Real-life persistence and tolerability with dimethyl fumarate.

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.