Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study

Naveen, R.; Nikiphorou, E.; Joshi, M.; Sen, P.; Lindblom, J.; Agarwal, V.; Lilleker, J. B.; Tan, A. L.; Salim, B.; Ziade, N.; Velikova, T.; Gracia-Ramos, A. E.; Kuwana, M.; Day, J.; Makol, A.; Distler, O.; Chinoy, H.; Traboco, L. S.; Wibowo, S. A. K.; Tehozol, E. A. Z.; Serrano, J. R.; Garcia-De La Torre, I.; Barman, B.; Singh, Y. P.; Ranjan, R.; Jain, A.; Pandya, S. C.; Pilania, R. K.; Sharma, A.; Manesh Manoj, M.; Gupta, V.; Kavadichanda, C. G.; Patro, P. S.; Ajmani, S.; Phatak, S.; Goswami, R. P.; Chowdhury, A. C.; Mathew, A. J.; Shenoy, P.; Asranna, A.; Bommakanti, K. T.; Shukla, A.; Pandey, A. K. R.; Chandwar, K.; Kardes, S.; Cansu, D. U.; Kim, M.; Makol, A.; Chatterjee, T.; Pauling, J. D.; Wincup, C.; Cavagna, L.; Del Papa, N.; Sambataro, G.; Fabiola, A.; Govoni, M.; Parisi, S.; Bocci, E. B.; Sebastiani, G. D.; Fusaro, E.; Sebastiani, M.; Quartuccio, L.; Franceschini, F.; Sainaghi, P. P.; Orsolini, G.; De Angelis, R.; Danielli, M. G.; Venerito, V.; Milchert, M.; Traboco, L. S.; Wibowo, S. A. K.; Tehozol, E. A. Z.; Serrano, J. R.; Garcia-De La Torre, I.; Loarce-Martos, J.; Prieto-Gonzalez, S.; Gil-Vila, A.; Gonzalez, R. A.; Kuwana, M.; Yoshida, A.; Nakashima, R.; Sato, S.; Kimura, N.; Kaneko, Y.; Knitza, J.; Tomaras, S.; Gromova, M. A.; Aharonov, O.; Gheita, T. A.; Hmamouchi, I.; Hoff, L. S.; Giannini, M.; Maurier, F.; Campagne, J.; Meyer, A.; Nagy-Vincze, M.; Langguth, D.; Limaye, V.; Needham, M.; Srivastav, N.; Hudson, M.; Landon-Cardinal, O.; Shaharir, S. S.; Zuleta, W. G. R.; Silva, J. A. P.; Fonseca, J. E.; Zimba, O.; Aggarwal, R.; Gupta, L.; Agarwal, V.; Parodis, I.

doi:10.1093/rheumatology/keac661

Objective: To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HC). Methods: Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March-December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type and background treatment. Results: Among 9462 complete respondents, 583 (6.2%) were SLE patients (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs were reported by 83.0% of SLE patients, major by 2.6%, hospitalization by 0.2%. AE and hospitalization frequencies were similar between patients with active and inactive SLE. Rashes were more frequent in SLE patients vs HC (OR; 95% CI: 1.2; 1.0, 1.5), chills less frequent in SLE vs AIRDs (0.6; 0.4, 0.8) and nrAIDs (0.5; 0.3, 0.8), and fatigue less frequent in SLE vs nrAIDs (0.6; 0.4, 0.9). Pfizer-recipients reported higher overall AE (2.2; 1.1, 4.2) and injection site pain (2.9; 1.6, 5.0) frequencies than recipients of other vaccines, Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5, 3.0), Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6, 4.3). Hospitalization frequencies were similar across vaccine types. AE frequencies were similar across treatment groups, although chills were less frequent in antimalarial users vs non-users (0.5; 0.3, 0.9). Conclusion: While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE.

Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study / Naveen, R.; Nikiphorou, E.; Joshi, M.; Sen, P.; Lindblom, J.; Agarwal, V.; Lilleker, J. B.; Tan, A. L.; Salim, B.; Ziade, N.; Velikova, T.; Gracia-Ramos, A. E.; Kuwana, M.; Day, J.; Makol, A.; Distler, O.; Chinoy, H.; Traboco, L. S.; Wibowo, S. A. K.; Tehozol, E. A. Z.; Serrano, J. R.; Garcia-De La Torre, I.; Barman, B.; Singh, Y. P.; Ranjan, R.; Jain, A.; Pandya, S. C.; Pilania, R. K.; Sharma, A.; Manesh Manoj, M.; Gupta, V.; Kavadichanda, C. G.; Patro, P. S.; Ajmani, S.; Phatak, S.; Goswami, R. P.; Chowdhury, A. C.; Mathew, A. J.; Shenoy, P.; Asranna, A.; Bommakanti, K. T.; Shukla, A.; Pandey, A. K. R.; Chandwar, K.; Kardes, S.; Cansu, D. U.; Kim, M.; Makol, A.; Chatterjee, T.; Pauling, J. D.; Wincup, C.; Cavagna, L.; Del Papa, N.; Sambataro, G.; Fabiola, A.; Govoni, M.; Parisi, S.; Bocci, E. B.; Sebastiani, G. D.; Fusaro, E.; Sebastiani, M.; Quartuccio, L.; Franceschini, F.; Sainaghi, P. P.; Orsolini, G.; De Angelis, R.; Danielli, M. G.; Venerito, V.; Milchert, M.; Traboco, L. S.; Wibowo, S. A. K.; Tehozol, E. A. Z.; Serrano, J. R.; Garcia-De La Torre, I.; Loarce-Martos, J.; Prieto-Gonzalez, S.; Gil-Vila, A.; Gonzalez, R. A.; Kuwana, M.; Yoshida, A.; Nakashima, R.; Sato, S.; Kimura, N.; Kaneko, Y.; Knitza, J.; Tomaras, S.; Gromova, M. A.; Aharonov, O.; Gheita, T. A.; Hmamouchi, I.; Hoff, L. S.; Giannini, M.; Maurier, F.; Campagne, J.; Meyer, A.; Nagy-Vincze, M.; Langguth, D.; Limaye, V.; Needham, M.; Srivastav, N.; Hudson, M.; Landon-Cardinal, O.; Shaharir, S. S.; Zuleta, W. G. R.; Silva, J. A. P.; Fonseca, J. E.; Zimba, O.; Aggarwal, R.; Gupta, L.; Agarwal, V.; Parodis, I.. - In: RHEUMATOLOGY. - ISSN 1462-0324. - 62:7(2023), pp. 2453-2463. [10.1093/rheumatology/keac661]