Rheumatology Unit, University of Modena and Reggio Emilia, School of Medicine, Modena, Italy; Rheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
J Autoimmun. 2021 Dec;125:102744. doi: 10.1016/j.jaut.2021.102744. Epub 2021 Nov 10.
Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53-1203) vs 825 (451-1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine, while a different type of vaccine could be administered to non-responder individuals.
自身免疫性系统性疾病（ASD）可能对 COVID-19 疫苗表现出免疫原性受损。我们的前瞻性观察性多中心研究旨在评估接种周期后的血清转化率和 6-12 个月的随访结果，以及疫苗在预防 COVID-19 方面的安全性和有效性。该研究纳入了 478 例未选择的 ASD 患者（平均年龄 59±15 岁），包括 101 例类风湿关节炎（RA）、38 例系统性红斑狼疮（SLE）、265 例系统性硬化症（SSc）、61 例冷球蛋白血症性血管炎（CV）和 13 例系统性血管炎的混杂病例。对照组包括 502 名来自普通人群的个体（平均年龄 59±14SD 岁）。通过在接种周期后 3 周内采集的样本，使用 SARS-CoV-2 IgG II Quant 抗体检测试剂盒（雅培实验室，芝加哥，IL）测量血清 IgG 中和抗体（NAb），评估 mRNA COVID-19 疫苗（BNT162b2 和 mRNA-1273）的免疫原性。我们前瞻性研究的短期结果显示，ASD 系列中的 NAb 水平明显低于对照组[286（53-1203）比 825（451-1542）BAU/mL，p<0.0001]，以及单个 ASD 亚组与对照组之间的水平。更有趣的是，与对照组相比，ASD 患者中疫苗无应答者的比例更高[13.2%（63/478），比 2.8%（14/502）；p<0.0001]。在不同的 ASD 亚组中也观察到疫苗无应答的发生率增加，在与 ASD 相关的间质性肺病患者中（p=0.009），以及在接受糖皮质激素治疗的患者中（p=0.002）、霉酚酸酯（p<0.0001）或利妥昔单抗（p<0.0001）治疗的患者中。在对疫苗有反应和无反应的 ASD 患者中，记录到了相似比例的疫苗相关不良事件。血清中和抗体弱/无转化的患者，被认为对 SARS-CoV-2 感染具有免疫力，发生 COVID-19 的风险较高。在接种周期后早期确定血清 NAb 可将 ASD 患者分为三组：有反应者、反应不佳者和无反应者。反应不佳者应优先考虑接种疫苗加强针，而无反应者可接种不同类型的疫苗。
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