Methoxy polyethylene glycol-epoetin beta for the treatment of anemia associated with chronic renal failure

Schmid, Holger

doi:10.1586/17474086.2016.1112734

Cited by 6 publications

(4 citation statements)

References 95 publications

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“…Continuous erythropoietin receptor activator-methoxy polyethylene glycol-epoetin beta (C.E.R.A.) is a continuous erythropoietin receptor activator with a longer t 1/2 compared with other ESAs such as epoetin beta, epoetin alfa, and darbepoetin, allowing for once-monthly/ 4-weekly dosing with stable hemoglobin levels (4,5). C.E.R.A.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD

Fischbach

Wühl

Reigner

et al. 2017

CJASN

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Section: Introductionmentioning

confidence: 99%

Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD

Fischbach

Wühl

Reigner

et al. 2017

CJASN

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“…A further addition of glucidic residues and sialic acid molecules has led to the development of methoxy polyethylene glycol‐epoetin beta , which has an even longer half‐life (135‐139 hours) and can be administered every two weeks or once a month . The dosages vary from 30 to 360 mcg and 15 mcg of methoxy polyethylene glycol‐epoetin beta correspond to about 1000 IU of epoetin alpha or beta.…”

Section: Recombinant Human Erythropoietin: Pharmaceutical Formulationmentioning

confidence: 99%

Erythropoiesis and chronic kidney disease–related anemia: From physiology to new therapeutic advancements

Cernaro

Coppolino

Visconti

et al. 2018

Medicinal Research Reviews

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Erythropoiesis is triggered by hypoxia and is strictly regulated by hormones, growth factors, cytokines, and vitamins to ensure an adequate oxygen delivery to all body cells. Abnormalities in one or more of these factors may induce different kinds of anemia requiring different treatments. A key player in red blood cell production is erythropoietin. It is a glycoprotein hormone, mainly produced by the kidneys, that promotes erythroid progenitor cell survival and differentiation in the bone marrow and regulates iron metabolism. A deficit in erythropoietin synthesis is the main cause of the normochromic normocytic anemia frequently observed in patients with progressive chronic kidney disease. The present review summarizes the most recent findings about each step of the erythropoietic process, going from the renal oxygen sensing system to the cascade of events induced by erythropoietin through its own receptor in the bone marrow. The paper also describes the new class of drugs designed to stabilize the hypoxia-inducible factor by inhibiting prolyl hydroxylase, with a discussion about their metabolism, disposition, efficacy, and safety. According to many trials, these drugs seem able to simulate tissue hypoxia and then stimulate erythropoiesis in patients affected by renal impairment. In conclusion, the in-depth investigation of all events involved in erythropoiesis is crucial to understand anemia pathophysiology and to identify new therapeutic strategies, in an attempt to overcome the potential side effects of the commonly used erythropoiesis-stimulating agents.

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“…Methoxy polyethylene glycol‐epoetin beta (continuous erythropoietin receptor activator, C.E.R.A.) is a synthetic ESA that contains a polyethylene glycol moiety, conferring a longer half‐life compared with other ESAs and allowing stable Hb levels to be achieved with less‐frequent (once‐monthly) dosing …”

Section: Introductionmentioning

confidence: 99%

“…is a synthetic ESA that contains a polyethylene glycol moiety, conferring a longer half-life compared with other ESAs and allowing stable Hb levels to be achieved with less-frequent (oncemonthly) dosing. 6,7 C.E.R.A. has been approved in Europe and the United States for the treatment of anaemia of CKD in adults since 2007, and is indicated either intravenously (IV) or subcutaneously (SC) for the correction and maintenance of Hb levels in patients with anaemia associated with CKD both on dialysis and not on dialysis.…”

Section: Introductionmentioning

confidence: 99%

Model‐based approach for methoxy polyethylene glycol‐epoetin beta drug development in paediatric patients with anaemia of chronic kidney disease

Chanu

Schaefer

Warady

et al. 2020

Brit J Clinical Pharma

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Aims Methoxy polyethylene glycol‐epoetin beta (continuous erythropoietin receptor activator, C.E.R.A.) is used for the treatment of anaemia in adults with chronic kidney disease (CKD). Patients treated with shorter‐acting erythropoiesis‐stimulating agents up to three times weekly can be switched to once‐monthly C.E.R.A.. Doses can be adjusted on a monthly basis based on haemoglobin (Hb) levels during the preceding period. A model‐based approach was applied to optimise C.E.R.A. development, more specifically the confirmatory trial of the paediatric plan. Methods Pharmacokinetic and pharmacodynamic data from a phase II paediatric study and phase II and III adult studies were analysed together using modelling and simulation to determine the pharmacokinetic/pharmacodynamic characteristics of C.E.R.A. in a broad population. Model‐based simulations of C.E.R.A. treatment outcomes in paediatric patients were performed, notably when administered subcutaneously and compared to clinical and real‐world data. Results Age and body weight explained differences in pharmacokinetics, while the pharmacodynamic characteristics of C.E.R.A. were similar between adult and paediatric populations. Simulated Hb levels (mean and 95% prediction interval 10.9 [10.6, 11.2] g dL−1) and C.E.R.A. doses (median and 95% prediction interval 105 [72, 159] μg) 20 weeks after switching to subcutaneous C.E.R.A. were confirmed by observed real‐world data from International Pediatric Dialysis Network registries (mean Hb was 10.8 g dL−1 and median C.E.R.A. dose was 100 μg). Conclusions These analyses have facilitated optimisation of the C.E.R.A. development programme in paediatric patients with anaemia of CKD to provide this patient population with faster access to the drug while avoiding unnecessary clinical trial exposure and related monitoring burden in children.

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Methoxy polyethylene glycol-epoetin beta for the treatment of anemia associated with chronic renal failure

Cited by 6 publications

References 95 publications

Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD

Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD

Erythropoiesis and chronic kidney disease–related anemia: From physiology to new therapeutic advancements

Model‐based approach for methoxy polyethylene glycol‐epoetin beta drug development in paediatric patients with anaemia of chronic kidney disease

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