Micelle-Associated Protein in Epoetin Formulations: A Risk Factor for Immunogenicity?

Hermeling, Suzanne; Schellekens, Huub; Crommelin, Daan J.A.; Jiskoot, Wim

doi:10.1023/b:pham.0000008034.61317.02

Cited by 114 publications

(73 citation statements)

References 12 publications

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“…They propose that the concentration of Tween 80 in the new formulation of epoetin alfa is so high that it leads to micelle formation and that epoetin molecules are integrated into the surface of these micelles. As a consequence, several epoetin molecules are presented to the recipient's immune system in a regular spatial configuration, which can trigger the immune system (33). Similar phenomena have been recognized in the immune recognition of viruses, where antigens integrated into the virus wall at regular distance appear to play an important role (34).…”

Section: Possible Causes and Risk Factors Of Immunogenicity Of Epoetinsmentioning

confidence: 73%

Anti-Erythropoietin Antibodies and Pure Red Cell Aplasia

Rossert¹,

Casadevall²,

Eckardt³

2004

Journal of the American Society of Nephrology

129

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Section: Possible Causes and Risk Factors Of Immunogenicity Of Epoetinsmentioning

confidence: 73%

Anti-Erythropoietin Antibodies and Pure Red Cell Aplasia

Rossert¹,

Casadevall²,

Eckardt³

2004

Journal of the American Society of Nephrology

129

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“…Schellekens et al (13) hypothesized an alternative explanation. They found that the concentration of polysorbate 80 in the new formulation of EPO-␣ is high and leads to micelle formation and that EPO molecules are integrated into the surface of these micelles.…”

Section: Why This Upsurge In Antibodies Cases?mentioning

confidence: 99%

Epoetin-Induced Autoimmune Pure Red Cell Aplasia

Casadevall

Eckardt

Rossert

2005

Journal of the American Society of Nephrology

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During the first 10 yr of therapy with recombinant human erythropoietin ([EPO]), only three cases of antibody-associated pure red cell aplasia have been described in patients who were treated with EPO, whereas several millions of patients have received this treatment. Thus, the possibility for epoetin to induce the formation of anti-EPO antibodies was considered extremely low. However, since 1998, a significant increase in the number of cases of EPO-induced pure red cell aplasia has been found in patients with chronic kidney disease with a peak in 2001 and 2002. The incidence rate seems now to be back to the baseline level. The change in formulation of epoetin ␣ sold outside the United States seems to be the cause of these antibodies.

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“…It has been proposed that the PS-80 released leachates from the rubber stoppers, which acted as adjuvants [120]. An alternative hypothesis suggests that the formation of anti-EPO Abs was induced by micelles loaded with aggregated rhEPO in PS-80 [121]. Note, here, that some ESA formulations contain PS-80 and others PS-20, which may impact on the stability of the drugs [122].…”

Section: Anti-epo Antibody-mediated Prcamentioning

confidence: 96%

Biosimilar epoetins and other “follow‐on” biologics: Update on the European experiences

Jelkmann¹

2010

American J Hematol

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After the patents of biopharmaceuticals have expired, based on specific regulatory approval pathways copied products (“biosimilars” or “follow‐on biologics”) have been launched in the EU. This article summarizes experiences with hematopoietic medicines, namely the epoetins (two biosimilars traded under five different brand names) and the filgrastims (two biosimilars, six brand names). Physicians and pharmacists should be familiar with the legal and pharmacological specialities of biosimilars: The production process can differ from that of the original, clinical indications can be extrapolated, glycoproteins contain varying isoforms, the formulation may differ from the original, and biopharmaceuticals are potentially immunogenic. Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs. Am. J. Hematol. 2010. © 2010 Wiley‐Liss, Inc.

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Micelle-Associated Protein in Epoetin Formulations: A Risk Factor for Immunogenicity?

Abstract: Eprex/Erypo contains micelle-associated epoetin, which may be a risk factor for the development of antibodies against epoetin.

Cited by 114 publications

References 12 publications

Anti-Erythropoietin Antibodies and Pure Red Cell Aplasia

Anti-Erythropoietin Antibodies and Pure Red Cell Aplasia

Epoetin-Induced Autoimmune Pure Red Cell Aplasia

Biosimilar epoetins and other “follow‐on” biologics: Update on the European experiences

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