
Adherence is a prerequisite for the efficacy of any drug, and previous studies have shown that non-adherence is associated with disease activity and increased health care cost in multiple sclerosis (MS). The aim of this study was to investigate rates and reasons for discontinuation of dimethyl fumarate (DMF) among people with MS on a national level and differences between clinics in Denmark.

Methods
This was a nationwide, registry and population study of patients treated with DMF. We calculated standard residuals (SR) demonstrate differences between clinics. For survival analysis regarding discontinuation rates and discontinuation due to specific AEs we used log-rank test Cox-proportional hazards and plotted Kaplan-Meier graphics.

Results
We included 2,448 people with MS, treated with DMF from 2013 to 2020. Average treatment duration was 26 months (5,382 treatment years). 49.2 % of patients who initiated treatment with DMF (n = 1205) were continuously treated. Reasons for discontinuation were adverse events (54.5 %, n = 656), active disease (26.1 %, n = 315), pregnancy (9.4 %, n = 113) or other reasons (13.2 %, n = 159). We compared SR to the mean regarding reasons for discontinuation and found significant differences between sites regarding gastrointestinal adverse events, flushing and lymphopenia. Discontinuation due to all adverse events, flushing and lymphopenia were more frequent in female than male patients.

Conclusion
In this population-based study, we found major differences between the MS clinics in rates and reason for discontinuation of DMF. Our results suggest that management strategies during DMF treatment can reduce discontinuation rates.
OriginalsprogEngelsk
Artikelnummer105127
TidsskriftMultiple Sclerosis and Related Disorders
Vol/bind80
Antal sider8
ISSN2211-0348
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
We thank Claire Gudex, MD, for comments on an earlier version of this paper. Finn Sellebjerg holds a professorship at the Faculty of Health Sciences and Medicine, University of Copenhagen, sponsored by the Danish Multiple Sclerosis Society.

Publisher Copyright:
© 2023

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