COVID-19 vaccination in autoimmune diseases (COVAD) Study: vaccine safety and tolerance in rheumatoid arthritis.
R, Naveen Parodis, Ioannis Joshi, Mrudula Sen, Parikshit Lindblom, Julius Agarwal, Vishwesh Lilleker, James B Tan, Ai Lyn Nune, Arvind Shinjo, Samuel Katsuyuki
R, Naveen
Parodis, Ioannis
Joshi, Mrudula
Sen, Parikshit
Lindblom, Julius
Agarwal, Vishwesh
Lilleker, James B
Tan, Ai Lyn
Nune, Arvind
Shinjo, Samuel Katsuyuki
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Affiliation
Sanjay Gandhi Postgraduate Institute of Medical Sciences; Karolinska Institutet and Karolinska University Hospital; Örebro University; Sandwell and West Birmingham NHS Trust; et al.
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Publication date
2022-10-31
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Abstract
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 in them.
Citation
R N, Parodis I, Joshi M, Sen P, Lindblom J, Agarwal V, Lilleker JB, Tan AL, Nune A, Shinjo SK, Salim B, Ziade N, Velikova T, Edgar Gracia-Ramos A, Saavedra MA, Day J, Makol A, Distler O, Chinoy H; COVAD Study Group; Agarwal V, Aggarwal R, Gupta L, Nikiphorou E. COVID-19 vaccination in autoimmune diseases (COVAD) Study: vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 Oct 31:keac624. doi: 10.1093/rheumatology/keac624.
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Article