PT  - JOURNAL ARTICLE
AU  - Kartnig, Felix
AU  - Mrak, Daniel
AU  - Simader, Elisabeth
AU  - Tobudic, Selma
AU  - Radner, Helga
AU  - Mandl, Peter
AU  - Göschl, Lisa
AU  - Hommer, Nikolaus
AU  - Mayer, Margareta
AU  - Hofer, Philipp
AU  - Hummel, Thomas
AU  - Deimel, Thomas
AU  - Geßl, Irina
AU  - Puchner, Antonia
AU  - Kerschbaumer, Andreas
AU  - Thalhammer, Renate
AU  - Handisurya, Alessandra
AU  - Kain, Renate
AU  - Winkler, Stefan
AU  - Smolen, Josef S
AU  - Stiasny, Karin
AU  - Perkmann, Thomas
AU  - Haslacher, Helmuth
AU  - Aberle, Judith H
AU  - Aletaha, Daniel
AU  - Heinz, Leonhard X
AU  - Sieghart, Daniela
AU  - Bonelli, Michael
TI  - Safety and immunogenicity of a third COVID-19 vaccination in patients with immune-mediated inflammatory diseases compared with healthy controls
AID  - 10.1136/ard-2022-222682
DP  - 2023 Feb 01
TA  - Annals of the Rheumatic Diseases
PG  - 292--300
VI  - 82
IP  - 2
4099  - http://ard.bmj.com/content/82/2/292.short
4100  - http://ard.bmj.com/content/82/2/292.full
SO  - Ann Rheum Dis2023 Feb 01; 82
AB  - Objectives A third COVID-19 vaccination is recommended for immunosuppressed patients. However, data on immunogenicity and safety of a third COVID-19 vaccination in patients with immune-mediated inflammatory diseases (IMIDs) are sparse and therefore addressed within this clinical trial.Methods 60 immunosuppressed patients and 48 healthy controls (HCs) received a third vaccination with an mRNA vaccine. The primary endpoint was defined as the presence of antibody levels against the receptor-binding domain (RBD)>1500 BAU/mL in patients with IMIDs versus HCs. Further endpoints included differences in neutralising antibodies and cellular immune responses after the third vaccination. Reactogenicity was recorded for 7 days, and safety was evaluated until week 4.Results Rate of individuals with anti-RBD antibodies>1500 BAU/mL was not significantly different after the third vaccination between patients with IMIDs and HCs (91% vs 100% p=0.101). Anti-RBD and neutralising antibody levels were significantly lower in patients with IMIDs after the third vaccination than in HCs (p=0.002 and p=0.016, respectively). In contrast, fold increase in antibody levels between week 0 and 4 was higher in patients with IMIDs. Treatment with biological (b) disease-modifying anti-rheumatic drugs (DMARD) or combination of bDMARDs and conventional synthetic DMARDs was associated with reduced antibody levels. Enhanced cellular immune response to wild type and Omicron peptide stimulation was observed after the third vaccination. No serious adverse event was attributed to the third vaccination.Conclusion Our clinical trial data support the immunogenicity and safety of a third COVID-19 vaccination in patients with IMIDs. However, effects of DMARD therapy on immunogenicity should be considered.Trial registration number EudraCT No: 2021-002693-10.Data are available upon reasonable request. Anonymised data will be available upon request.