Comparative evaluation of the safety and efficacy of recombinant FVIII in severe hemophilia A patients
Journal of Pharmacopuncture.. 2018;21((2)):76-81.
Objective: This study compared the safety and efficacy of Safacto versus xyntha in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received Safacto and 16 patients received Xyntha for four consecutive times. The dosage of FVIII was 40-50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. Results: Plasma level of FVIII clotting activity in Safacto and Xyntha were 1.96+/-0.5 IU/dl and 1.63+/-0.5 IU/dl and increased to 88.84+/-25.2 IU/dl and 100.09+/-17.8 IU/dl, respectively (P<0.001). Pain score and range of motion improvement were 9.3+/-0.9 and 8.7+/-0.1 in Safacto (P=0.17); and 9.4+/-0.8 and 8.8+/-0.3 in Xyntha (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that Safacto has a favorable efficacy and safety profile.
Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients
Saudi Pharmaceutical Journal. 2015;23((5)):544-8.
BACKGROUND The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. OBJECTIVE The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin()) and compare it with the innovator product Eprex(), as a standard rHuEPO. METHODS One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57). Each study group received rHuEPO at a dose of 80-120 IU/kg/week in 2-3 divided doses for a period of 3 months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2 weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3 months. RESULTS A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p < 0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p > 0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups. CONCLUSION Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex.
Investigation of the efficacy of a biogeneric recombinant human erythropoietin alfa in the correction of post-transplantation anemia: a randomized comparative trial with Eprex
Clinical Laboratory. 2012;58((11-12):):1179-85.
BACKGROUND Recombinant 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). METHODS Fifty 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. RESULTS Serum 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). CONCLUSIONS Epolyrec 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.