Disease Flare and Reactogenicity in Patients With Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination.
Disease Flare and Reactogenicity in Patients With Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination.
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DOI：
10.1002/art.41924
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发表时间：
2022-01
期刊：
影响因子：
--
通讯作者：
Paik JJ
中科院分区：
文献类型：
--
作者：
Connolly CM;Ruddy JA;Boyarsky BJ;Barbur I;Werbel WA;Geetha D;Garonzik-Wang JM;Segev DL;Christopher-Stine L;Paik JJ
评价风湿性和肌肉骨骼疾病（RMD）患者接种两剂SARS-CoV-2 mRNA疫苗后的疾病爆发和疫苗接种后反应（反应原性）。在2020年12月16日至2021年4月15日期间接受两剂SARS-CoV-2-mRNA疫苗接种的1377名RMD患者完成了问卷调查，详细描述了每次疫苗接种后7天内（D1，D2）发生的局部和全身反应，以及D2后一个月发生的RMD发作。使用改良Poisson回归评价人口统计学/临床特征与需要治疗的发作之间的关联。11%的人报告需要治疗;没有严重发作的报告。爆发与既往SARS-CoV-2感染（IRR 2.09，p=0.02）、接种疫苗前6个月内的爆发（IRR 2.36，p<0.001）和联合免疫调节治疗的使用（IRR 1.95，p<0.001）相关。最常报告的局部和全身反应包括注射部位疼痛（D1 87%，D2 86%）和疲乏（D1 60%，D2 80%）; D2后反应原性增加，尤其是全身反应。未报告过敏反应或SARS-CoV-2诊断。SARS-CoV-2疫苗接种后潜在RMD的爆发并不常见。未报告重度耀斑。局部和全身反应通常不会干扰日常活动。这些早期的安全性数据可以帮助解决RMD患者的疫苗犹豫。
To evaluate disease flare and post-vaccination reactions (reactogenicity) in patients with rheumatic and musculoskeletal diseases (RMD) following two-dose SARS-CoV-2 mRNA vaccination. 1377 patients with RMD who received two-dose SARS-CoV-2-mRNA vaccination between 16 December 2020 and April 15, 2021 completed questionnaires detailing local and systemic reactions experienced within 7 days of each vaccine dose (D1, D2), and one month after D2 detailing flare of RMD. Associations between demographic/clinical characteristics and flare requiring treatment were evaluated using modified Poisson regression. 11 percent reported flare requiring treatment; there were no reports of severe flares. Flare was associated with prior SARS-CoV-2 infection (IRR 2.09, p=0.02), flare in the six months preceding vaccination (IRR 2.36, p<0.001) and use of combination immunomodulatory therapy (IRR 1.95, p<0.001). The most frequently reported local and systemic reactions included injection site pain (D1 87%, D2 86%) and fatigue (D1 60%, D2 80%); reactogenicity increased after D2, particularly for systemic reactions. No allergic reactions or SARS-CoV-2 diagnoses were reported. Flare of underlying RMD following SARS-CoV-2 vaccination was uncommon. There were no reports of severe flare. Local and systemic reactions typically did not interfere with daily activity. These early safety data can help address vaccine hesitancy in patients with RMD.
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