Infusion parameters of 20% subcutaneous immunoglobulin for primary immunodeficiency diseases among patient support program participants.

Autor:	Meckley LM; Takeda Development Center Americas, Inc, Cambridge, Massachusetts. Electronic address: lisa.meckley@takeda.com., Wu Y; Takeda Development Center Americas, Inc, Cambridge, Massachusetts., Tzivelekis S; Takeda Development Center Americas, Inc, Cambridge, Massachusetts., Gandhi V; Takeda Development Center Americas, Inc, Cambridge, Massachusetts., Gladiator A; Takeda Pharmaceuticals International AG, Zurich, Switzerland.
Jazyk:	angličtina
Zdroj:	Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology [Ann Allergy Asthma Immunol] 2021 Nov; Vol. 127 (5), pp. 568-574.e1. Date of Electronic Publication: 2021 Jul 02.
DOI:	10.1016/j.anai.2021.06.023
Abstrakt:	Background: The safety and efficacy of subcutaneous immune globulin 20% (human) solution (Cuvitru; Ig20Gly) for primary immunodeficiency disease (PID) have been demonstrated in 2 pivotal trials. Objective: To describe patient characteristics and infusion parameters of patients with PID initiating Ig20Gly outside of a clinical trial setting. Methods: This retrospective, observational study analyzed records of patients participating in the HelloCuvitru program, a patient support program in the United States providing Ig20Gly free of charge for the first 4 infusions to patients aged 2 years or older who had PID and no previous experience of Ig20Gly. Data were collected retrospectively from patient records and during nurse visits. Results: A total of 817 patients (88% of 931 enrolled) completed 4 infusions. At the fourth Ig20Gly infusion, the median (interquartile range) dose was 0.55 (0.46-0.69) g/kg/mo, infusion rate per site was 40 (30.0-50.0) mL, and infusion rate per site was 47 (42.5-53.3) mL/h/site. By the fourth infusion, most patients (58%) received Ig20Gly at 2 infusion sites every 7 (30%) or 14 (25%) days. Median prescribed Ig20Gly dose per month was similar across age groups; median infusion volume per site increased with age. Most patients younger than 18 years received infusions every 14 days; patients aged 18 years or older were more likely to receive infusions weekly. Infusion parameters were similar regardless of whether patients received previous immunoglobulin subcutaneously or intravenously. Conclusion: In this large, real-world population of patients with PID, most Ig20Gly infusions were administered for less than 1 hour and required fewer than 2 infusion sites, consistent with the pivotal trials. Infusion rate per site was similar regardless of age, previous immunoglobulin treatment, or infusion frequency. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu