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 JB, Tan AL, Salim B, Ziade N, Velikova T, Gracia-Ramos AE, Kuwana M, Day J, Makol A, Distler O, Chinoy H, Wibowo SAK, Serrano JR, García-De La Torre I, Barman B, Singh YP, Ranjan R, Jain A, Pandya SC, Pilania RK, Sharma A, Manesh Manoj M, Gupta V, Kavadichanda CG, Patro PS, Ajmani S, Phatak S, Goswami RP, Chowdhury AC, Mathew AJ, Shenoy P, Asranna A, Bommakanti KT, Shukla A, Pandey AKR, Chandwar K, Kardeş S, Cansu DÜ, Kim M, Makol A, Chatterjee T, Pauling JD, Wincup C, Cavagna L, Del Papa N, Sambataro G, Fabiola A, Govoni M, Parisi S, Bocci EB, Sebastiani GD, Fusaro E, Sebastiani M, Quartuccio L, Franceschini F, Sainaghi PP, Orsolini G, De Angelis R, Danielli MG, Venerito V, Milchert M, Traboco LS, Wibowo SAK, Tehozol EAZ, Serrano JR, García-De La Torre I, Loarce-Martos J, Prieto-González S, Gil-Vila A, Gonzalez RA, Kuwana M, Yoshida A, Nakashima R, Sato S, Kimura N, Kaneko Y, Knitza J, Tomaras S, Gromova MA, Aharonov O, Gheita TA, Hmamouchi I, Hoff LS, 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 SS, Zuleta WGR, Silva JAP, Fonseca JE, Zimba O, Aggarwal R, Gupta L, Agarwal V, Parodis I (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Book Volume: 62

Pages Range: 2453-2463

Journal Issue: 7

DOI: 10.1093/rheumatology/keac661

Abstract

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.

Involved external institutions

Maulana Azad Medical College (MAMC) India (IN) Karolinska University Hospital / Karolinska Universitetssjukhuset Sweden (SE) Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) India (IN) King’s College London United Kingdom (GB) Byramjee Jeejeebhoy Government Medical College & Sassoon General Hospital India (IN) Instituto Mexicano del Seguro Social Mexico (MX) Royal Melbourne Hospital (RMH) Australia (AU) Mayo Clinic United States (USA) (US) Universitätsspital Zürich (USZ) Switzerland (CH) University of Manchester United Kingdom (GB) University of Indonesia (UI) / Universitas Indonesia Indonesia (ID) Mahatma Gandhi Mission Medical College and Hospital India (IN) NIHR Leeds Musculoskeletal Biomedical Research Unit (LMBRU) United Kingdom (GB) Fauji Foundation Hospital Pakistan (PK) Université Saint-Joseph (USJ) / جامعة القديس يوسف / Սուրբ Ժոզեֆի համալսարան Lebanon (LB) Aleksandrovska University Hospital / университетска болница "Александровска" Bulgaria (BG) Instituto Nacional de Enfermedades Respiratorias Mexico (MX) Universidad de Guadalajara (UDEG) Mexico (MX) St. Luke's Medical Center – Global City Philippines (PH) University of Pittsburgh United States (USA) (US)

How to cite

APA:

Naveen, R., Nikiphorou, E., Joshi, M., Sen, P., Lindblom, J., Agarwal, V.,... Parodis, I. (2023). Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study. Rheumatology, 62(7), 2453-2463. https://doi.org/10.1093/rheumatology/keac661

MLA:

Naveen, R., et al. "Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study." Rheumatology 62.7 (2023): 2453-2463.

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