Multiple sclerosis and related disorders · 2018
Real-life persistence and tolerability with dimethyl fumarate.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Sejbaek Tobias, Nybo Mads, Petersen Thor, Illes Zsolt
Аннотация
BACKGROUND: Dimethyl fumarate (DMF) has been registered for the treatment of relapsing-remitting multiple sclerosis (RRMS). Differences in tolerability between multiple sclerosis clinics in patients treated with DMF has not been examined.
AIM: We examined real-world tolerability to DMF, and also compared adherence data between two MS clinics.
METHODS: Adverse events (AE), discontinuation rates, and causes of discontinuation were investigated.
RESULTS: 253 patients participated in this retrospective study. In the total cohort, 27.7% of the patients discontinued DMF. Higher rate of discontinuation was associated with higher number of previous disease modifying treatments (p < 0.001). Reasons for discontinuation were primarily flushing (15%) and gastrointestinal AEs (51%). Grade III lymphopenia was detected only in 6 cases (2.4%). We observed differences between the two clinics: discontinuation because of AEs was different (Odds ratio 6.13, 95% CI: 3.0-12.7, p < 0.001), the mean treatment duration also differed (305.3 ± 186.3 vs 140.5 ± 114.4 days, p < 0.001), and dissimilarities in adherence were mainly related to flushing, gastrointestinal AEs, and consideration of lymphopenia (p < 0.0001). Better adherence was associated with prospectively planned management of gastrointestinal AEs and flushing.
CONCLUSION: Adherence in real-life was similar to pivotal trials. Differences in discontinuation rates at two MS clinics underline importance of AE management.
AIM: We examined real-world tolerability to DMF, and also compared adherence data between two MS clinics.
METHODS: Adverse events (AE), discontinuation rates, and causes of discontinuation were investigated.
RESULTS: 253 patients participated in this retrospective study. In the total cohort, 27.7% of the patients discontinued DMF. Higher rate of discontinuation was associated with higher number of previous disease modifying treatments (p < 0.001). Reasons for discontinuation were primarily flushing (15%) and gastrointestinal AEs (51%). Grade III lymphopenia was detected only in 6 cases (2.4%). We observed differences between the two clinics: discontinuation because of AEs was different (Odds ratio 6.13, 95% CI: 3.0-12.7, p < 0.001), the mean treatment duration also differed (305.3 ± 186.3 vs 140.5 ± 114.4 days, p < 0.001), and dissimilarities in adherence were mainly related to flushing, gastrointestinal AEs, and consideration of lymphopenia (p < 0.0001). Better adherence was associated with prospectively planned management of gastrointestinal AEs and flushing.
CONCLUSION: Adherence in real-life was similar to pivotal trials. Differences in discontinuation rates at two MS clinics underline importance of AE management.