Abstract | BACKGROUND: 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(®).
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Authors | Iain 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 |
Journal | Nephrology, 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 |
PMID | 25239637
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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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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