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- Titel:
Acetylcholine Receptor Antibody Titers and Clinical Course after Influenza Vaccination in Patients with Myasthenia Gravis: A DoubleBlind Randomized Controlled Trial (ProPATIent-Trial)
- Dokumenttyp:
- Article
- Autor(en):
- Tackenberg, Bjoern; Schneider, Maximilian; Blaes, Franz; Eienbroeker, Christian; Schade-Brittinger, Carmen; Wellek, Anne; Deschauer, Marcus; Eickmann, Markus; Klenk, Hans-Dieter; Mueller, Hans-Helge; Sommer, Norbert
- Abstract:
- Background: It is a continuousmatter of discussionwhether 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). Theywere allocated to receive seasonal influenza vaccine or placebo. The primary endpointwas the relative change of AChR-ab-titer over 12 weeks. A relative increase of 20% was set as noninferiority 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 groupwere 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 estimatewith 95% CI) was - for the AChR-ab-titer change 4 . 0% [-13.3%, 4.5%] (p=0.28 for testing a difference, p < 0.0001 for testing non-inferiority) and for the QMG change 0 . 00 [-0.17, 0.00] (p=0.79 for testing a difference). The occurrence of 74 adverse events (AE) was comparable between groups. The most common AE was flu-like symptoms. One serious AE (hospitalisation following gastrointestinal haemorrhage) in the verum group was not related to the vaccine. Interpretation: Influenza vaccination in MG is safe. Uprating the potential risk of a severe course ofMG exacerbation during influenza infection compared to the 95% CI differences for the endpoints, vaccination is principally indicated in this patient population. (c) 2018 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license.
- Zeitschriftentitel:
- EBioMedicine
- Jahr:
- 2018
- Band / Volume:
- 28
- Seitenangaben Beitrag:
- 143-150
- Volltext / DOI:
- doi:10.1016/j.ebiom.2018.01.007
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/29337134
- TUM Einrichtung:
- Neurologische Klinik und Poliklinik
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