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Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency
Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized wi...
Autores principales: | , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Springer US
2010
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2935975/ https://www.ncbi.nlm.nih.gov/pubmed/20454851 http://dx.doi.org/10.1007/s10875-010-9423-4 |
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author | Hagan, John B. Fasano, Mary B. Spector, Sheldon Wasserman, Richard L. Melamed, Isaac Rojavin, Mikhail A. Zenker, Othmar Orange, Jordan S. |
author_facet | Hagan, John B. Fasano, Mary B. Spector, Sheldon Wasserman, Richard L. Melamed, Isaac Rojavin, Mikhail A. Zenker, Othmar Orange, Jordan S. |
author_sort | Hagan, John B. |
collection | PubMed |
description | Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5–72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs. |
format | Text |
id | pubmed-2935975 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-29359752010-09-10 Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency Hagan, John B. Fasano, Mary B. Spector, Sheldon Wasserman, Richard L. Melamed, Isaac Rojavin, Mikhail A. Zenker, Othmar Orange, Jordan S. J Clin Immunol Article Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5–72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs. Springer US 2010-05-08 2010 /pmc/articles/PMC2935975/ /pubmed/20454851 http://dx.doi.org/10.1007/s10875-010-9423-4 Text en © The Author(s) 2010 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. |
spellingShingle | Article Hagan, John B. Fasano, Mary B. Spector, Sheldon Wasserman, Richard L. Melamed, Isaac Rojavin, Mikhail A. Zenker, Othmar Orange, Jordan S. Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency |
title | Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency |
title_full | Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency |
title_fullStr | Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency |
title_full_unstemmed | Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency |
title_short | Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency |
title_sort | efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, igpro20, in patients with primary immunodeficiency |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2935975/ https://www.ncbi.nlm.nih.gov/pubmed/20454851 http://dx.doi.org/10.1007/s10875-010-9423-4 |
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