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Risk of antibody-mediated PRCA

 

In patients receiving ESAs there is a small risk of developing antibody-mediated pure red cell aplasia (PRCA). Antibody-mediated PRCA is caused by a sudden, severe decrease in red blood cell production due to formation of antibodies to the endogenous erythropoietin. Consequently red blood cell precursors in the bone marrow are almost completely absent despite with normal levels of megakaryocytes and other precursors.

The normal incidence rate of antibody-mediated PRCA is 1-10 per 100,000 patient years, but between 1998 and 2001, this incidence rate went as high as 27 per 100,000 person-years1,2,3.Most reported cases resulted from subcutaneously administered epoetin alfa formulations manufactured and marketed outside the US2,3,4. The specific cause of antibody-mediated PRCA is not clear but it has been shown that minimal changes in manufacturing processes can alter products’ characteristics resulting in increased immunogenicity5,6,7.

Antibody-mediated PRCA is difficult to treat and when diagnosed, ESA therapy should be discontinued immediately. Successful treatment requires intensive management as it may be necessary to provide frequent blood transfusions and immunosuppressive treatment1.


References:

  1. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anaemia in chronic kidney disease. Available at: http://www.kidney.org/professionals/KDOQI/guidelines_anemia/index.htm  Accessed on: January 25, 2007.
  2. Bennett CL, Cournoyer D, Carson KR, 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. Blood 2005;106:3343–7.
  3. Bennett CL, Luminari S, Nissenson AR, et al. Pure Red-Cell Aplasia and Epoetin Therapy. N Engl J Med 2004;351:1403–8.
  4. Combe C, Tredree RL, Schellekens H. Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy. 2005;25:954–62.
  5. MacDougall IC. The Management of Anaemia in Chronic Kidney Disease – Current and Future Issues. European Renal & Genito-urinary Disease 2006. Available at: http://www.touchbriefings.com/pdf/1942/macdougall.pdf
    Accessed on: December 18, 2006.
  6. Fishbane S, Macdougall IC, Locatelli, F. Targeting Unmet Medical Needs in Patients With Anemia Due to Chronic Kidney Disease. Available at: http://www.medscape.com/viewprogram/5861
    Accessed on: December 18, 2006.
  7. Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant. 2006;21 Suppl 5:v13–v16.
PRCA
A serious condition in which erythropoiesis almost completely ceases. A patient affected with PRCA experiences a decrease in haemoglobin level of about 0.1 g/dL per day and has a reticulocyte count less than 10,000/µL.