Abstract：
OBJECTIVE: To evaluate immunogenicity, effectiveness and safety of COVID-19 vaccination in patients with pediatric autoimmune inflammatory rheumatic disease (pedAIIRD).
METHODS: A prospective cohort study was performed at the pediatric rheumatology department of the Wilhelmina Children\'s Hospital in Utrecht, the Netherlands. Vaccination dates, COVID-19 cases and vaccine-related adverse events (AEs) were registered for all pedAIIRD patients during regular clinic visits from March 2021 - August 2022. SARS-CoV-2 IgG antibody levels and T-cell responses were measured from serum samples after vaccination, and clinical and drug therapy data were collected from electronic medical records. Rate of COVID-19 disease was compared between vaccinated and unvaccinated patients in a time-varying Cox regression analysis.
RESULTS: A total of 157 patients were included in this study and 88 % had juvenile idiopathic arthritis (JIA). One hundred thirty-seven patients were fully vaccinated, of which 47 % used biological agents at the time of vaccination, and 20 patients were unvaccinated. Geometric mean concentrations (GMCs) of post-vaccine antibody levels against SARS-CoV-2 were above the threshold for positivity in patients who did and did not use biological agents at the time of vaccination, although biological users demonstrated significantly lower antibody levels (adjusted GMC ratio: 0.38, 95 % CI: 0.21 - 0.70). T-cell responses were adequate in all but two patients (9 %). The adjusted rate of reported COVID-19 was significantly lower for fully vaccinated patients compared to non-vaccinated patients (HR: 0.53, 95 % CI: 0.29 - 0.97). JIA disease activity scores were not significantly different after vaccination, and no serious AEs were reported.
CONCLUSIONS: COVID-19 mRNA vaccines were immunogenic (both cellular and humoral), effective and safe in a large cohort of pedAIIRD patients despite their use of immunosuppressive medication.
METHODS: A prospective cohort study was performed at the pediatric rheumatology department of the Wilhelmina Children\'s Hospital in Utrecht, the Netherlands. Vaccination dates, COVID-19 cases and vaccine-related adverse events (AEs) were registered for all pedAIIRD patients during regular clinic visits from March 2021 - August 2022. SARS-CoV-2 IgG antibody levels and T-cell responses were measured from serum samples after vaccination, and clinical and drug therapy data were collected from electronic medical records. Rate of COVID-19 disease was compared between vaccinated and unvaccinated patients in a time-varying Cox regression analysis.
RESULTS: A total of 157 patients were included in this study and 88 % had juvenile idiopathic arthritis (JIA). One hundred thirty-seven patients were fully vaccinated, of which 47 % used biological agents at the time of vaccination, and 20 patients were unvaccinated. Geometric mean concentrations (GMCs) of post-vaccine antibody levels against SARS-CoV-2 were above the threshold for positivity in patients who did and did not use biological agents at the time of vaccination, although biological users demonstrated significantly lower antibody levels (adjusted GMC ratio: 0.38, 95 % CI: 0.21 - 0.70). T-cell responses were adequate in all but two patients (9 %). The adjusted rate of reported COVID-19 was significantly lower for fully vaccinated patients compared to non-vaccinated patients (HR: 0.53, 95 % CI: 0.29 - 0.97). JIA disease activity scores were not significantly different after vaccination, and no serious AEs were reported.
CONCLUSIONS: COVID-19 mRNA vaccines were immunogenic (both cellular and humoral), effective and safe in a large cohort of pedAIIRD patients despite their use of immunosuppressive medication.
摘要：
目的：评估免疫原性，COVID-19疫苗在小儿自身免疫性炎症性风湿性疾病（pedAIRD）患者中的有效性和安全性。
方法：在乌得勒支Wilhelmina儿童医院儿科风湿病科进行了一项前瞻性队列研究，荷兰。疫苗接种日期,在2021年3月至2022年8月的定期门诊就诊期间，所有患者都登记了COVID-19病例和疫苗相关不良事件（AE）。从接种疫苗后的血清样本中测量SARS-CoV-2IgG抗体水平和T细胞应答,从电子病历中收集临床和药物治疗数据.在随时间变化的Cox回归分析中，比较了接种疫苗和未接种疫苗的患者之间的COVID-19疾病发生率。
结果：本研究共纳入157例患者，88%患有幼年特发性关节炎（JIA）。一百三十七名病人全面接种疫苗,其中47%的人在接种疫苗时使用生物制剂，20名患者未接种疫苗。在接种疫苗时使用和未使用生物制剂的患者中，针对SARS-CoV-2的疫苗后抗体水平的几何平均浓度（GMC）高于阳性阈值。尽管生物使用者表现出显著较低的抗体水平(校正GMC比率:0.38,95%CI:0.21-0.70).除两名患者（9％）外，所有患者的T细胞反应都足够。与未接种疫苗的患者相比，完全接种疫苗的患者报告的COVID-19的调整后比率显着降低(HR：0.53，95%CI：0.29-0.97)。接种后JIA疾病活动评分无显著差异，没有严重的AE报告。
结论：COVID-19mRNA疫苗具有免疫原性（细胞和体液），尽管使用了免疫抑制药物，但在大量患者中有效且安全。
方法：在乌得勒支Wilhelmina儿童医院儿科风湿病科进行了一项前瞻性队列研究，荷兰。疫苗接种日期,在2021年3月至2022年8月的定期门诊就诊期间，所有患者都登记了COVID-19病例和疫苗相关不良事件（AE）。从接种疫苗后的血清样本中测量SARS-CoV-2IgG抗体水平和T细胞应答,从电子病历中收集临床和药物治疗数据.在随时间变化的Cox回归分析中，比较了接种疫苗和未接种疫苗的患者之间的COVID-19疾病发生率。
结果：本研究共纳入157例患者，88%患有幼年特发性关节炎（JIA）。一百三十七名病人全面接种疫苗,其中47%的人在接种疫苗时使用生物制剂，20名患者未接种疫苗。在接种疫苗时使用和未使用生物制剂的患者中，针对SARS-CoV-2的疫苗后抗体水平的几何平均浓度（GMC）高于阳性阈值。尽管生物使用者表现出显著较低的抗体水平(校正GMC比率:0.38,95%CI:0.21-0.70).除两名患者（9％）外，所有患者的T细胞反应都足够。与未接种疫苗的患者相比，完全接种疫苗的患者报告的COVID-19的调整后比率显着降低(HR：0.53，95%CI：0.29-0.97)。接种后JIA疾病活动评分无显著差异，没有严重的AE报告。
结论：COVID-19mRNA疫苗具有免疫原性（细胞和体液），尽管使用了免疫抑制药物，但在大量患者中有效且安全。
