DSL-011 Efficacy and Safety of Epoetin Zeta in Dialysis Patients

Abstract

Background Anaemia in chronic kidney disease (CKD) remains one of the predictable and modifiable non-traditional cardiovascular risk factors. Epoetin zeta, which is a biosimilar product, is used in the treatment of anaemia associated with chronic kidney disease. Purpose This study was performed to evaluate the efficacy and safety of the biosimilar product epoetin zeta to maintain stable haemoglobin levels in dialysis patients. Materials and MethodsThis study was conducted in 2 dialysis centres with 33 patients. Before the study 30 of the 33 patients were on various erythropoiesis-stimulating agents (ESA). After a run-in period of 2 months, all patients were switched to epoetin zeta and were followed for 6 months. The initial weekly doses as well as the frequency of use per week were kept constant (1–3 times/week). During the follow-up, haemoglobin levels, iron status, dialysis efficiency, body weight and adverse events were monitored at least once a month. Results 33 patients were treated with biosimilar Epoetin zeta (27 men and 6 women); average age 59.1 (28–76) years; the frequency of used was 1–3 doses/week subcutaneously, over a period of 6 months. Dosing was to be adjusted to keep the Hb levels within 10.5–12 g/dl. Anaemia management and iron supplementation were at the discretion of the investigator and was to be in compliance with the current label. Throughout this study epoetin zeta was within the target range for Hb levels (10.5–11.5 g/dl ± 0.5 g/dl). The main AEs (adverse events) were in 1 patient hypotension (3%), in 1 patient in-dialyzer clotting (3%) and SAE (serious adverse event) was in 1 patient thrombosis of arteriovenous fistula (AVF) (3%). No anti-epoetin antibodies and no clinical signs of pure red cell aplasia (PRCA) were observed in any patients on the study. Conclusions Treatment of anaemia with Epoetin zeta was shown to be effective and safe. The mean Epoetin zeta doses remained stable in patients switched from all pre-study ESAs. The observed adverse events profile was in line with expectations for the study population. No conflict of interest.

Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility

“…Bajraktar et al81 evaluated the safety of epoetin zeta in 33 dialysis patients and reported that 3% of the patients develop hypotension, in-dialyzers clotting, or thrombosis of the arteriovenous fistula. Perani et al87 examined the immunological reaction of epoetin zeta in 12 patients with CKD.…”

“… 79 One German postmarketing surveillance study of IV administered epoetin zeta in 322 eligible elderly (age ≥75 years) patients from 40 centers showed epoetin zeta as effective at maintaining Hb levels with no significant difference in mean dose requirements or safety concerns. 80 A study by Bajraktar et al 81 assessing interchangeability switched 33 patients in two dialysis centers from various ESAs to epoetin zeta. The Bajraktar et al study reported that epoetin zeta maintained target Hb with equivalent mean dose, no PRCA, and a safety profile in line for the study population.…”

“…Eight studies reported the safety of epoetin zeta in patients with renal anemia. Of those, there are four clinical trials, 24 , 28 , 41 , 79 three observational studies, 76 , 81 , 87 and one post hoc analysis based on two clinical trials. 88 Table 4 summarizes the common adverse events observed in more than 5% of the patients in the four clinical trials.…”

“…Lonnemann and Wrenger’s 76 small clinical observational study assessing the use of epoetin zeta in ESRD reported 17 out of 18 patients as switching from various ESAs to epoetin zeta with no side effects after 6 months of epoetin zeta treatment. Bajraktar et al 81 evaluated the safety of epoetin zeta in 33 dialysis patients and reported that 3% of the patients develop hypotension, in-dialyzers clotting, or thrombosis of the arteriovenous fistula. Perani et al 87 examined the immunological reaction of epoetin zeta in 12 patients with CKD.…”

Clinical efficacy and safety of biosimilar epoetin: focus on epoetin zeta

“…Eight studies reported the safety of epoetin zeta in patients with renal anemia. Of those, there are four clinical trials, 9,10,16,18 three observational studies, 14,30,31 and one post-hoc analysis based on two clinical trials. 26 Again there was no reported cases of anti-epoetin antibodies or PRCA associated with the administration of epoetin zeta in these trials.…”