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Controlled Clinical Trial
. 2023 Feb;82(2):292-300.
doi: 10.1136/ard-2022-222682. Epub 2022 Sep 15.

Safety and immunogenicity of a third COVID-19 vaccination in patients with immune-mediated inflammatory diseases compared with healthy controls

Felix Kartnig #  1 , Daniel Mrak #  1 , Elisabeth Simader  1 , Selma Tobudic  2 , Helga Radner  1 , Peter Mandl  1 , Lisa Göschl  1 , Nikolaus Hommer  3 , Margareta Mayer  4 , Philipp Hofer  5 , Thomas Hummel  1 , Thomas Deimel  1 , Irina Geßl  1 , Antonia Puchner  1 , Andreas Kerschbaumer  1 , Renate Thalhammer  6 , Alessandra Handisurya  7 , Renate Kain  5 , Stefan Winkler  2 , Josef S Smolen  1 , Karin Stiasny  4 , Thomas Perkmann  6 , Helmuth Haslacher  6 , Judith H Aberle  4 , Daniel Aletaha  1 , Leonhard X Heinz  1 , Daniela Sieghart #  1 , Michael Bonelli #  8
Affiliations
Controlled Clinical Trial

Safety and immunogenicity of a third COVID-19 vaccination in patients with immune-mediated inflammatory diseases compared with healthy controls

Felix Kartnig et al. Ann Rheum Dis. 2023 Feb.

Abstract

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.

Keywords: Autoimmune Diseases; Covid-19; Vaccination.

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Conflict of interest statement

Competing interests: DM reports support for meeting attendances from Pfizer. AK reports about contracts and personal fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Merck Sharp and Dohme. PM reports speaker fees from AbbVie, Janssen and Novartis and research grants from AbbVie, BMS, Novartis, Janssen, MSD and UCB. JSS reports about grants, consulting and personal fees from AbbVie, Astra-Zeneca, Lilly, Novartis, Amgen, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung and UCB. AH reports fees from MDGH. HH received grants from Glock Health, BlueSky Immunotherapies and Neutrolis. DA received grants and consulting fees from AbbVie, Amgen, Lilly, Merck, Novartis, Pfizer, Roche and Sandoz. MB reports about personal fees from Eli-Lilly. All other authors declare no competing interests.

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