Comparative efficacy and safety of biosimilar darbepoetin alfa in adults with anemia of chronic kidney disease

Abstract

Introduction: The present study compared the efficacy, safety, and immunogenicity of the biosimilar darbepoetin alfa to the reference innovator darbepoetin alfa in the treatment of anemia in chronic kidney disease (CKD) patients. Materials and Methods: Out of 140 randomized individuals, 107 individuals were administered biosimilar darbepoetin alfa (study arm) and 33 individuals received reference innovator darbepoetin alfa (reference arm). Primary objective evaluated was hemoglobin responder rate for individuals achieving >1 g/dL rise in Hb from baseline to week 8. The secondary objectives were proportion of individuals achieving rise in hemoglobin (>1 g/dL rise from baseline) at week 24 to assess the proportion of individuals maintaining mean Hb within target range and evaluation of safety. Results: The hemoglobin responder rate for individuals achieving >1 g/dL rise in Hb from baseline to week 8 was similar in both the study and reference arms (56 [62.92%] and 22 [70.97%]). Overall, 86.27% individuals treated with biosimilar darbepoetin alfa achieved hemoglobin rise >1 g/dl as compared to 86.67% individuals in the reference darbepoetin arm at 24 weeks. Individuals maintaining Hb value within the target range at the end of week 24 were also similar in both the arms (60.80% and 60.00% in study and reference arms, respectively). There were 147 treatment emergent adverse events (34.58% in the study arm and 42.42% in the reference arm). Conclusion: The biosimilar darbepoetin alfa (DarbeRelTM) showed clinical biosimilarity to reference innovator darbepoetin alfa in anemia of CKD.

Keywords

• Anemia
• chronic kidney disease
• darbepoetin alfa
• hemoglobin