Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study
单位：[1]Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing 100730, China[2]Department of Rheumatology and Immunology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China[3]Department of Rheumatology, Changhai Hospital, Shanghai, China[4]Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China[5]Department of Rheumatology, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[6]Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, China[7]Department of Rheumatology, The First Affiliated Hospital of Kunming Medical University, Kunming, China昆明医科大学附属第一医院[8]Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China[9]Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China[10]Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China[11]Department of Rheumatology, Xiangya Hospital, Central South University, Changsha, China[12]Department of Rheumatology, Beijing Hospital, Beijing, China[13]Department of Rheumatology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China[14]Department of Rheumatology, The Second Xiangya Hospital of Central South University, Changsha, China[15]Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China[16]Department of Rheumatology, Peking University Third Hospital, Beijing, China[17]Department of Rheumatology, Tongji Hospital, Tongji Medical College of 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[18]Department of Rheumatology, Guangdong Second Provincial General Hospital, Guangzhou, China[19]Department of Rheumatology, The Third Hospital of Hebei Medical University, Shijiazhuang, China[20]Department of Rheumatology, Zhuzhou Central Hospital, Zhuzhou, China[21]Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China[22]Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China[23]Department of Rheumatology, Union Hospital, Tongji Medical College of 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[24]Department of Rheumatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China[25]Department of Rheumatology, Jiangsu Province Hospital, Nanjing, China江苏省人民医院[26]Department of Rheumatology, Peking University First Hospital, Beijing, China[27]Department of Rheumatology, Tianjin Medical University General Hospital, Tianjin, China[28]Department of Rheumatology, The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, China
Objective The equivalence of the biosimilar HS016 to adalimumab (Humira) for the treatment of active ankylosing spondylitis (AS) patients has been previously validated. The aim was to compare the efficacy of HS016 and adalimumab in stratified subgroups at different time points using Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) and short form 36 (SF-36) questionnaires. Methods We carried out a multicenter, randomized, double-blind, parallel, positive control, phase 3 trial of patients with active AS. They were selected randomly to be subcutaneously administered 40 mg HS016 or adalimumab every 2 weeks for a total treatment period of 24 weeks in a 2:1 ratio. A health surveys were used to assess mental and physical improvements of patients as well as other factors. Results HAQ-S revealed that changes in scores from baseline in both groups were time dependent until 14 weeks and that during the first 4 weeks of treatment the changes declined rapidly. The SF-36 health survey revealed that both HS016 and adalimumab produced rapid beneficial effects against AS during the first 2 weeks of therapy, which gradually declined between 2 and 12 weeks and flattened out after 12 weeks until 24 weeks. Conclusion This trial demonstrated that both HS016 and adalimumab produced rapid improvements in symptoms during the first 2 weeks of treatment. These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction.
基金：
Chinese National Key Technology R&D Program, Ministry of Science and Technology [2017YFC0907601]; Medicine and Health Technology Innovation Project, Chinese Academy of Medical Sciences [2019-I2M-2-008]; ZHEJIANG HISUN PHARMACEUTICAL CO., LTD.
第一作者单位：[1]Department of Rheumatology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Immunologic Diseases, Ministry of Science and Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, No. 1 Shuaifuyuan, Dongcheng District, Beijing 100730, China
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推荐引用方式(GB/T 7714)：
Su Jinmei,Li Mengtao,He Lan,et al.Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study[J].CLINICAL RHEUMATOLOGY.2022,41(3):731-739.doi:10.1007/s10067-021-05943-w.
APA：
Su Jinmei,Li Mengtao,He Lan,Zhao Dongbao,Wan Weiguo...&Zeng Xiaofeng.(2022).Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study.CLINICAL RHEUMATOLOGY,41,(3)
MLA：
Su Jinmei,et al."Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study".CLINICAL RHEUMATOLOGY 41..3(2022):731-739
