Vitor Alves Cruz, Camila Guimarães, Jozelia Rêgo, Ketty Lysie Libardi Lira Machado, Samira Tatiyama Miyamoto, Ana Paula Neves Burian, Laiza Hombre Dias, Flavia Zon Pretti, Danielle Cristina Filgueira Alves Batista, José Geraldo Mill, Yasmin Gurtler Pinheiro de Oliveira, Carolina Strauss Estevez Gadelha, Maria da Penha Gomes Gouveia, Anna Carolina Simões Moulin, Bárbara Oliveira Souza, Laura Gonçalves Rodrigues Aguiar, Gabriel Smith Sobral Vieira, Luiza Lorenzoni Grillo, Marina Deorce de Lima, Laís Pizzol Pasti, Heitor Filipe Surlo, Filipe Faé, Isac Ribeiro Moulaz, Mariana de Oliveira Macabú, Priscila Dias Cardoso Ribeiro, Vanessa de Oliveira Magalhães, Mariana Freitas de Aguiar, Erika Biegelmeyer, Flávia Maria Matos Melo Campos Peixoto, Cristiane Kayser, Alexandre Wagner Silva de Souza, Charlles Heldan de Moura Castro, Sandra Lúcia Euzébio Ribeiro, Camila Maria Paiva França Telles, Juliana Bühring, Raquel Lima de Lima, Sérgio Henrique Oliveira Dos Santos, Samuel Elias Basualt..
{"title":"类风湿性关节炎患者使用 CoronaVac 和 ChAdOx1 疫苗预防 SARS-CoV-2 的安全性：巴西多中心研究的数据更安全","authors":"Vitor Alves Cruz, Camila Guimarães, Jozelia Rêgo, Ketty Lysie Libardi Lira Machado, Samira Tatiyama Miyamoto, Ana Paula Neves Burian, Laiza Hombre Dias, Flavia Zon Pretti, Danielle Cristina Filgueira Alves Batista, José Geraldo Mill, Yasmin Gurtler Pinheiro de Oliveira, Carolina Strauss Estevez Gadelha, Maria da Penha Gomes Gouveia, Anna Carolina Simões Moulin, Bárbara Oliveira Souza, Laura Gonçalves Rodrigues Aguiar, Gabriel Smith Sobral Vieira, Luiza Lorenzoni Grillo, Marina Deorce de Lima, Laís Pizzol Pasti, Heitor Filipe Surlo, Filipe Faé, Isac Ribeiro Moulaz, Mariana de Oliveira Macabú, Priscila Dias Cardoso Ribeiro, Vanessa de Oliveira Magalhães, Mariana Freitas de Aguiar, Erika Biegelmeyer, Flávia Maria Matos Melo Campos Peixoto, Cristiane Kayser, Alexandre Wagner Silva de Souza, Charlles Heldan de Moura Castro, Sandra Lúcia Euzébio Ribeiro, Camila Maria Paiva França Telles, Juliana Bühring, Raquel Lima de Lima, Sérgio Henrique Oliveira Dos Santos, Samuel Elias Basualt..","doi":"10.1186/s42358-024-00397-5","DOIUrl":null,"url":null,"abstract":"Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. This data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.","PeriodicalId":48634,"journal":{"name":"Advances in Rheumatology","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with rheumatoid arthritis: data from the Brazilian multicentric study safer\",\"authors\":\"Vitor Alves Cruz, Camila Guimarães, Jozelia Rêgo, Ketty Lysie Libardi Lira Machado, Samira Tatiyama Miyamoto, Ana Paula Neves Burian, Laiza Hombre Dias, Flavia Zon Pretti, Danielle Cristina Filgueira Alves Batista, José Geraldo Mill, Yasmin Gurtler Pinheiro de Oliveira, Carolina Strauss Estevez Gadelha, Maria da Penha Gomes Gouveia, Anna Carolina Simões Moulin, Bárbara Oliveira Souza, Laura Gonçalves Rodrigues Aguiar, Gabriel Smith Sobral Vieira, Luiza Lorenzoni Grillo, Marina Deorce de Lima, Laís Pizzol Pasti, Heitor Filipe Surlo, Filipe Faé, Isac Ribeiro Moulaz, Mariana de Oliveira Macabú, Priscila Dias Cardoso Ribeiro, Vanessa de Oliveira Magalhães, Mariana Freitas de Aguiar, Erika Biegelmeyer, Flávia Maria Matos Melo Campos Peixoto, Cristiane Kayser, Alexandre Wagner Silva de Souza, Charlles Heldan de Moura Castro, Sandra Lúcia Euzébio Ribeiro, Camila Maria Paiva França Telles, Juliana Bühring, Raquel Lima de Lima, Sérgio Henrique Oliveira Dos Santos, Samuel Elias Basualt..\",\"doi\":\"10.1186/s42358-024-00397-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. This data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.\",\"PeriodicalId\":48634,\"journal\":{\"name\":\"Advances in Rheumatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-08-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Rheumatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s42358-024-00397-5\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s42358-024-00397-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Safety of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with rheumatoid arthritis: data from the Brazilian multicentric study safer
Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. This data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.
期刊介绍：
Formerly named Revista Brasileira de Reumatologia, the journal is celebrating its 60th year of publication.
Advances in Rheumatology is an international, open access journal publishing pre-clinical, translational and clinical studies on all aspects of paediatric and adult rheumatic diseases, including degenerative, inflammatory and autoimmune conditions. The journal is the official publication of the Brazilian Society of Rheumatology and welcomes original research (including systematic reviews and meta-analyses), literature reviews, guidelines and letters arising from published material.
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