新冠疫苗接种后免疫性肌炎（IIM）发作的时间和趋势：COVAD-1 和 -2 调查的联合分析。
Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and -2 surveys.
机构信息
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Maulana Azad Medical College, New Delhi, Delhi, India.
出版信息
Rheumatology (Oxford). 2024 Jan 4;63(1):127-139. doi: 10.1093/rheumatology/kead180.
OBJECTIVES
Disease flares in the post-coronavirus disease 2019 (COVID-19) vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs).
METHODS
The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022, respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history and vaccination details. Flares of IIMs were defined as (a) patient self-reported, (b) immunosuppression (IS) denoted, (c) clinical sign directed and (d) with >7.9-point minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models.
RESULTS
Of 15 165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians) and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7% and 19.6% patients by definitions (a) to (d), respectively, with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR 1.2; 95% CI 1.03, 1.6, P = 0.025) were prone to flares, while those receiving rituximab (OR 0.3; 95% CI 0.1, 0.7, P = 0.010) and AZA (OR 0.3, 95% CI 0.1, 0.8, P = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (OR 1.19; 95% CI 1.11, 1.27, P < 0.001) were associated with disparity between self-reported and IS-denoted flares.
CONCLUSION
A diagnosis of IIMs confers an equal risk of flares in the post-COVID-19 vaccination period to AIRDs, with active disease, female gender and comorbidities conferring a higher risk. Disparity between patient- and physician-reported outcomes represents a future avenue for exploration.
目的
新冠肺炎（COVID-19）疫苗接种后疾病发作是一个突出的问题，尽管其风险因素尚不清楚。我们研究了特发性炎性肌病（IIM）和其他自身免疫性风湿病（AIRD）患者中的这些发作。
方法
COVAD-1 和 -2 全球调查分别于 2021 年和 2022 年进行，我们收集了人口统计学、合并症、AIRD 详细信息、COVID-19 感染史和疫苗接种细节。IIM 发作定义为：（a）患者自述，（b）免疫抑制（IS）表示，（c）临床体征指导，（d）>7.9 分最小临床显著改善差异恶化患者报告的结局测量信息系统（PROMIS）PROMISPF10a 评分。使用回归模型分析发作的危险因素。
结果
在 15165 名总受访者中，包括 1278 名 IIM（年龄 63 岁，70.3%为女性，80.8%为白种人）和 3453 名 AIRD。分别根据定义（a）至（d），患者的 IIM 发作率分别为 9.6%、12.7%、8.7%和 19.6%，中位发作时间为 71.5（10.7-235）天，与 AIRD 相似。接种疫苗前患有活动性 IIM 的患者（OR 1.2；95%CI 1.03，1.6，P=0.025）易发作，而接受利妥昔单抗（OR 0.3；95%CI 0.1，0.7，P=0.010）和 AZA（OR 0.3，95%CI 0.1，0.8，P=0.016）的患者发作风险较低。女性和合并症易导致需要改变 IS 的发作。哮喘（OR 1.62；95%CI 1.05，2.50，P=0.028）和更高的疼痛视觉模拟评分（OR 1.19；95%CI 1.11，1.27，P<0.001）与患者报告和 IS 表示的发作之间的差异相关。
结论
诊断为 IIM 与 AIRD 一样，在 COVID-19 疫苗接种后时期疾病发作的风险相等，活动性疾病、女性和合并症会增加风险。患者和医生报告结果之间的差异代表了未来探索的一个途径。
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