Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial
Publication Date
5-1-2025
Document Type
Article
Publication Title
Nephrology
Abstract
Aim: Efepoetin alfa, a novel long-acting erythropoietin (EPO)-hybrid Fc fusion protein, represents a promising erythropoiesis-stimulating agent (ESA) for addressing anaemia in chronic kidney disease (CKD) patients. This Phase 3 trial was to assess the efficacy and tolerability of subcutaneous efepoetin alfa in comparison to subcutaneous methoxy polyethylene glycol-epoetin beta in stage 3 or 4 CKD patients. Methods: A randomised, multicentre, open-label Phase 3 trial enrolled 391 CKD stage 3 or stage 4 patients. Subjects underwent a 20-week correction period followed by an 8-week evaluation period. Responders continued treatment for an extra 24-week extension to evaluate long-term safety, maintenance effectiveness, and the longer treatment interval. Results: In the efepoetin alfa Q2W (every 2 weeks) group, the response rate was 75.6%; while in the methoxy polyethylene glycol-epoetin beta Q2W group, the response rate was 69.3%. The difference in the response rate was 6.3% with 95% CI (confidence interval) –3.1% to 15.5%. The lower limit of the 95% CI was above the prespecified non-inferiority margin of −9.0%. Adverse event rates were comparable between the treatment groups. Conclusion: Efepoetin alfa demonstrated non-inferiority to methoxy polyethylene glycol-epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels among stage 3 and 4 CKD patients. Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol-epoetin beta.
APA Citation
Roger, S.,
Wong, C.,
Vejakama, P.,
Rahardjo, K.,
Hsu, B.,
Lee, C.,
Wu, I.,
Lee, C.,
Situmorang, T.,
Krisanapan, P.,
Mazlan, S.,
Peng, Y.,
Sarwono, J.,
De Asis, N.,
Solimen, D.,
Jonny.,
Sangthawan, P.,
Chen, J.,
Wang, C.,
Chung, S.,
Villaflor, A.,
Yang, C.,
Kan, W.,
Yang, Y.,
Rubio-Bicol, J.,
Yan, L.,
Lee, S.,
Chiu, Y.,
Chen, C.,
Na, K.,
Hassah, W.,
Kang, Y.,
&
Choi, B.
(5-1-2025).
Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial.
Faculty Research and Scholarly Works.
DOI:10.1111/nep.70046