The use of epoetin alfa biosimilar in the anemia management in hemodialysis patients

  • I. O. Dudar SI «Institute of Nephrology NAMS of Ukraine» https://orcid.org/0000-0002-4372-8240
  • E. K. Krasjuk MNE «Kyiv City Center of nephrology and dialysis»
  • Y. I. Honchar SI «Institute of Nephrology NAMS of Ukraine»
  • O. M. Loboda SI «Institute of Nephrology NAMS of Ukraine» https://orcid.org/0000-0001-8410-6926
  • I. M. Shifris SI «Institute of Nephrology NAMS of Ukraine»
  • V. F. Krot SI «Institute of Nephrology NAMS of Ukraine»
  • V. M. Savchuk MNE «Kyiv City Center of nephrology and dialysis»
Keywords: chronic kidney disease, anemia, hemodialysis, epoetin alfa, hemoglobin.

Abstract

 Abstract. The present study aimed to evaluate the efficacy and safety of EMAVAIL (epoetin alfa) in the correction of anemia in hemodialysis patients.

Methods. A total of 36 patients undergoing regular hemodialysis were enrolled in this prospective study. Among the patients were 19 (53%) men and 17 (47%) women with severe anemia (hemoglobin (Hb) level ≤ 90 g/L). The mean patients' age was 48.41±1.82 years, an average dialysis vintage consisted of 42.38±10.41 months. All the patients had thrice-weekly hemodialysis sessions, with a mean duration of 12.6 ± 0.51 hours per week and Kt/V 1.27 ± 0.08. All the patients were treated with biosimilar of epoetin alfa EMAVAIL intravenously three times a week in adjustable doses. The follow-up period was 56 days.

Results. At the study entry, the mean Hb level in hemodialysis patients was 81.7±0,93 g/L. In 56 days of anemia treatment, the concentration of Hb increased to 109.17±1.75 g/L. Eventually, 32 (89%) patients achieved the target Hb level (110 g/L); 6 (17%) patients had adverse events (mild hypertension). There were no serious adverse events.

Conclusions. EMAVAIL is an effective and safe epoetin alfa biosimilar for anemia management in hemodialysis patients.

Downloads

Download data is not yet available.

References

WHO. Haemoglobin Concentrations for the Diagnosis of Anaemia and Assessment of Severity. Vitamin and Mineral Nutrition Information System. Geneva, Switzerland: WHO; 2011. Available from:  https://www.who.int/vmnis/indicators/haemoglobin.pdf.

Palaka E, Grandy S, van Haalen H, McEwan P, Darlington O.  The Impact of CKD Anaemia on Patients: Incidence, Risk Factors, and Clinical Outcomes—A Systematic Literature Review. Int J Nephrol 2020 Jul 1;2020:7692376. doi: 10.1155/2020/7692376.

Hörl WH. Anaemia management and mortality risk in chronic kidney disease. Nat Rev Nephrol. 2013 May;9(5):291-301. doi: 10.1038/nrneph.2013.21.

Johansen KL, Finkelstein FO, Revicki DA, Evans C,  Wan S, Gitlin M, Agodoa IL. Systematic review of the impact of erythropoiesis-stimulating agents on fatigue in dialysis patients. Nephrol Dial Transplant. 2012 Jun;27(6):2418-25. doi: 10.1093/ndt/gfr697.

Kamyar Kalantar-Zadeh. History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology. Am J Nephrol. 2017;45:235–247 doi: 10.1159/000455387.

Kolesnyk MO, hol. redaktor. Natsionalnyi reiestr khvorykh na khronichnu khvorobu nyrok ta patsientiv z hostrym poshkodzhenniam nyrok: 2019 rik / uklad. NI Kozliuk, OО Razvazhaieva; Derzhavna ustanova «Instytut nefrolohii NAMN Ukrainy». Kyiv; 2020.179 s. [In Ukrainian].

Kolesnyk MO, hol. redaktor. Natsionalnyi reiestr khvorykh na khronichnu khvorobu nyrok : 2013 rik  / uklad. N. I. Kozliuk, S. S. Nikolaienko, M. V. Kulyzkyi ; Derzhavna ustanova „Instytut nefrolohii NAMN Ukrainy”. Kyiv; 2014. 200 s. [In Ukrainian].

Trotta F, Belleudi V, Fusco D, et al. Comparative effectiveness and safety of erythropoiesis-stimulatingagents (biosimilars vs originators) in clinical practice: a population-basedcohort study in Italy. BMJ Open. 2017; 7(3): e011637. Published online 2017 Mar 10. doi: 10.1136/bmjopen-2016-011637.

Jones M, Ibels L, Schenkel B,  Zagari M.  Impact of epoetin alfa on clinical end points in patients with chronic renal failure: A meta-analysis. Kidney Int. 2004 Mar;65(3):757-67. doi: 10.1111/j.1523-1755.2004.00450.x.

Krapf R, Hulter HN. Arterial Hypertension Induced by Erythropoietin and Erythropoiesis-Stimulating Agents (ESA). Clin J Am Soc Nephrol. 2009 Feb;4(2):470-80. doi: 10.2215/CJN.05040908.

Mary S Lee, John S Lee, Jong Y Lee. Prevention of Erythropoietin-Associated Hypertension.  Hypertension. 2007 Aug;50(2):439-45. doi: 10.1161/HYPERTENSIONAHA.107.090423.


Abstract views: 168
PDF Downloads: 17916
Published
2021-02-28
How to Cite
Dudar, I. O., Krasjuk, E. K., Honchar, Y. I., Loboda, O. M., Shifris, I. M., Krot, V. F., & Savchuk, V. M. (2021). The use of epoetin alfa biosimilar in the anemia management in hemodialysis patients. Ukrainian Journal of Nephrology and Dialysis, (3(71), 36-43. https://doi.org/10.31450/ukrjnd.3(71).2021.05

Most read articles by the same author(s)