Kobayashi Roger H, Mandujano Jose Fernando, Rehman Syed M, Kobayashi Ai Lan, Geng Bob, Atkinson Thomas Prescott, Melamed Isaac, Turpel-Kantor Eva, Clodi Elisabeth, Gupta Sudhir
Department of Pediatrics, Division of Immunology and Allergy, UCLA School of Medicine, Los Angeles, CA 90095, USA.
Pediatric Pulmonary Associates of North Texas, Frisco, TX 75034, USA.
Immunotherapy. 2021 Jul;13(10):813-824. doi: 10.2217/imt-2021-0064. Epub 2021 May 6.
Subcutaneous human immunoglobulin (16.5%; octanorm/cutaquig) was efficacious and well tolerated in patients with primary immunodeficiencies in a Phase III study. A subanalysis of pediatric data is presented here. Children (2-16 years) previously treated with intravenous human immunoglobulin received weekly subcutaneous human immunoglobulin infusions over 64 weeks. The main objective was to assess the efficacy of cutaquig in preventing serious bacterial infections. 38 children received 2213 infusions of cutaquig. No serious bacterial infections developed during the study. The rate of other infections was 3.1 per person-year and the rate of adverse drug reactions was 0.083 per infusion. Higher immunoglobulin G trough levels were achieved with cutaquig compared with previous intravenous therapy. Once-weekly infusions of cutaquig were efficacious and well tolerated in children with primary immunodeficiencies.
在一项III期研究中，皮下注射人免疫球蛋白（16.5%；Octanorm/Cutaquig）对原发性免疫缺陷患者有效且耐受性良好。本文展示了儿科数据的亚分析。此前接受静脉注射人免疫球蛋白治疗的儿童（2至16岁）在64周内每周接受皮下注射人免疫球蛋白输注。主要目的是评估Cutaquig预防严重细菌感染的疗效。38名儿童接受了2213次Cutaquig输注。研究期间未发生严重细菌感染。其他感染率为每人每年3.1次，药物不良反应率为每次输注0.083次。与先前的静脉治疗相比，Cutaquig可实现更高的免疫球蛋白G谷浓度。每周一次输注Cutaquig对原发性免疫缺陷儿童有效且耐受性良好。
