Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS)
Identifieur interne : 001E22 ( Ncbi/Checkpoint ); précédent : 001E21; suivant : 001E23Incidence 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 [ 0931-0509 ] ; 2014.
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).
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.
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®,
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®.
Url:
DOI: 10.1093/ndt/gfu297
PubMed: 25239637
PubMed Central: 4339685
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: 002784
- to stream Pmc, to step Curation: 002634
- to stream Pmc, to step Checkpoint: 001521
- to stream PubMed, to step Corpus: 002F50
- to stream PubMed, to step Curation: 002E72
- to stream PubMed, to step Checkpoint: 002E72
- to stream Ncbi, to step Merge: 001E22
- to stream Ncbi, to step Curation: 001E22
Links to Exploration step
PMC:4339685Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><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="1"><nlm:aff id="gfu297_af1"><addr-line>Department of Renal Medicine</addr-line>,<institution>King's College Hospital</institution>,<addr-line>London</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Casadevall, Nicole" sort="Casadevall, Nicole" uniqKey="Casadevall N" first="Nicole" last="Casadevall">Nicole Casadevall</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af2"><addr-line>Service d'Immunologie et Hématologie Biologiques</addr-line>,<institution>Hôpital Saint Antoine</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af3"><addr-line>Division of Nephrology and Dialysis</addr-line>,<institution>Alessandro Manzoni Hospital</institution>,<addr-line>Lecco</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Combe, Christian" sort="Combe, Christian" uniqKey="Combe C" first="Christian" last="Combe">Christian Combe</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af4"><addr-line>Service de Néphrologie</addr-line>,<institution>Centre Hospitalier Universitaire de Bordeaux and Unité INSERM 1026, Université de Bordeaux</institution>,<addr-line>Bordeaux</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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="1"><nlm:aff id="gfu297_af5"><institution>Centre de Recherche des Cordelliers, Ecole de Médecine</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af6"><addr-line>Division of Nephrology and Dialysis</addr-line>,<institution>Hospital ‘Dimiccoli’</institution>,<addr-line>Barletta</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af7"><addr-line>Klinik für Nephrologie</addr-line>,<institution>Universitätsklinik Essen</institution>,<addr-line>Essen</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af8"><addr-line>Department Internal Medicine IV</addr-line>,<institution>Universitätsklinik Homburg/Saar</institution>,<addr-line>Homburg/Saar</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Messner, Hans" sort="Messner, Hans" uniqKey="Messner H" first="Hans" last="Messner">Hans Messner</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af9"><addr-line>Department of Medical Biophysics</addr-line>,<institution>University of Toronto</institution>,<addr-line>Toronto</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mcneil, John" sort="Mcneil, John" uniqKey="Mcneil J" first="John" last="Mcneil">John Mcneil</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af10"><addr-line>Department of Epidemiology and Preventive Medicine</addr-line>,<institution>Monash University Melbourne</institution>,<addr-line>Melbourne</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af11"><addr-line>Department of Renal Medicine</addr-line>,<institution>Kent and Canterbury Hospital</institution>,<addr-line>Canterbury</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af12"><addr-line>Dialysis and Hypertension Department</addr-line>,<institution>Azienda Ospedaliero-Universitaria di Bologna, Policlinico S Orsola-Malpighi</institution>,<addr-line>Bologna</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af13"><addr-line>Nephrology Department</addr-line>,<institution>Hospital Universitario Valdecilla</institution>,<addr-line>Santander</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Percheson, Paul" sort="Percheson, Paul" uniqKey="Percheson P" first="Paul" last="Percheson">Paul Percheson</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Potamianou, Anna" sort="Potamianou, Anna" uniqKey="Potamianou A" first="Anna" last="Potamianou">Anna Potamianou</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Foucher, Arnaud" sort="Foucher, Arnaud" uniqKey="Foucher A" first="Arnaud" last="Foucher">Arnaud Foucher</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fife, Daniel" sort="Fife, Daniel" uniqKey="Fife D" first="Daniel" last="Fife">Daniel Fife</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Merit, Veronique" sort="Merit, Veronique" uniqKey="Merit V" first="Véronique" last="Mérit">Véronique Mérit</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vercammen, Els" sort="Vercammen, Els" uniqKey="Vercammen E" first="Els" last="Vercammen">Els Vercammen</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25239637</idno><idno type="pmc">4339685</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339685</idno><idno type="RBID">PMC:4339685</idno><idno type="doi">10.1093/ndt/gfu297</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">002784</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002784</idno><idno type="wicri:Area/Pmc/Curation">002634</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002634</idno><idno type="wicri:Area/Pmc/Checkpoint">001521</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001521</idno><idno type="wicri:source">PubMed</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><idno type="wicri:Area/Ncbi/Merge">001E22</idno><idno type="wicri:Area/Ncbi/Curation">001E22</idno><idno type="wicri:Area/Ncbi/Checkpoint">001E22</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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="1"><nlm:aff id="gfu297_af1"><addr-line>Department of Renal Medicine</addr-line>,<institution>King's College Hospital</institution>,<addr-line>London</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Casadevall, Nicole" sort="Casadevall, Nicole" uniqKey="Casadevall N" first="Nicole" last="Casadevall">Nicole Casadevall</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af2"><addr-line>Service d'Immunologie et Hématologie Biologiques</addr-line>,<institution>Hôpital Saint Antoine</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af3"><addr-line>Division of Nephrology and Dialysis</addr-line>,<institution>Alessandro Manzoni Hospital</institution>,<addr-line>Lecco</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Combe, Christian" sort="Combe, Christian" uniqKey="Combe C" first="Christian" last="Combe">Christian Combe</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af4"><addr-line>Service de Néphrologie</addr-line>,<institution>Centre Hospitalier Universitaire de Bordeaux and Unité INSERM 1026, Université de Bordeaux</institution>,<addr-line>Bordeaux</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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="1"><nlm:aff id="gfu297_af5"><institution>Centre de Recherche des Cordelliers, Ecole de Médecine</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af6"><addr-line>Division of Nephrology and Dialysis</addr-line>,<institution>Hospital ‘Dimiccoli’</institution>,<addr-line>Barletta</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af7"><addr-line>Klinik für Nephrologie</addr-line>,<institution>Universitätsklinik Essen</institution>,<addr-line>Essen</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af8"><addr-line>Department Internal Medicine IV</addr-line>,<institution>Universitätsklinik Homburg/Saar</institution>,<addr-line>Homburg/Saar</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Messner, Hans" sort="Messner, Hans" uniqKey="Messner H" first="Hans" last="Messner">Hans Messner</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af9"><addr-line>Department of Medical Biophysics</addr-line>,<institution>University of Toronto</institution>,<addr-line>Toronto</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mcneil, John" sort="Mcneil, John" uniqKey="Mcneil J" first="John" last="Mcneil">John Mcneil</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af10"><addr-line>Department of Epidemiology and Preventive Medicine</addr-line>,<institution>Monash University Melbourne</institution>,<addr-line>Melbourne</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af11"><addr-line>Department of Renal Medicine</addr-line>,<institution>Kent and Canterbury Hospital</institution>,<addr-line>Canterbury</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af12"><addr-line>Dialysis and Hypertension Department</addr-line>,<institution>Azienda Ospedaliero-Universitaria di Bologna, Policlinico S Orsola-Malpighi</institution>,<addr-line>Bologna</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></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:aff id="gfu297_af13"><addr-line>Nephrology Department</addr-line>,<institution>Hospital Universitario Valdecilla</institution>,<addr-line>Santander</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Percheson, Paul" sort="Percheson, Paul" uniqKey="Percheson P" first="Paul" last="Percheson">Paul Percheson</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Potamianou, Anna" sort="Potamianou, Anna" uniqKey="Potamianou A" first="Anna" last="Potamianou">Anna Potamianou</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Foucher, Arnaud" sort="Foucher, Arnaud" uniqKey="Foucher A" first="Arnaud" last="Foucher">Arnaud Foucher</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fife, Daniel" sort="Fife, Daniel" uniqKey="Fife D" first="Daniel" last="Fife">Daniel Fife</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Merit, Veronique" sort="Merit, Veronique" uniqKey="Merit V" first="Véronique" last="Mérit">Véronique Mérit</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vercammen, Els" sort="Vercammen, Els" uniqKey="Vercammen E" first="Els" last="Vercammen">Els Vercammen</name><affiliation wicri:level="1"><nlm:aff id="gfu297_af14"><institution>Janssen, Pharmaceutical Companies of Johnson & Johnson</institution>,<addr-line>Titusville, NJ</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Nephrology Dialysis Transplantation</title><idno type="ISSN">0931-0509</idno><idno type="eISSN">1460-2385</idno><imprint><date when="2014">2014</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"><sec><title>Background</title><p>Subcutaneous administration of Eprex<sup>®</sup> (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<sup>®</sup> and to compare this with the PRCA incidence with subcutaneous NeoRecormon<sup>®</sup> (epoetin beta) and Aranesp<sup>®</sup> (darbepoetin alfa).</p></sec><sec><title>Methods</title><p>PRIMS was a multicentre, multinational, non-interventional, parallel-group, immunogenicity surveillance registry. Adults with CKD receiving or about to initiate subcutaneous Eprex<sup>®</sup>, NeoRecormon<sup>®</sup> or Aranesp<sup>®</sup> 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.</p></sec><sec><title>Results</title><p>Of the 15 333 patients enrolled, 5948 received Eprex<sup>®</sup> (8377 patient-years) and 9356 received NeoRecormon<sup>®</sup>/Aranesp<sup>®</sup> (14 286 patient-years). No treatment data were available for 29 patients. Among 23 patients with LOE, five cases of PRCA were confirmed (Eprex<sup>®</sup>, <italic>n</italic> = 3; NeoRecormon<sup>®</sup>, <italic>n</italic> = 1; Aranesp<sup>®</sup>, <italic>n</italic> = 1). Based on exposed time, PRCA incidence was 35.8/100 000 patient-years (95% CI 7.4–104.7) for Eprex<sup>®</sup> versus 14.0/100 000 patient-years (95% CI 1.7–50.6) for NeoRecormon<sup>®</sup>/Aranesp<sup>®</sup>. The incidence of PRCA with Eprex<sup>®</sup> 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.</p></sec><sec><title>Conclusion</title><p>This large, prospective registry demonstrates that PRCA is rare with subcutaneous administration of either the new coated-stopper syringe presentation of Eprex<sup>®</sup>, or NeoRecormon<sup>®</sup> or Aranesp<sup>®</sup>.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Pollock, C" uniqKey="Pollock C">C Pollock</name></author><author><name sortKey="Johnson, Dw" uniqKey="Johnson D">DW Johnson</name></author><author><name sortKey="Horl, Wh" uniqKey="Horl W">WH Hörl</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rossert, J" uniqKey="Rossert J">J Rossert</name></author><author><name sortKey="Casadevall, N" uniqKey="Casadevall N">N Casadevall</name></author><author><name sortKey="Eckardt, Ku" uniqKey="Eckardt K">KU Eckardt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Boven, K" uniqKey="Boven K">K Boven</name></author><author><name sortKey="Knight, J" uniqKey="Knight J">J Knight</name></author><author><name sortKey="Bader, F" uniqKey="Bader F">F Bader</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mckoy, Jm" uniqKey="Mckoy J">JM McKoy</name></author><author><name sortKey="Stonecash, Re" uniqKey="Stonecash R">RE Stonecash</name></author><author><name sortKey="Cournoyer, D" uniqKey="Cournoyer D">D Cournoyer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Casadevall, N" uniqKey="Casadevall N">N Casadevall</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Casadevall, N" uniqKey="Casadevall N">N Casadevall</name></author><author><name sortKey="Eckardt, Ku" uniqKey="Eckardt K">KU Eckardt</name></author><author><name sortKey="Rossert, J" uniqKey="Rossert J">J Rossert</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bennett, Cl" uniqKey="Bennett C">CL Bennett</name></author><author><name sortKey="Luminari, S" uniqKey="Luminari S">S Luminari</name></author><author><name sortKey="Nissenson, Ar" uniqKey="Nissenson A">AR Nissenson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Boven, K" uniqKey="Boven K">K Boven</name></author><author><name sortKey="Stryker, S" uniqKey="Stryker S">S Stryker</name></author><author><name sortKey="Knight, J" uniqKey="Knight J">J Knight</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Jacob, A" uniqKey="Jacob A">A Jacob</name></author><author><name sortKey="Sandhu, K" uniqKey="Sandhu K">K Sandhu</name></author><author><name sortKey="Nicholas, J" uniqKey="Nicholas J">J Nicholas</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Howman, R" uniqKey="Howman R">R Howman</name></author><author><name sortKey="Kulkarni, H" uniqKey="Kulkarni H">H Kulkarni</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Macdougall, Ic" uniqKey="Macdougall I">IC Macdougall</name></author><author><name sortKey="Rossert, J" uniqKey="Rossert J">J Rossert</name></author><author><name sortKey="Casadevall, N" uniqKey="Casadevall N">N Casadevall</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Macdougall, Ic" uniqKey="Macdougall I">IC Macdougall</name></author><author><name sortKey="Roger, Sd" uniqKey="Roger S">SD Roger</name></author><author><name sortKey="De Francisco, A" uniqKey="De Francisco A">A de Francisco</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jenke, D" uniqKey="Jenke D">D Jenke</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ryan, Mh" uniqKey="Ryan M">MH Ryan</name></author><author><name sortKey="Heavner, Ga" uniqKey="Heavner G">GA Heavner</name></author><author><name sortKey="Brigham Burke, M" uniqKey="Brigham Burke M">M Brigham-Burke</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Seidl, A" uniqKey="Seidl A">A Seidl</name></author><author><name sortKey="Hainzl, O" uniqKey="Hainzl O">O Hainzl</name></author><author><name sortKey="Richter, M" uniqKey="Richter M">M Richter</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Locatelli, F" uniqKey="Locatelli F">F Locatelli</name></author><author><name sortKey="Del Vecchio, L" uniqKey="Del Vecchio L">L Del Vecchio</name></author><author><name sortKey="Pozzoni, P" uniqKey="Pozzoni P">P Pozzoni</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fotiou, F" uniqKey="Fotiou F">F Fotiou</name></author><author><name sortKey="Aravind, S" uniqKey="Aravind S">S Aravind</name></author><author><name sortKey="Wang, Pp" uniqKey="Wang P">PP Wang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Praditpornsilpa, K" uniqKey="Praditpornsilpa K">K Praditpornsilpa</name></author><author><name sortKey="Kupatawintu, P" uniqKey="Kupatawintu P">P Kupatawintu</name></author><author><name sortKey="Mongkonsritagoon, W" uniqKey="Mongkonsritagoon W">W Mongkonsritagoon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wish, Jb" uniqKey="Wish J">JB Wish</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Haag Weber, M" uniqKey="Haag Weber M">M Haag-Weber</name></author><author><name sortKey="Eckardt, Ku" uniqKey="Eckardt K">KU Eckardt</name></author><author><name sortKey="Horl, Wh" uniqKey="Horl W">WH Hörl</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Verhelst, D" uniqKey="Verhelst D">D Verhelst</name></author><author><name sortKey="Rossert, J" uniqKey="Rossert J">J Rossert</name></author><author><name sortKey="Casadevall, N" uniqKey="Casadevall N">N Casadevall</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Porter, S" uniqKey="Porter S">S Porter</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><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></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Macdougall, Iain C" sort="Macdougall, Iain C" uniqKey="Macdougall I" first="Iain C." last="Macdougall">Iain C. Macdougall</name></noRegion><name sortKey="Stevens, Paul" sort="Stevens, Paul" uniqKey="Stevens P" first="Paul" last="Stevens">Paul Stevens</name></country><country name="France"><noRegion><name sortKey="Casadevall, Nicole" sort="Casadevall, Nicole" uniqKey="Casadevall N" first="Nicole" last="Casadevall">Nicole Casadevall</name></noRegion><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"><noRegion><name sortKey="Messner, Hans" sort="Messner, Hans" uniqKey="Messner H" first="Hans" last="Messner">Hans Messner</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Mcneil, John" sort="Mcneil, John" uniqKey="Mcneil J" first="John" last="Mcneil">John Mcneil</name></noRegion></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"><noRegion><name sortKey="Percheson, Paul" sort="Percheson, Paul" uniqKey="Percheson P" first="Paul" last="Percheson">Paul Percheson</name></noRegion><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)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Ncbi/Checkpoint
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001E22 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Ncbi/Checkpoint/biblio.hfd -nk 001E22 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Ncbi
|étape= Checkpoint
|type= RBID
|clé= PMC:4339685
|texte= Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS)
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Ncbi/Checkpoint/RBID.i -Sk "pubmed:25239637" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Ncbi/Checkpoint/biblio.hfd \
| NlmPubMed2Wicri -a AustralieFrV1
| This area was generated with Dilib version V0.6.33. |  |