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.
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Roger Simon D, Wong Chew Ming, Vejakama Phisitt, Rahardjo Kuspudji Dwitanto, Hsu Bang-Gee, Lee Chang Meng, Wu I-Wen, Lee Chin-Chan, Situmorang Tunggul Diapari, Krisanapan Pajaree, Mazlan Sadanah Aqashiah, Peng Yu-Sen, Sarwono Johanes, De Asis Norman, Solimen Domingo, Jonny, Sangthawan Pornpen, Chen Jin-Bor, Wang Chia-Liang, Chung Sungjin, Villaflor Agnes Jeans, Yang Chul Woo, Kan Wei-Chih, Yang Yu, Rubio-Bicol Jenny, Yan Lee Yee, Lee Sang Ho, Chiu Yi-Wen, Chen Cheng-Hsu, Na Ki Young, Hassah Wan Hasnul Halimi Wan, Kang Young Sun, Choi Bum-Soon, Aquitania Grace, Na Ki Ryang, Wu Mai-Szu, Ahmad Mohd Kamil, Isidto Rey, Wu Vincent, Leong Goh Bak, Sung Junne-Ming, Noppakun Kajohnsak, Chou Kang-Ju, Abdul Wahab Mohamad Zaimi, Shin Seok Joon, Nugroho Pringgodigdo
Аннотация
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.