Rheumatology Unit, Department of Clinical Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
Rheumatology Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy.
Clin Exp Rheumatol. 2023 Apr;41(4):922-927. doi: 10.55563/clinexprheumatol/if8nka. Epub 2023 Apr 18.
Data on the safety of anti-SARS-CoV-2 vaccines in patients with rare rheumatic diseases, such as systemic vasculitis (SV), are limited. The aim of this study was to evaluate the occurrence of a disease flare and the appearance of adverse events (AEs) following administration of anti-SARS-CoV-2 vaccine in a multicentre cohort of patients with SV.
Patients with SV and healthy controls (HC) from two different Italian rheumatology centres were asked to complete a questionnaire assessing disease flares occurrence, defined as new onset of clinical manifestations related to vasculitis needing an implementation of therapy, and local/systemic AEs appearance following anti SARS-CoV-2 vaccination.
107 patients with SV (57 ANCA-associated) and 107 HC were enrolled. A disease flare occurred in only one patient (0.93%) with microscopic polyangiitis after the first dose of an mRNA vaccine. After both the first and the second vaccine dose administration, no significant differences in AEs between patients with SV and HC were observed; no serious AEs were reported as well.
These data suggest a good risk profile for anti-SARS-CoV-2 vaccine in patients with systemic vasculitis.
关于抗 SARS-CoV-2 疫苗在系统性血管炎（SV）等罕见风湿病患者中的安全性数据有限。本研究旨在评估在意大利两个不同风湿病中心的 SV 患者和健康对照者（HC）多中心队列中，接种抗 SARS-CoV-2 疫苗后疾病发作和出现不良事件（AE）的情况。
要求 SV 患者和 HC 填写一份问卷，评估疾病发作情况，定义为新出现与血管炎相关的临床表现，需要实施治疗，以及接种抗 SARS-CoV-2 疫苗后的局部/全身 AE 发生情况。
共纳入 107 例 SV 患者（57 例为抗中性粒细胞胞浆抗体相关性）和 107 例 HC。仅 1 例显微镜下多血管炎患者（0.93%）在接种 mRNA 疫苗第一剂后出现疾病发作。在接种第一剂和第二剂疫苗后，SV 患者与 HC 之间的 AE 无显著差异；也未报告严重 AE。
这些数据表明，抗 SARS-CoV-2 疫苗在系统性血管炎患者中的风险状况良好。
