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.
Efepoetin alfa showed a 6.3% higher response rate compared to methoxy polyethylene glycol-epoetin beta in correcting anemia in CKD patients, but the clinical significance of this difference is uncertain.
Where it sits
this study against the rest of the erythropoietin (epo) corpusSummary and findings
This Phase 3 trial evaluated the efficacy and tolerability of subcutaneous efepoetin alfa compared to methoxy polyethylene glycol-epoetin beta in 391 stage 3 or 4 CKD patients. The response rate for efepoetin alfa was 75.6%, while it was 69.3% for methoxy polyethylene glycol-epoetin beta. The study found non-inferiority of efepoetin alfa with a difference in response rates of 6.3%.
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.
Background
Not reported in abstract.
Methods
Not reported in abstract.
Results
Not reported in abstract.
Interpretation
Not reported in abstract.
Limitations
Not reported in abstract.