1. Home
  2. Vol 51, No 3 (2019)
  3. Hustrini

Clinical Comparison of Renogen, a Biosimilar Epoetin-a, with the Originator, Eprex, in Chronic Kidney Disease Anemia in Indonesia: A Preliminary Study

Ni Made Hustrini, Parlindungan Siregar, Arini Setiawati, Pringgodigdo Nugroho

Abstract


Background: treatment of erythropoietin (EPO) is essential in chronic kidney disease (CKD) patients to maintain optimal hemoglobin (Hb) level. Renogen is a biosimilar epoetin-α, and Eprex is the originator epoetin-α. This study aimed to compare the efficacy and tolerance of Renogen with Eprex in CKD anemia. Methods: Renogen and Eprex were compared in a randomized (2:1), open-label study for 8 weeks, proceeded by 4 weeks adjustment (maintenance) phase, in anemic CKD patients undergoing HD in Cipto Mangunkusumo General Hospital, Jakarta, from June 2017 to October 2018. Results: a total of 45 patients (31 received biosimilar EPO and 14 received originator EPO) were included in the study.  At baseline, mean (SD) Hb levels were 10.9 (0.74) g/dL and 10.9 (0.61) g/dL in biosimilar and originator EPO groups, respectively. At end of study (8 weeks), mean (SD) Hb levels were 10.5 (1.28) g/dL and 11.0 (1.13) g/dL in biosimilar EPO and originator EPO groups, respectively.  The proportion of patients with Hb levels maintained within the target range (>10 g/dL) during 8 weeks randomization phase were 58.1% and 71.4% in biosimilar EPO and originator EPO, respectively (p=0.60; NS). There were no significant difference in epoetin dose between the 2 groups, and there was no drug-related adverse event in either group. Conclusion: Hb level at >10 g/dL could be maintained for 8 weeks of treatment with both originator and biosimilar EPO (more consistent with originator EPO and more fluctuations with biosimilar EPO), with similar epoetin dose and no drug-related adverse event.


Keywords


renal anemia; erythropoietin; biosimilar; hemodialysis

References


Beiraghdar F, Panahi Y, Einollahi B, et al. Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients. Saudi Pharm J. 2015; 23(5): 544-8.

Harzallah A, Zouaghi K, Dridi A, et al. Therapeutic Efficacy of a biosimilar epoetin alfa in hemodialysis patients. Saudi J Kidney Dis Transpl. 2015;26(1):78-82.

NCPC (North China Pharmaceutical) International Corp. Featured products. 2018.

Locatelli F, Pisoni RL, Combe C, et al. Anemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol. Dial. Transplant. 2004;19:121-32.

Schmid H, Schiffl H. Erythropoiesis stimulating agents and anaemia of end-stage renal disease. Cardiovasc Hematol Agents Med Chem. 2010;8(3):164-72.

Shahani S, Braga-Basaria M, Maggio M, Basaria S. Androgens and erythropoiesis: past and present. J Endocrinol Invest. 2009;32:704-16.

Goh BL, Ong LM, Sivanandam S, Lim TO, Morad Z. Randomized trial on the therapeutic equivalence between Eprex and GerEpo in patients on haemodialysis. Nephrol. 2007;12:431-6.

Baltar J, Moran N, Ortega F, Rebollo P, Cofan F, Campistol JM. Erythropoietin safety and efficacy in chronic allograft nephropathy. Transpl Proc. 2007;39:2245-7.

London G, Mann J, Goldsmith D, et al. Long term treatment with biosimilar epoetin-a (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study. Clinical Nephrology. 2018;89(1):1-9.

Stoppa G, D’Amore C, Conforti A, et al. Comparative safety of originator and biosimilar epoetin alfa drugs: an observational prospective multicenter study. Bio Drugs. 2018;32:367-75.


Full Text: PDF

Refbacks

  • There are currently no refbacks.