Investigation of the Efficacy of a Biogeneric Recombinant Human Erythropoietin Alfa in the Correction of Post-Transplantation Anemia: A Randomized Comparative Trial with Eprex

Article

Author: Mohammad Torkaman ; Fatemeh Beiraghdar ; Eisa Tahmasbpour Marzony ; Romina Mohammadi ; Yunes Panahi ; Amirhossein Sahebkar ; Behzad Einollahi

BACKGROUNDRecombinant human erythropoietin is the cornerstone of therapy for anemia associated with chronic kidney disease or renal transplantation. However, it is not affordable and available for all patients. The present randomized double-blind trial compared the efficacy and safety of a biogeneric erythropoietin, Epolyrec, with the original product, Eprex, in correcting post-transplantation anemia (PTA).METHODSFifty patients who had undergone kidney transplantation surgery and had a hemoglobin level of < 11 g/L and a hematocrit of < 30% were recruited. These patients were randomly assigned to Epolyrec (n = 25) or Eprex (n = 25) at a dosage of 80 - 120 IU/kg body weight, three times/week. Patients were followed-up for two months unless they achieved the target levels for hemoglobin (1 g/L increase compared to baseline) and hematocrit (2 - 3% increase compared to baseline). Hemoglobin, hematocrit, and complete blood count with differential (CBC/DIFF) were evaluated at baseline and at months 1 and 2 of study. Other biochemical parameters were assessed at baseline and at the end of trial.RESULTSSerum hemoglobin and hematocrit progressively increased from baseline to month 2 in both Epolyrec (p = 0.001) and Eprex (p < 0.001) groups, with no significant difference between the groups (p > 0.05). Mean corpuscular hemoglobin (MCH) and platelet count showed a significant increase during the course of the trial in both Epolyrec (p = 0.041 and 0.004 for MCH and platelet count, respectively) and Eprex (p = 0.036 and 0.003) groups. However, no significant change was observed between the groups regarding erythrocyte count, mean corpuscular volume, white blood cell count or reticulocyte count from baseline to the end of trial in any of the groups (p > 0.05). The incidence of adverse events were generally low in both groups and without any significant difference between Epolyrec and Eprex (p > 0.05).CONCLUSIONSEpolyrec was equivalent to Eprex with respect to efficacy and safety. Hence, Epolyrec could represent a much more affordable and available biogeneric alternative to Eprex in correcting PTA.

01 Jan 2013·Clinical LaboratoryQ4 · MEDICINE

Investigation of the Efficacy of a Biogeneric Recombinant Human Erythropoietin Alfa in the Management of Renal Anemia in Patients on Hemodialysis: A Multi-center Clinical Trial

Q4 · MEDICINE

Article

Author: Sahebkar, Amirhossein ; Panahi, Yunes ; Beiraghdar, Fatemeh ; Ghadiani, Mohammad Hassan ; Einollahi, Behzad ; Nemati, Eghlim ; Maghsoudi, Nader ; Marzony, Eisa Tahmasbpour

BACKGROUNDRecombinant human erythropoietin (rHuEPO) is the cornerstone therapy for anemia associated with chronic kidney disease. However, not all patients with renal anemia receive sufficient doses of rHuEPO due to its high cost. The present trial aimed to evaluate the efficacy of Epolyrec, a biogeneric rHuEPO, in the management of renal anemia in patients on hemodialysis.METHODSSeventy-two patients with end stage renal disease (ESRD) who were receiving hemodialysis were assigned to receive Epolyrec subcutaneously at a dose of 40-80 IU/Kg in 2-3 divided doses after each dialysis session for 12 weeks. Hemoglobin, hematocrit, and CBC/DIFF together with biomarkers of iron status, renal function, and trace elements were evaluated at baseline and during the course of trial.RESULTSHemoglobin concentrations and hematocrit progressively increased from baseline (8.45 +/- 1.42 mg/dL and 27.05 +/- 4.64% for hemoglobin and hematocrit, respectively) to the end of trial (10.56 +/- 1.93 and 34.06 +/- 6.70) (p < 0.001). RBC count (p = 0.026), reticulocyte count (p = 0.045), and MCV (p < 0.001) were also significantly increased at the end of trial (3.86 +/- 0.91x10(6)/microL, 0.78 +/- 0.31%, and 93.50 +/- 10.90 fL for RBC count, reticulocyte count, and MCV, respectively) compared to baseline (0.98 +/- 3.38, 0.18 +/- 0.63, and 89.75 +/- 9.35). Serum iron and ferritin were decreased while creatinine and phosphorous increased by the end of trial. No significant change was observed in WBC count, RDW, MCH, MCHC, BUN, PTH, Na, Ca, K, and Mg (p > 0.05). The frequencies of evaluated side effects were generally low and < 10%.CONCLUSIONSEpolyrec is clinically efficacious in the elevation of hemoglobin and hematocrit in anemic ESRD patients receiving hemodialysis. Future comparative trials are warranted to compare the efficacy and safety of Epolyrec to those of innovator products.

100 Deals associated with Recombinant erythropoietin biosimilar(ReceptoPharm, Inc.)

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KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	DB00016

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Indication	Country/Location	Organization	Date
Anemia	IR	ReceptoPharm, Inc.	01 Jan 2015

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