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Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

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Title: Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey
Authors: R. Naveen, Darpan R. Thakare, Masataka Kuwana, John D. Pauling, Jessica Day, Mrudula Joshi, Ioannis Parodis, Parikshit Sen, Kshitij Jagtap, Elena Nikiphorou, Sreoshy Saha, Vishwesh Agarwal, Tulika Chatterjee, James B. Lilleker, Sinan Kardes, Marcin Milchert, Tamer Gheita, Babur Salim, Tsvetelina Velikova, Abraham Edgar Gracia-Ramos, Ai Lyn Tan, Arvind Nune, Lorenzo Cavagna, Miguel A. Saavedra, Samuel Katsuyuki Shinjo, Nelly Ziade, Johannes Knitza, Oliver Distler, Hector Chinoy, Bhupen Barman, Yogesh Preet Singh, Rajiv Ranjan, Avinash Jain, Sapan C. Pandya, Rakesh Kumar Pilania, Aman Sharma, Manesh Manoj M, 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, Arunkumar R. Pande, Kunal Chandwar, Döndü Üsküdar Cansu, Chris Wincup, Ashima Makol, 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, Lisa S. Traboco, Suryo Anggoro Kusumo Wibowo, Jorge Rojas Serrano, Ignacio García-De La Torre, Erick Adrian Zamora Tehozol, Jesús Loarce-Martos, Sergio Prieto-González, Raquel Aranega Gonzalez, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Stylianos Tomaras, Margarita Aleksandrovna Gromova, Or Aharonov, 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, Océane Landon-Cardinal, Syahrul Sazliyana Shaharir, Wilmer Gerardo Rojas Zuleta, José António Pereira Silva, João Eurico Fonseca, Olena Zimba, Rohit Aggarwal, Latika Gupta, Vikas Agarwal
Contributors: Naveen, R., Thakare, D. R., Kuwana, M., Pauling, J. D., Day, J., Joshi, M., Parodis, I., Sen, P., Jagtap, K., Nikiphorou, E., Saha, S., Agarwal, V., Chatterjee, T., Lilleker, J. B., Kardes, S., Milchert, M., Gheita, T., Salim, B., Velikova, T., Gracia-Ramos, A. E., Tan, A. L., Nune, A., Cavagna, L., Saavedra, M. A., Shinjo, S. K., Ziade, N., Knitza, J., Distler, O., Chinoy, H., 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., Pande, A. R., Chandwar, K., Cansu, D. U., Wincup, C., Makol, A., 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., Traboco, L. S., Wibowo, S. A. K., Serrano, J. R., La Torre, I. G. -D., Tehozol, E. A. Z., Loarce-Martos, J., Prieto-Gonzalez, S., Gonzalez, R. A., Yoshida, A., Nakashima, R., Sato, S., Kimura, N., Kaneko, Y., Tomaras, S., Gromova, M. A., Aharonov, O., 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.
Source: Rheumatol Int
2023, ' Systemic sclerosis and COVID-19 vaccine safety : short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey ', Rheumatology International, vol. 43, no. 7, pp. 1265-1275 . https://doi.org/10.1007/s00296-023-05310-9
COVAD Study Group 2023, 'Systemic sclerosis and COVID-19 vaccine safety : short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey', Rheumatology International, vol. 43, no. 7, pp. 1265-1275. https://doi.org/10.1007/s00296-023-05310-9
Publisher Information: Springer Science and Business Media LLC, 2023.
Publication Year: 2023
Subject Terms: Adverse event, Adult, Male, COVID-19 Vaccines, Autoimmune diseases, COVID-19/prevention & control, Adverse events, COVID-19, Systemic sclerosis, Vaccination, Rheumatic Diseases/drug therapy, Observational Research, Scleroderma, Autoimmune Diseases, Systemic sclerosi, Autoimmune Diseases/epidemiology, Rheumatic Diseases, Autoimmune disease, Humans, BNT162 Vaccine, Fatigue, Scleroderma, Systemic, Systemic, Vaccination/adverse effects, 3. Good health, Female, Self Report, COVID-19 Vaccines/adverse effects
Description: The safety profile of COVID-19 vaccines is understudied in patients with systemic sclerosis (SSc). We compared short-term adverse events (AEs) 7 days following vaccination in patients with SSc vs other rheumatic (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). The COVID-19 Vaccination in autoimmune diseases (COVAD) self-reporting e-survey was circulated by a group of > 110 collaborators in 94 countries from March to December 2021. AEs were analyzed between different groups using regression models. Of 10,679 complete respondents [73.8% females, mean age 43 years, 53% Caucasians], 478 had SSc. 83% had completed two vaccine doses, Pfizer-BioNTech (BNT162b2) (51%) was the most common. Minor and major AEs were reported by 81.2% and 3.3% SSc patients, respectively, and did not differ significantly with disease activity or different vaccine types, though with minor symptom differences. Frequencies of AEs were not affected by background immunosuppression, though SSc patients receiving hydroxychloroquine experienced fatigue less commonly (OR 0.4; 95% CI 0.2-0.8). Frequency of AEs and hospitalisations were similar to other AIRDs, nrAIDs, and HC except a higher risk of chills (OR 1.3; 95% CI 1.0-1.7) and fatigue (OR 1.3; 95% CI 1.0-1.6) compared to other AIRDs. COVID-19 vaccines were largely safe and well tolerated in SSc patients in the short term. Background immunosuppression and disease activity did not influence the vaccination-related short-term AEs.
Document Type: Article
Other literature type
File Description: application/vnd.openxmlformats-officedocument.wordprocessingml.document; application/pdf
Language: English
ISSN: 1437-160X
DOI: 10.1007/s00296-023-05310-9
Access URL: https://pubmed.ncbi.nlm.nih.gov/37000295
https://research.manchester.ac.uk/en/publications/3376c0b1-4312-4bb7-9cea-9eb3973e25ff
https://doi.org/10.1007/s00296-023-05310-9
https://kclpure.kcl.ac.uk/ws/files/241622895/Systemic_Sclerosis_and_COVID-19_vaccine_safety-_Short_Term_Insights_From.docx
https://hdl.handle.net/11379/573365
https://hdl.handle.net/11380/1305487
https://doi.org/10.1007/s00296-023-05310-9
http://www.scopus.com/inward/record.url?scp=85159682435&partnerID=8YFLogxK
https://research.manchester.ac.uk/en/publications/3376c0b1-4312-4bb7-9cea-9eb3973e25ff
https://www.mendeley.com/catalogue/79bd27d7-57b1-3d81-a194-2edc3d546b7d/
https://doi.org/10.1007/s00296-023-05310-9
Rights: Springer Nature TDM
Accession Number: edsair.doi.dedup.....3c51b634cea3e3b0b4868d04e85187ce
Database: OpenAIRE
Description
Abstract:The safety profile of COVID-19 vaccines is understudied in patients with systemic sclerosis (SSc). We compared short-term adverse events (AEs) 7 days following vaccination in patients with SSc vs other rheumatic (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). The COVID-19 Vaccination in autoimmune diseases (COVAD) self-reporting e-survey was circulated by a group of > 110 collaborators in 94 countries from March to December 2021. AEs were analyzed between different groups using regression models. Of 10,679 complete respondents [73.8% females, mean age 43 years, 53% Caucasians], 478 had SSc. 83% had completed two vaccine doses, Pfizer-BioNTech (BNT162b2) (51%) was the most common. Minor and major AEs were reported by 81.2% and 3.3% SSc patients, respectively, and did not differ significantly with disease activity or different vaccine types, though with minor symptom differences. Frequencies of AEs were not affected by background immunosuppression, though SSc patients receiving hydroxychloroquine experienced fatigue less commonly (OR 0.4; 95% CI 0.2-0.8). Frequency of AEs and hospitalisations were similar to other AIRDs, nrAIDs, and HC except a higher risk of chills (OR 1.3; 95% CI 1.0-1.7) and fatigue (OR 1.3; 95% CI 1.0-1.6) compared to other AIRDs. COVID-19 vaccines were largely safe and well tolerated in SSc patients in the short term. Background immunosuppression and disease activity did not influence the vaccination-related short-term AEs.
ISSN:1437160X
DOI:10.1007/s00296-023-05310-9