Article
Multiple sclerosis: Detecting adverse effects with routine practice data
Multiple Sklerose: Unerwünschte Ereignisse mit Routinedaten erkennen
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Authors
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Christine Marx
- Central Research Institute of Ambulatory Health Care in the Federal Republic of Germany, Berlin, Germany
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Alicia Basoglu
- University of Münster, Münster, Germany
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Klaus Berger
- University of Münster, Münster, Germany
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Ursula Drechsel-Bäuerle
- Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, Langen, Germany
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Brigitte Keller-Stanislawski
- Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, Langen, Germany
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Ellen Kexel
- Department of Care Management, BKK Dachverband e.V, Berlin, Germany
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Kristina Kraft
- University of Münster, Münster, Germany
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Alexander Stahmann
- German Multiple Sclerosis Register, MS Forschungs- und Projektentwicklungs-gGmbH, Hannover, Germany
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Maike Below
- Central Research Institute of Ambulatory Health Care in the Federal Republic of Germany, Berlin, Germany
| Published: | November 7, 2023 |
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Outline
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Background: Multiple sclerosis (MS) is an indication in which new therapies play a crucial role. During recent years, numerous new drugs have been approved for the treatment of MS – a trend that is likely to be continued. However, except for clinical studies, there is often little or no experience in the use of these new drugs – especially regarding adverse effects.
The project VerSI-MS-PV (funded by the German Federal Joint Committee, G-BA) is investigating which data sources can be used for an advanced detection of the adverse effects of these drugs in MS patients in current practice. The project therefore analyzes and compares various data sources concerning treatment of MS patients.
Materials and methods: Four different data sources were compared over the course of the project: One primary data source (data from a German registry), two secondary data sources containing physicians’ claims and prescription data and one linked data source. The focus of this abstract lays on the claims data from 44 member insurances of the German BKK Health Insurance Fund database (data set 1) and physicians’ claims and prescription data from 12 out of the 17 regional Associations of Statutory Health Insurance Physicians (SHI) (data set 2). All data sets included data of SHI insured patients diagnosed with MS. Patients younger than 18 years, patients without a disease modifying treatment, treatment switcher, and pregnant patients were excluded from the analysis.
Results: In both data sets MS patients treated with Natalizumab (N=207 in data set 1 and N=2,667 in data set 2) or interferone (N=2,558 in data set 1 and N=25,858 in data set 2) were analyzed. Known safety signals for Natalizumab could be successfully replicated in both data sets. However, when it came to herpes simplex and herpes zoster infections the data sets differed in their results with only data set 2 showing significant differences between patients treated with Natalizumab and patients treated with interferone (“Herpes simplex” (OR=1,36 [1,08; 1,73], p=0,01) and “Herpes zoster” (OR=1,59 [1,31; 1,94], p<0,001). Compared to data set 2, data set 1 was considerably smaller. This resulted in a discrepancy regarding these specific infections, as data set 1 appeared not to be representative.
Conclusion: Overall, results are promising and indicate that signal replication is possible with both examined secondary data sources. Hence, routine data can play an important role in the detection of adverse effects. A broad data set is more advantageous than a narrow one. In the future, routine data should also be used regularly as a supporting source for the identification of (potential) adverse effects. Currently existing obstacles to the use of this data could be reduced by adapting the legal framework.
