Hizentra for the treatment of primary immunodeficiency
Hizentra for the treatment of primary immunodeficiency
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DOI：
10.1586/1744666x.2014.957678
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发表时间：
2014-10-01
影响因子：
4.4
通讯作者：
Wasserman, Richard L.
中科院分区：
文献类型：
--
作者：
Wasserman, Richard L.
免疫球蛋白（IgG）替代疗法已成为近60年来治疗原发性免疫缺陷疾病的基石。在此期间，研究不断完善目标IgG谷水平和IgG替代剂量，以使原发性免疫缺陷病患者获得有效的保护免受感染。制造商还改进了IgG制剂，使患者能够接受临床有益剂量的IgG替代品，并提高了安全性和耐受性。本文将介绍Hizentra（R），一种用于皮下（sc.）输注，讨论其生产工艺和药代动力学特征，并审查其耐受性和疗效数据，在临床试验中进行评估。与浓度较低的sc. IgG产品相比，新的高浓度sc. IgG产品可以改善患者的生活质量和治疗依从性，因为其给药选择灵活，输注部位较少，输注时间较短，从而获得与较高稳态IgG水平一致的有利患者结局。
Immunoglobulin (IgG) replacement therapy has been the cornerstone of treatment for primary immunodeficiency disease for nearly 60 years. During this time, research has continually refined the target IgG trough level and IgG replacement dosages to allow patients with primary immunodeficiency disease to achieve effective protection from infection. Manufacturers have also improved IgG formulations to allow patients to receive clinically beneficial dosages of IgG replacement with improved safety and tolerability. This review will introduce Hizentra (R), a highly concentrated (20%) IgG solution for subcutaneous (sc.) infusion, discuss its manufacturing process and pharmacokinetic profile and review its tolerability and efficacy data as evaluated in clinical trials. New highly concentrated sc. IgG products may improve patient quality of life and adherence to therapy because of the flexible dosing options, fewer infusion sites and less infusion time, compared with less concentrated sc. IgG products, resulting in favorable patient outcomes consistent with higher steady-state IgG levels.