Biosimilar erythropoietin in anemia treatment (BEAT)—Efficacy and safety of a 1:1 dose conversion from EPREX(®) to EPIAO(®) in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study

EPREX(®)/ERYPO(®)/PROCRIT(®) (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO(®) is a biosimilar formulation of EPREX(®), and making it a 1:1 dose conversion from EPREX(®) according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO(®) in subjects with end-stage renal disease receiving hemodialysis after intravenous administration. METHODS: This study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX(®) to EPIAO(®) in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX(®) (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX(®) or EPIAO(®). Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO(®)/EPREX(®) in parallel groups. RESULTS: A total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO(®) or EPREX(®), there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO(®) and EPREX(®) groups. Most adverse events were mild to moderate and were reverted/resolved. CONCLUSION: EPIAO(®) demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis.