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Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).

AbstractBACKGROUND:
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).
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.
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.
CONCLUSION:
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(®).
AuthorsIain C Macdougall, Nicole Casadevall, Francesco Locatelli, Christian Combe, Gerard M London, Salvatore Di Paolo, Andreas Kribben, Danilo Fliser, Hans Messner, John McNeil, Paul Stevens, Antonio Santoro, Angel L M De Francisco, Paul Percheson, Anna Potamianou, Arnaud Foucher, Daniel Fife, Véronique Mérit, Els Vercammen, PRIMS study group
JournalNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association (Nephrol Dial Transplant) Vol. 30 Issue 3 Pg. 451-60 (Mar 2015) ISSN: 1460-2385 [Electronic] England
PMID25239637 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Copyright© The Author 2014. Published by Oxford University Press on behalf of ERA-EDTA.
Chemical References
  • Autoantibodies
  • Recombinant Proteins
  • epoetin beta
  • Erythropoietin
  • Darbepoetin alfa
  • Epoetin Alfa
Topics
  • 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, immunology)
  • Registries
  • Risk Assessment
  • Severity of Illness Index

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