Efficacy, safety, and immunogenicity of UB-851 versus Eprex® in patients with renal anemia receiving hemodialysis: A randomized, double-masked, phase III trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Anemia is a common complication in patients with chronic kidney disease (CKD), for which recombinant human erythropoietin (rhEPO) is the standard treatment. UB-851 is a biosimilar rhEPO developed as an alternative to epoetin alfa (Eprex ® ). This study evaluated the clinical equivalence, safety, and immunogenicity of UB-851 compared with epoetin alfa in patients with anemia due to CKD receiving hemodialysis. METHODS: In this 52-week, multicenter, randomized, parallel-group, phase III trial, patients with anemic CKD undergoing maintenance hemodialysis were assigned to receive either UB-851 or epoetin alfa. Part I (weeks 1-24) included dose titration and hemoglobin (Hb) maintenance. Part II (weeks 25-52) focused on long-term safety and immunogenicity. The primary endpoint was the change in Hb levels from baseline to the efficacy evaluation period (weeks 21-24). The secondary endpoints included epoetin dose, adverse events (AEs), and anti-drug antibody formation. RESULTS: A total of 201 participants were randomized, and the mean change in Hb levels during the efficacy period was within the predefined equivalence margin (±0.6 g/dL) in both the intention-to-treat and per-protocol populations. Differences in weekly epoetin dose changes between the groups also fell within the predefined equivalence range (±45 IU/kg/wk). No significant differences were observed in the laboratory parameters, electrocardiograms, or vital signs. No anti-epoetin antibodies were detected in the UB-851 group. Regarding AEs, the UB-851 appears to be biosimilar to epoetin alfa. CONCLUSION: UB-851 demonstrated clinical equivalence with epoetin alfa in maintaining Hb levels in patients with anemic CKD undergoing hemodialysis. The safety and immunogenicity profiles were comparable, supporting UB-851 as a biosimilar to epoetin alfa.
Authors: Chien-Hsing Wu, Chih-Chung Shiao, Hsien-Yi Wang, Ya-Chung Tian, Yi-Wen Chiu, Wen-Hung Huang, Shin-Hung Tsai, Hua-Chang Fang, Chin-Chan Lee, Bang-Gee Hsu, Horng-Rong Chang, Chien-Yu Lin, Chee-Hong Chan, Wei-Jie Wang, Kuo-Ching Huang, Szu-Chia Chen, Chia-Liang Wang, Chung-Yu Huang, Der-Cherng Tarng
Institutions: Kaohsiung Chang Gung Memorial Hospital, Cheng Shiu University, Saint Mary's Hospital Luodong, Chi Mei Medical Center, Chia Nan University of Pharmacy and Science, Chang Gung Memorial Hospital, Taoyuan Chang Gung Memorial Hospital, Linkou Chang Gung Memorial Hospital, Kaohsiung Medical University, Kaohsiung Medical University Chung-Ho Memorial Hospital, Cheng Hsin General Hospital, Kaohsiung Veterans General Hospital, Keelung Chang Gung Memorial Hospital, Tzu Chi Foundation, Hualien Tzu Chi Medical Center, Chung Shan Medical University Hospital, Chung Shan Medical University, En Chu Kong Hospital, Chang Bing Show Chwan Memorial Hospital, Tao Yuan General Hospital, Ministry of Health and Welfare, Kaohsiung Municipal Hsiao-Kang Hospital, Kuang Tien General Hospital, National Yang Ming Chiao Tung University, Taipei Veterans General Hospital
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4417333464