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Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency
INTRODUCTION: An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites. METHODS: Patients were treated every 3 or 4 weeks with 254–1029 mg/kg/infusion of IVIG. RESULTS: Overall, Biotest-IVIG infusions were well t...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389237/ https://www.ncbi.nlm.nih.gov/pubmed/22392046 http://dx.doi.org/10.1007/s10875-012-9656-5 |
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author | Wasserman, Richard L. Church, Joseph A. Stein, Mark Moy, James White, Martha Strausbaugh, Steven Schroeder, Harry Ballow, Mark Harris, James Melamed, Isaac Elkayam, David Lumry, William Suez, Daniel Rehman, Syed M. |
author_facet | Wasserman, Richard L. Church, Joseph A. Stein, Mark Moy, James White, Martha Strausbaugh, Steven Schroeder, Harry Ballow, Mark Harris, James Melamed, Isaac Elkayam, David Lumry, William Suez, Daniel Rehman, Syed M. |
author_sort | Wasserman, Richard L. |
collection | PubMed |
description | INTRODUCTION: An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites. METHODS: Patients were treated every 3 or 4 weeks with 254–1029 mg/kg/infusion of IVIG. RESULTS: Overall, Biotest-IVIG infusions were well tolerated. The proportion of infusions that were associated with adverse events during infusion, and up to 72 h after infusion, including those unrelated to study product, was 27.7% with an upper 95% confidence limit ≤30.6%. Two serious bacterial infections (SBIs) were observed resulting in a serious bacterial infection rate of 0.035 per person per year and an upper one-sided 99% confidence limit of ≤0.136 SBI/patient/year. The number of days of work or school missed due to infection were relatively low at 2.28 days/patient/year. Two patients were hospitalized for infection producing a rate of 0.21 hospitalization days/patient/year. The IgG half-life was approximately 30 days with variation among individuals. CONCLUSIONS: Pharmacokinetic parameters of specific antibody activities were essentially the same as those of total IgG. Biotest-IVIG is safe and effective in the treatment of PID. |
format | Online Article Text |
id | pubmed-3389237 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-33892372012-07-11 Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency Wasserman, Richard L. Church, Joseph A. Stein, Mark Moy, James White, Martha Strausbaugh, Steven Schroeder, Harry Ballow, Mark Harris, James Melamed, Isaac Elkayam, David Lumry, William Suez, Daniel Rehman, Syed M. J Clin Immunol Article INTRODUCTION: An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites. METHODS: Patients were treated every 3 or 4 weeks with 254–1029 mg/kg/infusion of IVIG. RESULTS: Overall, Biotest-IVIG infusions were well tolerated. The proportion of infusions that were associated with adverse events during infusion, and up to 72 h after infusion, including those unrelated to study product, was 27.7% with an upper 95% confidence limit ≤30.6%. Two serious bacterial infections (SBIs) were observed resulting in a serious bacterial infection rate of 0.035 per person per year and an upper one-sided 99% confidence limit of ≤0.136 SBI/patient/year. The number of days of work or school missed due to infection were relatively low at 2.28 days/patient/year. Two patients were hospitalized for infection producing a rate of 0.21 hospitalization days/patient/year. The IgG half-life was approximately 30 days with variation among individuals. CONCLUSIONS: Pharmacokinetic parameters of specific antibody activities were essentially the same as those of total IgG. Biotest-IVIG is safe and effective in the treatment of PID. Springer US 2012-03-06 2012 /pmc/articles/PMC3389237/ /pubmed/22392046 http://dx.doi.org/10.1007/s10875-012-9656-5 Text en © The Author(s) 2012 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Article Wasserman, Richard L. Church, Joseph A. Stein, Mark Moy, James White, Martha Strausbaugh, Steven Schroeder, Harry Ballow, Mark Harris, James Melamed, Isaac Elkayam, David Lumry, William Suez, Daniel Rehman, Syed M. Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency |
title | Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency |
title_full | Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency |
title_fullStr | Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency |
title_full_unstemmed | Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency |
title_short | Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency |
title_sort | safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (ivig) in patients with primary immunodeficiency |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389237/ https://www.ncbi.nlm.nih.gov/pubmed/22392046 http://dx.doi.org/10.1007/s10875-012-9656-5 |
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