PDF(Pubmed)
Abstract：
Novel mechanisms of COVID-19 vaccines raised concern about their potential immunogenicity in patients with rheumatoid arthritis (RA) undergoing immunomodulatory treatments. We designed a retrospective single-center study to investigate their effectiveness and safety in this population, analyzing data from the first vaccination program (December 2020-October 2021). Inclusion criteria were availability of post-vaccination serology and a minimum subsequent follow-up of 6 months. Binding antibody units (BAU/mL) ≥ 7.1 defined an adequate serological response. Post-vaccine COVID-19 incidence and its timing since vaccination, adverse events (AEs), and RA flares were recorded. Adjusted logistic and linear multivariate regression analyses were carried out to identify factors associated with vaccine response. We included 118 patients (87.2% women, age 65.4 ± 11.6 years, evolution 12.0 ± 9.6 years), of whom 95.8% had a complete vaccination schedule. Adequate humoral immunogenicity was achieved in 88.1% of patients and was associated with previous COVID-19 and mRNA vaccines, whereas smoking, aCCP, age, and DMARDs exerted a negative impact. Post-vaccine COVID-19 occurred in 18.6% of patients, a median of 6.5 months after vaccination. Vaccine AE (19.5%) and RA flares (1.7%) were mostly mild and inversely associated with age. Our results suggest that COVID-19 vaccines induce adequate humoral immunogenicity, with an acceptable safety profile in RA patients.
摘要：
COVID-19疫苗的新机制引起了人们对其在接受免疫调节治疗的类风湿性关节炎（RA）患者中潜在免疫原性的关注。我们设计了一项回顾性单中心研究，以调查其在该人群中的有效性和安全性。分析第一次疫苗接种计划（2020年12月至2021年10月）的数据。纳入标准是疫苗接种后血清学的可用性和至少6个月的后续随访。结合抗体单位（BAU/mL）≥7.1定义了足够的血清学反应。疫苗后COVID-19的发病率及其自疫苗接种以来的时间，不良事件（AE），并记录RA耀斑。进行了调整的逻辑和线性多变量回归分析，以确定与疫苗反应相关的因素。我们纳入了118名患者(87.2%为女性,年龄65.4±11.6岁，进化12.0±9.6年)，其中95.8%有完整的疫苗接种计划。88.1%的患者获得了足够的体液免疫原性，并且与以前的COVID-19和mRNA疫苗相关，而吸烟,aCCP,年龄,和DMARDs产生了负面影响。疫苗后COVID-19发生在18.6%的患者中，疫苗接种后的中位数为6.5个月。疫苗AE（19.5％）和RA耀斑（1.7％）大多是轻度的，与年龄成反比。我们的结果表明，COVID-19疫苗诱导足够的体液免疫原性，在RA患者中具有可接受的安全性。
