| Autor: |
Björn Tackenberg, Maximilian Schneider, Franz Blaes, Christian Eienbröker, Carmen Schade-Brittinger, Anne Wellek, Marcus Deschauer, Markus Eickmann, Hans-Dieter Klenk, Hans-Helge Müller, Norbert Sommer |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| Předmět: |
|
| Zdroj: |
EBioMedicine, Vol 28, Iss C, Pp 143-150 (2018) |
| Druh dokumentu: |
article |
| ISSN: |
2352-3964 |
| DOI: |
10.1016/j.ebiom.2018.01.007 |
| Popis: |
Background: It is a continuous matter of discussion whether immune activation by vaccination in general and Influenza vaccination in particular increases the risk for clinical deterioration of autoimmune diseases. This prospective study investigated the serological and clinical course of autoimmune Myasthenia gravis (MG) after a seasonal influenza vaccination. Methods: This randomized, placebo-controlled, double-blind study enrolled MG patients with antibodies against acetylcholine-receptors (AChR-ab). They were allocated to receive seasonal influenza vaccine or placebo. The primary endpoint was the relative change of AChR-ab-titer over 12 weeks. A relative increase of 20% was set as non-inferiority margin. Secondary endpoints were clinical changes in the modified Quantitative Myasthenia Gravis Score (QMG), increase of anti-influenza-ELISA-antibodies, and changes of treatment. The study is registered with Clinicaltrialsregister.eu, EudraCT number 2006-004374-27. Findings: 62 patients were included. Mean ± standard deviation (median) in the vaccine and placebo group were AChR-ab-titer changes of −6.0% ± 23.3% (−4.0%) and −2.8% ± 22.0% (−0.5%) and QMG score changes of −0.08 ± 0.27 (0.17) and 0.11 ± 0.31 (0.00), respectively. The difference between groups (Hodges-Lehmann estimate with 95% CI) was - for the AChR-ab-titer change 4·0% [−13.3%, 4.5%] (p = 0.28 for testing a difference, p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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