Safety of Coronavac and ChAdOx1 Vaccines Against SARS-CoV-2 in Patients with Rheumatoid Arthritis Data from the Brazilian Multicentric Study Safer
Author:
Cruz Vitor Alves1ORCID, Guimarães Camila2, Rêgo Jozelia2, Machado Ketty Lysie Libardi Lira3, Miyamoto Samira Tatiyama3, Burian Ana Paula Neves4, Dias Laiza Hombre3, Pretti Flavia Zon3, Batista Danielle Cristina Filgueira Alves4, Mill José Geraldo3, de Oliveira Yasmin Gurtler Pinheiro3, Gadelha Carolina Strauss Estevez3, Gouveia Maria da Penha Gomes3, Moulin Anna Carolina Simões3, Souza Bárbara Oliveira3, Aguiar Laura Gonçalves Rodrigues3, Vieira Gabriel Smith Sobral3, Grillo Luiza Lorenzoni4, de Lima Marina Deorce3, Pasti Laís Pizzol3, Surlo Heitor Filipe3, Faé Filipe3, Moulaz Isac Ribeiro3, Macabú Mariana de Oliveira3, Ribeiro Priscila Dias Cardoso5, Magalhães Vanessa de Oliveira5, de Aguiar Mariana Freitas5, Biegelmeyer Erika5, Peixoto Flávia Maria Matos Melo Campos5, Kayser Cristiane5, de Souza Alexandre Wagner Silva5, Castro Charlles Heldan de Moura5, Ribeiro Sandra Lúcia Euzébio6, Telles Camila Maria Paiva França6, Bühring Juliana6, de Lima Raquel Lima6, Santos Sérgio Henrique Oliveira dos6, Dias Samuel Elias Basualto6, de Melo Natália Seixas6, Sanches Rosely Holanda da Silva6, Boechat Antonio Luiz6, Sartori Natália Sarzi7, Hax Vanessa7, Dória Lucas Denardi7, de Rezende Rodrigo Poubel Vieira8, Baptista Katia Lino8, Fortes Natália Rodrigues Querido8, de Melo Ana Karla Guedes9, Melo Tâmara Santos9, Vieira Rejane Maria Rodrigues de Abreu10, Vieira Adah Sophia Rodrigues11, kakehasi Adriana maria12, Tavares Anna Carolina Faria Moreira Gomes12, de Landa Aline Teixeira13, Costa Pollyana Vitoria Thomaz da13, Azevedo Valderilio Feijó14, Martins-Filho Olindo Assis15, Peruhype-Magalhães Vanessa15, Pinheiro Marcelo de Medeiros5, Monticielo Odirlei André7, Reis-Neto Edgard Torres dos5, Ferreira Gilda Aparecida12, de Souza Viviane Angelina13, Teixeira-Carvalho Andréa15, Xavier Ricardo Machado7, Sato Emilia Inoue5, Valim Valeria3, Pileggi Gecilmara Salviato5, Silva Nilzio Antonio da2
Affiliation:
1. Universidade Federal de Goias - Campus Colemar Natal e Silva: Universidade Federal de Goias 2. UFG: Universidade Federal de Goias 3. UFES: Universidade Federal do Espirito Santo 4. Universidade Federal do Espírito Santo: Universidade Federal do Espirito Santo 5. Unifesp EPM: Universidade Federal de Sao Paulo Escola Paulista de Medicina 6. UFAM: Universidade Federal do Amazonas 7. UFRGS: Universidade Federal do Rio Grande do Sul 8. UFF: Universidade Federal Fluminense 9. UFPB: Universidade Federal da Paraiba 10. Hospital Geral de Fortaleza 11. Universidade de Fortaleza 12. UFMG: Universidade Federal de Minas Gerais 13. UFJF: Universidade Federal de Juiz de Fora 14. UFPR: Universidade Federal do Parana 15. Rene Rachou Research Centre: Fundacao Oswaldo Cruz Instituto Rene Rachou
Abstract
Abstract
BACKGROUND
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 comorbidities associated. However, few studies in the literature assessed the safety of the COVID-19 vaccine in patients with RA.
OBJECTIVE
Evaluate the safety of vaccines against SARS-CoV-2 in patients with RA.
METHODS
These 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.
RESULTS
A total of 188 patients with RA were include in the study, most of them female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The more 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 (41,42% vs 25%, p = 0.02) and pain at injection (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. Only nonsevere AEs were related, and no patients had flare after the vaccination.
CONCLUSION
In the comparison between the two immunizers in patients with RA, the local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than in CoronaVac, especially in the first dose. In general, 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.
Publisher
Research Square Platform LLC
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