1. Safety of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with rheumatoid arthritis: data from the Brazilian multicentric study safer.
- Author
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Cruz VA, Guimarães C, Rêgo J, Machado KLLL, Miyamoto ST, Burian APN, Dias LH, Pretti FZ, Batista DCFA, Mill JG, de Oliveira YGP, Gadelha CSE, da Penha Gomes Gouveia M, Moulin ACS, Souza BO, Aguiar LGR, Vieira GSS, Grillo LL, de Lima MD, Pasti LP, Surlo HF, Faé F, Moulaz IR, Macabú MO, Ribeiro PDC, Magalhães VO, de Aguiar MF, Biegelmeyer E, Peixoto FMMMC, Kayser C, de Souza AWS, de Moura Castro CH, Ribeiro SLE, Telles CMPF, Bühring J, de Lima RL, Dos Santos SHO, Dias SEB, de Melo NS, da Silva Sanches RH, Boechat AL, Sartori NS, Hax V, Dória LD, de Rezende RPV, Baptista KL, Fortes NRQ, de Melo AKG, Melo TS, de Abreu Vieira RMR, Vieira ASR, Kakehasi AM, Tavares ACFMG, de Landa AT, da Costa PVT, Azevedo VF, Martins-Filho OA, Peruhype-Magalhães V, de Medeiros Pinheiro M, Monticielo OA, Dos Reis-Neto ET, Ferreira GA, de Souza VA, Teixeira-Carvalho A, Xavier RM, Sato EI, Valim V, Pileggi GS, and da Silva NA
- Subjects
- Humans, Female, Male, Brazil epidemiology, Middle Aged, Prospective Studies, Adult, SARS-CoV-2 immunology, Aged, Headache chemically induced, Headache etiology, Myalgia chemically induced, Myalgia etiology, Arthralgia etiology, Vaccines, Inactivated, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid complications, COVID-19 prevention & control, COVID-19 complications, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, ChAdOx1 nCoV-19 adverse effects
- 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 associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA., Objective: To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA., Methods: 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., Results: 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., Conclusion: 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., (© 2024. The Author(s).)
- Published
- 2024
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