Article
Research project VAC-MAC – VACcination of Multiple sclerosis/Arthritis/Colitis patients – comparison of vaccination-related adverse events between MAC patients
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Authors
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Katharina Meiszl
- Ruhr University Bochum, Department of Medical Informatics, Biometry and Epidemiology, Bochum, Germany
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Robin Denz
- Ruhr University Bochum, Department of Medical Informatics, Biometry and Epidemiology, Bochum, Germany
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Marianne C. Tokic
- Ruhr University Bochum, Department of Medical Informatics, Biometry and Epidemiology, Bochum, Germany
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Jale Basten
- Ruhr University Bochum, Department of Medical Informatics, Biometry and Epidemiology, Bochum, Germany
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Kerstin Hellwig
- Ruhr University Bochum, Department of Neurology, St. Josef Hospital, Bochum, Germany
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Thomas Grüter
- Ruhr University Bochum, Department of Neurology, St. Josef Hospital, Bochum, Germany
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Theresa Oganowski
- Ruhr University Bochum, Department of Neurology, St. Josef Hospital, Bochum, Germany
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Stephanie Stock
- University of Cologne, Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, Cologne, Germany
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Dusan Simic
- University of Cologne, Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, Cologne, Germany
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Arim Shukri
- University of Cologne, Institute of Health Economics and Clinical Epidemiology (IGKE), Faculty of Medicine and University Hospital Cologne, Cologne, Germany
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Uta Kiltz
- Ruhr University Bochum, Rheumazentrum Ruhrgebiet, Herne, Germany
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Maria Zacharopoulou
- Ruhr University Bochum, Rheumazentrum Ruhrgebiet, Herne, Germany
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Horst Vollmar
- Ruhr University Bochum, Institute of General Practice and Family Medicine (AM RUB), Medical Faculty, Bochum, Germany
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Ina Otte
- Ruhr University Bochum, Institute of General Practice and Family Medicine (AM RUB), Medical Faculty, Bochum, Germany
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Romy Lauer
- Ruhr University Bochum, Institute of General Practice and Family Medicine (AM RUB), Medical Faculty, Bochum, Germany
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Anastasia Suslow
- Ruhr University Bochum, Institute of General Practice and Family Medicine (AM RUB), Medical Faculty, Bochum, Germany
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Andreas Stallmach
- Jena University Hospital, Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena, Germany
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Anika Franz
- Jena University Hospital, Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), Jena, Germany
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Ursula Marschall
- BARMER Institute for Health System Research, Department Medicine and Health Services Research, Wuppertal, Germany
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Joachim Saam
- BARMER Institute for Health System Research, Department Medicine and Health Services Research, Wuppertal, Germany
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Catharina Schumacher
- BARMER Institute for Health System Research, Department Medicine and Health Services Research, Wuppertal, Germany
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Heike van de Sand
- University of Cologne, PMV Research Group, Medical Faculty and University Hospital Cologne, Cologne, Germany
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Ingo Meyer
- University of Cologne, PMV Research Group, Medical Faculty and University Hospital Cologne, Cologne, Germany
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Nina Timmesfeld
- Ruhr University Bochum, Department of Medical Informatics, Biometry and Epidemiology, Bochum, Germany
| Published: | November 13, 2024 |
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Outline
Text
Background: Individuals affected by autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, or chronic inflammatory bowel disease (MAC patients) may exhibit an increased risk of acquiring vaccine-preventable infections, including herpes zoster, pneumococcal infection, and influenza, as a consequence of the disease itself or the immunomodulation [1]. Thus, prevention of diseases by vaccinations is an important aim in MAC patients. Pharmacoepidemiologic studies are conducted to evaluate the safety of such vaccinations [2], typically excluding vulnerable patient groups such as MAC patients. It is therefore unclear whether and to what extent the respective vaccines can be used safely in the presence of an autoimmune disease. Due to concerns regarding the absence of safety evaluations, MAC patients are often not adequately vaccinated [3], [4]. One aim of the VAC-MAC project is to analyze vaccination-related adverse events regarding the deterioration of MAC disease to evaluating the safety of vaccinations in MAC patients. The aim of this talk is to execute a comparative analysis of various adverse events observed following an administration of different vaccinations in MAC patients.
Materials and Methods: The analysis is based on data from the BARMER health insurance fund, which includes approximately 9 million insured individuals in Germany from 2013 to 2021. MAC patients are defined as adults who fulfill at least one of the case definitions for MAC diseases. The analysis examines three different inactivated vaccines, including the herpes zoster vaccine, the pneumococcal vaccine, and the influenza vaccine. The outcomes that indicate a deterioration of MAC disease are defined in accordance with three distinct vaccination-related adverse events: (a) outpatient visit within 90 days of vaccination due to MAC disease, (b) hospitalization within 180 days of vaccination due to MAC disease, as well as (c) prescription for more than three days of incapacity for work within 90 days of vaccination due to MAC disease. Administered immunomodulation with an immunosuppressive effect against MAC disease is included as a confounder. The self-controlled case series method is used as the analysis method.
Results: In this talk, the results of the analysis will be presented. The occurrence of the respective adverse events after each vaccination will be estimated by conditional logistic regression models, considering the immunosuppressive medication. The most important indicator for evaluation is the calculated incidence rate ratio.
Conclusion: The analysis of secondary data offers new scientific findings regarding the safety of vaccines in MAC patients, thereby enabling the expansion of existing knowledge base concerning the safety of drugs in vulnerable patient groups.
References
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