TY - JOUR
T1 - Discontinuation of dimethyl fumarate in multiple sclerosis - a nationwide study
AU - Roar, Malte
AU - Nielsen, Amalie Rhode Høgh
AU - Berg, Jonas Munksgaard
AU - Sirakov, Georgi
AU - Stilund, Morten
AU - Schäfer, Jakob
AU - Ratzer, Rikke
AU - Frederiksen, Jette
AU - Asgari, Nasrin
AU - Ashna, Said Nasim
AU - Jensen, Henrik Boye
AU - Kant, Matthias
AU - Theódorsdóttir, Ásta
AU - Illes, Zsolt
AU - Sellebjerg, Finn
AU - Magyari, Melinda
AU - Schlosser, Louise Mose
AU - Nordborg, Hilde
AU - Wergeland, Stig
AU - Sejbaek, Tobias
N1 - 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.
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Adherence
KW - Adverse events
KW - Dimethyl fumarate
KW - Discontinuation
KW - Multiple sclerosis
KW - Nationwide registry
U2 - 10.1016/j.msard.2023.105127
DO - 10.1016/j.msard.2023.105127
M3 - Journal article
C2 - 37956521
AN - SCOPUS:85176426387
SN - 2211-0348
VL - 80
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
M1 - 105127
ER -