Epoetin‐associated pure red cell aplasia: past, present, and future considerations

BACKGROUND: Since 1988, millions of patients have received epoetin products intravenously (IV) and subcutaneously. In 1998, epoetin‐associated pure red cell aplasia (PRCA) was first reported and causation was attributed to formulations without human serum albumin (HSA), subcutaneous administration, and uncoated rubber stoppers.

[1]  S. Belknap,et al.  Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project. , 2005, Blood.

[2]  J. Kaufman.  Subcutaneous erythropoietin therapy: efficacy and economic implications. , 1998, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[3]  I. Macdougall,et al.  Treatment of erythropoietin-induced pure red cell aplasia: a retrospective study , 2004, The Lancet.

[4]  J. Wauters,et al.  High prevalence in Switzerland of pure red-cell aplasia due to anti-erythropoietin antibodies in chronic dialysis patients: report of five cases. , 2004, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[5]  J. Kugler,et al.  Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. , 1993, Journal of the National Cancer Institute.

[6]  G. Wells,et al.  Anti-erythropoietin antibody-mediated pure red cell aplasia after treatment with recombinant erythropoietin products: recommendations for minimization of risk. , 2004, Journal of the American Society of Nephrology : JASN.

[7]  M. Daha,et al.  The detection of anti-erythropoietin antibodies in human serum and plasma. Part I. Validation of the protocol for a radioimmunoprecipitation assay. , 2003, Journal of immunological methods.

[8]  J. Adamson,et al.  Recombinant human erythropoietin in anemic patients with end-stage renal disease. Results of a phase III multicenter clinical trial. , 1989, Annals of internal medicine.

[9]  Patrick Mayeux,et al.  Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. , 2002, The New England journal of medicine.

[10]  B. Alobeid,et al.  Anti‐erythropoietin antibody–mediated pure red cell aplasia in a living donor liver transplant recipient treated for hepatitis C virus , 2007, Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society.

[11]  Kai-Uwe Eckardt,et al.  Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. , 2005, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[12]  Allen R Nissenson,et al.  Pure red-cell aplasia and epoetin therapy. , 2004, The New England journal of medicine.

[13]  D. Reda,et al.  Potential cost savings of erythropoietin administration in end-stage renal disease. , 2002, The American journal of medicine.

[14]  P. Schatz,et al.  Hematide is immunologically distinct from erythropoietin and corrects anemia induced by antierythropoietin antibodies in a rat pure red cell aplasia model. , 2007, Experimental hematology.

[15]  I. Macdougall,et al.  Re-challenging patients who developed pure red cell aplasia with epoetin: can it be done? , 2004, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[16]  R. Peces,et al.  Antibodies against recombinant human erythropoietin in a patient with erythropoietin-resistant anemia. , 1996, The New England journal of medicine.

[17]  N. Casadevall,et al.  Pure red-cell aplasia due to anti-erythropoietin antibodies. , 2003, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[18]  A. Santoro,et al.  Successful resumption of epoetin alfa after rituximab treatment in a patient with pure red cell aplasia. , 2004, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[19]  Steven J. Swanson,et al.  Evaluation of Methods to Detect and Characterize Antibodies against Recombinant Human Erythropoietin , 2004, Nephron Clinical Practice.

[20]  S S Prabhakar,et al.  Antibodies to recombinant human erythropoietin causing pure red cell aplasia. , 1997, Clinical nephrology.

[21]  M. Parnham,et al.  Non-clinical safety studies on biosimilar recombinant human erythropoietin. , 2007, Basic & clinical pharmacology & toxicology.

[22]  A. Sanyal,et al.  Antibody-Mediated Pure Red Cell Aplasia Due to Epoetin Alfa During Antiviral Therapy of Chronic Hepatitis C , 2005, The American Journal of Gastroenterology.

[23]  L. Sokol,et al.  Pure red-cell aplasia and recombinant erythropoietin. , 2002, The New England journal of medicine.

[24]  A. Levin,et al.  Successful reintroduction of a different erythropoiesis-stimulating agent after pure red cell aplasia: relapse after successful therapy with prednisone. , 2005, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[25]  A. Mooney,et al.  Four cases of pure red cell aplasia secondary to epoetin beta, with strong temporal relationships. , 2004, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[26]  I. Macdougall.  Novel erythropoiesis-stimulating agents: a new era in anemia management. , 2008, Clinical journal of the American Society of Nephrology : CJASN.

[27]  N. Casadevall,et al.  Autoantibodies against erythropoietin in a patient with pure red-cell aplasia. , 1996, The New England journal of medicine.

[28]  N. Casadevall.  Antibodies against rHuEPO: native and recombinant. , 2002, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[29]  N. Casadevall,et al.  The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. , 2005, Kidney international.

[30]  C. Bauer,et al.  Erythropoietin: Molecular Physiology and Clinical Applications , 1993 .