Abstract：
Aim: To assess the long-term safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% in European routine clinical practice. Materials & methods: This prospective, noninterventional, open-label, post-authorization safety study (EUPAS5812) sourced data on adverse events, immunogenicity, treatment regimens and product administration for 106 adult patients prescribed fSCIG 10% across 17 sites in six European countries from July 2014 to February 2020. Results: In total, 1171 treatment-emergent adverse events were reported in 94 patients (88.7%); 25.5% of these events were considered related to fSCIG 10%. Positive binding antibody titers developed in three patients; no neutralizing antibodies to recombinant human hyaluronidase were detected. Conclusion: This real-world study of fSCIG 10% is the longest to date and confirms its long-term safety and tolerability in adults with antibody deficiency diseases.
One way that the immune system fights infection is by making proteins known as antibodies, also called immunoglobulins. In conditions known as primary immunodeficiency diseases or secondary immunodeficiency diseases, the immune system may not work properly and so treatment with immunoglobulins might be needed. This study looked at the use of an antibody treatment called hyaluronidase-facilitated subcutaneous immunoglobulin (or fSCIG) in European adults mostly with primary immunodeficiency diseases in the real world. Details of adverse events and how fSCIG was used was taken from patient medical records and other documents, and information provided by patients. Of 106 patients, 94 (88.7%) reported 1171 adverse events which started during fSCIG treatment, and 25.5% of these events were considered related to patients receiving fSCIG. For the 105 patients who had information available, 66 patients (62.9%) were treated with fSCIG every 4 weeks. The study results support that fSCIG has a beneficial safety profile in adults with primary or secondary immunodeficiency diseases.
One way that the immune system fights infection is by making proteins known as antibodies, also called immunoglobulins. In conditions known as primary immunodeficiency diseases or secondary immunodeficiency diseases, the immune system may not work properly and so treatment with immunoglobulins might be needed. This study looked at the use of an antibody treatment called hyaluronidase-facilitated subcutaneous immunoglobulin (or fSCIG) in European adults mostly with primary immunodeficiency diseases in the real world. Details of adverse events and how fSCIG was used was taken from patient medical records and other documents, and information provided by patients. Of 106 patients, 94 (88.7%) reported 1171 adverse events which started during fSCIG treatment, and 25.5% of these events were considered related to patients receiving fSCIG. For the 105 patients who had information available, 66 patients (62.9%) were treated with fSCIG every 4 weeks. The study results support that fSCIG has a beneficial safety profile in adults with primary or secondary immunodeficiency diseases.
摘要：
目的：评估10％透明质酸酶促进皮下免疫球蛋白（fSCIG）在欧洲常规临床实践中的长期安全性。材料与方法：这是前瞻性的，非干预性，开放标签，授权后安全性研究(EUPAS5812)来源于不良事件的数据，免疫原性,2014年7月至2020年2月,在6个欧洲国家的17个研究机构中,106例成年患者的治疗方案和产品给药规定了fSCIG10%.结果：总的来说，94例患者（88.7%）报告了1171例治疗引起的不良事件；这些事件中的25.5%被认为与fSCIG10%相关。在三名患者中出现了阳性结合抗体滴度；未检测到针对重组人透明质酸酶的中和抗体。结论：这项对fSCIG10％的真实世界研究是迄今为止最长的，并证实了其在患有抗体缺乏疾病的成年人中的长期安全性和耐受性。
免疫系统对抗感染的一种方法是制造被称为抗体的蛋白质，也称为免疫球蛋白。在称为原发性免疫缺陷疾病或继发性免疫缺陷疾病的情况下，免疫系统可能无法正常工作，因此可能需要使用免疫球蛋白进行治疗。这项研究着眼于在现实世界中大多数患有原发性免疫缺陷疾病的欧洲成年人中使用称为透明质酸酶促进皮下免疫球蛋白（或fSCIG）的抗体治疗。不良事件的详细信息以及fSCIG的使用方法来自患者的医疗记录和其他文件，以及患者提供的信息。106名患者中,94（88.7%）报告了在fSCIG治疗期间开始的1171起不良事件，这些事件中有25.5%被认为与接受fSCIG的患者有关.对于有信息的105名患者，66例(62.9%)患者每4周接受fSCIG治疗。研究结果支持fSCIG在患有原发性或继发性免疫缺陷疾病的成年人中具有有益的安全性。
免疫系统对抗感染的一种方法是制造被称为抗体的蛋白质，也称为免疫球蛋白。在称为原发性免疫缺陷疾病或继发性免疫缺陷疾病的情况下，免疫系统可能无法正常工作，因此可能需要使用免疫球蛋白进行治疗。这项研究着眼于在现实世界中大多数患有原发性免疫缺陷疾病的欧洲成年人中使用称为透明质酸酶促进皮下免疫球蛋白（或fSCIG）的抗体治疗。不良事件的详细信息以及fSCIG的使用方法来自患者的医疗记录和其他文件，以及患者提供的信息。106名患者中,94（88.7%）报告了在fSCIG治疗期间开始的1171起不良事件，这些事件中有25.5%被认为与接受fSCIG的患者有关.对于有信息的105名患者，66例(62.9%)患者每4周接受fSCIG治疗。研究结果支持fSCIG在患有原发性或继发性免疫缺陷疾病的成年人中具有有益的安全性。
