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      Pure red cell aplasia induced by epoetin zeta

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          Abstract

          Pure red cell aplasia (PRCA) may develop in patients with chronic kidney disease receiving erythropoiesis-stimulating agents (ESA). We report on a 72-year-old patient who developed hypo-proliferative anaemia unresponsive to ESA following the administration of epoetin zeta subcutaneously for 7 months. On the basis of severe isolated hypoplasia of the erythroid line in the bone marrow and high-titre neutralizing anti-erythropoietin antibodies (Ab), a diagnosis of Ab-mediated PRCA was made. Epoetin zeta was discontinued and the patient was given steroids. This was associated with anaemia recovery. To our knowledge this is the first PRCA case related to epoetin zeta.

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          Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

          Andreas Seidl, Otmar Hainzl, Marleen Richter … (2011)
          ABSTRACT Purpose Following two cases of neutralizing antibodies to epoetin alfa in an investigational clinical study, a small number of individual syringes of two drug product batches were found to contain unusually high levels of aggregation at the end of the clinical trial. Methods We undertook an extensive analytical approach to determine the root-cause of the increased aggregation in the affected batches. Results Soluble tungsten was found in the syringes, most likely derived from the pins used to manufacture the syringes. Spiking of epoetin alfa with sodium polytungstate or an extract of tungsten pins used to manufacture the syringes induced the formation of aggregates, both dimers that appeared to be covalently linked by disulphide bonds as well as higher-order aggregates. Sodium polytungstate had also a strong denaturing effect on the protein. Conclusions We propose tungsten-mediated unfolding and aggregation of epoetin alfa in pre-filled syringes as a potential root cause for increased immunogenicity. This finding may be more broadly applicable to this and other classes of therapeutic proteins.
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            Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights.

            Iain C. MacDougall, Simon Roger, Angel de Francisco … (2012)
            Antibody-mediated pure red cell aplasia is a very rare but devastating condition affecting patients receiving treatment with erythropoiesis-stimulating agents. New cases continue to emerge, generally in clusters, consistent with an 'environmental' trigger to its pathogenesis. Defining the causes of antibody-mediated pure red cell aplasia is clearly of importance for patients with chronic kidney disease, but any developments in this area may also have relevance to other disease areas as therapeutic delivery of endogenous proteins rapidly increases. This review focuses on the current knowledge regarding the etiology of antibody-mediated pure red cell aplasia and the current approach to therapy.
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              Treatment of erythropoietin-induced pure red cell aplasia: a retrospective study.

              Anne Krüger, Kai-Uwe Eckardt, Norman D. Verhelst … (2004)
              Recombinant human erythropoietin is the standard treatment for anaemia related to chronic kidney disease, and its widespread use has been favoured by a very high therapeutic index. However, since 1998, more than 200 patients worldwide with chronic kidney disease treated in this way have developed neutralising antibodies to erythropoietin, causing pure red cell aplasia. We aimed to collate clinical and pathological features in patients unequivocally shown to have erythropoietin-induced pure red cell aplasia. We retrospectively obtained data from the files of 47 patients with pure red cell aplasia. We assessed treatment and outcome of patients and defined recovery from pure red cell aplasia as an increase in reticulocyte counts to more than 20 000 per microL in patients who were no longer transfusion-dependent. When patients developed pure red cell aplasia, all were receiving erythropoietin subcutaneously, and the product most typically prescribed was epoetin alfa (Eprex, Ortho Biotech). The median delay between start of erythropoietin treatment and occurrence of pure red cell aplasia was 11 months (IQR 7.5-14). Nine patients received no immunosuppressive treatment, and none of these recovered. Of 37 patients who received immunosuppressive therapy, 29 (78%) recovered. All six patients who received a kidney transplant recovered within 1 month, and recovery rates were between 56% and 88% in patients treated with corticosteroids, corticosteroids plus cyclophosphamide, or ciclosporin. No relapse of pure red cell aplasia happened after stopping immunosuppressive treatment, but no patient was rechallenged with erythropoietin. Immunosuppressive treatment accelerates recovery from erythropoietin-induced pure red cell aplasia.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Kidney J
                Journal ID (iso-abbrev): Clin Kidney J
                Journal ID (publisher-id): ckj
                Journal ID (hwp): ndtplus
                Title: Clinical Kidney Journal
                Publisher: Oxford University Press
                ISSN (Print): 2048-8505
                ISSN (Electronic): 2048-8513
                Publication date (Print): August 2016
                Publication date (Electronic): 04 May 2016
                Publication date PMC-release: 04 May 2016
                Volume: 9
                Issue: 4
                Pages: 599-602
                Affiliations
                [1 ]Department of Nephrology and Dialysis, Versilia Hospital , Lido di Camaiore (LU), Italy
                [2 ]Department of Nephrology and Dialysis, A. Manzoni Hospital , Lecco, Italy
                Author notes
                Correspondence and offprint requests to: Lucia Del Vecchio; E-mail: l.delvecchio@ 123456ospedale.lecco.it
                Article
                Publisher ID: sfw030
                DOI: 10.1093/ckj/sfw030
                PMC ID: 4957714
                PubMed ID: 27478604
                SO-VID: 907bbbf2-33ba-4508-ae6d-81143a626565
                Copyright © © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Date received : 16 February 2016
                Date accepted : 4 April 2016
                Categories
                Subject: Pure Red Cell Aplasia

                ScienceOpen disciplines: Nephrology
                Keywords: anaemia,chronic kidney disease,epoetin zeta,erythropoietin,pure red cell aplasia
                Data availability:
                ScienceOpen disciplines: Nephrology
                Keywords: anaemia, chronic kidney disease, epoetin zeta, erythropoietin, pure red cell aplasia

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