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 Tehozol; Jorge 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

doi:10.1093/rheumatology/keac661

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

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

11 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 language	English
Pages (from-to)	2453-2463
Number of pages	11
Journal	Rheumatology (United Kingdom)
Volume	62
Issue number	7
DOIs	https://doi.org/10.1093/rheumatology/keac661
Publication status	Published - 1 Jul 2023

Keywords

adverse events
COVID-19
rheumatology
systemic lupus erythematosus
vaccine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/rheumatology/keac661

Cite this

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., ... Parodis, I. (2023). Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study. Rheumatology (United Kingdom), 62(7), 2453-2463. https://doi.org/10.1093/rheumatology/keac661

@article{71331b3a07a14e9c8a21013126ae0d1f,

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

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.",

keywords = "adverse events, COVID-19, rheumatology, systemic lupus erythematosus, vaccine",

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

note = "Publisher Copyright: {\textcopyright} 2022 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology.",

year = "2023",

month = jul,

day = "1",

doi = "10.1093/rheumatology/keac661",

language = "English",

volume = "62",

pages = "2453--2463",

journal = "Rheumatology (United Kingdom)",

issn = "1462-0324",

publisher = "Oxford University Press",

number = "7",

}

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, Traboco, LS, Wibowo, SAK, Tehozol, EAZ, 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, 'Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study', Rheumatology (United Kingdom), vol. 62, no. 7, pp. 2453-2463. https://doi.org/10.1093/rheumatology/keac661

TY - JOUR

T1 - Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus

T2 - results from the COVAD study

AU - Naveen, R.

AU - Nikiphorou, Elena

AU - Joshi, Mrudula

AU - Sen, Parikshit

AU - Lindblom, Julius

AU - Agarwal, Vishwesh

AU - Lilleker, James B.

AU - Tan, Ai Lyn

AU - Salim, Babur

AU - Ziade, Nelly

AU - Velikova, Tsvetelina

AU - Gracia-Ramos, Abraham Edgar

AU - Kuwana, Masataka

AU - Day, Jessica

AU - Makol, Ashima

AU - Distler, Oliver

AU - Chinoy, Hector

AU - Traboco, Lisa S.

AU - Wibowo, Suryo Anggoro Kusumo

AU - Tehozol, Erick Adrian Zamora

AU - Serrano, Jorge Rojas

AU - García-De La Torre, Ignacio

AU - Barman, Bhupen

AU - Singh, Yogesh Preet

AU - Ranjan, Rajiv

AU - Jain, Avinash

AU - Pandya, Sapan C.

AU - Pilania, Rakesh Kumar

AU - Sharma, Aman

AU - Manesh Manoj, M.

AU - Gupta, Vikas

AU - Kavadichanda, Chengappa G.

AU - Patro, Pradeepta Sekhar

AU - Ajmani, Sajal

AU - Phatak, Sanat

AU - Goswami, Rudra Prosad

AU - Chowdhury, Abhra Chandra

AU - Mathew, Ashish Jacob

AU - Shenoy, Padnamabha

AU - Asranna, Ajay

AU - Bommakanti, Keerthi Talari

AU - Shukla, Anuj

AU - Pandey, Arun Kumar R.

AU - Chandwar, Kunal

AU - Kardeş, Sinan

AU - Cansu, Döndü Üsküdar

AU - Kim, Minchul

AU - Makol, Ashima

AU - Chatterjee, Tulika

AU - Pauling, John D.

AU - Wincup, Chris

AU - Cavagna, Lorenzo

AU - Del Papa, Nicoletta

AU - Sambataro, Gianluca

AU - Fabiola, Atzeni

AU - Govoni, Marcello

AU - Parisi, Simone

AU - Bocci, Elena Bartoloni

AU - Sebastiani, Gian Domenico

AU - Fusaro, Enrico

AU - Sebastiani, Marco

AU - Quartuccio, Luca

AU - Franceschini, Franco

AU - Sainaghi, Pier Paolo

AU - Orsolini, Giovanni

AU - De Angelis, Rossella

AU - Danielli, Maria Giovanna

AU - Venerito, Vincenzo

AU - Milchert, Marcin

AU - Traboco, Lisa S.

AU - Wibowo, Suryo Anggoro Kusumo

AU - Tehozol, Erick Adrian Zamora

AU - Serrano, Jorge Rojas

AU - García-De La Torre, Ignacio

AU - Loarce-Martos, Jesús

AU - Prieto-González, Sergio

AU - Gil-Vila, Albert

AU - Gonzalez, Raquel Aranega

AU - Kuwana, Masataka

AU - Yoshida, Akira

AU - Nakashima, Ran

AU - Sato, Shinji

AU - Kimura, Naoki

AU - Kaneko, Yuko

AU - Knitza, Johannes

AU - Tomaras, Stylianos

AU - Gromova, Margarita Aleksandrovna

AU - Aharonov, Or

AU - Gheita, Tamer A.

AU - Hmamouchi, Ihsane

AU - Hoff, Leonardo Santos

AU - Giannini, Margherita

AU - Maurier, François

AU - Campagne, Julien

AU - Meyer, Alain

AU - Nagy-Vincze, Melinda

AU - Langguth, Daman

AU - Limaye, Vidya

AU - Needham, Merrilee

AU - Srivastav, Nilesh

AU - Hudson, Marie

AU - Landon-Cardinal, Oceane

AU - Shaharir, Syahrul Sazliyana

AU - Zuleta, Wilmer Gerardo Rojas

AU - Silva, Jose António Pereira

AU - Fonseca, João Eurico

AU - Zimba, Olena

AU - Aggarwal, Rohit

AU - Gupta, Latika

AU - Agarwal, Vikas

AU - Parodis, Ioannis

PY - 2023/7/1

Y1 - 2023/7/1

N2 - 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.

AB - 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.

KW - adverse events

KW - COVID-19

KW - rheumatology

KW - systemic lupus erythematosus

KW - vaccine

UR - http://www.scopus.com/inward/record.url?scp=85166438135&partnerID=8YFLogxK

U2 - 10.1093/rheumatology/keac661

DO - 10.1093/rheumatology/keac661

M3 - Article

C2 - 36413073

AN - SCOPUS:85166438135

SN - 1462-0324

VL - 62

SP - 2453

EP - 2463

JO - Rheumatology (United Kingdom)

JF - Rheumatology (United Kingdom)

IS - 7

ER -

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

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UN SDGs

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