PDF(Pubmed)
Abstract：
To investigate humoral responses and safety of mRNA SARS-CoV-2 vaccines in systemic autoimmune and autoinflammatory rheumatic disease (SAARD) patients subjected or not to treatment modifications during vaccination.
A nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis.
Patients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls.
In SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.
A nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis.
Patients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls.
In SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.
摘要：
研究SARS-CoV-2mRNA疫苗在全身性自身免疫和自身炎症性风湿性疾病（SAARD）患者中的体液反应和安全性。
全国，多中心研究，包括605名SAARD患者和116名对照，前瞻性评估血清抗SARS-CoV-2S1蛋白IgG抗体滴度，副作用,和疾病活动，完成疫苗接种后一个月，在不同的治疗修改策略方面(没有，部分和扩展的修改)。通过数据驱动的多变量逻辑回归分析确定与体液反应障碍相关的独立危险因素。
与对照组以及未进行免疫抑制治疗的SAARD患者相似，对疫苗的反应延长了治疗修改（97.56％vs100％，p=0.2468和97.56%vs97.46%，p分别>0.9999）。相比之下,部分或无治疗改变的患者在87.50%和84.50%的反应，分别。此外，与没有或有部分修饰的SAARD患者相比，接受延长治疗修饰的SAARD患者的抗SARS-CoV-2抗体水平更高（中位数：7.90vs7.06vs7.1，p=0.0003和p=0.0195）。霉酚酸酯（MMF），利妥昔单抗（RTX）和甲氨蝶呤（MTX）对抗SARS-CoV-2体液反应产生负面影响。在10.5%的接种疫苗的患者中，注意到轻微的临床恶化；然而，在不同的改良治疗SAARD亚组中,病情恶化的发生率没有差异.SAARD患者和对照组之间的副作用通常相当。
在SAARD患者中，SARS-CoV-2mRNA疫苗是有效和安全的,在副作用和疾病发作方面。MMF治疗，RTX和/或MTX损害抗SARS-CoV-2抗体反应，在延长治疗修改后恢复，而不影响疾病活动。
全国，多中心研究，包括605名SAARD患者和116名对照，前瞻性评估血清抗SARS-CoV-2S1蛋白IgG抗体滴度，副作用,和疾病活动，完成疫苗接种后一个月，在不同的治疗修改策略方面(没有，部分和扩展的修改)。通过数据驱动的多变量逻辑回归分析确定与体液反应障碍相关的独立危险因素。
与对照组以及未进行免疫抑制治疗的SAARD患者相似，对疫苗的反应延长了治疗修改（97.56％vs100％，p=0.2468和97.56%vs97.46%，p分别>0.9999）。相比之下,部分或无治疗改变的患者在87.50%和84.50%的反应，分别。此外，与没有或有部分修饰的SAARD患者相比，接受延长治疗修饰的SAARD患者的抗SARS-CoV-2抗体水平更高（中位数：7.90vs7.06vs7.1，p=0.0003和p=0.0195）。霉酚酸酯（MMF），利妥昔单抗（RTX）和甲氨蝶呤（MTX）对抗SARS-CoV-2体液反应产生负面影响。在10.5%的接种疫苗的患者中，注意到轻微的临床恶化；然而，在不同的改良治疗SAARD亚组中,病情恶化的发生率没有差异.SAARD患者和对照组之间的副作用通常相当。
在SAARD患者中，SARS-CoV-2mRNA疫苗是有效和安全的,在副作用和疾病发作方面。MMF治疗，RTX和/或MTX损害抗SARS-CoV-2抗体反应，在延长治疗修改后恢复，而不影响疾病活动。
