Citations 2
Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study
Naveen, R, Nikiphorou, Elena , Joshi, Mrudula , Sen, Parikshit , Lindblom, Julius , Agarwal, Vishwesh , Tan, Ai Lyn , Salim, Babur , Ziadé, Nelly , Velikova, Tsvetelina , Gracia‐Ramos, Abraham Edgar , Kuwana, Masataka , Chinoy, Hector , Tehozol, Erick Adrian Zamora , Torre, Ignacio García-De La, Group, COVAD Study, Singh, Yogesh Preet , Ranjan, Rajiv , Pandya, Sapan C , Sharma, Aman , Manoj, Manesh , Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Pandey, Arun Kumar R, Kardeş, Sinan , Kim, Minchul , Pauling, John D , Wincup, Chris , Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Milchert, Marcin , Serrano, Jorge Rojas, Torre, Ignacio García-De La, Loarce‐Martos, Jesus , Prieto‐González, Sergio , Kuwana, Masataka, Nakashima, Ran , Sato, Shinji , Kimura, Naoki , Kaneko, Yuko , Tomaras, Stylianos, Aharonov, Or, Maurier, F. , Meyer, Alain , Nagy‐Vincze, Melinda , Limaye, Vidya, Needham, Merrilee , Srivastav, Nilesh , Hudson, Marie, Landon‐Cardinal, Océane , Shaharir, Syahrul Sazliyana , Zuleta, Wilmer Gerardo Rojas, Silva, José António Pereira, Gupta, Latika, Agarwal, Vikas , Parodis, Ioannis , Ravichandran, Naveen , Danieli, Maria Giovanna , Gupta, Latika , Naveen, R , Lilleker, James B , Tan, Ai Lyn , Ziade, Nelly , Gracia-Ramos, Abraham Edgar , Kuwana, Masataka , Day, Jessica , Distler, Oliver , Chinoy, Hector , Gupta, Latika , Parodis, Ioannis , Milchert, Marcin , Agarwal, Vikas , Joshi, Mrudula , Agarwal, Vishwesh , Salim, Babur , Velikova, Tsvetelina , Pauling, John D , Wincup, Chris , Zamora Tehozol, Erick Adrian , Sen, Parikshit , De Angelis, Rossella , Singh, Yogesh Preet , Day, Jessica , Makol, Ashima , Distler, Oliver , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Rojas Serrano, Jorge , Torre, Ignacio García-De La, Group, COVAD Study, Barman, Bhupen , Jain, Avinash , Pilania, Rakesh Kumar , Gupta, Vikas , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Chandwar, Kunal , Cansu, Döndü Üsküdar , Chatterjee, Tulika , Cavagna, Lorenzo , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Serrano, Jorge Rojas, Torre, Ignacio García-De La, Gil‐Vila, Albert , Gonzalez, Raquel Aranega, Kuwana, Masataka, Yoshida, Akira, Knitza, Johannes , Tomaras, Stylianos , Gromova, Margarita Aleksandrovna , Gheita, Tamer A. , Hmamouchi, Ihsane , Hoff, Leonardo Santos , Giannini, Margherita , Campagne, Julien , Langguth, Daman , Limaye, Vidya , Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , Aggarwal, Rohit
Rheumatology | November 21, 2022 | Volume: 62 | Issue: 7 | Pages: 2453-2463
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.
COVID-19 vaccination in autoimmune diseases (COVAD) study: vaccine safety and tolerance in rheumatoid arthritis
Naveen, R, Parodis, Ioannis , Joshi, Mrudula , Sen, Parikshit , Lindblom, Julius , Agarwal, Vishwesh , Tan, Ai Lyn , Nune, Arvind , Shinjo, Samuel Katsuyuki , Salim, Babur , Ziadé, Nelly , Velikova, Tsvetelina , Gracia‐Ramos, Abraham Edgar , Chinoy, Hector , Gupta, Vikas , Gupta, Latika, Nikiphorou, Elena , Group, COVAD Study, Singh, Yogesh Preet , Pandya, Sapan C , Sharma, Aman , Patro, Pradeepta Sekhar , Ajmani, Sajal, Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Asranna, Ajay, Bommakanti, Keerthi Talari, Shukla, Anuj , Pandey, Arun Kumar R, Kardeş, Sinan , Kim, Min‐Chul , Pauling, John D , Wincup, Chris , Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Milchert, Marcin , Tehozol, Erick Adrian Zamora , Loarce‐Martos, Jesus , Prieto‐González, Sergio , González, Raquel , Kuwana, Masataka, Nakashima, Ran , Sato, Shinji , Kimura, Naoki , Kaneko, Yuko , Tomaras, Stylianos , Aharonov, Or, Maurier, F. , Meyer, Alain , Nagy‐Vincze, Melinda , Limaye, Vidya, Needham, Merrilee , Srivastav, Nilesh , Hudson, Marie , Landon‐Cardinal, Océane, Shaharir, Syahrul Sazliyana , Zuleta, Wilmer Gerardo Rojas, Silva, José António Pereira, Agarwal, Vikas , Ravichandran, Naveen , Danieli, Maria Giovanna , Gupta, Latika , Naveen, R , Lilleker, James B , Tan, Ai Lyn , Nune, Arvind , Shinjo, Samuel Katsuyuki , Salim, Babur , Ziade, Nelly , Velikova, Tsvetelina , Gracia-Ramos, Abraham Edgar , Saavedra, Miguel A , Day, Jessica , Makol, Ashima , Distler, Oliver , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Nikiphorou, Elena , Milchert, Marcin , Agarwal, Vikas , Joshi, Mrudula , Agarwal, Vishwesh , Parodis, Ioannis , Pauling, John D , Wincup, Chris , Zamora Tehozol, Erick Adrian , Sen, Parikshit , De Angelis, Rossella , Singh, Yogesh Preet , Day, Jessica , Makol, Ashima , Distler, Oliver , Aggarwal, Rohit , Group, COVAD Study, Barman, Bhupen , Ranjan, Rajiv , Jain, Avinash , Pilania, Rakesh Kumar , M, Manoj, Kavadichanda, Chengappa G. , Ajmani, Sajal , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Chandwar, Kunal , Cansu, Döndü Üsküdar , Chatterjee, Tulika , Cavagna, Lorenzo , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Rojas Serrano, Jorge , Torre, Ignacio García‐De La , Gil‐Vila, Albert , Gonzalez, Raquel Aranega, Kuwana, Masataka , Yoshida, Akira , Knitza, Johannes , Gromova, Margarita Aleksandrovna , Gheita, Tamer A. , Hmamouchi, Ihsane , Hoff, Leonardo Santos , Giannini, Margherita , Campagne, Julien , Langguth, Daman , Limaye, Vidya , Landon‐Cardinal, Océane , Fonseca, João Eurico , Zimba, Olena
Rheumatology | October 31, 2022 | Volume: 62 | Issue: 7 | Pages: 2366-2376
Abstract Objectives The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in 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; they had a mean (s.d.) age of 50.7 (13.7) years, 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 odds ratio [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 as to the safety of COVID-19 vaccination.