Safety of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with rheumatoid arthritis: data from the Brazilian multicentric study safer

IF 2 4区医学 Q3 RHEUMATOLOGY

Advances in Rheumatology Pub Date : 2024-08-12 DOI:10.1186/s42358-024-00397-5

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..

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引用次数: 0

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.

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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

免疫介导的风湿性疾病 (IMRD) 患者已被列为 COVID-19 疫苗接种的优先对象，以降低感染严重性风险。类风湿性关节炎（RA）患者发生严重COVID-19后果的风险很高，尤其是那些正在接受免疫抑制或患有相关合并症的患者。然而，很少有研究评估 COVID-19 疫苗在类风湿性关节炎患者中的安全性。本研究旨在评估SARS-CoV-2疫苗对RA患者的安全性。该研究是一项巴西多中心前瞻性 IV 期研究，旨在评估 COVID-19 疫苗在巴西 IMRDs 中的安全性。在接种两剂 ChAdOx1（牛津/阿斯利康）或 CoronaVac（Sinovac/Butantan）疫苗后，对所有中心的风湿性关节炎患者的不良事件（AEs）进行了评估。疫苗接种后AEs的分层采用日记形式，每天填写，每次接种28天后交回。共纳入188名RA患者，其中90%为女性。109名患者接种了CoronaVac，79名患者接种了ChAdOx1。仅观察到轻微的不良反应，主要发生在首次用药后。与 CoronaVac 相比，ChAdOx1 出现注射疼痛（66% 对 32%，p < 0.001）、关节痛（62% 对 22%，p < 0.001）和肌痛（45% 对 20%，p < 0.001）的频率更高。第二剂后更常见的不良反应是注射疼痛（37%）、关节痛（31%）、肌痛（23%）、头痛（21%）和疲劳（18%）。关节痛（41.4% 对 25%，p = 0.02）和注射疼痛（51.4% 对 27%，p = 0.001）更常见于 ChAdOx1。没有出现严重的不良反应。关于 RA 活动水平，COVID-19 疫苗在三个时间段内均无明显差异。在对两种免疫接种剂的RA患者进行比较时，ChAdOx1的局部反应和肌肉骨骼症状比CoronaVac更常见，尤其是在第一剂后。总之，AE 主要发生在首次接种后，且症状轻微，这与类风湿性关节炎患者接种其他免疫剂的数据相同。接种疫苗不会加重疾病的活动程度。

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来源期刊

Advances in Rheumatology Medicine-Rheumatology

CiteScore

4.00

自引率

4.30%

发文量

审稿时长

53 weeks

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.