原发性和继发性免疫缺陷患者皮下注射20%免疫球蛋白治疗的转换：加拿大真实世界研究
Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study.
作者信息
Keith Paul K, Cowan Juthaporn, Kanani Amin, Kim Harold, Lacuesta Gina, Lee Jason K, Chen Jie, Park Michelle, Gladiator André
机构信息
Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, ON, L8N 3Z5, Canada.
Division of Infectious Diseases, Department of Medicine; Department of Biochemistry, Microbiology, and Immunology; Centre for Infection, Immunity and Inflammation, University of Ottawa, The Ottawa Hospital Research Institute, Ottawa, ON, K1H 8M5, Canada.
出版信息
Allergy Asthma Clin Immunol. 2022 Aug 7;18(1):70. doi: 10.1186/s13223-022-00709-8.
BACKGROUND
Real-world data on transitioning to Immune Globulin Subcutaneous (Human) 20% solution (Ig20Gly) are limited. This study aimed to assess infusion parameters and experience of patients with primary (PID) or secondary immunodeficiencies (SID) transitioning to Ig20Gly in clinical practice in Canada.
METHODS
Patients with PID or SID who received subcutaneous immunoglobulin (SCIG) for ≥ 3 months before transitioning to Ig20Gly were eligible for this multicenter (n = 6), phase 4, non-interventional, prospective, single-arm study. Ig20Gly infusion parameters, dosing, and adverse events were collected from patient medical records at Ig20Gly initiation and 3, 6, and 12 months post-initiation. Patient satisfaction and quality of life were assessed 12 months post-initiation using validated questionnaires.
RESULTS
The study included 125 patients (PID, n = 60; SID, n = 64; PID + SID, n = 1). Median volume per infusion was 30.0 ml at initiation, and 40.0 ml at 6 and 12 months post-initiation. Most patients administered Ig20Gly weekly and used two infusion sites (primarily abdomen). At each time point, median infusion duration was ≤ 1 h. At 12 months, 61% of infusions were administered via a pump and 39% manually. Headache and infusion-site reactions were the most reported adverse events of interest. Patients expressed overall satisfaction with Ig20Gly at 12 months post-initiation, with all respondents indicating they would like to continue Ig20Gly.
CONCLUSIONS
This study provides a detailed description of Ig20Gly infusion parameters, tolerability, and quality of life in clinical practice among patients with PID or SID switching to Ig20Gly from another SCIG and confirms the feasibility of infusing Ig20Gly via pump or manual administration. Trial registration NCT03716700, Registered 31 August 2018, https://clinicaltrials.gov/ct2/show/NCT03716700.
背景
关于转换为皮下注射用20%人免疫球蛋白溶液（Ig20Gly）的真实世界数据有限。本研究旨在评估加拿大临床实践中，原发性免疫缺陷（PID）或继发性免疫缺陷（SID）患者转换为Ig20Gly的输注参数及体验。
方法
在转换为Ig20Gly之前接受皮下免疫球蛋白（SCIG）治疗≥3个月的PID或SID患者符合本多中心（n = 6）、4期、非干预、前瞻性、单臂研究的条件。在开始使用Ig20Gly时以及开始后3、6和12个月，从患者病历中收集Ig20Gly的输注参数、剂量和不良事件。开始后12个月，使用经过验证的问卷评估患者满意度和生活质量。
结果
该研究纳入了125例患者（PID，n = 60；SID，n = 64；PID + SID，n = 1）。开始时每次输注的中位数体积为30.0 ml，开始后6个月和12个月为40.0 ml。大多数患者每周使用Ig20Gly，并使用两个输注部位（主要是腹部）。在每个时间点，输注持续时间中位数≤1小时。在12个月时，61%的输注通过泵进行，39%为手动输注。头痛和输注部位反应是最常报告的不良事件。开始后12个月，患者对Ig20Gly总体表示满意，所有受访者均表示愿意继续使用Ig20Gly。
结论
本研究详细描述了PID或SID患者从另一种SCIG转换为Ig20Gly在临床实践中的Ig20Gly输注参数、耐受性和生活质量，并证实了通过泵或手动给药输注Ig20Gly的可行性。试验注册号NCT03716700，于2018年8月31日注册，https://clinicaltrials.gov/ct2/show/NCT03716700 。
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