Anti-Erythropoietin (EPO) antibodies

Indication

Anti-Erythropoietin (EPO) antibodies are associated with a very rare side effect of treatment with recombinant human erythropoietin (rHuEPO), where anti-EPO antibodies cause the development of pure red cell aplasia (PRCA), ie lack of erythropoiesis.

Method

Serum samples (> 1 mL required) are analyzed by radio-immunoprecipitation (RIP). The sample will be reported as negative or positive.

Interpretation

The event rate for antibody-mediated PRCA for Epogen and Eprex were very low from 1989 to 1998, but the number of cases of Eprex-associated PRCA markedly increased after 1999, even after the introduction of subcutaneous administration. In contrast, rates remained low for Epogen and NeoRecormon. PRCA is an extremely rare adverse effect of treatment with erythropoiesis-stimulating agents (ESAs), although cases continue to emerge across the product class. The most recent and plausible explanation for development of anti-EPO have been leaching of tungsten (from the tungsten pins used in the manufacture of glass syringes) into the syringe contents. This explanation has widespread applicability to ESA treatment and potentially to other therapeutic proteins. With the introduction of ESA biosimilars extra care should be taken to monitor the risk of development of anti-EPO as adverse event. Biosimilars are products with an identical amino acid sequence as the original product, but the product may have undetectable differences of characteristics of the protein that may trigger an immune event.

References

Thorpe et al. Assays for detecting and diagnosing antibody-mediated pure red cell aplasia (PRCA): an assessment of available procedures. Nephrol Dial Transplant. 2005 May;20 Suppl 4:iv16-22.

Evens et al. Epoetin-induced pure red-cell aplasia (PRCA): preliminary results from the research on adverse drug events and reports (RADAR) group. Best Pract Res Clin Haematol. 2005;18(3):481-9.

Jelkmann. Biosimilar recombinant human erythropoietins (epoetins) and future erythropoiesis-stimulating treatments. Expert Opin Biol Ther. 2012 May;12(5):581-92.

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