高级检索
当前位置: 首页 > 详情页

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

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

单位: [1]Peking Union Med Coll & Chinese Acad Med Sci, Key Lab Rheumatol & Clin Immunol, Natl Clin Res Ctr Immunol Dis,Dept Rheumatol, Peking Union Med Coll Hosp,Minist Sci & Technol,M, Beijing, Peoples R China [2]Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Rheumatol & Immunol, 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, Affiliated Hosp 1, Dept Rheumatol, Hefei, Peoples R China [7]Kunming Med Univ, Affiliated Hosp 1, Dept Rheumatol, Kunming, Yunnan, Peoples R China [8]Shandong Univ, Qilu Hosp, Dept Rheumatol, Jinan, Peoples R China [9]Fudan Univ, Zhongshan Hosp, Dept Rheumatol, Shanghai, Peoples R China [10]Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Rheumatol, 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, Affiliated Hosp 1, Dept Rheumatol, Taiyuan, Peoples R China [14]Cent South Univ, Xiangya Hosp 2, Dept Rheumatol, Changsha, Peoples R China [15]Harbin Med Univ, Affiliated Hosp 1, Dept Rheumatol, Harbin, Peoples R China [16]Peking Univ Third Hosp, Dept Rheumatol, Beijing, Peoples R China [17]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Rheumatol, Wuhan, Peoples R China [18]Guangdong Second Prov Gen Hosp, Dept Rheumatol, Guangzhou, Peoples R China [19]Hebei Med Univ, Hosp 3, Dept Rheumatol, 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, Tongji Med Coll, Union Hosp, Dept Rheumatol, Wuhan, Peoples R China [24]Guangzhou Med Univ, Affiliated Hosp 2, Dept Rheumatol, 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, Affiliated Hosp 2, Dept Rheumatol, Taiyuan, Peoples R China
出处:
ISSN:

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

摘要:
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.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2019]版:
大类 | 2 区 医学
小类 | 2 区 药学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 药学
JCR分区:
出版当年[2018]版:
Q1 PHARMACOLOGY & PHARMACY
最新[2024]版:
Q1 PHARMACOLOGY & PHARMACY

影响因子: 最新[2024版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

第一作者:
第一作者单位: [1]Peking Union Med Coll & Chinese Acad Med Sci, Key Lab Rheumatol & Clin Immunol, Natl Clin Res Ctr Immunol Dis,Dept Rheumatol, Peking Union Med Coll Hosp,Minist Sci & Technol,M, Beijing, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:622 今日访问量:0 总访问量:452 更新日期:2025-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)