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

Maria del Carmen Popoca-Martínez; Julio Flores-Garnica; Odette Díaz-Avendaño; Emmanuel Canales-Vázquez; Raúl Meixueiro-Montes De Oca

doi:doi:10.11648/j.cmr.20140305.15

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

Maria del Carmen Popoca-Martínez, Julio Flores-Garnica, Odette Díaz-Avendaño, Emmanuel Canales-Vázquez, Raúl Meixueiro-Montes De Oca

Published in Clinical Medicine Research (Volume 3, Issue 5)

Received: 21 August 2014 Accepted: 3 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.

Published in	Clinical Medicine Research (Volume 3, Issue 5)
DOI	10.11648/j.cmr.20140305.15
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), 2014. Published by Science Publishing Group

Keywords

Biosimilar rHuEPO, Safety, Efficacy, Renal Anemia, Hemodialysis

References

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[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.
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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://article.sciencepublishinggroup.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
Y1  - 2014/09/20
PY  - 2014
N1  - https://doi.org/10.11648/j.cmr.20140305.15
DO  - 10.11648/j.cmr.20140305.15
T2  - Clinical Medicine Research
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
ER  -

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Author Information

Maria del Carmen Popoca-Martínez

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

Nephrology Department, General Hospital “Dr. Darío Fernández Fierro” ISSSTE, Av. Revolución 1182, Col. San José Insurgentes, México City 03900, Mexico
Odette Díaz-Avendaño
Emmanuel Canales-Vázquez

Clinical Research Department, Laboratorios PISA SA de CV. Miguel ángel de Quevedo 555, Colonia Romero De Terreros, México City 04310 Mexico
Raúl Meixueiro-Montes De Oca

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://article.sciencepublishinggroup.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}
}

Copy | Download

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
Y1  - 2014/09/20
PY  - 2014
N1  - https://doi.org/10.11648/j.cmr.20140305.15
DO  - 10.11648/j.cmr.20140305.15
T2  - Clinical Medicine Research
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
ER  -

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