Jia Li, Zhixin Xue, Zhenbiao Wu, Liqi Bi, Huaxiang Liu, Lijun Wu, Shengyun Liu, Xiangyang Huang, Yong Wang, Yan Zhang, Wufang Qi, Lan He, Lie Dai, Lingyun Sun, Xiaomei Li, Zongwen Shuai, Yi Zhao, Yanyan Wang, Jian Xu, Hao Zhang, Hao Yu, Xiaoxiang Chen, Chunde Bao
OBJECTIVE: To assess the clinical equivalence of TQ-Z2301, a biosimilar of adalimumab, to the reference adalimumab in the treatment of Chinese patients with active ankylosing spondylitis. METHODS: This multicenter, randomized, double-blind, positive-controlled phase III clinical trial was conducted in 19 centers across China. Chinese adults with active ankylosing spondylitis despite being treated with non-steroidal anti-inflammatory drugs for ≥ 4 weeks were randomized in a 1:1 ratio to subcutaneously receive 40 mg of TQ-Z2301 or adalimumab every other week for 24 weeks...
June 8, 2022: Clinical Rheumatology