Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry
Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry
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DOI：
10.1136/annrheumdis-2021-221490
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发表时间：
2021-12-31
影响因子：
27.4
通讯作者：
Mariette, Xavier
中科院分区：
文献类型：
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作者：
Machado, Pedro M.;Lawson-Tovey, Saskia;Mariette, Xavier
目的描述SARS-CoV-2疫苗在炎症性/自身免疫性风湿性和肌肉骨骼疾病(I-RMD)人群中的安全性。方法医生报告的I-RMD和非炎症性RMD(NI-RMD)患者接种SARS-CoV-2疫苗的登记。从2021年2月5日至2021年7月27日，我们收集了人口统计学、疫苗接种、RMD诊断、疾病活动性、免疫调节/免疫抑制治疗、闪光、不良事件(AEs)和SARS-CoV-2突破性感染的数据。对数据进行描述性分析。结果这项研究包括来自30个国家的5121名参与者，其中90%患有I-RMD(n=4604，女性68%，平均年龄60.5岁)，10%NI-RMD(n=517，女性77%，平均年龄71.4)。炎性关节疾病(58%)、结缔组织疾病(18%)和血管炎(12%)是最常见的诊断组；54%接受了传统的合成抗风湿药物(DMARDS)，42%接受了生物DMARDS，35%接受了免疫抑制剂。大多数患者接种了辉瑞/BioNTech疫苗(70%)、17%的阿斯利康/牛津和8%的莫德纳。在完全接种疫苗的病例中，0.7%的I-RMD患者和1.1%的NI-RMD患者报告了突破性感染。据报道，4.4%的病例(重度)出现I-RMD耀斑，1.5%的病例因药物改变而发生。AEs发生率为37%(I-RMD为37%，NI-RMD为40%)，重度AEs为0.5%(I-RMD为0.4%，NI-RMD为1.9%)。结论SARS-CoV-2疫苗在I-RMD患者中的安全性令人放心，与NI-RMD患者的安全性相当。大多数患者对疫苗的耐受性良好，罕见的I-RMD发作报告和非常罕见的严重急性脑炎报告。这些发现应该会让风湿学家和疫苗接受者放心，并增强对I-RMD患者接种SARS-CoV-2疫苗安全性的信心。
Objectives To describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD). Methods Physician-reported registry of I-RMD and non-inflammatory RMD (NI-RMDs) patients vaccinated against SARS-CoV-2. From 5 February 2021 to 27 July 2021, we collected data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events (AEs) and SARS-CoV-2 breakthrough infections. Data were analysed descriptively. Results The study included 5121 participants from 30 countries, 90% with I-RMDs (n=4604, 68% female, mean age 60.5 years) and 10% with NI-RMDs (n=517, 77% female, mean age 71.4). Inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnostic groups; 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants. Most patients received the Pfizer/BioNTech vaccine (70%), 17% AstraZeneca/Oxford and 8% Moderna. In fully vaccinated cases, breakthrough infections were reported in 0.7% of I-RMD patients and 1.1% of NI-RMD patients. I-RMD flares were reported in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. AEs were reported in 37% of cases (37% I-RMD, 40% NI-RMD), serious AEs in 0.5% (0.4% I-RMD, 1.9% NI-RMD). Conclusion The safety profiles of SARS-CoV-2 vaccines in patients with I-RMD was reassuring and comparable with patients with NI-RMDs. The majority of patients tolerated their vaccination well with rare reports of I-RMD flare and very rare reports of serious AEs. These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients.