Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study,Journal of Clinical Immunology

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Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study
Journal of Clinical Immunology ( IF 9.1 ) Pub Date : 2020-10-06 , DOI: 10.1007/s10875-020-00876-6
Juthaporn Cowan ₁ , Vincent R Bonagura _{2,

3} , Patricia L Lugar ₄ , Paul J Maglione ₅ , Niraj C Patel ₆ , Donald C Vinh ₇ , Jutta H Hofmann ₈ , Michaela Praus ₉ , Mikhail A Rojavin ₁₀

Affiliation

University of Ottawa, 501 Smyth Road, Box 223, Ottawa, ON, K1H 8L6, Canada.
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA.
Feinstein Institute for Medical Research, Hofstra-NS-LIJ School of Medicine, Rm. 1236, 350 Community Drive, Manhasset, NY, 11030, USA.
Duke University Medical Center, 1821 Hillandale Rd, Suite 25A, Durham, NC, 27705, USA.
Boston University School of Medicine, Pulmonary Center, R304, Boston, MA, 02118, USA.
Levine Children's Hospital, Atrium Health, 1000 Blythe Blvd, 32861, Charlotte, NC, 28232, USA.
McGill University Health Centre - Research Institute, 1001 Decarie Blvd, Block E, Rm EM3-3230 (Mail Drop: EM3-3211), Montreal, QC, H4A 3J1, Canada.
CSL Behring AG, Wankdorfstrasse 10, 3014, Bern, Switzerland.
CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041, Marburg, Germany.
CSL Behring LLC, 1020 First Avenue, King of Prussia, PA, 19406, USA.

Purpose

To evaluate the safety and tolerability of IgPro20 manual push (also known as rapid push) infusions at flow rates of 0.5–2.0 mL/min.

Methods

Patients with primary immunodeficiency (PID) with previous experience administering IgPro20 (Hizentra^®, CSL Behring, King of Prussia, PA, USA) were enrolled in the Hizentra^® Label Optimization (HILO) study (NCT03033745) and assigned to Pump-assisted Volume Cohort, Pump-assisted Flow Rate Cohort, or Manual Push Flow Rate Cohort; this report describes the latter. Patients administered IgPro20 via manual push at 0.5, 1.0, and 2.0 mL/min/site for 4 weeks each. Responder rates (percentage of patients who completed a predefined minimum number of infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated.

Results

Sixteen patients were treated; 2 patients (12.5%) discontinued at the 1.0-mL/min level (unrelated to treatment). Responder rates were 100%, 100%, and 87.5% at 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Mean weekly infusion duration decreased from 103–108 to 23–28 min at the 0.5- and 2.0-mL/min flow rates, respectively. Rates of treatment-related treatment-emergent adverse events (TEAEs) per infusion were 0.023, 0.082, and 0.025 for the 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Most TEAEs were mild local reactions and tolerability (infusions without severe local reactions/total infusions) was 100% across flow rate levels. Serum IgG levels (mean [SD]) were similar at study start (9.36 [2.53] g/L) and end (9.58 [2.12] g/L).

Conclusions

Subcutaneous IgPro20 manual push infusions at flow rates up to 2.0 mL/min were well tolerated and reduced infusion time in treatment-experienced patients with PID.

Trial Registration

NCT03033745

中文翻译：

在原发性免疫缺陷患者中以高输注速率手动推送皮下 IgPro20 的安全性和耐受性：来自 HILO 研究的手动推送给药队列的结果

目的

评估流速为 0.5–2.0 mL/min 的 IgPro20 手动推注（也称为快速推注）的安全性和耐受性。

方法

曾有使用 IgPro20（Hizentra ^®，CSL Behring，普鲁士国王，宾夕法尼亚州，美国）经验的原发性免疫缺陷 (PID) 患者参加 Hizentra ^®标签优化 (HILO) 研究 (NCT03033745) 并分配到泵辅助容量队列，泵辅助流量队列，或手动推动流量队列；本报告描述了后者。患者通过手动推送以 0.5、1.0 和 2.0 mL/min/站点分别施用 IgPro20，持续 4 周。评估了响应率（完成预定最少输注次数的患者百分比）、安全性结果和血清免疫球蛋白 G (IgG) 谷值水平。

结果

治疗了 16 名患者；2 名患者 (12.5%) 以 1.0-mL/min 的水平停药（与治疗无关）。在 0.5、1.0 和 2.0 mL/min 流速下，响应率分别为 100%、100% 和 87.5%。在 0.5 和 2.0 mL/min 流速下，平均每周输注持续时间分别从 103-108 减少到 23-28 分钟。对于 0.5-、1.0-和 2.0-mL/min 流速，每次输注的治疗相关治疗出现不良事件 (TEAE) 的发生率分别为 0.023、0.082 和 0.025。大多数 TEAE 是轻微的局部反应，耐受性（无严重局部反应的输注/总输注）在流速水平上为 100%。在研究开始 (9.36 [2.53] g/L) 和结束 (9.58 [2.12] g/L) 时，血清 IgG 水平（平均 [SD]）相似。