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

R. Naveen, Elena Nikiphorou, Mrudula Joshi, Parikshit Sen, Julius Lindblom, Vishwesh Agarwal, James B. Lilleker, Ai Lyn Tan, Babur Salim, Nelly Ziade, Tsvetelina Velikova, Abraham Edgar Gracia-Ramos, Masataka Kuwana, Jessica Day, Ashima Makol, Oliver Distler, Hector Chinoy, Lisa S. Traboco, Suryo Anggoro Kusumo Wibowo, Erick Adrian Zamora TehozolJorge Rojas Serrano, Ignacio García-De La Torre, Bhupen Barman, Yogesh Preet Singh, Rajiv Ranjan, Avinash Jain, Sapan C. Pandya, Rakesh Kumar Pilania, Aman Sharma, M. Manesh Manoj, Vikas Gupta, Chengappa G. Kavadichanda, Pradeepta Sekhar Patro, Sajal Ajmani, Sanat Phatak, Rudra Prosad Goswami, Abhra Chandra Chowdhury, Ashish Jacob Mathew, Padnamabha Shenoy, Ajay Asranna, Keerthi Talari Bommakanti, Anuj Shukla, Arun Kumar R. Pandey, Kunal Chandwar, Sinan Kardeş, Döndü Üsküdar Cansu, Minchul Kim, Ashima Makol, Tulika Chatterjee, John D. Pauling, Chris Wincup, Lorenzo Cavagna, Nicoletta Del Papa, Gianluca Sambataro, Atzeni Fabiola, Marcello Govoni, Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani, Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi, Giovanni Orsolini, Rossella De Angelis, Maria Giovanna Danielli, Vincenzo Venerito, Marcin Milchert, Lisa S. Traboco, Suryo Anggoro Kusumo Wibowo, Erick Adrian Zamora Tehozol, Jorge Rojas Serrano, Ignacio García-De La Torre, Jesús Loarce-Martos, Sergio Prieto-González, Albert Gil-Vila, Raquel Aranega Gonzalez, Masataka Kuwana, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Johannes Knitza, Stylianos Tomaras, Margarita Aleksandrovna Gromova, Or Aharonov, Tamer A. Gheita, Ihsane Hmamouchi, Leonardo Santos Hoff, Margherita Giannini, François Maurier, Julien Campagne, Alain Meyer, Melinda Nagy-Vincze, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Marie Hudson, Oceane Landon-Cardinal, Syahrul Sazliyana Shaharir, Wilmer Gerardo Rojas Zuleta, Jose António Pereira Silva, João Eurico Fonseca, Olena Zimba, Rohit Aggarwal, Latika Gupta, Vikas Agarwal, Ioannis Parodis

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2453-2463
Number of pages11
JournalRheumatology (United Kingdom)
Volume62
Issue number7
DOIs
Publication statusPublished - 1 Jul 2023

Keywords

  • adverse events
  • COVID-19
  • rheumatology
  • systemic lupus erythematosus
  • vaccine

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