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COVID-19 vaccination in autoimmune diseases (COVAD) Study: vaccine safety and tolerance in rheumatoid arthritis
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Örebro University, School of Medical Sciences. Örebro University Hospital. Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.ORCID iD: 0000-0002-4875-5395
Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, India.
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2023 (English)In: Rheumatology, ISSN 1462-0324, E-ISSN 1462-0332, Vol. 62, no 7, p. 2366-2376Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in rheumatoid arthritis (RA) patients.

METHODS: An online self-reported questionnaire (March-December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). Descriptive and multivariable regression analyses were performed.

RESULTS: Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA who had a mean (standard deviation) age of 50.7 (13.7) years, and 74.2% were women, and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both OR = 0.7; 95%CI = 0.5-0.9), and injection site pain (OR = 0.6; 95%CI = 0.5-0.8) with similar major AE and hospitalization frequencies.

CONCLUSION: Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs providing reassurance to the safety of COVID-19 vaccination.

Place, publisher, year, edition, pages
Oxford University Press, 2023. Vol. 62, no 7, p. 2366-2376
Keywords [en]
Adverse effects, COVID-19, autoimmune diseases, rheumatoid arthritis, vaccination
National Category
Rheumatology and Autoimmunity
Identifiers
URN: urn:nbn:se:oru:diva-102154DOI: 10.1093/rheumatology/keac624ISI: 000886025900001PubMedID: 36315075Scopus ID: 2-s2.0-85149134170OAI: oai:DiVA.org:oru-102154DiVA, id: diva2:1710654
Note

Funding agency:

National Institution for HealthResearch Manchester Biomedical Research Centre Funding Scheme

Available from: 2022-11-14 Created: 2022-11-14 Last updated: 2023-12-08Bibliographically approved

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Parodis, Ioannis

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