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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

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单位: [1]Peking Union Med Coll & Chinese Acad Med Sci, Peking Union Med Coll Hosp, Natl Clin Res Ctr Immunol Dis,Minist Educ, Dept Rheumatol,Minist Sci & Technol,Key Lab Rheum, 1 Shuaifuyuan, Beijing 100730, Peoples R China [2]Xi An Jiao Tong Univ, Dept Rheumatol & Immunol, Affiliated Hosp 1, Xian, Peoples R China [3]Changhai Hosp, Dept Rheumatol, Shanghai, Peoples R China [4]Fudan Univ, Huashan Hosp, Dept Rheumatol, Shanghai, Peoples R China [5]Sichuan Univ, West China Hosp, Dept Rheumatol, Chengdu, Peoples R China [6]Anhui Med Univ, Dept Rheumatol, Affiliated Hosp 1, Hefei, Peoples R China [7]Kunming Med Univ, Dept Rheumatol, Affiliated Hosp 1, Kunming, Yunnan, Peoples R China [8]Shandong Univ, Dept Rheumatol, Qilu Hosp, Jinan, Peoples R China [9]Fudan Univ, Zhongshan Hosp, Dept Rheumatol, Shanghai, Peoples R China [10]Zhejiang Univ, Dept Rheumatol, Sch Med, Affiliated Hosp 2, Hangzhou, Peoples R China [11]Cent South Univ, Xiangya Hosp, Dept Rheumatol, Changsha, Peoples R China [12]Beijing Hosp, Dept Rheumatol, Beijing, Peoples R China [13]Shanxi Med Univ, Dept Rheumatol, Affiliated Hosp 1, Taiyuan, Peoples R China [14]Cent South Univ, Dept Rheumatol, Xiangya Hosp 2, Changsha, Peoples R China [15]Harbin Med Univ, Dept Rheumatol, Affiliated Hosp 1, Harbin, Peoples R China [16]Peking Univ Third Hosp, Dept Rheumatol, Beijing, Peoples R China [17]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Rheumatol, Tongji Med Coll, Wuhan, Peoples R China [18]Guangdong Second Prov Gen Hosp, Dept Rheumatol, Guangzhou, Peoples R China [19]Hebei Med Univ, Dept Rheumatol, Hosp 3, Shijiazhuang, Hebei, Peoples R China [20]Zhuzhou Cent Hosp, Dept Rheumatol, Zhuzhou, Peoples R China [21]Shanghai Guanghua Hosp Integrated Tradit Chinese, Dept Rheumatol, Shanghai, Peoples R China [22]China Japan Friendship Hosp, Dept Rheumatol, Beijing, Peoples R China [23]Huazhong Univ Sci & Technol, Union Hosp, Dept Rheumatol, Tongji Med Coll, Wuhan, Peoples R China [24]Guangzhou Med Univ, Dept Rheumatol, Affiliated Hosp 2, Guangzhou, Peoples R China [25]Jiangsu Prov Hosp, Dept Rheumatol, Nanjing, Peoples R China [26]Peking Univ First Hosp, Dept Rheumatol, Beijing, Peoples R China [27]Tianjin Med Univ Gen Hosp, Dept Rheumatol, Tianjin, Peoples R China [28]Shanxi Med Univ, Dept Rheumatol, Affiliated Hosp 2, Taiyuan, Peoples R China
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关键词: Adalimumab Ankylosing spondylitis Biosimilar HS016

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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.

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 4 区 风湿病学
最新[2025]版:
大类 | 3 区 医学
小类 | 4 区 风湿病学
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出版当年[2020]版:
Q3 RHEUMATOLOGY
最新[2023]版:
Q2 RHEUMATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

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第一作者单位: [1]Peking Union Med Coll & Chinese Acad Med Sci, Peking Union Med Coll Hosp, Natl Clin Res Ctr Immunol Dis,Minist Educ, Dept Rheumatol,Minist Sci & Technol,Key Lab Rheum, 1 Shuaifuyuan, Beijing 100730, Peoples R China
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