Volume 3, Issue 5, September 2014, Page: 136-141
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, 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, Nephrology Department, General Hospital “Dr. Darío Fernández Fierro” ISSSTE, Av. Revolución 1182, Col. San José Insurgentes, México City 03900, Mexico
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
Received: Aug. 21, 2014;       Accepted: Sep. 3, 2014;       Published: Sep. 20, 2014
DOI: 10.11648/j.cmr.20140305.15      View  2618      Downloads  422
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.
Keywords
Biosimilar rHuEPO, Safety, Efficacy, Renal Anemia, Hemodialysis
To cite this article
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, Clinical Medicine Research. Vol. 3, No. 5, 2014, pp. 136-141. doi: 10.11648/j.cmr.20140305.15
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