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Update on Anemia Management in Nephrology, Including Current Guidelines on the Use of Erythropoiesis-Stimulating Agents and Implications of the Introduction of "Biosimilars"

^aDepartment of Nephrology, Dialysis and Renal Transplantation, A. Manzoni Hospital, Lecco, Italy; ^bPrivate Consultant, Zwingenberg, Germany

Key Words. Erythropoiesis-stimulating agents • Nephrology • Chronic kidney disease • Quality of life • Hemoglobin levels • Biosimilars

Correspondence: Francesco Locatelli, M.D., F.R.C.P., Department of Nephrology and Dialysis, A. Manzoni Hospital, Via dell'Eremo 9/11, IT-23900 Lecco, Italy. Telephone: 39-0341-489-850; Fax: 39-0341-489-860; e-mail: f.locatelli{at}ospedale.lecco.it

Received February 6, 2009; accepted for publication April 29, 2009.

Disclosures: Francesco Locatelli: Consultant/advisory role: Amgen, Roche, Affimax; Harald Becker: Consultant/advisory role: Ortho Biotech International; Ownership interest: Johnson & Johnson.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.

Several million patients with chronic kidney disease (CKD) have benefited from the use of erythropoiesis-stimulating agents (ESAs) to correct severe anemia. However, mortality data now suggest that treating CKD patients to achieve a hemoglobin (Hb) level >13 g/dl can be harmful. For levels of 11.5–13 g/dl, there is no evidence of either harm or benefit compared with a lower Hb level. Quality of life studies are variable in quality but do suggest superior outcomes and functional status. In the 9 years following 1997, the target Hb level recommended by international guidelines tended to increase, especially for patients without accompanying cardiovascular disease. However, strangely enough, the most recent target level of the Kidney Disease Outcomes Quality Initiative is 11–12 g/dl, which is exactly the range advocated by the same group a decade earlier. The relative importance of quality of life compared with other outcomes, the use of iron, and the impact of venous thrombotic events continue to be debated. In addition, new issues have arisen from the introduction of "biosimilar" erythropoietins, biopharmaceuticals that refer to the existing agents and are submitted for marketing authorization after the existing agents' protection expires. Biosimilars can resemble the agents on which they are modeled but cannot fully copy their properties. The complexity in molecular structure, the possible presence of impurities (which may include bacterial endotoxins), and the inherent immunogenicity of such agents have required authorities to develop a sophisticated regulatory framework.

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