About: Response to the Letter to the Editor by Ewenstein BM and Reininger AJ

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An Entity of Type : http://linked.opendata.cz/ontology/domain/vavai/Vysledek, within Data Space : linked.opendata.cz associated with source document(s)

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rdf:type	skos:Concept http://linked.opendata.cz/ontology/domain/vavai/Vysledek
rdfs:seeAlso	http://dx.doi.org/10.1111/hae.12154
Description	We disagree with the statement made by Ewenstein & Reininger that it is not relevant to study PUPs for the comparison of inhibitor risk between different products. Although the European regulatory agencies have put more focus on studying inhibitor development in previously treated patients (PTPs), there is an ongoing discussion on how PTP and PUP data can complement one another. Indeed, the European Medicines Agency (EMA) currently recommends PUP studies to investigate efficacy and safety in this patient population and that clinical trial data, addressing efficacy and safety with respect to immunogenicity and other adverse events in all age groups, be generated; guidance was further developed following an increased rate of notifications of inhibitor development in PTPs treated with recombinant FVIII, which gave reason for an expert meeting. The EMA has acknowledged that in daily practice, the most significant and clinically relevant inhibitors may occur in PUPs. Some haemophilia treaters recommend that investigation of inhibitor development, specifically between PUPs treated with plasma-derived FVIII compared with recombinant FVIII, should be a high priority. We disagree with the statement made by Ewenstein & Reininger that it is not relevant to study PUPs for the comparison of inhibitor risk between different products. Although the European regulatory agencies have put more focus on studying inhibitor development in previously treated patients (PTPs), there is an ongoing discussion on how PTP and PUP data can complement one another. Indeed, the European Medicines Agency (EMA) currently recommends PUP studies to investigate efficacy and safety in this patient population and that clinical trial data, addressing efficacy and safety with respect to immunogenicity and other adverse events in all age groups, be generated; guidance was further developed following an increased rate of notifications of inhibitor development in PTPs treated with recombinant FVIII, which gave reason for an expert meeting. The EMA has acknowledged that in daily practice, the most significant and clinically relevant inhibitors may occur in PUPs. Some haemophilia treaters recommend that investigation of inhibitor development, specifically between PUPs treated with plasma-derived FVIII compared with recombinant FVIII, should be a high priority. (en)
Title	Response to the Letter to the Editor by Ewenstein BM and Reininger AJ Response to the Letter to the Editor by Ewenstein BM and Reininger AJ (en)
skos:prefLabel	Response to the Letter to the Editor by Ewenstein BM and Reininger AJ Response to the Letter to the Editor by Ewenstein BM and Reininger AJ (en)
skos:notation	RIV/00216208:11130/13:10209736!RIV14-MSM-11130___
http://linked.open...avai/predkladatel	2. lékařská fakulta
http://linked.open...avai/riv/aktivita	I
http://linked.open...avai/riv/aktivity	I
http://linked.open...iv/cisloPeriodika	4
http://linked.open...vai/riv/dodaniDat	2014
http://linked.open...aciTvurceVysledku	Komrska, Vladimír
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Univerzita Karlova v Praze / 2. lékařská fakulta
http://linked.open...dnocenehoVysledku	102664
http://linked.open...ai/riv/idVysledku	RIV/00216208:11130/13:10209736
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	products; inhibitor development; recombinant factor-viii; severe hemophilia-a; previously untreated patients (en)
http://linked.open.../riv/klicoveSlovo	previously untreated patients severe hemophilia-a inhibitor development recombinant factor-viii products
http://linked.open...odStatuVydavatele	GB - Spojené království Velké Británie a Severního Irska
http://linked.open...ontrolniKodProRIV	[23B3DF2B4E1E]
http://linked.open...i/riv/nazevZdroje	Haemophilia : the official journal of the World Federation of Hemophilia
http://linked.open...in/vavai/riv/obor	FD
http://linked.open...ichTvurcuVysledku	1 (xsd:int)
http://linked.open...cetTvurcuVysledku	4 (xsd:int)
http://linked.open...UplatneniVysledku	2013
http://linked.open...v/svazekPeriodika	19
http://linked.open...iv/tvurceVysledku	Jansen, M. Klukowska, A. Komrska, Vladimír Laguna, P.
http://linked.open...ain/vavai/riv/wos	000320552100008
issn	1351-8216
number of pages	2 (xsd:int)
http://bibframe.org/vocab/doi	10.1111/hae.12154
http://localhost/t...ganizacniJednotka	11130

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