Pure Red-Cell Aplasia After the Erythropoietin Treatment in Patients with Renal Failure

Overview

Since the nineties of the previous century, incidence of pure red-cell aplasia (PRCA) in patients with chronic renalfailure (CRF) and renal anaemia treated with recombinant human erythropoietin (rHuEPO) has significantlyincreased. Due to the positive effects of rHuEPO on quality of life, lowering of morbidity and mortality of patientswith CRF, such increased incidence has attained a widespread interest, though PRCA remains only a rare complication.The responsibility for the development of PRCA lies with the neutralizing anti-erythropoietin antibodies.The rise of antibodies and development of PRCA is related to the subcutaneous administration of erythropoietin andin the vast majority of patients to the treatment with Eprex®, one of the epoetins alpha. At present, the most probableexplanation is a change of the stabilizer in Eprex® formulation, which is related to the increased immunogenity ofthe product. The subcutaneous administration of rHuEPO, preferred for medical and economical reasons in bothAmerican and European guidelines, is known for its higher immunization power. Properties of the product,emphasized by the route of administration, can cause the rise of these antibodies. To prevent the rise of anti-erythropoietinantibodies and the development of PRCA, regulatory authorities and Eprex® producers decided thatEprex® cannot be administered to CRF patients subcutaneously, but only intravenously. Also the requirements onthe handling of Eprex®have become more stringent. Limitations do not concern either epoetin beta (NeoRecormon®)or other epoetins alpha (of which the latter are not available in this country). Therapy of PRCA in patients treatedwith rHuEPO is based on suspension of rHuEPO and on the immunosuppressive therapy.Many questions concerningPRCA in CRF patients treated with rHuEPO remain unsolved. It is necessary to study further the ethiopathogenesisof this complication and possibly adjust preventive and therapeutic measures.

Key words:
pure red-cell aplasia, renal anaemia, chronic renal failure, recombinant human erythropoietin, antibodies.