Comparison of the efficacy and safety of the adalimumab biosimilar TQ-Z2301 and adalimumab for the treatment of Chinese patients with active ankylosing spondylitis: a multi-center, randomized, double-blind, phase III clinical trial.
Jia LiZhixin XueZhen-Biao WuLiqi BiHuaxiang LiuLijun WuShengyun LiuXiangyang HuangYong WangYan ZhangWufang QiLan HeLie DaiLingyun SunXiao-Mei LiZongwen ShuaiYi ZhaoYanyan WangJian XuHao ZhangHao YuXiaoxiang ChenChunde BaoPublished in: Clinical rheumatology (2022)
The study (CTR20181863) was registered in the Chinese Clinical Trial Registry on 19 October 2018. Key Points • TQ-Z2301 showed the equivalence of efficacy compared with the reference adalimumab for the treatment of Chinese patients with active ankylosing spondylitis. • The safety, immunogenicity, and pharmacokinetics profiles of TQZ-2301 were similar to those of the reference adalimumab.