1. Discontinuation of dimethyl fumarate in multiple sclerosis - a nationwide study.
- Author
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Roar M, Nielsen ARH, Berg JM, Sirakov G, Stilund M, Schäfer J, Ratzer R, Frederiksen J, Asgari N, Ashna SN, Jensen HB, Kant M, Theódorsdóttir Á, Illes Z, Sellebjerg F, Magyari M, Schlosser LM, Nordborg H, Wergeland S, and Sejbaek T
- Subjects
- Humans, Male, Female, Dimethyl Fumarate adverse effects, Immunosuppressive Agents adverse effects, Multiple Sclerosis drug therapy, Multiple Sclerosis chemically induced, Multiple Sclerosis, Relapsing-Remitting drug therapy, Lymphopenia chemically induced
- 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., Competing Interests: Declaration of Competing Interest M Stilund has served on scientific advisory boards for Sanofi, received support for congress participation or received speaker honoraria from Biogen, Teva, Merck, Roche and Sanofi. M. Stilund has eceived grants for his research from Novartis, and is currently engaged in sponsor-initiated research projects by Bayer, Jansen, Shionogi and Sanofi. J Schäfer has served on a scientific advisory board with Sanofi, received speaker honoraria from Novartis and travel compensation for congress participation from Merck, Roche and Sanofi. R Ratzer has served on scientific advisory boards, received speaker honoraria and received support for congress participation from Merck, Sanofi, Roche, Medtronic and Ipsen. Á Theódórsdóttir has served on scientific advisory boards for Roche and Sanofi and steering committee for Novartis, received research grand from Novartis and Sanofi, and has received support for congress participation from Roche, Biogen, Novartis, Merck and Sanofi. ÁT is currently engaged in sponsor-initiated research projects by Novartis and Roche. F Sellebjerg has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi Genzyme. His-laboratory has received research support from Biogen, Merck, Novartis, Roche and Sanofi Genzyme. T Sejbaek received has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Biogen, Merck, Novartis, Roche and Sanofi. T. Sejbaeks received unrestricted research grants to his research institution from Biogen, Merck and Roche, and is currently engaged in sponsor-initiated research projects by Eisai, Lundbeck, Roche and Sanofi. All other authors have no conflicts of interests., (Copyright © 2023. Published by Elsevier B.V.)
- Published
- 2023
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