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      Lessons learned from peginesatide in the treatment of anemia associated with chronic kidney disease in patients on dialysis

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      Author(s): ,
      Publication date (Electronic):
      Journal: Biologics : Targets & Therapy
      Publisher: Dove Medical Press
      Keywords: anemia, hemodialysis, chronic kidney disease, peginesatide

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          Abstract

          Peginesatide is the newest erythropoietin-stimulating agent (ESA) in the quest for the ideal treatment of anemia in chronic kidney disease (CKD) patients. Reduced frequency of administration along with a possibly lower cost as a result of simpler manufacturing techniques compared with other available agents makes peginesatide a highly desirable product in the competitive ESA market. Peginesatide is noninferior to the other ESAs, and has a good safety profile in patients on hemodialysis. The higher rates of adverse cardiovascular events reported in CKD patients not on dialysis in the recent Phase III studies require further, better planned, studies. Peginesatide had to be withdrawn from the market in the US after some reports of hypersensitivity reactions to the drug. This is a setback, but the scientific advances gained as a result of this product development can be used to develop other, newer products.

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          Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis.

          Iain C. MacDougall, Robert Provenzano, Amit Sharma … (2013)
          Peginesatide is a peptide-based erythropoiesis-stimulating agent (ESA) that may have therapeutic potential for anemia in patients with advanced chronic kidney disease. We evaluated the safety and efficacy of peginesatide, as compared with another ESA, darbepoetin, in 983 such patients who were not undergoing dialysis.
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            CERA (Continuous Erythropoietin Receptor Activator): a new erythropoiesis-stimulating agent for the treatment of anemia.

            Iain C. MacDougall (2005)
            Anemia is a common and debilitating condition in patients with chronic kidney disease and patients with cancer. Over the last 10 to 15 years, the introduction of erythropoietic therapy has transformed the management of anemia in both these conditions. The first therapeutic agent to be used for the stimulation of erythropoiesis was recombinant human erythropoietin (epoetin). At the turn of this century, darbepoetin alfa, a second-generation erythropoietic agent, became available. Darbepoetin alfa contains two additional N-linked carbohydrate chains, which confer greater metabolic stability in vivo. More recently, a third-generation molecule, Continuous Erythropoietin Receptor Activator (CERA), incorporating a large polymer chain, has been developed. CERA has an elimination half-life in humans that is considerably longer than the half-life of either epoetin or darbepoetin alfa. CERA may also have different receptor binding characteristics and pharmacology from other erythropoietic agents; these characteristics are the subject of ongoing investigation. CERA is currently in phase III clinical trials.
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              Peginesatide in patients with anemia undergoing hemodialysis.

              , Krishna Polu, Anne-Marie Duliege … (2013)
              Peginesatide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), is a potential therapy for anemia in patients with advanced chronic kidney disease. We conducted two randomized, controlled, open-label studies (EMERALD 1 and EMERALD 2) involving patients undergoing hemodialysis. Cardiovascular safety was evaluated by analysis of an adjudicated composite safety end point--death from any cause, stroke, myocardial infarction, or serious adverse events of congestive heart failure, unstable angina, or arrhythmia--with the use of pooled data from the two EMERALD studies and two studies involving patients not undergoing dialysis. In the EMERALD studies, 1608 patients received peginesatide once monthly or continued to receive epoetin one to three times a week, with the doses adjusted as necessary to maintain a hemoglobin level between 10.0 and 12.0 g per deciliter for 52 weeks or more. The primary efficacy end point was the mean change from the baseline hemoglobin level to the mean level during the evaluation period; noninferiority was established if the lower limit of the two-sided 95% confidence interval was -1.0 g per deciliter or higher in the comparison of peginesatide with epoetin. The aim of evaluating the composite safety end point in the pooled cohort was to exclude a hazard ratio with peginesatide relative to the comparator ESA of more than 1.3. In an analysis involving 693 patients from EMERALD 1 and 725 from EMERALD 2, peginesatide was noninferior to epoetin in maintaining hemoglobin levels (mean between-group difference, -0.15 g per deciliter; 95% confidence interval [CI], -0.30 to -0.01 in EMERALD 1; and 0.10 g per deciliter; 95% CI, -0.05 to 0.26 in EMERALD 2). The hazard ratio for the composite safety end point was 1.06 (95% CI, 0.89 to 1.26) with peginesatide relative to the comparator ESA in the four pooled studies (2591 patients) and 0.95 (95% CI, 0.77 to 1.17) in the EMERALD studies. The proportions of patients with adverse and serious adverse events were similar in the treatment groups in the EMERALD studies. The cardiovascular safety of peginesatide was similar to that of the comparator ESA in the pooled cohort. Peginesatide, administered monthly, was as effective as epoetin, administered one to three times per week, in maintaining hemoglobin levels in patients undergoing hemodialysis. (Funded by Affymax and Takeda Pharmaceutical; ClinicalTrials.gov numbers, NCT00597753 [EMERALD 1], NCT00597584 [EMERALD 2], NCT00598273 [PEARL 1], and NCT00598442 [PEARL 2].).
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                Author and article information

                Journal
                Journal ID (nlm-ta): Biologics
                Journal ID (iso-abbrev): Biologics
                Journal ID (publisher-id): Biologics: Targets and Therapy
                Title: Biologics : Targets & Therapy
                Publisher: Dove Medical Press
                ISSN (Print): 1177-5475
                ISSN (Electronic): 1177-5491
                Publication date Collection: 2013
                Publication date (Print): 2013
                Publication date (Electronic): 11 November 2013
                Volume: 7
                Pages: 243-246
                Affiliations
                Barts Health NHS Trust, William Harvey Research Unit, London, UK
                Author notes
                Correspondence: Muhammad Magdi Yaqoob, Barts Health NHS Trust, William Harvey Research Unit, London, UK, Tel +44 20 3594 2658, Fax +44 20 3594 3253, Email m.m.yaqoob@ 123456qmul.ac.uk
                Article
                Publisher ID: btt-7-243
                DOI: 10.2147/BTT.S34935
                PMC ID: 3848525
                SO-VID: 895977a5-8da5-4e7e-957b-dd2ebc516407
                Copyright © © 2013 Kaushik and Yaqoob. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License
                License:

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Subject: Review

                Keywords: peginesatide,hemodialysis,chronic kidney disease,anemia
                Data availability:
                Keywords: peginesatide, hemodialysis, chronic kidney disease, anemia

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