In:
Medicine, Ovid Technologies (Wolters Kluwer Health), Vol. 101, No. 47 ( 2022-11-25), p. e31426-
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1536-5964
DOI:
10.1097/MD.0000000000031426
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2022
detail.hit.zdb_id:
2049818-4
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