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Abstract：
Mixed cryoglobulinemia syndrome (MCs) is a rare immunoproliferative systemic disorder with cutaneous and multiple organ involvement. Our multicenter survey study aimed to investigate the prevalence and outcome of COVID-19 and the safety and immunogenicity of COVID-19 vaccines in a large MCs series.
The survey included 430 unselected MCs patients (130 M, 300 F; mean age 70 ± 10.96 years) consecutively collected at 11 Italian referral centers. Disease classification, clinico-serological assessment, COVID-19 tests, and vaccination immunogenicity were carried out according to current methodologies.
A significantly higher prevalence of COVID-19 was found in MCs patients compared to Italian general population (11.9% vs 8.0%, p < 0.005), and the use of immunomodulators was associated to a higher risk to get infected (p = 0.0166). Moreover, higher mortality rate was recorded in MCs with COVID-19 compared to those without (p < 0.01). Patients\' older age (≥ 60 years) correlated with worse COVID-19 outcomes. The 87% of patients underwent vaccination and 50% a booster dose. Of note, vaccine-related disease flares/worsening were significantly less frequent than those associated to COVID-19 (p = 0.0012). Impaired vaccination immunogenicity was observed in MCs patients compared to controls either after the first vaccination (p = 0.0039) and also after the booster dose (p = 0.05). Finally, some immunomodulators, namely, rituximab and glucocorticoids, hampered the vaccine-induced immunogenicity (p = 0.029).
The present survey revealed an increased prevalence and morbidity of COVID-19 in MCs patients, as well an impaired immunogenicity even after booster vaccination with high rate of no response. Therefore, MCs can be included among frail populations at high risk of infection and severe COVID-19 manifestations, suggesting the need of a close monitoring and specific preventive/therapeutical measures during the ongoing pandemic.
The survey included 430 unselected MCs patients (130 M, 300 F; mean age 70 ± 10.96 years) consecutively collected at 11 Italian referral centers. Disease classification, clinico-serological assessment, COVID-19 tests, and vaccination immunogenicity were carried out according to current methodologies.
A significantly higher prevalence of COVID-19 was found in MCs patients compared to Italian general population (11.9% vs 8.0%, p < 0.005), and the use of immunomodulators was associated to a higher risk to get infected (p = 0.0166). Moreover, higher mortality rate was recorded in MCs with COVID-19 compared to those without (p < 0.01). Patients\' older age (≥ 60 years) correlated with worse COVID-19 outcomes. The 87% of patients underwent vaccination and 50% a booster dose. Of note, vaccine-related disease flares/worsening were significantly less frequent than those associated to COVID-19 (p = 0.0012). Impaired vaccination immunogenicity was observed in MCs patients compared to controls either after the first vaccination (p = 0.0039) and also after the booster dose (p = 0.05). Finally, some immunomodulators, namely, rituximab and glucocorticoids, hampered the vaccine-induced immunogenicity (p = 0.029).
The present survey revealed an increased prevalence and morbidity of COVID-19 in MCs patients, as well an impaired immunogenicity even after booster vaccination with high rate of no response. Therefore, MCs can be included among frail populations at high risk of infection and severe COVID-19 manifestations, suggesting the need of a close monitoring and specific preventive/therapeutical measures during the ongoing pandemic.
摘要：
目的：混合性冷球蛋白血症综合征（MCs）是一种罕见的全身免疫增殖性疾病，皮肤和多器官受累。我们的多中心调查研究旨在调查大型MC系列中COVID-19的患病率和结果以及COVID-19疫苗的安全性和免疫原性。
方法：该调查包括430名未选择的MC患者（130M，300F；平均年龄70±10.96岁）在11个意大利转诊中心连续收集。疾病分类,临床血清学评估，COVID-19测试，和疫苗接种免疫原性根据目前的方法进行。
结果：与意大利普通人群相比，MCs患者的COVID-19患病率明显更高（11.9％vs8.0％，p<0.005)，免疫调节剂的使用与更高的感染风险相关(p=0.0166)。此外，与没有COVID-19的MC相比，有COVID-19的MC的死亡率更高(p<0.01)。患者年龄较大（≥60岁）与COVID-19预后较差相关。87％的患者接受了疫苗接种，50％的患者接受了加强剂量。值得注意的是，与疫苗相关的疾病爆发/恶化的频率明显低于与COVID-19相关的疾病(p=0.0012)。在第一次接种后(p=0.0039)和加强剂量后(p=0.05),与对照相比,在MC患者中观察到受损的接种免疫原性。最后,一些免疫调节剂，即,利妥昔单抗和糖皮质激素，阻碍了疫苗诱导的免疫原性（p=0.029）。
结论：本调查显示MCs患者中COVID-19的患病率和发病率增加，以及受损的免疫原性，即使在加强疫苗接种后，高的无反应率。因此,MC可以包括在感染高风险和严重COVID-19表现的脆弱人群中，建议在正在进行的大流行期间需要密切监测和具体的预防/治疗措施。
方法：该调查包括430名未选择的MC患者（130M，
结果：与意大利普通人群相比，MCs患者的COVID-19患病率明显更高（11.9％vs8.0％，
结论：本调查显示MCs患者中COVID-19的患病率和发病率增加，
