TITLE:
Biosimilar Epoetin Zeta in Nephrology: Effect of Injection Frequency on Weekly Dose
AUTHORS:
Gerhard Lonnemann, Eike Wrenger
KEYWORDS:
Epoetin Zeta; Renal Anemia; Drug Efficiency; Injection Frequency; Chronic Hemodialysis
JOURNAL NAME:
International Journal of Clinical Medicine,
Vol.3 No.7,
December
31,
2012
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
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.