Anderson-Smits Colin, Park Michelle, Bell Judith, Mitchell Sarah, Hartley Louise, Hawe Emma
Takeda Development Center Americas, Inc., Cambridge, MA 02142, USA.
RTI Health Solutions, Didsbury, Manchester, M20 2LS, UK.
Immunotherapy. 2022 Apr;14(5):373-387. doi: 10.2217/imt-2021-0265. Epub 2022 Feb 7.
Identify and describe published literature on the use of subcutaneous immunoglobulin (SCIG) as initial immunoglobulin (IG)-replacement therapy for patients with primary immunodeficiency diseases (PID). We systematically identified and summarized literature in MEDLINE, Embase, BioSciences Information Service and Cochrane Library assessing efficacy/effectiveness, safety/tolerability, health-related quality-of-life (HRQoL) and dosing regimens of SCIG for IG-naive patients with PID. Sixteen studies were included. In IG-naive patients, SCIG managed/reduced infections and demonstrated similar pharmacokinetic parameters to IG-experienced patients; adverse events were mostly minor injection-site pain or discomfort. Three studies reported improvements in HRQoL. Quality of studies was difficult to assess due to limited reporting. Although studies were lacking, available data suggest IG-naive and IG-experienced patients initiating SCIG likely have similar outcomes.
识别并描述已发表的关于皮下注射免疫球蛋白(SCIG)作为原发性免疫缺陷病(PID)患者初始免疫球蛋白(IG)替代疗法的文献。我们系统地在MEDLINE、Embase、生物科学信息服务数据库和Cochrane图书馆中识别并总结了评估SCIG用于初治PID患者的疗效/有效性、安全性/耐受性、健康相关生活质量(HRQoL)和给药方案的文献。共纳入16项研究。在初治PID患者中,SCIG能控制/减少感染,且其药代动力学参数与有IG使用经验的患者相似;不良事件大多为轻微的注射部位疼痛或不适。三项研究报告了HRQoL的改善。由于报告有限,研究质量难以评估。尽管研究数量不足,但现有数据表明,初治PID患者和有IG使用经验的患者开始使用SCIG可能会有相似的结果。