Safety and disease flare of autoimmune inflammatory rheumatic diseases: a large real-world survey on inactivated COVID-19 vaccines.
Safety and disease flare of autoimmune inflammatory rheumatic diseases: a large real-world survey on inactivated COVID-19 vaccines.
复制标题
DOI：
10.1136/annrheumdis-2021-221736
复制
发表时间：
2022-03
影响因子：
27.4
通讯作者：
Zhang Z
中科院分区：
文献类型：
--
作者：
Fan Y;Geng Y;Wang Y;Deng X;Li G;Zhao J;Ji L;Zhang X;Song Z;Zhang H;Sun X;Gao D;Xie W;Huang H;Hao Y;Zhang Z
COVID-19疫苗对减少SARS-CoV-2感染和重症病例具有重要意义。由于自身免疫性炎症性风湿病（AIIRDs）患者更容易感染SARS-CoV-2，因此强烈建议根据新指南接种疫苗。然而，禽流感患者在很大程度上被排除在疫苗试验之外，导致关于COVID-19疫苗安全性的数据非常有限。值得注意的是，以往的研究主要集中在mRNA和腺病毒载体疫苗上；然而，对世卫组织批准并在中国、巴西、土耳其和印度尼西亚等人口最多的国家广泛使用的COVID-19灭活疫苗知之甚少。2一项由40382名参与者组成的大型随机临床试验表明，两种COVID-19灭活疫苗可显著降低症状性COVID-19的风险。我们进行了一项真实世界的调查，以评估在中国接受任何剂量的COVID-19灭活疫苗的aird患者的安全性和疾病爆发情况。从2021年8月1日到2021年10月15日，符合条件的参与者通过社交媒体或访问门诊部的邀请完成了一份预定义的25个问题的问卷。从接种疫苗到完成调查的时间间隔没有限制。共有1507名接受COVID-19灭活疫苗的成年AIIRDs患者参与了本研究（流程图见在线补充图1）。参与者的中位年龄为39岁（IQR 31-51岁）。女性1166例（77.4%），有过敏史的209例（13.9%）。系统性红斑狼疮（SLE）（614例，40.7%）是参与者中最常见的AIIRD，其次是类风湿性关节炎（RA）（434例，28.8%）、白塞氏病（BD， 122例，8.1%）、银屑病关节炎/银屑病（PsA/PsO）（76例，5.0%）、原发性干燥综合征（74例，4.9%）和强直性脊柱炎（44例，2.9%）（在线补充图2）。在所有参与者中，450/1507（29.9%）参与者在接种疫苗后出现不良事件（ae）（表1）。据报道，287名（19.0%）参与者出现局部不良反应，如注射部位疼痛、红肿。同时，260例（17.3%）患者在接种疫苗后报告了全身性不良反应。疲劳或失眠（123例，8.2%）是报告最多的系统性AE，其次是头痛（82例，5.4%）和皮疹（55例，3.6%）。从接种疫苗到ae发作的中位时间为2天。大多数ae为轻度至中度且自限性。总体而言，28例（1.9%）患者自我报告严重不良事件。只有3名病人因严重腹泻、头痛和咳嗽而住院。无相关AE报告或致死性AE，包括心肌炎、特发性血小板减少性紫癜、过敏性休克或死亡。158名（10.5%）参与者报告了现有AIIRDs的耀斑，53名（3.5%）参与者需要增加治疗。
COVID-19 vaccines are of great importance in reducing SARS-CoV-2 infection and severe cases. Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) have been strongly recommended to be vaccinated according to the novel guidance because they are more vulnerable to SARS-CoV-2 infection. 1 However, patients with AIIRDs were largely excluded from vaccine trials, leading to very limited data on the safety of COVID-19 vaccines. Notably, previous studies mainly focused on mRNA and adenovirus vector vaccines; however, little is known about inactivated COVID-19 vaccines that also have been authorised by WHO and widely used in several most populated countries, for instance, China, Brazil, Turkey and Indonesia. 2 A large randomised clinical trial consisting of 40 382 participants has demonstrated two inactivated COVID-19 vaccines significantly reduced the risk of symptomatic COVID-19. 3 We conducted a real-world survey to evaluate the safety profiles and disease flare in patients with AIIRDs who received any dose of inactivated COVID-19 vaccines in China. From 1 Aug 2021 to 15 Oct 2021, eligible participants completed a predefined 25-question-based questionnaire by invitation on social media or visiting the outpatient department. There was no restriction on the time interval from vaccination to completing the survey. In total, 1507 adults patients with AIIRDs who received inactivated COVID-19 vaccine participated in this study (flow diagram in online supplemental figure 1). The median age of participants was 39 (IQR 31–51) years. There were 1166 (77.4%) female patients and 209 (13.9%) patients with self-identified allergic history. Systemic lupus erythematosus (SLE)(614, 40.7%) was the most common AIIRD among participants, followed by rheumatoid arthritis (RA)(434, 28.8%), Behcet’s disease (BD, 122, 8.1%), psoriatic arthritis/psoriasis (PsA/PsO)(76, 5.0%), primary Sjogren’s syndrome (74, 4.9%) and ankylosing spondylitis (44, 2.9%)(online supplemental figure 2). Among all participants, 450/1507 (29.9%) participants experienced adverse events (AEs) after vaccination (table 1). Local AEs, such as pain, redness or swelling at injection site, were reported to occur in 287 (19.0%) participants. Meanwhile, 260 (17.3%) patients reported systemic AEs after vaccination. Fatigue or sleepless (123, 8.2%) was the most reported systemic AE, followed by headache (82, 5.4%) and skin rash (55, 3.6%). The median time from vaccination shot to onset of AEs was 2 days. Most AEs were mild to moderate and self-limiting. Overall, 28 (1.9%) patients self-reported severe AEs. There were only three patients who were hospitalised due to serious diarrhoea, headache and cough. No one reported AE of interests or fatal AE, including myocarditis, idiopathic thrombocytopenic purpura, anaphylactic shock or death. Flare of existing AIIRDs was reported by 158 (10.5%) participants, with requirement of treatment escalation in 53 (3.5%)