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Neuropsychiatr Dis Treat. 2019 May 28;15:1439-1457. doi: 10.2147/NDT.S200930. eCollection 2019.

Drug-use patterns and severe adverse events with disease-modifying drugs in patients with multiple sclerosis: a cohort study based on German claims data.

Author information

1
Institute of Epidemiology and Social Medicine, University of Münster, 48149 Münster, Germany.
2
Cancer Registry North Rhine-Westphalia, 44801, Bochum, Germany.
3
Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, 28359 Bremen, Germany.
4
InGef - Institute for Applied Health Research Berlin GmbH, 10117 Berlin, Germany.

Abstract

Purpose: To describe drug-use patterns in patients with multiple sclerosis (MS) using disease-modifying drugs (DMDs) and to estimate the incidence of severe adverse events (SAEs) of treatment. Methods: We conducted a cohort study within the German Pharmacoepidemiological Research Database between January 1, 2006 and December 31, 2013. MS patients on DMDs were described in terms of clinical characteristics and drug-use patterns. Next, we assessed the incidence of AEs in new users of fingolimod, natalizumab, glatiramer acetate, and IFNβ1a. Results: Among approximately 11 million insured members of German Statutory Health Insurance, the DMD-user cohort comprised 15,377 patients with MS, with a mean age of 39.6 years and 68% females. Nearly half of all DMD users had a diagnosis of depression, with prevalence ranging from 40.1% for IFNβ1a to 62.3% for immunoglobulins. The overall rate of MS relapses per patient and year was 0.34 (95% CI 0.33-0.34). During an average follow-up of 1,650 days, the majority (42.4%) of MS patients were adherent to DMD treatment ("continuous single users"), followed by patients interrupting treatment (39.5%, "interrupters"). Switch of DMD treatment (11.9%) was less frequent, and only 5.6% discontinued treatment. Treatment discontinuation was most common in users of natalizumab (7.5%) and IFNβ1b (7.0%). The most frequent SAE was hospitalization for depression, followed by any infectious disease and any malignancy. The incidence rate of all adverse events did not significantly differ across different DMDs. Conclusion: Treatment discontinuation with DMDs and treatment switch were rare. Causes of rather frequent DMD-treatment interruption have to be evaluated in further studies based on primary data collection. Active safety monitoring of new DMDs based on claims data requires large data sets to detect rare AEs and availability of up-to-date data.

KEYWORDS:

adverse events; claims data; disease-modifying drugs; drug-use patterns; multiple sclerosis

Conflict of interest statement

Mrs Alexandra Simbrich, Dr Jasmine Thibaut, and Professor Klaus Berger report grants from the German Ministry of Education and Research and Biogen Germany, during the conduct of the study. The authors report no other conflicts of interest in this work.

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