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Changes in Efficacy Indicators for Adalimumab Biosimilar Candidate (HS016) for the Treatment of Active Ankylosing Spondylitis at Various Time Points(Open Access)

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机构： [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, Beijing, 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 [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 [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 [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 [24]Department of Rheumatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China [25]Department of Rheumatology, Jiangsu Province Hospital, Nanjing, China [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

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关键词： adalimumab ankylosing spondylitis HS016 phase III clinical trial subanalysis

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Objectives: A phase III, 24-weeks Chinese clinical trial demonstrated that efficacy and safety outcomes of treatments with 40 mg/0.8 ml HS016 (n = 416) or adalimumab (n = 232) for active ankylosing spondylitis (AS) patients was comparable. In the present study, a subanalysis of the clinical trial was conducted to determine whether also individual efficacy indicators were comparable between HS016 and adalimumab. Methods: The individual efficacy indicators total and nocturnal back pain, global assessment of disease activity, swollen joint count, Maastricht AS Enthesitis Score, Bath AS Disease Activity Index, Bath AS Functional Index, Bath AS Metrology Index and chest expansion, were assessed at baseline and every 2 weeks during the treatment period. Results: This subanalysis revealed no significant difference between the patient groups treated with HS016 or adalimumab for any individual efficacy indicator investigated at any time point (all p > 0.05) beside faster total back pain score improvements in the adalimumab group on week 10, 12 and 22, which became equal at week 24. Among these indicators, chest expansion showed a significant increase at each time point compared with baseline, whereas all other efficacy indicators showed significant decreases compared with baseline at each time point (all p < 0.05). All efficacy indicators had increased or decreased rapidly by week 2, and the values continued to increase/decrease up to week 12, with subsequent smaller changes thereafter up to week 24 of treatment. Conclusion: The response trajectory of most individual efficacy indicators was comparable between HS016 and adalimumab at each time point during the 24 weeks of the trial. Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=37910, identifier [ChiCTR1900022520] © Copyright © 2020 Su, Li, He, Zhao, Wan, Liu, Xu, Xu, Liu, Jiang, Wu, Zuo, Huang, Liu, Li, Zhang, Liu, Dong, Li, Chen, Li, He, Lu, Huang, Tao, Wang, Zhang, Wei, Li and Zeng.

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出版当年[2021]版：

大类 | 2 区医学

小类 | 2 区药学

最新[2023]版：

大类 | 2 区医学

小类 | 2 区药学

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出版当年[2020]版：

Q1 PHARMACOLOGY & PHARMACY

最新[2023]版：

Q1 PHARMACOLOGY & PHARMACY

影响因子： 4.4 最新[2023版] 5 最新五年平均 5.811 出版当年[2020版] 6.006 出版当年五年平均 4.225 出版前一年[2019版] 5.988 出版后一年[2021版]

第一作者：

第一作者机构： [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, Beijing, China

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Changes in Efficacy Indicators for Adalimumab Biosimilar Candidate (HS016) for the Treatment of Active Ankylosing Spondylitis at Various Time Points(Open Access)

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