Biosimilar Epoetin Zeta in Nephrology: Effect of Injection Frequency on Weekly Dose

Abstract

Aim: This observational clinical study tested the effect of injection frequency of the biosimilar epoetin zeta on the weekly dose needed to maintain stable hemoglobin levels in chronic kidney diseases (CKD) patients on intermittent high-flux hemodialysis (HD). Patients and Methods: CKD patients (n = 33) on regular HD therapy 3 times a week were treated for 18 months with epoetin zeta i.v. The hemoglobin levels, the weekly dose as well as the injection frequency of epoetin zeta were monitored at least every two weeks. Patients were followed in three time periods: 1) extended follow-up (months 1 - 18); 2) intervention phase (months 19 - 21); and 3) post intervention observation phase (months 28 - 30). During extended follow-up the majority of patients (n = 21) received only one injection of epoetin zeta per week. During the intervention phase, injection frequency was increased to 3 injections per week in all patients accompanied by a reduction in weekly doses of approximately 20% - 30%. Following a 9 month period of dose adjustment all parameters were monitored again in the post-intervention phase. Results: During the first 18 months of epoetin zeta therapy the mean hemoglobin level was stable between 11 and 12 g/dl. The mean weekly dose of epoetin zeta was 7939 IU/week in month 6 and 7909 IU/week in month 18 (p = not significant). The mean frequency (injections/week) was 1.27 in month 6 and 1.29 in month 18 (not significant). Compared to month 18, at the end of the observation at month 30, hemoglobin levels were stable, mean injection frequency increased to 2.25 (p < 0.001) and the mean weekly dose decreased to 5469 IU/week (-31.7%, p < 0.001). Conclusions: Increasing the injection frequency of the short acting biosimilar epoetin zeta to two to three injections per week reduces the weekly dose and thereby the costs of ESA therapy of renal anemia significantly.

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G. Lonnemann and E. Wrenger, "Biosimilar Epoetin Zeta in Nephrology: Effect of Injection Frequency on Weekly Dose," International Journal of Clinical Medicine, Vol. 3 No. 7, 2012, pp. 598-602. doi: 10.4236/ijcm.2012.37108.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] C. Baldamus, S. Krivoshiev, M. Wolf-Pflugmann, M. Siebert-Weigel, R. Koytchev and A. Bronn, “Long-Term Safety and Tolerability of Epoetin Zeta, Administered Intravenously, for Maintenance Treatment of Renal Anemia,” Advances in Therapy, Vol. 25, No. 11, 2008, pp. 1215-1228. doi:10.1007/s12325-008-0111-1
[2] S. Krivoshiev, V. V. Todorov, J. Manitius, S. Czekalski, P. Scigalla and R. Koytchev, “Comparison of the Therapeutic Effects of Epoetin Zeta and Epoetin Alpha in the Correction of Renal Anaemia,” Current Medical Research and Opinion, Vol. 24, No. 5, 2008, pp. 1407-1415. doi:10.1185/030079908X297402
[3] H. Schellekens, “Assessing the Bioequivalence of Biosimilars the Retacrit Case,” Drug Discovery Today, Vol. 14, No. 9-10, 2009, pp. 495-499. doi:10.1016/j.drudis.2009.02.003
[4] V. Wizemann, B. Rutkowski, C. Baldamus, P. Scigalla and R. Koytchev, “Comparison of the Therapeutic Effects of Epoetin Zeta to Epoetin Alfa in the Maintenance Phase of Renal Anaemia Treatment,” Current Medical Research and Opinion, Vol. 24, No. 3, 2008, pp. 625-637. doi:10.1185/030079908X273264
[5] G. Lonnemann and E. Wrenger, “Biosimilar Epoetin Zeta in Nephrology—A Single-Dialysis Center Experience,” Clinical Nephrology, Vol. 75, No. 1, 2011, pp. 59-62.
[6] E. Orazi, “[Switch from Darbepoetin-Alpha to Epoetin- Alpha: Cost and Efficacy Comparison for Haemodialytic Patients over One Year Follow-Up in a Single Centre],” G Ital Nefrol, Vol. 25, No. 2, 2008, pp. 223-226.
[7] F. Ranchon, S. Hedoux, M. Laville, D. Fouque, E. Decullier, F. Chapuis and L. Huot, “[Direct Medical Cost of Eryt-hropoiesis-Stimulating Agents in Anaemia Treatment of Chronic Renal Failure Patient: A Literature Review],” Nephrologie & Therapeutique, Vol. 6, No. 2, 2010, pp. 97-104. doi:10.1016/j.nephro.2009.10.004
[8] D. Goldsmith, “2009: A Requiem for rHuEPOs--But Should We Nail down the Coffin in 2010?” inical Journal of the American Society of Nephrology, Vol. 5, No. 5, 2010, pp. 929-935. doi:10.2215/CJN.09131209
[9] X. Song, S. R. Long, W. D. Marder, S. D. Sullivan and J. Kallich, “The Impact of Methodological Approach on Cost Findings in Comparison of Epoetin Alfa with Darbepoetin Alfa,” Annals of Pharmacotherapy, Vol. 43, No. 7, 2009, pp. 1203-1210. doi:10.1345/aph.1L590

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