On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events

Therapy by human immunoglobulin G (IgG) concentrates is a success story ongoing for decades with an ever increasing demand for this plasma product. The success of IgG concentrates on a clinical level is documented by the slowly increasing number of registered indication and the more rapid increase o...

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Main Authors:	Späth, Peter J., Granata, Guido, La Marra, Fabiola, Kuijpers, Taco W., Quinti, Isabella
Format:	Online
Language:	English
Published:	Frontiers Media S.A. 2015
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318428/

id	pubmed-4318428
recordtype	oai_dc
spelling	pubmed-43184282015-02-19 On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events Späth, Peter J. Granata, Guido La Marra, Fabiola Kuijpers, Taco W. Quinti, Isabella Immunology Therapy by human immunoglobulin G (IgG) concentrates is a success story ongoing for decades with an ever increasing demand for this plasma product. The success of IgG concentrates on a clinical level is documented by the slowly increasing number of registered indication and the more rapid increase of the off-label uses, a topic dealt with in another contribution to this special issue of Frontiers in Immunology. A part of the success is the adverse event (AE) profile of IgG concentrates which is, even at life-long need for therapy, excellent. Transmission of pathogens in the last decade could be entirely controlled through the antecedent introduction by authorities of a regulatory network and installing quality standards by the plasma fractionation industry. The cornerstone of the regulatory network is current good manufacturing practice. Non-infectious AEs occur rarely and mainly are mild to moderate. However, in recent times, the increase in frequency of hemolytic and thrombotic AEs raised worrying questions on the possible background for these AEs. Below, we review elements of non-infectious AEs, and particularly focus on hemolysis and thrombosis. We discuss how the introduction of plasma fractionation by ion-exchange chromatography and polishing by immunoaffinity chromatographic steps might alter repertoire of specificities and influence AE profiles and efficacy of IgG concentrates. Frontiers Media S.A. 2015-02-05 /pmc/articles/PMC4318428/ /pubmed/25699039 http://dx.doi.org/10.3389/fimmu.2015.00011 Text en Copyright © 2015 Späth, Granata, La Marra, Kuijpers and Quinti. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Späth, Peter J. Granata, Guido La Marra, Fabiola Kuijpers, Taco W. Quinti, Isabella
spellingShingle	Späth, Peter J. Granata, Guido La Marra, Fabiola Kuijpers, Taco W. Quinti, Isabella On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events
author_facet	Späth, Peter J. Granata, Guido La Marra, Fabiola Kuijpers, Taco W. Quinti, Isabella
author_sort	Späth, Peter J.
title	On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events
title_short	On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events
title_full	On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events
title_fullStr	On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events
title_full_unstemmed	On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events
title_sort	on the dark side of therapies with immunoglobulin concentrates: the adverse events
description	Therapy by human immunoglobulin G (IgG) concentrates is a success story ongoing for decades with an ever increasing demand for this plasma product. The success of IgG concentrates on a clinical level is documented by the slowly increasing number of registered indication and the more rapid increase of the off-label uses, a topic dealt with in another contribution to this special issue of Frontiers in Immunology. A part of the success is the adverse event (AE) profile of IgG concentrates which is, even at life-long need for therapy, excellent. Transmission of pathogens in the last decade could be entirely controlled through the antecedent introduction by authorities of a regulatory network and installing quality standards by the plasma fractionation industry. The cornerstone of the regulatory network is current good manufacturing practice. Non-infectious AEs occur rarely and mainly are mild to moderate. However, in recent times, the increase in frequency of hemolytic and thrombotic AEs raised worrying questions on the possible background for these AEs. Below, we review elements of non-infectious AEs, and particularly focus on hemolysis and thrombosis. We discuss how the introduction of plasma fractionation by ion-exchange chromatography and polishing by immunoaffinity chromatographic steps might alter repertoire of specificities and influence AE profiles and efficacy of IgG concentrates.
publisher	Frontiers Media S.A.
publishDate	2015
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318428/
_version_	1613184694051930112

On the Dark Side of Therapies with Immunoglobulin Concentrates: The Adverse Events

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