Pure red cell aplasia induced by epoetin zeta

Panichi, Vincenzo; Ricchiuti, Guido; Scatena, Alessia; Vecchio, Lucia Del; Locatelli, Francesco

doi:10.1093/ckj/sfw030

Cited by 11 publications

(7 citation statements)

References 15 publications

(19 reference statements)

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“…A change in the manufacturing process was implemented (introduction of low-tungsten syringes) and, following the completion of a clinical study, HX575 was approved by the EMA for SC administration in CKD patients in March 2016 [ 25 ]. Considering post-approval data for EU-authorized biosimilar epoetins, a patient with CKD-related anemia receiving SC epoetin zeta in Italy was reported to have developed immune-mediated PRCA [ 26 ]. In contrast to EMA-approved and regulated biosimilar epoetins, confirmed cases of PRCA have been reported in 23 Thai patients receiving regionally manufactured copy epoetins not approved in Europe [ 27 ].…”

Section: Initial Concerns About the Introduction Of Biosimilar Epoetimentioning

confidence: 99%

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

Aapro

Krendyukov

Schiestl³

et al. 2018

BioDrugs

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High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs. The European Medicines Agency (EMA) was the first regulatory authority to establish legislative procedures for the approval of biosimilars when they published their guidelines on similar biological medicinal products in 2005. Biosimilar epoetins were first approved in 2007, and a wealth of data has been collected over the last decade. Two biosimilar epoetins (under five commercial names) have been approved by the EMA so far. The availability of epoetin biosimilars generated discussion among the oncology community regarding prescribing these products, their efficacy, and their safety. These agents are approved only if they are shown in extensive analytical and clinical testing to have comparable quality, safety, and efficacy to the reference medicine, and real-world studies provide further data that biosimilar epoetins are an effective and well-tolerated option for the treatment of chemotherapy-induced anemia in patients with cancer. Other countries have adopted similar regulatory pathways to those in Europe and have approved epoetin biosimilars. The now extensive European experience with biosimilar epoetins should reassure regulators from other territories.

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Section: Initial Concerns About the Introduction Of Biosimilar Epoetimentioning

confidence: 99%

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

Aapro

Krendyukov

Schiestl³

et al. 2018

BioDrugs

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“…A single event of epoetin-associated PRCA was observed in 1 patient out of the 6,337 patients included in the safety analysis set of this study. The details of this case of PRCA have been reported previously [ 11 ]. The exposure-adjusted incidence rate of PRCA was 0.84 per 10,000 patient-years, which was substantially lower than the incidence rate of 4.5 per 10,000 patient-years observed for Eprex (epoetin-α, Johnson & Johnson, USA) in 2002 [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

“…After the peak incidence rate of PRCA associated with epoetin-α treatment in 2002 [ 6 ], few cases of PRCA caused by biosimilar epoetin products have been reported, these included 2 cases for HX575 (binocrit; Sandoz GmbH, Kundl, Austria) in 2012 (1 confirmed, 1 possible) [ 16 ], 1 case for epoetin-θ/epoetin-β/darbepoetin-α in 2013 [ 17 ], and this case for epoetin-ζ during the study period of PASCO II. All of these PRCA cases occurred in patients with renal anemia who received SC epoetins [ 11 , 16 , 17 ]. The safety profiles of these biosimilars were overall comparable with the epoetin reference products [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study

Patsialas¹,

Fowler²,

Guilatco³

et al. 2023

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Epoetin has been used to treat patients with renal anemia since 1988. Anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been associated with epoetin usage, and a PRCA incidence of 4.5 per 10,000 patient-years was observed for epoetin-α (Eprex) in 2002. The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. One PRCA in 1 (0.02%) patient in group R who tested positive for neutralizing antibodies was reported. Overall, 527 adverse events of special interest (AESI) including PRCA occurred in 418 (6.60%) patients, lack of efficacy occurred in 34 (0.54%), and thromboembolic events in 389 (6.14%) patients. 41 adverse drug reactions other than AESIs were reported in 28 (0.44%) patients. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern.

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“…Most of the cases described (92%) by 2004 were connected to subcutaneous EPO and to the most commonly used drug, epoetin alfa. However, the literature also comprises cases involving associations between PRCA and epoetin beta, zetaepoetina,20 and darbepoetin alfa,21 although in Brazil only epoetin alfa is regularly used.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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Pure red cell aplasia induced by epoetin zeta

Cited by 11 publications

References 15 publications

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study

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

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