Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study
机构：[1]Department of Dermatology, Peking University People’s Hospital, No. 11 Xizhimen South Avenue, Beijing 100044, China[2]Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[3]Department of Dermatology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China[4]Department of Dermatology, Shanghai Skin Disease Hospital, Shanghai, China[5]Department of Dermatology, Liaoning Provincial People’s Hospital, Shenyang, China[6]Department of Dermatology, General Hospital of Shenyang Military Region, Shenyang, China[7]Department of Dermatology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China[8]Department of Dermatology, Tianjin Medical University General Hospital, Tianjin, China[9]Department of Dermatology, The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, China浙江大学医学院附属第一医院[10]Department of Dermatology, The First Affiliated Hospital of Dalian Medical University, Dalian, China大连医科大学附属第一医院[11]Department of Dermatology, Jiangsu Provincial People’s Hospital, Nanjing, China[12]Department of Dermatology, The First Hospital of Jilin University, Changchun, China[13]Department of Dermatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China中山大学附属第二医院[14]Department of Dermatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[15]Department of Dermatology, The First Affiliated Hospital of Kunming Medical University, Kunming, China内科科室皮肤科昆明医科大学附属第一医院[16]Department of Dermatology, Changhai Hospital, Shanghai, China[17]Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China[18]Department of Dermatology, Shengjing Hospital, China Medical University, Shenyang, China中国医科大学附属盛京医院[19]Department of Dermatology, The First Hospital of China Medical University, Shenyang, China[20]Department of Dermatology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China[21]Department of Dermatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[22]Shanghai Henlius Biotech, Inc., Shanghai, China
Introduction: Adalimumab has been used successfully in the treatment of psoriasis. The objective of the study is to compare the efficacy, safety, and immunogenicity between HLX03, an adalimumab biosimilar, and adalimumab in Chinese patients with moderate-to-severe plaque psoriasis. Methods: In this double-blind, active-controlled, parallel-group study, 262 patients with moderate-to-severe plaque psoriasis were randomized (1:1) to receive HLX03 or adalimumab (80 mg at week 1, 40 mg at week 2, and then 40 mg every 2 weeks) for 48 weeks. The primary endpoint was improvement in Psoriasis Area and Severity Index (PASI) score at week 16 comparing to baseline. Equivalence was demonstrated if 95% confidence interval (CI) of the between group difference fell within the equivalence margins of +/- 15%. Other efficacy endpoints, safety and immunogenicity were also evaluated. Results: In the full analysis set, PASI improvements at week 16 was 83.5% (n = 131) in the HLX03 group and 82.0% (n = 130) in the adalimumab group, with a least-square-mean difference of 1.5% (95% CI - 3.9% to 6.8%). There were no significant between-group differences in all secondary efficacy analyses including proportion of patients achieving >= 75% improvement from baseline PASI (PASI 75), physician global assessment (PGA) 0/1 (clear or almost clear) and change in dermatology life quality index (DLQI) score. The incidences of adverse events and the proportion of patients with antidrug antibodies were also comparable between the two treatment groups. Conclusion: HLX03 demonstrated equivalent efficacy, similar safety and immunogenicity to reference adalimumab, supporting its development as an alternative treatment for patients with plaque psoriasis in China.
基金：
Shanghai Henlius Biotech, Inc., Shanghai, China; Shanghai Henlius Biotech, Inc.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类|3 区医学
小类|3 区医学：研究与实验3 区药学
最新[2023]版：
大类|3 区医学
小类|3 区医学：研究与实验3 区药学
JCR分区：
出版当年[2022]版：
Q2PHARMACOLOGY & PHARMACYQ3MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q2MEDICINE, RESEARCH & EXPERIMENTALQ2PHARMACOLOGY & PHARMACY
第一作者机构：[1]Department of Dermatology, Peking University People’s Hospital, No. 11 Xizhimen South Avenue, Beijing 100044, China
通讯作者：
推荐引用方式(GB/T 7714)：
Lin Cai,Linfeng Li,Hao Cheng,et al.Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study[J].ADVANCES IN THERAPY.2022,39(1):583-597.doi:10.1007/s12325-021-01899-0.
APA：
Lin Cai,Linfeng Li,Hao Cheng,Yangfeng Ding,Zhenshu Biao...&Jianzhong Zhang.(2022).Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study.ADVANCES IN THERAPY,39,(1)
MLA：
Lin Cai,et al."Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study".ADVANCES IN THERAPY 39..1(2022):583-597
