Fishbane S, et al. - In this 24-week, comparative, clinical trial, researchers compared intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa with respect to the safety and efficacy in patients on hemodialysis with ESKD and anemia. They found that the efficacy and safety displayed by epoetin alfa-epbx vs epoetin alfa were not different to an extent that can be considered as clinically meaningful.

Methods

• Researchers performed a 24-week, multicenter, double-blind comparative efficacy and safety study.
• Study participants were 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa.
• Participants were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx.
• According to the epoetin alfa prescribing information, they adjusted dosing.
• The least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment were coprimary efficacy end points.

Results

• Between epoetin alfa-epbx and epoetin alfa, the reported least squares mean difference in weekly hemoglobin was -0.12 g/dl and the 95% confidence interval (-0.25 to 0.01) was contained within the prespecified equivalence margin (-0.5 to 0.5 g/dl).
• They found that 0.37 U/kg per week was the least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight, and the 95% confidence interval (-10.40 to 11.13) was contained within the prespecified equivalence margin (-45 to 45 U/kg per week).
• Similar findings were reported between the epoetin alfa-epbx vs epoetin alfa groups with regards to the incidences of adverse events (77.1% vs 75.3%), serious adverse events (24.9% vs 27.0%), and deaths (n=5 vs 6).
• Data revealed that at baseline, five patients tested positive for anti-recombinant human erythropoietin antibodies.
• Wile on study treatment, the development of anti-recombinant human erythropoietin antibodies was reported in two additional patients (n=1 per group).
• They found that all patients tested negative for neutralizing antibodies.
• An event of pure red cell aplasia was not experienced by patients in either group.