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Comparison of the Therapeutic Effects of Two Recombinant Erythropoietin Beta, Biosimilar and Reference Formulations in Patients with Chronic Kidney Disease under Hemodialysis

Received: 21 August 2014    Accepted: 03 September 2014    Published: 20 September 2014
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Abstract

Anemia is common in patients with chronic kidney diseases under hemodialysis and it’s managed with recombinant erythropoietin formulation. The objective of the study is to compare the safety and efficacy of two recombinant erythropoietin formulations in patients undergoing hemodialysis with chronic kidney diseases. In this randomized, controlled, prospective, parallel open study 70 patients were treated for 24 weeks with either reference β recombinant erythropoietin (100 IU/kg) or biosimilar β recombinant erythropoietin (100 IU/kg). The primary efficacy endpoint was the hemoglobin and hematocrit levels from baseline to 24 week of treatment. The secondary endpoints were safety, weekly doses of both erythropoietins required to maintain hemoglobin levels and immunogenicity. There was no significant difference between the two preparations in terms of hemoglobin and hematocrit levels achieved. The weekly doses of both erythropoietins required to maintain hemoglobin levels were the same in both groups. The frequency of adverse events was similar in the two groups of treatment. Two patients of the reference erythropoietin group developed anti-erythropoietin antibodies. The biosimilar erythropoietin was comparable since the safety and efficacy point of view with the innovator erythropoietin in hemodialysis patients based on hemoglobin changes. The biosimilar erythropoietin when administered subcutaneously will be equally efficacious and may be interchangeable as therapy.

DOI 10.11648/j.cmr.20140305.15
Published in Clinical Medicine Research (Volume 3, Issue 5, September 2014)
Page(s) 136-141
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Biosimilar rHuEPO, Safety, Efficacy, Renal Anemia, Hemodialysis

References
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[2] Hsu CY, McCulloch CE, Curhan GC. Epidemiology of anemia associated with chronic renal insufficiency among adults in the United States: results from the Third National Health and Nutrition Examination Survey. J Am Soc Nephrol 2002; 13: 504-510.
[3] McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004; 20: 1501-1510.
[4] Besarab A, Bolton WK, Browne JK, et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998; 339: 584-590.
[5] Revicki Da, Brown RE, Feeney DH, et al. Health-related quality of life associated with recombinant human erythropoietin therapy for predialysis chronic renal disease patients. Am J Kidney Dis 1995; 25: 548-554.
[6] Collins AJ, Brenner RM, Ofman JJ; et al. Epoetin alfa use in patients with ESRD : an analysis of recent US prescribing patterns and hemoglobin outcomes. Am J Kidney Dis 2005; 46: 481-488.
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[11] Ifudu O. Patient characteristics determining rHuEPO dose requirements. Nephrol Dial Transplant 2002; 17(5): 38-41.
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[16] Storring PL, Tiplady RJ, Gaintes Das RE, et la. Epoetin alfa ans beta differ in their erythropoietin isoform compositions and biological properties. Br J Haematol 1998; 100: 79-89.
[17] Chamberlain P. Biogenerics: Europe takes another step forward while the FDA dives for cover. Drug Discov Today 2004; 9: 817-820.
[18] Hernandez-Bastida A, Meixueiro-Montes de Oca R. Equivalence on efficay and safety of two formulations of insulin glargine (biosimilar and reference) in the treatment of patients with type 2 diabetes. Clinical Medicine Research 2014; 3(2): 50-55.
[19] Palma-Aguirre J, Alvarez-Etchegaray S, Meixueiro-Montes de Oca R. Pharmacokinetic and pharmacodynamic biocomparability of two r-hGH (innovator and biosimilar) formulations after subcutaneous administration in healthy volunteers. Int J Pharm Pract & Drug Res 2014; 4(1): 62-66.
[20] Locatelli F, Aljama P, Barany P, et al. Revised European best practice guidelines for the management of anemia in patients with chronic renal failure. Nephrol Dial Transplant 2004; 19(Suppl 2): 1-47.
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Author Information
  • Nephrology Department, General Hospital “Dr. Darío Fernández Fierro” ISSSTE, Av. Revolución 1182, Col. San José Insurgentes, México City 03900, Mexico

  • Nephrology Department, General Hospital “Dr. Darío Fernández Fierro” ISSSTE, Av. Revolución 1182, Col. San José Insurgentes, México City 03900, Mexico

  • Clinical Research Department, Laboratorios PISA SA de CV. Miguel ángel de Quevedo 555, Colonia Romero De Terreros, México City 04310 Mexico

  • Clinical Research Department, Laboratorios PISA SA de CV. Miguel ángel de Quevedo 555, Colonia Romero De Terreros, México City 04310 Mexico

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  • APA Style

    Maria del Carmen Popoca-Martínez, Julio Flores-Garnica, Odette Díaz-Avendaño, Emmanuel Canales-Vázquez, Raúl Meixueiro-Montes De Oca. (2014). Comparison of the Therapeutic Effects of Two Recombinant Erythropoietin Beta, Biosimilar and Reference Formulations in Patients with Chronic Kidney Disease under Hemodialysis. Clinical Medicine Research, 3(5), 136-141. https://doi.org/10.11648/j.cmr.20140305.15

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    ACS Style

    Maria del Carmen Popoca-Martínez; Julio Flores-Garnica; Odette Díaz-Avendaño; Emmanuel Canales-Vázquez; Raúl Meixueiro-Montes De Oca. Comparison of the Therapeutic Effects of Two Recombinant Erythropoietin Beta, Biosimilar and Reference Formulations in Patients with Chronic Kidney Disease under Hemodialysis. Clin. Med. Res. 2014, 3(5), 136-141. doi: 10.11648/j.cmr.20140305.15

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    AMA Style

    Maria del Carmen Popoca-Martínez, Julio Flores-Garnica, Odette Díaz-Avendaño, Emmanuel Canales-Vázquez, Raúl Meixueiro-Montes De Oca. Comparison of the Therapeutic Effects of Two Recombinant Erythropoietin Beta, Biosimilar and Reference Formulations in Patients with Chronic Kidney Disease under Hemodialysis. Clin Med Res. 2014;3(5):136-141. doi: 10.11648/j.cmr.20140305.15

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  • @article{10.11648/j.cmr.20140305.15,
      author = {Maria del Carmen Popoca-Martínez and Julio Flores-Garnica and Odette Díaz-Avendaño and Emmanuel Canales-Vázquez and Raúl Meixueiro-Montes De Oca},
      title = {Comparison of the Therapeutic Effects of Two Recombinant Erythropoietin Beta, Biosimilar and Reference Formulations in Patients with Chronic Kidney Disease under Hemodialysis},
      journal = {Clinical Medicine Research},
      volume = {3},
      number = {5},
      pages = {136-141},
      doi = {10.11648/j.cmr.20140305.15},
      url = {https://doi.org/10.11648/j.cmr.20140305.15},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.cmr.20140305.15},
      abstract = {Anemia is common in patients with chronic kidney diseases under hemodialysis and it’s managed with recombinant erythropoietin formulation. The objective of the study is to compare the safety and efficacy of two recombinant erythropoietin formulations in patients undergoing hemodialysis with chronic kidney diseases. In this randomized, controlled, prospective, parallel open study 70 patients were treated for 24 weeks with either reference β recombinant erythropoietin (100 IU/kg) or biosimilar β recombinant erythropoietin (100 IU/kg). The primary efficacy endpoint was the hemoglobin and hematocrit levels from baseline to 24 week of treatment. The secondary endpoints were safety, weekly doses of both erythropoietins required to maintain hemoglobin levels and immunogenicity. There was no significant difference between the two preparations in terms of hemoglobin and hematocrit levels achieved. The weekly doses of both erythropoietins required to maintain hemoglobin levels were the same in both groups. The frequency of adverse events was similar in the two groups of treatment. Two patients of the reference erythropoietin group developed anti-erythropoietin antibodies. The biosimilar erythropoietin was comparable since the safety and efficacy point of view with the innovator erythropoietin in hemodialysis patients based on hemoglobin changes. The biosimilar erythropoietin when administered subcutaneously will be equally efficacious and may be interchangeable as therapy.},
     year = {2014}
    }
    

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  • TY  - JOUR
    T1  - Comparison of the Therapeutic Effects of Two Recombinant Erythropoietin Beta, Biosimilar and Reference Formulations in Patients with Chronic Kidney Disease under Hemodialysis
    AU  - Maria del Carmen Popoca-Martínez
    AU  - Julio Flores-Garnica
    AU  - Odette Díaz-Avendaño
    AU  - Emmanuel Canales-Vázquez
    AU  - Raúl Meixueiro-Montes De Oca
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    JF  - Clinical Medicine Research
    JO  - Clinical Medicine Research
    SP  - 136
    EP  - 141
    PB  - Science Publishing Group
    SN  - 2326-9057
    UR  - https://doi.org/10.11648/j.cmr.20140305.15
    AB  - Anemia is common in patients with chronic kidney diseases under hemodialysis and it’s managed with recombinant erythropoietin formulation. The objective of the study is to compare the safety and efficacy of two recombinant erythropoietin formulations in patients undergoing hemodialysis with chronic kidney diseases. In this randomized, controlled, prospective, parallel open study 70 patients were treated for 24 weeks with either reference β recombinant erythropoietin (100 IU/kg) or biosimilar β recombinant erythropoietin (100 IU/kg). The primary efficacy endpoint was the hemoglobin and hematocrit levels from baseline to 24 week of treatment. The secondary endpoints were safety, weekly doses of both erythropoietins required to maintain hemoglobin levels and immunogenicity. There was no significant difference between the two preparations in terms of hemoglobin and hematocrit levels achieved. The weekly doses of both erythropoietins required to maintain hemoglobin levels were the same in both groups. The frequency of adverse events was similar in the two groups of treatment. Two patients of the reference erythropoietin group developed anti-erythropoietin antibodies. The biosimilar erythropoietin was comparable since the safety and efficacy point of view with the innovator erythropoietin in hemodialysis patients based on hemoglobin changes. The biosimilar erythropoietin when administered subcutaneously will be equally efficacious and may be interchangeable as therapy.
    VL  - 3
    IS  - 5
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