| Title | Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial |
| Authors | Su, Jinmei Li, Mengtao He, Lan Zhao, Dongbao Wan, Weiguo Liu, Yi Xu, Jianhua Xu, Jian Liu, Huaxiang Jiang, Lindi Wu, Huaxiang Zuo, Xiaoxia Huang, Cibo Liu, Xiumei Li, Fen Zhang, Zhiyi Liu, Xiangyuan Dong, Lingli Li, Tianwang Chen, Haiying Li, Jingyang He, Dongyi Lu, Xin Huang, Anbin Tao, Yi Wang, Yanyan Zhang, Zhuoli Wei, Wei Li, Xiaofeng Zeng, Xiaofeng |
| Affiliation | Peking Union Med Coll & Chinese Acad Med Sci, Dept Rheumatol, Peking Union Med Coll Hosp, 1 Shuaifuyuan, Beijing 100730, Peoples R China Minist Sci & Technol, Natl Clin Res Ctr Immunol Dis, 1 Shuaifuyuan, Beijing 100730, Peoples R China Minist Educ, Key Lab Rheumatol & Clin Immunol, 1 Shuaifuyuan, Beijing 100730, Peoples R China Xi An Jiao Tong Univ, Dept Rheumatol & Immunol, Affiliated Hosp 1, Xian 710061, Peoples R China Changhai Hosp, Dept Rheumatol, Shanghai 200433, Peoples R China Fudan Univ, Huashan Hosp, Dept Rheumatol, Shanghai 201907, Peoples R China Sichuan Univ, West China Hosp, Dept Rheumatol, Chengdu 610000, Peoples R China Anhui Med Univ, Dept Rheumatol, Affiliated Hosp 1, Hefei 230001, Peoples R China Kunming Med Univ, Affiliated Hosp 1, Dept Rheumatol, Kunming 650032, Yunnan, Peoples R China Shandong Univ, Dept Rheumatol, Qilu Hosp, Jinan 250001, Peoples R China Fudan Univ, Zhongshan Hosp, Dept Rheumatol, Shanghai 200032, Peoples R China Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Rheumatol, Hangzhou 310009, Peoples R China Cent South Univ, Xiangya Hosp, Dept Rheumatol, Changsha 410008, Peoples R China Beijing Hosp, Dept Rheumatol, Beijing 100010, Peoples R China Shanxi Med Univ, Dept Rheumatol, Affiliated Hosp 1, Taiyuan 30001, Peoples R China Cent South Univ, Dept Rheumatol, Xiangya Hosp 2, Changsha 410007, Peoples R China Harbin Med Univ, Dept Rheumatol, Affiliated Hosp 1, Harbin 150001, Peoples R China Peking Univ, Hosp 3, Dept Rheumatol, Beijing 100089, Peoples R China Huazhong Univ Sci & Technol, Dept Rheumatol, Tongji Hosp, Tongji Med Coll, Wuhan 430030, Peoples R China Guangdong Second Prov Gen Hosp, Dept Rheumatol, Guangzhou 510310, Peoples R China Hebei Med Univ, Hosp 3, Dept Rheumatol, Shijiazhuang 050000, Hebei, Peoples R China Zhuzhou Cent Hosp, Dept Rheumatol, Zhuzhou 412000, Peoples R China Shanghai Guanghua Hosp Integrated Tradit Chinese, Dept Rheumatol, Shanghai 200052, Peoples R China China Japan Friendship Hosp, Dept Rheumatol, Beijing 100020, Peoples R China Huazhong Univ Sci & Technol, Dept Rheumatol, Union Hosp, Tongji Med Coll, Wuhan 430022, Peoples R China Guangzhou Med Univ, Dept Rheumatol, Affiliated Hosp 2, Guangzhou 510260, Peoples R China Jiangsu Prov Hosp, Dept Rheumatol, Nanjing 210000, Peoples R China Peking Univ, Hosp 1, Dept Rheumatol, Beijing 100034, Peoples R China Tianjian Med Univ, Dept Rheumatol, Gen Hosp, Tianjin 300052, Peoples R China Shanxi Med Univ, Dept Rheumatol, Affiliated Hosp 2, Taiyuan 030001, Peoples R China Peking Union Med Coll & Chinese Acad Med Sci, Dept Rheumatol, Peking Union Med Coll Hosp, 1 Shuaifuyuan, Beijing 100730, Peoples R China Minist Sci & Technol, Natl Clin Res Ctr Immunol Dis, 1 Shuaifuyuan, Beijing 100730, Peoples R China Minist Educ, Key Lab Rheumatol & Clin Immunol, 1 Shuaifuyuan, Beijing 100730, Peoples R China Xi An Jiao Tong Univ, Dept Rheumatol & Immunol, Affiliated Hosp 1, Xian 710061, Peoples R China Changhai Hosp, Dept Rheumatol, Shanghai 200433, Peoples R China Fudan Univ, Huashan Hosp, Dept Rheumatol, Shanghai 201907, Peoples R China Sichuan Univ, West China Hosp, Dept Rheumatol, Chengdu 610000, Peoples R China Anhui Med Univ, Dept Rheumatol, Affiliated Hosp 1, Hefei 230001, Peoples R China Kunming Med Univ, Affiliated Hosp 1, Dept Rheumatol, Kunming 650032, Yunnan, Peoples R China Shandong Univ, Dept Rheumatol, Qilu Hosp, Jinan 250001, Peoples R China Fudan Univ, Zhongshan Hosp, Dept Rheumatol, Shanghai 200032, Peoples R China Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Rheumatol, Hangzhou 310009, Peoples R China Cent South Univ, Xiangya Hosp, Dept Rheumatol, Changsha 410008, Peoples R China Beijing Hosp, Dept Rheumatol, Beijing 100010, Peoples R China Shanxi Med Univ, Dept Rheumatol, Affiliated Hosp 1, Taiyuan 30001, Peoples R China Cent South Univ, Dept Rheumatol, Xiangya Hosp 2, Changsha 410007, Peoples R China Harbin Med Univ, Dept Rheumatol, Affiliated Hosp 1, Harbin 150001, Peoples R China Peking Univ, Hosp 3, Dept Rheumatol, Beijing 100089, Peoples R China Huazhong Univ Sci & Technol, Dept Rheumatol, Tongji Hosp, Tongji Med Coll, Wuhan 430030, Peoples R China Guangdong Second Prov Gen Hosp, Dept Rheumatol, Guangzhou 510310, Peoples R China Hebei Med Univ, Hosp 3, Dept Rheumatol, Shijiazhuang 050000, Hebei, Peoples R China Zhuzhou Cent Hosp, Dept Rheumatol, Zhuzhou 412000, Peoples R China Shanghai Guanghua Hosp Integrated Tradit Chinese, Dept Rheumatol, Shanghai 200052, Peoples R China China Japan Friendship Hosp, Dept Rheumatol, Beijing 100020, Peoples R China Huazhong Univ Sci & Technol, Dept Rheumatol, Union Hosp, Tongji Med Coll, Wuhan 430022, Peoples R China Guangzhou Med Univ, Dept Rheumatol, Affiliated Hosp 2, Guangzhou 510260, Peoples R China Jiangsu Prov Hosp, Dept Rheumatol, Nanjing 210000, Peoples R China Peking Univ, Hosp 1, Dept Rheumatol, Beijing 100034, Peoples R China Tianjian Med Univ, Dept Rheumatol, Gen Hosp, Tianjin 300052, Peoples R China Shanxi Med Univ, Dept Rheumatol, Affiliated Hosp 2, Taiyuan 030001, Peoples R China |
| Keywords | RECOMMENDATIONS INFLIXIMAB 52-WEEK CT-P13 |
| Issue Date | Jun-2020 |
| Publisher | BIODRUGS |
| Abstract | Objective The aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis. Methods A multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. The primary endpoint was to achieve at least a 20% improvement (ASAS20) in patients at 24 weeks according to the Assessment of Spondyloarthritis International Society criteria. The secondary endpoint included other efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters. Results Following the random assignment of 648 patients into HS016 (n = 416) and adalimumab (n = 232) groups, no significant difference was found in the ASAS20 response rates at 24 weeks between the HS016 (364/416, 87.5%) and adalimumab (209/232, 90.1%) treatments and the difference between the response rates (- 2.59%; 90% confidence interval [CI] - 6.77 to 1.60) was within the predefined equivalence margin (+/- 15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05). Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases. Plasma concentrations of HS016 and adalimumab from weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (C-max,C-ss) was equivalent for HS016 (7356.6 ng/mL) and adalimumab (7600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the adalimumab group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody (NAb) tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the adalimumab group (p > 0.05). Conclusion HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period. |
| URI | http://hdl.handle.net/20.500.11897/586575 |
| ISSN | 1173-8804 |
| DOI | 10.1007/s40259-020-00408-z |
| Indexed | SCI(E) |
| Appears in Collections: | 第三医院 第一医院 |
