Antibodies to endogenous and recombinant erythropoietin

Mayeux, Patrick; Casadevall, Nicole

doi:10.1007/3-7643-7543-4_14

Cited by 2 publications

(3 citation statements)

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“…Development of anemia secondary to neutralizing antibody formation was observed in these animals similar to what was reported in the renal transplant patients (Piercy et al, 1998;Mayeux and Casadevall 2003). A similar reaction was also observed in rhesus monkeys dosed with a hybrid molecule containing recombinant human EPO (Coscarella et al, 1998).…”

Section: Immunogenicity Data From Non-clinical Studiessupporting

confidence: 78%

“…The association of recombinant human erythropoietin (EPO) treatment, specifically Epoetin alpha, with pure red cell aplasia (severe anemia) in chronic renal failure patients has been directly attributed to the development of anti-EPO antibodies that cross-react with endogenous EPO (Casadevall et al, 2002). The sudden increase in the incidence of neutralizing antibody development to EPO has been attributed to a change in the formulation, besides other causes (Mayeux and Casadevall, 2003). This has heightened the concerns significantly around product quality, handling, transport and storage, and on product delivery mechanisms.…”

Section: Breakdown Of Immune Tolerancementioning

confidence: 99%

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Immunogenicity of Biotherapeutics—An Overview

Subramanyam

2006

Journal of Immunotoxicology

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With the recent increase in the approval and use of biotherapeutics in clinical practice, management of the development of anti-drug antibodies (ADA) has become a key issue for effective long-term use of these drugs. In most instances, the clinical benefit derived from the use of the therapeutics outweighs the risk of developing ADA. In rare instances, however, safety issues accompany development of ADA. Although it is unclear why certain individuals generate an immune response while others tolerate the drug, growing experience from the clinic has facilitated a better appreciation of many patient-, disease- and product-related factors that contribute to immunogenicity. Furthermore, improvements in protein production, purification and delivery methods along with use of humanized or fully human recombinant proteins have helped to reduce the rates of immunogenicity considerably. This document provides an overview of the scientific reasons for developing an immunogenic response, factors that contribute to the immunogenicity of biotherapeutics, clinical impact of immunogenicity and general strategies used to manage this risk.

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Section: Immunogenicity Data From Non-clinical Studiessupporting

confidence: 78%

Section: Breakdown Of Immune Tolerancementioning

confidence: 99%

Immunogenicity of Biotherapeutics—An Overview

Subramanyam

2006

Journal of Immunotoxicology

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“…In rare cases, antibodies to administered rHuEPO are produced in patients which also recognize and neutralize endogenously produced EPO, resulting in the development of antibody mediated pure red cell aplasia (PRCA) 57. Although extremely rare before 1998, with only three cases being reported, by 2003 there were over 160 patients worldwide diagnosed with antibody‐positive PRCA after receiving rHuEPO with the majority of cases outside the USA 58. Since millions of patients had been treated with rHuEPO prior to 1998, it was hypothesized that changes in the manufacturing procedure and or formulation may have accounted for this increase 57…”

Section: Properties Of Glycosylated and Glycoengineered Proteinsmentioning

confidence: 99%