ESA Biosimilar Effective for Anemia in Hemodialysis Patients
For hemodialysis (HD) patients with anemia, the biosimilar erythropoiesis-stimulating agent (ESA) epoetin alfa-epbx appears to be as safe and effective as epoetin alfa over the short term, according to new study findings.
In a multicenter, double-blind study, Steven Fishbane, MD, of Hofstra Northwell School of Medicine in Hempstead, New York, and colleagues randomly assigned 612 HD patients with stable hemoglobin levels, adequate dialysis, and sufficient iron stores who were receiving intravenous epoetin alfa to continue on epoetin alfa or switch to epoetin alfa-epbx for 24 weeks. Drug dosing was adjusted during the treatment period.
According to an online report in the Clinical Journal of the American Society of Nephrology, the least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin over the trial period was -0.12 g/dL – within the prespecified equivalence margin of -0.5 to 0.5 g/dL. The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week – within the prespecified equivalence margin of -45 to 45 U/kg per week. These margins were established based on previous studies.
Adverse events occurred in 77.1% vs 75.3% of epoetin alfa-epbx and epoetin alfa recipients, respectively. Serious adverse events occurred in 24.9% vs 27.0% and deaths in 5 vs 6, respectively. These differences were considered minor. During the trial 5 patients at baseline and 1 patient per group tested positive for anti-recombinant human erythropoietin antibodies. However, none of the patients had neutralizing antibodies or pure red cell aplasia.
"The results of this study demonstrating no clinically meaningful differences in efficacy and safety between epoetin alfa-epbx and epoetin alfa support the opportunity to expand the benefits of erythropoietin therapy to more patients at a lower overall cost," concluded the authors.
This study was funded by Hospira Inc., a subsidiary of Pfizer Inc., which markets epoetin alfa-epbx (Retacrit).
Fishbane S, Singh B, Kumbhat S, et al. Intravenous epoetin alfa-epbx versus epoetin alfa for treatment of anemia in end-stage kidney disease. Clin J Am Soc Nephrol. doi: 10.2215/CJN.11631017