University of California at Irvine, Irvine, California.
Allergy Associates of the Palm Beaches, North Palm Beach, Florida.
Ann Allergy Asthma Immunol. 2019 Sep;123(3):271-279.e1. doi: 10.1016/j.anai.2019.06.004. Epub 2019 Jun 20.
The subcutaneous immune globulin (SCIG) 20% product, Ig20Gly, was shown to be efficacious and well tolerated in 2 phase 2/3 North American and European studies at infusion volumes up to 60 mL/site and rates up to 60 mL/h/site in patients with primary immunodeficiency diseases.
To assess patient experience after switching to Ig20Gly with fast infusion rates and large infusion volumes/site in the North American study.
In this analysis of the open-label phase 2/3 study in which patients aged ≥2 years received weekly Ig20Gly infusions for up to approximately 1.3 years, tolerability and infusion parameters were assessed throughout the study for all patients and by prestudy treatment regimen (intravenous [IV] switchers or SC switchers).
Overall, 61% of patients reached the infusion rate of ≥60 mL/h/site and continued at this rate for 1 or more subsequent infusions; the median infusion number when patients first reached ≥60 mL/h/site was 3. No association was found between higher infusion volumes or rates and increased incidences of local and systemic adverse events (AEs) in the total population and patients younger than 16 years. Infusion parameters and tolerability were generally comparable regardless of the route of prestudy treatment (IV or SC switchers); however, IV switchers experienced lower rates of local AEs than SC switchers and had a slightly higher median infusion volume per site and longer infusion duration vs SC switchers.
High Ig20Gly infusion rates of at least 60 mL/h/site and volumes ≥60 mL/site were well tolerated during onboarding and throughout treatment, regardless of prestudy treatment.
ClinicalTrials.gov Identifier NCT01218438.
皮下免疫球蛋白（SCIG）20%产品 Ig20Gly 在两项北美和欧洲的 2/3 期研究中显示出疗效和良好的耐受性，在 2 岁及以上患者中，每次输注剂量高达 60ml/部位，输注速率高达 60ml/h/部位。
评估在北美研究中以较高的输注速率和较大的输注剂量/部位切换到 Ig20Gly 后的患者体验。
在这项开放标签的 2/3 期研究的分析中，年龄≥2 岁的患者接受每周 Ig20Gly 输注，最长约 1.3 年，在整个研究期间，所有患者和根据预研究治疗方案（静脉[IV]切换者或 SC 切换者）评估了耐受性和输注参数。
总体而言，61%的患者达到了≥60ml/h/部位的输注速率，并在随后的 1 次或多次输注中继续保持该速率；当患者首次达到≥60ml/h/部位时，中位数输注次数为 3 次。在全人群和年龄小于 16 岁的患者中，未发现较高的输注量或速率与局部和全身不良事件（AE）发生率增加之间存在关联。无论预研究治疗途径（IV 切换者或 SC 切换者）如何，输注参数和耐受性通常都是可比的；然而，IV 切换者的局部 AE 发生率低于 SC 切换者，且每个部位的中位输注体积和输注时间略长于 SC 切换者。
在启动治疗和整个治疗过程中，以至少 60ml/h/部位的高 Ig20Gly 输注率和≥60ml/部位的输注剂量均具有良好的耐受性，而与预研究治疗无关。
ClinicalTrials.gov 标识符 NCT01218438。
