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DOI: 10.1055/a-1982-3811
Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
Abstract
Purpose This study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority.
Patients and methods It was an open-label, randomized, comparative, parallel, multi-center study in hemodialysis patients with anemia. The reference product at an individualized dose 3 times a week was given in 4–8 weeks of titration period and hemoglobin (Hb) level was controlled to reach the range of 10–12 g/dL. Then, the subjects were randomly administered with reference or test product with the same dose regimen. The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period. The safety was evaluated based on the adverse events incidence.
Results There was no statistical difference in the change of Hb between test and reference (0.14 g/dL and 0.75 g/dL respectively, with p>0.05), also for the mean changes of weekly dosage between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The instability rate of Hb in both test and reference was not statistically significantly different as well (26 and 15% respectively, with p>0.05).
Conclusion This study proves that the efficacy indicated by the change instability of Hb and safety indicated by adverse event incidence of Epodion and the reference product on chronic kidney disease were similar.
Publication History
Received: 20 July 2022
Accepted: 31 July 2022
Article published online:
27 March 2023
© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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References
- 1 Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl. 2013;31–150
- 2 Kementerian Kesehatan RI. Situasi penyakit ginjal kronis. Jakarta: Pusat Data dan Informasi Kementerian Kesehatan RI; 2017
- 3 Luyckx VA, Tonelli M, Stanifer JW. The global burden of kidney disease and the sustainable development goals. Bulletin of the WHO 2018; 96: 414-422
- 4 Indonesian Ministry of Health Basic Health Research Report (In Bahasa: Riset Kesehatan Dasar). Jakarta. 2013
- 5 Phrommintikul A, Haas SJ, Elsik M, Krum H. Mortality and target hemoglobin concentrations in anemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. The lancet. 2007
- 6 Pollock C, Johnson DW, Horl WH, Rossert J, Casadevall N. et al. Pure red cell aplasia induced by erythropoiesis-stimulating agents. 2008
- 7 Casadevall N. Antibodies against rHuEPO: Native and recombinant. Nephrol Dial Transplant 2002; 17: 42-47
- 8 Zadeh KK. History of Erythropoiesis-Stimulating Agent, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology. 2017
- 9 Kalantar-Zadeh K. History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology. Am J Nephrol 2017; 45: 235-47
- 10 World Health Organization (WHO) Guidelines On Evaluation of Similar Biotherapeutic Products (SBPs). Geneva. 2009
- 11 European Medicines Agency (EMA) Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency. 2017
- 12 ICH Expert Working Group. Guideline for Good Clinical Practice – ICH Harmonized Tripartite Guideline. Geneva: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 1996. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_ Guideline.pdf. Accessed September 12, 2014
- 13 Ahmad MN, Asif N, Khanzada SW. et.al. Comparative effectiveness of erythropoietin alpha and beta in hemodialysis patients: a single-center prospective observational study. Taylor & Francis: Journal of Community Hospital Internal Medicine Perspectives 2021; 11: 782-786
- 14 Loughnan A, Ali GR, Abeygunasekara SC. Comparison of the Therapeutic Efficacy of Epoetin Beta and Epoetin Alfa in Maintenance Phase Hemodialysis Patients. Taylor & Francis: Renal Failure 2011; 33: 373-375
- 15 Lim SK, Goh BL, Visvanathan R. et.al. A multicentre, multinational, double-blind, randomized, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alfa) vs. Eprex in patients with anemia of chronic renal failure. BMC Nephrology 2021; 22: 391 DOI: 10.1186/s12882-021-02601-w.
- 16 Hustrini NM, Siregar P, Setiawati A, Nugroho P. 2019. Clinical comparison of renogen, a biosimilar epoetin-a, with the originator. Acta Medica Indonesiana – Indonesia Journal Internal Medicine Vol. 51, Number 3, July 2019
- 17 Haag-Weber M, Eckardt KU, Hörl WH, Roger SD, Vetter A, Roth K. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in nondialysis patients with renal anemia: A multi-center, randomized, double-blind study. Clin Nephrol 2012; 77: 8-17
- 18 Drüeke TB. Lessons from clinical trials with erythropoiesis-stimulating agents (ESAs). Ren Replace Ther 2018; 4: 46