单位：[1]Department of Rheumatology and Immunology, Changhai Hospital, Naval Medical University, Shanghai, China[2]Department of Rheumatology, Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China[3]Department of Rheumatology and Immunology, China-Japan Union Hospital of Jilin University, Changchun, Jilin Province, China吉林大学中日联谊医院[4]Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China[5]Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China四川大学华西医院[6]Department of Rheumatology, The First Affiliated Hospital of Air Force Medical University of PLA, Xi’an, Shaanxi Province, China[7]Department of Rheumatology and Immunology, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China[8]Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China[9]Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China[10]Department of Rheumatology and Immunology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China[11]Department of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, China[12]Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China[13]Department of Rheumatology, The First Hospital of China Medical University, Shenyang , Liaoning Province, China[14]Medical Department, R&D, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, Shanghai, China[15]Department of Rheumatology and Immunology, Chinese PLA General Hospital, Beijing, China
Introduction The aim of this work is to examine the efficacy and safety of prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu in active ankylosing spondylitis (AS) patients. Methods This double-blind, phase III trial with non-inferiority design randomized adult patients with active AS in a 3:1:1 ratio to receive twice-weekly 25-mg prefilled liquid Yisaipu for a total of 48 injections (group I, n = 330), once-weekly 50-mg prefilled liquid Yisaipu for 24 injections (group II, n = 110), or twice-weekly 25-mg lyophilized Yisaipu for 48 injections (group III, n = 110). Both physicians and patients who received 25-mg twice-weekly lyophilized or liquid Yisaipu were blinded to treatment assignment while patients who received 50-mg once-weekly liquid Yisaipu received treatment in an open-label design. In addition, 90 patients in the PK/PD study were randomized in a 1:1:1 ratio to each group. The primary outcome was the proportion of patients who achieved ASAS20 at week 24. Results A total of 640 subjects were enrolled. The proportion of patients who attained ASAS20 at week 24 was 85.56% in group I, 85.71% in group II, and 83.45% in group III (group I vs. III, P = 0.545; group II vs. III, P = 0.605). The difference between group I and III was 2.10% (95% CI - 5.06%, 9.27%) and 2.26% (95% CI - 6.21%, 10.73%) between group II and III, meeting the non-inferiority threshold (Delta = - 15%) (P < 0.001). Except for a statistical difference between group I (75.83%) and group III at week 8 (64.75%, P = 0.011), there was no statistical difference in the ASAS20 attainment rate among the three groups at other time points. The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05). No deaths were reported. Conclusions Once-weekly 50-mg or twice-weekly 25-mg prefilled liquid Yisaipu is safe and non-inferior to twice-weekly 25-mg lyophilized Yisaipu.
第一作者单位：[1]Department of Rheumatology and Immunology, Changhai Hospital, Naval Medical University, Shanghai, China
通讯作者：
推荐引用方式(GB/T 7714)：
Dongbao Zhao,Dongyi He,Liqi Bi,et al.Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial[J].RHEUMATOLOGY and THERAPY.2021,8(1):361-374.doi:10.1007/s40744-021-00276-1.
APA：
Dongbao Zhao,Dongyi He,Liqi Bi,Huaxiang Wu,Yi Liu...&Feng Huang.(2021).Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial.RHEUMATOLOGY and THERAPY,8,(1)
MLA：
Dongbao Zhao,et al."Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial".RHEUMATOLOGY and THERAPY 8..1(2021):361-374
