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Historical and Clinical Overview of Recombinant Human Erythropoietin

Recombinant human erythropoietin (RHuEPO) has not only improved the management of renal anaemia, it also provides therapeutic benefit to patients with a variety of other clinical conditions.

In a recently published expert review, Dr. Thomas Ng of Phase One Clinical Trials Unit Ltd. in Plymouth, United Kingdom, and colleagues highlight historical and functional aspects of RHuEPO, and discuss the applications and potential problems in clinical practice.

Red blood cell proliferation, differentiation, and maturation are largely dependent on erythropoietin, a sialoglycoprotein produced primarily in the kidneys. Although its role was recognised for decades, the purification of erythropoietin was delayed due to technical limitations until 1977, when researchers successfully characterised human erythropoietin from the urine of aplastic anaemia patients.

Prior to clinical introduction of RHuEPO in 1988, the only available treatment for anaemia in patients with chronic renal failure was blood transfusion. Currently, 4 different variations of RHuEPO exist (alpha, beta, delta, and omega), and a hyperglycosylated RhuEPO, known as novel erythropoiesis stimulating protein (NESP), has recently been introduced.

RHuEPO may be administered either intravenously or subcutaneously and should be used concomitantly with iron in dialysis patients. A suggested definition of failure to respond to treatment is a haemoglobin increase of less than 10 g/L after 4 weeks of standard dose administration, however, RHuEPO resistance varies between settings.

In addition to renal disease, RHuEPO is used to treat anaemia associated with other conditions requiring blood product support, including premature birth, malignancy, bone marrow/stem cell transplantation, surgery, HIV, rheumatological disorders, haemolysis, and anaemia in the critically ill.

Furthermore, RHuEPO may benefit neurological recovery, congestive heart failure, and provide alternative treatment for patients in non-acute situations where blood transfusion is refused for personal or religious reasons.

Common adverse effects of RHuEPO therapy are flu-like symptoms, which are generally mild and respond well to supportive therapy. A serious, rare complication in renal patients is pure red cell aplasia (PRCA), which requires RHuEPO discontinuation.
Postgrad Med J 2003 Jul;79:933:367-376. "Recombinant erythropoietin in clinical practice"

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