Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).
Identifieur interne : 002A68 ( PubMed/Checkpoint ); précédent : 002A67; suivant : 002A69Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).
Auteurs : Iain C. Macdougall [Royaume-Uni] ; Nicole Casadevall [France] ; Francesco Locatelli [Italie] ; Christian Combe [France] ; Gerard M. London [France] ; Salvatore Di Paolo [Italie] ; Andreas Kribben [Allemagne] ; Danilo Fliser [Allemagne] ; Hans Messner [Canada] ; John Mcneil [Australie] ; Paul Stevens [Royaume-Uni] ; Antonio Santoro [Italie] ; Angel L M. De Francisco [Espagne] ; Paul Percheson [États-Unis] ; Anna Potamianou [États-Unis] ; Arnaud Foucher [États-Unis] ; Daniel Fife [États-Unis] ; Véronique Mérit [États-Unis] ; Els Vercammen [États-Unis]Source :
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association [ 1460-2385 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anémie (traitement médicamenteux), Autoanticorps (sang), Darbépoétine alfa (immunologie), Enregistrements, Femelle, Humains, Incidence, Indice de gravité médicale, Mâle, Pronostic, Protéines recombinantes (immunologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Époétine alfa (immunologie), Érythroblastopénie chronique acquise (immunologie), Érythroblastopénie chronique acquise (épidémiologie), Érythropoïétine (immunologie), Études prospectives, Évaluation des risques.
- MESH :
- immunologie : Darbépoétine alfa, Protéines recombinantes, Époétine alfa, Érythroblastopénie chronique acquise, Érythropoïétine.
- sang : Autoanticorps.
- traitement médicamenteux : Anémie.
- épidémiologie : Érythroblastopénie chronique acquise.
- Adulte, Adulte d'âge moyen, Enregistrements, Femelle, Humains, Incidence, Indice de gravité médicale, Mâle, Pronostic, Sujet âgé, Sujet âgé de 80 ans ou plus, Études prospectives, Évaluation des risques.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Anemia (drug therapy), Autoantibodies (blood), Darbepoetin alfa (immunology), Epoetin Alfa (immunology), Erythropoietin (immunology), Female, Humans, Incidence, Male, Middle Aged, Prognosis, Prospective Studies, Recombinant Proteins (immunology), Red-Cell Aplasia, Pure (epidemiology), Red-Cell Aplasia, Pure (immunology), Registries, Risk Assessment, Severity of Illness Index.
- MESH :
- chemical , blood : Autoantibodies.
- drug therapy : Anemia.
- epidemiology : Red-Cell Aplasia, Pure.
- chemical , immunology : Darbepoetin alfa, Epoetin Alfa, Erythropoietin, Recombinant Proteins, Red-Cell Aplasia, Pure.
- Adult, Aged, Aged, 80 and over, Female, Humans, Incidence, Male, Middle Aged, Prognosis, Prospective Studies, Registries, Risk Assessment, Severity of Illness Index.
Abstract
Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa).
DOI: 10.1093/ndt/gfu297
PubMed: 25239637
Affiliations:
- Allemagne, Australie, Canada, Espagne, France, Italie, Royaume-Uni, États-Unis
- Angleterre, Aquitaine, Grand Londres, New Jersey, Nouvelle-Aquitaine, Ontario, Victoria (État), Île-de-France
- Bordeaux, Londres, Melbourne, Paris, Toronto
- Université de Toronto
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pubmed:25239637Le document en format XML
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De Francisco</name><affiliation wicri:level="1"><nlm:affiliation>Nephrology Department, Hospital Universitario Valdecilla, Santander, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Nephrology Department, Hospital Universitario Valdecilla, Santander</wicri:regionArea><wicri:noRegion>Santander</wicri:noRegion></affiliation></author><author><name sortKey="Percheson, Paul" sort="Percheson, Paul" uniqKey="Percheson P" first="Paul" last="Percheson">Paul Percheson</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Potamianou, Anna" sort="Potamianou, Anna" uniqKey="Potamianou A" first="Anna" last="Potamianou">Anna Potamianou</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Foucher, Arnaud" sort="Foucher, Arnaud" uniqKey="Foucher A" first="Arnaud" last="Foucher">Arnaud Foucher</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Fife, Daniel" sort="Fife, Daniel" uniqKey="Fife D" first="Daniel" last="Fife">Daniel Fife</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Merit, Veronique" sort="Merit, Veronique" uniqKey="Merit V" first="Véronique" last="Mérit">Véronique Mérit</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Vercammen, Els" sort="Vercammen, Els" uniqKey="Vercammen E" first="Els" last="Vercammen">Els Vercammen</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25239637</idno><idno type="pmid">25239637</idno><idno type="doi">10.1093/ndt/gfu297</idno><idno type="wicri:Area/PubMed/Corpus">002F50</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002F50</idno><idno type="wicri:Area/PubMed/Curation">002E72</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002E72</idno><idno type="wicri:Area/PubMed/Checkpoint">002E72</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">002E72</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).</title><author><name sortKey="Macdougall, Iain C" sort="Macdougall, Iain C" uniqKey="Macdougall I" first="Iain C" last="Macdougall">Iain C. Macdougall</name><affiliation wicri:level="3"><nlm:affiliation>Department of Renal Medicine, King's College Hospital, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Renal Medicine, King's College Hospital, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Casadevall, Nicole" sort="Casadevall, Nicole" uniqKey="Casadevall N" first="Nicole" last="Casadevall">Nicole Casadevall</name><affiliation wicri:level="3"><nlm:affiliation>Service d'Immunologie et Hématologie Biologiques, Hôpital Saint Antoine, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service d'Immunologie et Hématologie Biologiques, Hôpital Saint Antoine, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation wicri:level="1"><nlm:affiliation>Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco</wicri:regionArea><wicri:noRegion>Lecco</wicri:noRegion></affiliation></author><author><name sortKey="Combe, Christian" sort="Combe, Christian" uniqKey="Combe C" first="Christian" last="Combe">Christian Combe</name><affiliation wicri:level="3"><nlm:affiliation>Service de Néphrologie, Centre Hospitalier Universitaire de Bordeaux and Unité INSERM 1026, Université de Bordeaux, Bordeaux, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Néphrologie, Centre Hospitalier Universitaire de Bordeaux and Unité INSERM 1026, Université de Bordeaux, Bordeaux</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName></affiliation></author><author><name sortKey="London, Gerard M" sort="London, Gerard M" uniqKey="London G" first="Gerard M" last="London">Gerard M. London</name><affiliation wicri:level="3"><nlm:affiliation>Centre de Recherche des Cordelliers, Ecole de Médecine, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre de Recherche des Cordelliers, Ecole de Médecine, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Di Paolo, Salvatore" sort="Di Paolo, Salvatore" uniqKey="Di Paolo S" first="Salvatore" last="Di Paolo">Salvatore Di Paolo</name><affiliation wicri:level="1"><nlm:affiliation>Division of Nephrology and Dialysis, Hospital 'Dimiccoli', Barletta, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Nephrology and Dialysis, Hospital 'Dimiccoli', Barletta</wicri:regionArea><wicri:noRegion>Barletta</wicri:noRegion></affiliation></author><author><name sortKey="Kribben, Andreas" sort="Kribben, Andreas" uniqKey="Kribben A" first="Andreas" last="Kribben">Andreas Kribben</name><affiliation wicri:level="1"><nlm:affiliation>Klinik für Nephrologie, Universitätsklinik Essen, Essen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinik für Nephrologie, Universitätsklinik Essen, Essen</wicri:regionArea><wicri:noRegion>Essen</wicri:noRegion><wicri:noRegion>Essen</wicri:noRegion><wicri:noRegion>Essen</wicri:noRegion></affiliation></author><author><name sortKey="Fliser, Danilo" sort="Fliser, Danilo" uniqKey="Fliser D" first="Danilo" last="Fliser">Danilo Fliser</name><affiliation wicri:level="1"><nlm:affiliation>Department Internal Medicine IV, Universitätsklinik Homburg/Saar, Homburg/Saar, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department Internal Medicine IV, Universitätsklinik Homburg/Saar, Homburg/Saar</wicri:regionArea><wicri:noRegion>Homburg/Saar</wicri:noRegion><wicri:noRegion>Homburg/Saar</wicri:noRegion><wicri:noRegion>Homburg/Saar</wicri:noRegion></affiliation></author><author><name sortKey="Messner, Hans" sort="Messner, Hans" uniqKey="Messner H" first="Hans" last="Messner">Hans Messner</name><affiliation wicri:level="4"><nlm:affiliation>Department of Medical Biophysics, University of Toronto, Toronto, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medical Biophysics, University of Toronto, Toronto</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Mcneil, John" sort="Mcneil, John" uniqKey="Mcneil J" first="John" last="Mcneil">John Mcneil</name><affiliation wicri:level="3"><nlm:affiliation>Department of Epidemiology and Preventive Medicine, Monash University Melbourne, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Epidemiology and Preventive Medicine, Monash University Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Stevens, Paul" sort="Stevens, Paul" uniqKey="Stevens P" first="Paul" last="Stevens">Paul Stevens</name><affiliation wicri:level="1"><nlm:affiliation>Department of Renal Medicine, Kent and Canterbury Hospital, Canterbury, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Renal Medicine, Kent and Canterbury Hospital, Canterbury</wicri:regionArea><wicri:noRegion>Canterbury</wicri:noRegion></affiliation></author><author><name sortKey="Santoro, Antonio" sort="Santoro, Antonio" uniqKey="Santoro A" first="Antonio" last="Santoro">Antonio Santoro</name><affiliation wicri:level="1"><nlm:affiliation>Dialysis and Hypertension Department, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S Orsola-Malpighi, Bologna, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Dialysis and Hypertension Department, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S Orsola-Malpighi, Bologna</wicri:regionArea><wicri:noRegion>Bologna</wicri:noRegion></affiliation></author><author><name sortKey="De Francisco, Angel L M" sort="De Francisco, Angel L M" uniqKey="De Francisco A" first="Angel L M" last="De Francisco">Angel L M. De Francisco</name><affiliation wicri:level="1"><nlm:affiliation>Nephrology Department, Hospital Universitario Valdecilla, Santander, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Nephrology Department, Hospital Universitario Valdecilla, Santander</wicri:regionArea><wicri:noRegion>Santander</wicri:noRegion></affiliation></author><author><name sortKey="Percheson, Paul" sort="Percheson, Paul" uniqKey="Percheson P" first="Paul" last="Percheson">Paul Percheson</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Potamianou, Anna" sort="Potamianou, Anna" uniqKey="Potamianou A" first="Anna" last="Potamianou">Anna Potamianou</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Foucher, Arnaud" sort="Foucher, Arnaud" uniqKey="Foucher A" first="Arnaud" last="Foucher">Arnaud Foucher</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Fife, Daniel" sort="Fife, Daniel" uniqKey="Fife D" first="Daniel" last="Fife">Daniel Fife</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Merit, Veronique" sort="Merit, Veronique" uniqKey="Merit V" first="Véronique" last="Mérit">Véronique Mérit</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Vercammen, Els" sort="Vercammen, Els" uniqKey="Vercammen E" first="Els" last="Vercammen">Els Vercammen</name><affiliation wicri:level="2"><nlm:affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author></analytic><series><title level="j">Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association</title><idno type="eISSN">1460-2385</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Anemia (drug therapy)</term><term>Autoantibodies (blood)</term><term>Darbepoetin alfa (immunology)</term><term>Epoetin Alfa (immunology)</term><term>Erythropoietin (immunology)</term><term>Female</term><term>Humans</term><term>Incidence</term><term>Male</term><term>Middle Aged</term><term>Prognosis</term><term>Prospective Studies</term><term>Recombinant Proteins (immunology)</term><term>Red-Cell Aplasia, Pure (epidemiology)</term><term>Red-Cell Aplasia, Pure (immunology)</term><term>Registries</term><term>Risk Assessment</term><term>Severity of Illness Index</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anémie (traitement médicamenteux)</term><term>Autoanticorps (sang)</term><term>Darbépoétine alfa (immunologie)</term><term>Enregistrements</term><term>Femelle</term><term>Humains</term><term>Incidence</term><term>Indice de gravité médicale</term><term>Mâle</term><term>Pronostic</term><term>Protéines recombinantes (immunologie)</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Époétine alfa (immunologie)</term><term>Érythroblastopénie chronique acquise (immunologie)</term><term>Érythroblastopénie chronique acquise (épidémiologie)</term><term>Érythropoïétine (immunologie)</term><term>Études prospectives</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Autoantibodies</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Anemia</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Red-Cell Aplasia, Pure</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Darbépoétine alfa</term><term>Protéines recombinantes</term><term>Époétine alfa</term><term>Érythroblastopénie chronique acquise</term><term>Érythropoïétine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Darbepoetin alfa</term><term>Epoetin Alfa</term><term>Erythropoietin</term><term>Recombinant Proteins</term><term>Red-Cell Aplasia, Pure</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Autoanticorps</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Anémie</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Érythroblastopénie chronique acquise</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Incidence</term><term>Male</term><term>Middle Aged</term><term>Prognosis</term><term>Prospective Studies</term><term>Registries</term><term>Risk Assessment</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Enregistrements</term><term>Femelle</term><term>Humains</term><term>Incidence</term><term>Indice de gravité médicale</term><term>Mâle</term><term>Pronostic</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Études prospectives</term><term>Évaluation des risques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa).</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25239637</PMID><DateCreated><Year>2015</Year><Month>02</Month><Day>25</Day></DateCreated><DateCompleted><Year>2016</Year><Month>06</Month><Day>02</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1460-2385</ISSN><JournalIssue CitedMedium="Internet"><Volume>30</Volume><Issue>3</Issue><PubDate><Year>2015</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association</Title><ISOAbbreviation>Nephrol. Dial. Transplant.</ISOAbbreviation></Journal><ArticleTitle>Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).</ArticleTitle><Pagination><MedlinePgn>451-60</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/ndt/gfu297</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa).</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">PRIMS was a multicentre, multinational, non-interventional, parallel-group, immunogenicity surveillance registry. Adults with CKD receiving or about to initiate subcutaneous Eprex(®), NeoRecormon(®) or Aranesp(®) for anaemia were enrolled and followed for up to 3 years. Unexplained loss or lack of effect (LOE), including suspected PRCA, was reported, with antibody testing for confirmation of PRCA.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of the 15 333 patients enrolled, 5948 received Eprex(®) (8377 patient-years) and 9356 received NeoRecormon(®)/Aranesp(®) (14 286 patient-years). No treatment data were available for 29 patients. Among 23 patients with LOE, five cases of PRCA were confirmed (Eprex(®), n = 3; NeoRecormon(®), n = 1; Aranesp(®), n = 1). Based on exposed time, PRCA incidence was 35.8/100 000 patient-years (95% CI 7.4-104.7) for Eprex(®) versus 14.0/100 000 patient-years (95% CI 1.7-50.6) for NeoRecormon(®)/Aranesp(®). The incidence of PRCA with Eprex(®) was not significantly different versus comparator ESAs (rate ratio: 2.56; 95% CI 0.43-15.31). An analysis based on observed time produced similar findings.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">This large, prospective registry demonstrates that PRCA is rare with subcutaneous administration of either the new coated-stopper syringe presentation of Eprex(®), or NeoRecormon(®) or Aranesp(®).</AbstractText><CopyrightInformation>© The Author 2014. Published by Oxford University Press on behalf of ERA-EDTA.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Macdougall</LastName><ForeName>Iain C</ForeName><Initials>IC</Initials><AffiliationInfo><Affiliation>Department of Renal Medicine, King's College Hospital, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Casadevall</LastName><ForeName>Nicole</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Service d'Immunologie et Hématologie Biologiques, Hôpital Saint Antoine, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Locatelli</LastName><ForeName>Francesco</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Combe</LastName><ForeName>Christian</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Service de Néphrologie, Centre Hospitalier Universitaire de Bordeaux and Unité INSERM 1026, Université de Bordeaux, Bordeaux, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>London</LastName><ForeName>Gerard M</ForeName><Initials>GM</Initials><AffiliationInfo><Affiliation>Centre de Recherche des Cordelliers, Ecole de Médecine, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Di Paolo</LastName><ForeName>Salvatore</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Division of Nephrology and Dialysis, Hospital 'Dimiccoli', Barletta, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kribben</LastName><ForeName>Andreas</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Klinik für Nephrologie, Universitätsklinik Essen, Essen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fliser</LastName><ForeName>Danilo</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department Internal Medicine IV, Universitätsklinik Homburg/Saar, Homburg/Saar, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Messner</LastName><ForeName>Hans</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Medical Biophysics, University of Toronto, Toronto, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McNeil</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Epidemiology and Preventive Medicine, Monash University Melbourne, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stevens</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Renal Medicine, Kent and Canterbury Hospital, Canterbury, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Santoro</LastName><ForeName>Antonio</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Dialysis and Hypertension Department, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S Orsola-Malpighi, Bologna, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De Francisco</LastName><ForeName>Angel L M</ForeName><Initials>AL</Initials><AffiliationInfo><Affiliation>Nephrology Department, Hospital Universitario Valdecilla, Santander, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Percheson</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Potamianou</LastName><ForeName>Anna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foucher</LastName><ForeName>Arnaud</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fife</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mérit</LastName><ForeName>Véronique</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vercammen</LastName><ForeName>Els</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Janssen, Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>PRIMS study group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>09</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Nephrol Dial Transplant</MedlineTA><NlmUniqueID>8706402</NlmUniqueID><ISSNLinking>0931-0509</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001323">Autoantibodies</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011994">Recombinant Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C103998">epoetin beta</NameOfSubstance></Chemical><Chemical><RegistryNumber>11096-26-7</RegistryNumber><NameOfSubstance UI="D004921">Erythropoietin</NameOfSubstance></Chemical><Chemical><RegistryNumber>15UQ94PT4P</RegistryNumber><NameOfSubstance UI="D000068256">Darbepoetin alfa</NameOfSubstance></Chemical><Chemical><RegistryNumber>64FS3BFH5W</RegistryNumber><NameOfSubstance UI="D000068817">Epoetin Alfa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266</RefSource><PMID Version="1">11904577</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Pharm Sci. 2001 Jan;90(1):1-11</RefSource><PMID Version="1">11064373</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Pharm Res. 2012 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Version="1">16504928</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Am Soc Nephrol. 2005 Mar;16 Suppl 1:S67-9</RefSource><PMID Version="1">15938038</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Kidney Int. 2005 Jun;67(6):2346-53</RefSource><PMID Version="1">15882278</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nephrol Dial Transplant. 2005 May;20 Suppl 3:iii33-40</RefSource><PMID Version="1">15824129</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2004 Sep 30;351(14):1403-8</RefSource><PMID Version="1">15459301</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2004 May 29;363(9423):1768-71</RefSource><PMID Version="1">15172775</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Am Soc Nephrol. 2004 Feb;15(2):398-406</RefSource><PMID Version="1">14747386</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nephrol Dial Transplant. 2003 Nov;18 Suppl 8:viii37-41</RefSource><PMID Version="1">14608000</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PDA J Pharm Sci Technol. 2002 Nov-Dec;56(6):332-71</RefSource><PMID Version="1">12497770</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000740" MajorTopicYN="N">Anemia</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001323" MajorTopicYN="N">Autoantibodies</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068256" MajorTopicYN="N">Darbepoetin alfa</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068817" MajorTopicYN="N">Epoetin Alfa</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004921" MajorTopicYN="N">Erythropoietin</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015994" MajorTopicYN="N">Incidence</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011379" MajorTopicYN="N">Prognosis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011994" MajorTopicYN="N">Recombinant Proteins</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012010" MajorTopicYN="N">Red-Cell Aplasia, Pure</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012042" MajorTopicYN="N">Registries</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk 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PubStatus="medline"><Year>2016</Year><Month>6</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25239637</ArticleId><ArticleId IdType="pii">gfu297</ArticleId><ArticleId IdType="doi">10.1093/ndt/gfu297</ArticleId><ArticleId IdType="pmc">PMC4339685</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Aquitaine</li><li>Grand Londres</li><li>New Jersey</li><li>Nouvelle-Aquitaine</li><li>Ontario</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Bordeaux</li><li>Londres</li><li>Melbourne</li><li>Paris</li><li>Toronto</li></settlement><orgName><li>Université de Toronto</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Macdougall, Iain C" sort="Macdougall, Iain C" uniqKey="Macdougall I" first="Iain C" last="Macdougall">Iain C. Macdougall</name></region><name sortKey="Stevens, Paul" sort="Stevens, Paul" uniqKey="Stevens P" first="Paul" last="Stevens">Paul Stevens</name></country><country name="France"><region name="Île-de-France"><name sortKey="Casadevall, Nicole" sort="Casadevall, Nicole" uniqKey="Casadevall N" first="Nicole" last="Casadevall">Nicole Casadevall</name></region><name sortKey="Combe, Christian" sort="Combe, Christian" uniqKey="Combe C" first="Christian" last="Combe">Christian Combe</name><name sortKey="London, Gerard M" sort="London, Gerard M" uniqKey="London G" first="Gerard M" last="London">Gerard M. London</name></country><country name="Italie"><noRegion><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name></noRegion><name sortKey="Di Paolo, Salvatore" sort="Di Paolo, Salvatore" uniqKey="Di Paolo S" first="Salvatore" last="Di Paolo">Salvatore Di Paolo</name><name sortKey="Santoro, Antonio" sort="Santoro, Antonio" uniqKey="Santoro A" first="Antonio" last="Santoro">Antonio Santoro</name></country><country name="Allemagne"><noRegion><name sortKey="Kribben, Andreas" sort="Kribben, Andreas" uniqKey="Kribben A" first="Andreas" last="Kribben">Andreas Kribben</name></noRegion><name sortKey="Fliser, Danilo" sort="Fliser, Danilo" uniqKey="Fliser D" first="Danilo" last="Fliser">Danilo Fliser</name></country><country name="Canada"><region name="Ontario"><name sortKey="Messner, Hans" sort="Messner, Hans" uniqKey="Messner H" first="Hans" last="Messner">Hans Messner</name></region></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Mcneil, John" sort="Mcneil, John" uniqKey="Mcneil J" first="John" last="Mcneil">John Mcneil</name></region></country><country name="Espagne"><noRegion><name sortKey="De Francisco, Angel L M" sort="De Francisco, Angel L M" uniqKey="De Francisco A" first="Angel L M" last="De Francisco">Angel L M. De Francisco</name></noRegion></country><country name="États-Unis"><region name="New Jersey"><name sortKey="Percheson, Paul" sort="Percheson, Paul" uniqKey="Percheson P" first="Paul" last="Percheson">Paul Percheson</name></region><name sortKey="Fife, Daniel" sort="Fife, Daniel" uniqKey="Fife D" first="Daniel" last="Fife">Daniel Fife</name><name sortKey="Foucher, Arnaud" sort="Foucher, Arnaud" uniqKey="Foucher A" first="Arnaud" last="Foucher">Arnaud Foucher</name><name sortKey="Merit, Veronique" sort="Merit, Veronique" uniqKey="Merit V" first="Véronique" last="Mérit">Véronique Mérit</name><name sortKey="Potamianou, Anna" sort="Potamianou, Anna" uniqKey="Potamianou A" first="Anna" last="Potamianou">Anna Potamianou</name><name sortKey="Vercammen, Els" sort="Vercammen, Els" uniqKey="Vercammen E" first="Els" last="Vercammen">Els Vercammen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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