Pure red cell aplasia and anti-erythropoietin antibodies in patients on hemodialysis: a report of two cases and a literature review

Lacreta, Gabriela; Bucharles, Sérgio Gardano Elias; Sevignani, Gabriela; Riella, Miguel C.; Nascimento, Marcelo Mazza do

doi:10.1590/2175-8239-jbn-2018-0054

Cited by 8 publications

(6 citation statements)

References 25 publications

(24 reference statements)

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“…Aggregation present in rhEPO preparation were held responsible for the ADA effect. These ADAs, in severe cases, lead to clinically relevant autoimmunity known as pure red cell aplasia (PRCA) [72][73][74]. Three orthologous analysis procedures, viz., Western blot, dynamic light scattering and SEC-HPLC were applied for detecting any high molecular aggregates in our final products, and the results confirmed that GBPD002 did not contain any such macromolecular entity.…”

Section: Discussionmentioning

confidence: 99%

Development and qualification of a high-yield recombinant human Erythropoietin biosimilar

Nag¹,

Islam²,

Khan³

et al. 2023

Preprint

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Recombinant human erythropoietin (rhEPO) has been saving millions of lives worldwide as a potent and safe treatment for the lack of erythrocyte, which is caused by chronic kidney disease (CKD) and other issues. Several biosimilars of rhEPO have been approved since the expiry of the relevant patents to provide cost-effective options but the price of rhEPO is still high for the affordability of global community. Therefore, development of biosimilar of rhEPO at a lower price is highly necessary. Here we report the development and characterization of a biosimilar of rhEPO with high-yield satisfying regulatory requirements. The hEPO-expressing cDNA was stably expressed in CHO cells with successive transfection. The master cell bank (MCB) and working cell bank (WCB) were established from the best selected clone and characterized for 50 passages. The rhEPO was expressed from the WCB in single-use suspension culture system with a high-titer (1.24 +/- 0.16 g/L). To the best of our knowledge this is the highest reported rhEPO titer to date. The rhEPO was purified using a series of validated chromatography unit processes including virus inactivation and filtration. The purified EPO was formulated in serum-free buffer, sterile filtered, and analyzed as the biosimilar of reference product Eprex(R). Physicochemical analysis strongly suggested similarities between the developed rhEPO (GBPD002) and the reference. The in vitro and in vivo functional assays confirmed the similar biofunctionality of the GBPD002 and Eprex(R). GBPD002 could provide a less-expensive solution to the needful communities as an effective and safe biosimilar where rhEPO treatment is necessary.

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Section: Discussionmentioning

confidence: 99%

Development and qualification of a high-yield recombinant human Erythropoietin biosimilar

Nag¹,

Islam²,

Khan³

et al. 2023

Preprint

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“…The mechanism of drug-induced PRCA is mostly unexplained in the medical literature but erythropoietin induced PRCA is well explained by autoimmunity or antibody-mediated mechanisms [2]. Five main factors determine the pathogenesis of erythropoietin mediated PRCA.…”

Section: Discussionmentioning

confidence: 99%

“…Rapid onset normochromic normocytic anaemia, low reticulocyte count and severe hypoplastic erythroid lineage with normal other cell lines in the bone marrow is the classical picture of PRCA [1]. Anaemia in a patient with chronic kidney disease could be due to several factors such as impaired production of erythropoietin, iron deficiency (functional/absolute), Vitamin B12 and folic acid deficiency, suboptimal dialysis or gastrointestinal blood loss [2]. The incidence of erythropoietin antibody-mediated PRCA is 0.02-0.03 per 10000 patient-years [3].…”

Section: Introductionmentioning

confidence: 99%

Erythropoietn; A rare culprit of anemia in chronic kidney disease

Navaradnam

Kumanan

Sooriyakumar

2021

J. Postgrad. Inst. Med.

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This is an open-access article distributed under a Creative Commons Attribution-Share Alike 4.is0 International License (CC BY-SA 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are attributed and materials are shared under the same license. 2020 Full blood count White cell count (4-10×10 9 /l) Abs.Neutrophils (2-7×10 9 /l) Abs.Lymphocytes (1-3×10 9 /l) Abs.Eosinophil(0.04-0.6×10 9 /l) Abs.Basophil(0.0-0.09 ×10 9 /l) Haemoglobin (130-170g/l) HCT(0.40-0.50) MCV (83-101fL) Red cell count (4.5-5.5×10 12 /l) Platelets (150-410×10 9 /l))

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“…Selain pengunaan obat-obatan yang menginduksi terbentuknya antibodi dengan mekanisme yang belum jelas, pada beberapa penyakit juga dapat ditemukan antibodi anti-EPO seperti pada tymoma, rheumatoid artritis, systemic Lupus Erythematosus, dan Leukemia Limfositik Kronik (Lim, 2005). Pada kasus yang dilaporkan oleh Lacreta, terdapat 2 pasien di Brazil dengan PRCA dan salah satunya menderita penyakit ginjal polikistik.keduanya diberi terapi transfusi darah untuk mengatasi kondisi anemia dan diberi terapi imunosupresan (Lacreta et al, 2019). Dari penelitian yang dilakukan oleh Christie, penambahan partikel untuk pelarut rekombinan EPO dan pemberian EPO dalam jumlah yang besar dapat menginisiasi terbentuknya antibodi (Christie et al, 2015).…”

Section: Gangguan Nutrisiunclassified

Risk Factor for Erythropoietin Resistance in Hemodialysis Patient : Literature Review

Putri

Sholikhah

Sukirto

2020

ADMJ

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Anaemia become the complication of chronic kidney disease (CKD) which was caused by decreasing of erythropoietin. Erythropoietin stimulating agent (ESA) therapy is one of therapy to overcome the problem, but until 34% of patients have lack of response to ESA treatment. Anaemia in CKD related to the worsen of the diseases, quality of life, and mortality of patients. Decreasing of the response to erythropoietin need to be evaluated to correct anaemic condition. This review is aim to explain the risk factor for erythropoietin resistance. The literature for this review was collected through PUBMED and google scholar. Erythropoietin is glycoprotein secreted 90% by interstitial cells of kidney and 10% by liver cells. The functions of erythropoietin are stimulate the proliferation and cells differentiation in bone marrow, and enhance erythropoiesis. Renal damage can inhibit the secretion of erythropoietin. In patients with ESA treatment, risk factors for resistance are iron deficiency, inadequate haemodialysis, inflammation, hyperparathyroid, nutrition disturbance, antibody mediated Pure Red Cell Aplastic (PRCA). The risk factor can be influenced by genetic variation. Conclusion of this review, there are several factor that influence the response of erythropoietin in hemodialisa patients. Hence, study related anaemia in CKD need further study to optimalize the treatment.

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Pure red cell aplasia and anti-erythropoietin antibodies in patients on hemodialysis: a report of two cases and a literature review

Cited by 8 publications

References 25 publications

Development and qualification of a high-yield recombinant human Erythropoietin biosimilar

Development and qualification of a high-yield recombinant human Erythropoietin biosimilar

Erythropoietn; A rare culprit of anemia in chronic kidney disease

Risk Factor for Erythropoietin Resistance in Hemodialysis Patient : Literature Review

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