Abstract：
Vulnerable subjects, including systemic lupus erythematosus (SLE) patients, have been prioritised to receive anti-SARS-CoV-2 vaccines. Few data about the safety of these vaccines in SLE are available. The aim of our study is to investigate the safety of anti-SARS-CoV-2 vaccines in SLE. We included 452 SLE patients, referring to seven tertiary centres, who were immunised. A total of 119 (26%) reported side effects (SE) after the first and/or the second shot (the most frequent SE were fever, local reaction, fatigue, and arthralgia). Patients with constitutional symptoms and those on an immunosuppressive regimen (especially belimumab) showed more SE. In addition, 19 (4%) had a flare after the immunisation (flares classified by organ involvement: six musculoskeletal with constitutional symptoms, four renal, three cardio-respiratory, three haematological, two mucocutaneous). None of the patients needed hospitalisation and none died. Moreover, 15 required a transient increase in corticosteroids and four were treated with steroid pulses. One patient required an additional rituximab course. Anti-dsDNA, moderate/high DAS before vaccine, and belimumab were found more frequently in patients with disease flare. Anti-SARS-CoV-2 vaccines are safe in SLE patients, and they should be recommended in these patients, as the potential benefits widely outweigh the risk of SE. Treatment adjustment might be considered with the aim of minimising SE risk and flare.
摘要：
弱势群体,包括系统性红斑狼疮（SLE）患者，已被优先接受抗SARS-CoV-2疫苗。关于这些疫苗在SLE中的安全性的数据很少。我们的研究目的是研究抗SARS-CoV-2疫苗在SLE中的安全性。我们纳入了452例SLE患者，指七个三级中心，接种疫苗的人。共有119例（26％）在第一次和/或第二次注射后报告了副作用（SE）（最常见的SE是发烧，局部反应,疲劳,和关节痛）。有全身症状的患者和接受免疫抑制方案的患者（尤其是贝利木单抗）表现出更多的SE。此外,19（4％）在免疫接种后出现了耀斑（按器官受累分类的耀斑：6种肌肉骨骼有体质症状，四个肾，三个心肺，三个血液学，两个粘膜皮肤）。没有患者需要住院治疗，也没有死亡。此外，15个需要皮质类固醇的短暂增加，四个用类固醇脉冲治疗。一名患者需要额外的利妥昔单抗疗程。抗dsDNA，疫苗接种前中度/高度DAS，在疾病发作患者中发现贝利木单抗更为常见.抗SARS-CoV-2疫苗在SLE患者中是安全的，应该在这些患者中推荐它们，因为潜在的好处远远超过了SE的风险。可能会考虑进行治疗调整，以最大程度地减少SE风险和耀斑。
