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

Issued Date

2022-11-25

Resource Type

Review

ISSN

00257974

eISSN

15365964

DOI

10.1097/MD.0000000000031426

Scopus ID

2-s2.0-85143103081

Pubmed ID

36451454

Journal Title

Medicine (United States)

Volume

101

Issue

47

Rights Holder(s)

SCOPUS

Bibliographic Citation

Medicine (United States) Vol.101 No.47 (2022) , E31426

Suggested Citation

Miao B., Isachkina A.N., Shutov E.V., Selyutin A.A., Kvitkova L.V., Shilo V.Y., Vetchinnikova O.N., Alexandrov I.V., Perlin D.V., Zuev A.V., Davydkin I.L., Mironova T.P., Solovyova O.M., Tutin A.P., Omelchenko A.M., Vareesangthip K., Khadikova N.G., Li M., Li X. Biosimilar erythropoietin in anemia treatment (BEAT) - Efficacy and safety of a 1:1 dose conversion from EPREX<sup>®</sup>to EPIAO<sup>®</sup>in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study. Medicine (United States) Vol.101 No.47 (2022) , E31426. doi:10.1097/MD.0000000000031426 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/85368

Title

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

Author(s)

Miao B.
 Isachkina A.N.
 Shutov E.V.
 Selyutin A.A.
 Kvitkova L.V.
 Shilo V.Y.
 Vetchinnikova O.N.
 Alexandrov I.V.
 Perlin D.V.
 Zuev A.V.
 Davydkin I.L.
 Mironova T.P.
 Solovyova O.M.
 Tutin A.P.
 Omelchenko A.M.
 Vareesangthip K.
 Khadikova N.G.
 Li M.
 Li X.

Author's Affiliation

Siriraj Hospital
 Moscow Regional Research and Clinical Institute
 Pavlov University
 Samara State Medical University
 State Budgetary Healthcare Institution of the Republic of Karelia v.A. Baranov Republican Hospital
 Limited Liability Company "kupchinski Tsentr Ambulatornogo Dializa"
 State-financed Health Institution "municipal Clinical Hospital No. 1" of Orenburg
 St. Petersburg Budgetary Public Health Care Institution "nikolayevsky Hospital"
 Saint Petersburg State-financed Health Institution "municipal Mariinsky Hospital"
 Limited Liability Company "MEDITSYNSKY TSENTR VYSOKIKH TEKHNOLOGYII POLIKLINIKA No. 1 (Medical Center of High Technologies Policlinic No. 1"
 Ltd.
 Saint Petersburg State Budget Institution of Healthcare city Hospital of Saint Martyr Elizabeth
 State Budgetary Healthcare Institution of the city of Moscow City Clinical Hospital named after S.P. Botkin of Moscow City Healthcare Department
 Ltd.
 Autonomous Public Health Care Institution in the Kemerov region "S.V. Belyaev Kemerovo Regional Clinical Hospital
 Volgograd Regional Center of Urology and Nephrology

Other Contributor(s)

Mahidol University

Abstract

Background: 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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/85368

Collections

Scopus 2022