作者
Lin Cai,Congjun Jiang,Guoqiang Zhang,Hong Fang,Jinyan Wang,Yumei Li,Hui Xu,Rong Xiao,Yangfeng Ding,Kun Huang,Chunlei Zhang,Litao Zhang,Bin Chen,Xin‐Suo Duan,Weili Pan,Guang‐Ming Han,Rongyi Chen,Lunfei Liu,Shoumin Zhang,Juan Tao,Xiao-Wen Pang,Jianbin Yu,Huiping Wang,Yi Zhao,Chengxin Li,Xiaojing Kang,Lan-Ying Qin,Xiaofang Zhu,Juan Su,Shanshan Li,Chunjun Yang,Wenli Feng,Tiechi Lei,Shan Jiang,Ruihua Fang,M. T. Lin,Qianjin Lu,Chunxing Xu,Xiaogang Wang,Jianzhong Zhang
摘要
Abstract Background Xeligekimab (GR1501) is a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A and has shown potential efficacy in treating moderate-to-severe psoriasis in preliminary trials. Objectives To evaluate the efficacy and safety of xeligekimab in Chinese patients with moderate-to-severe psoriasis. Methods A total of 420 Chinese patients were randomized to 200 mg xeligekimab every 2 weeks (n = 281) or placebo (n = 139) for the first 12 weeks, followed by an extension of the treatment schedule to xeligekimab every 4 weeks for a further 40 weeks. Efficacy was assessed by evaluating achievement of Physician Global Assessment (PGA) 0/1 and 75%, 90% and 100% improvement in Psoriasis Area and Severity Index (PASI 75, PASI 90 and PASI 100, respectively). The safety profile was also evaluated. Results At week 12, PASI 75, PASI 90 and PASI 100 were achieved in 90.7%, 74.4% and 30.2% of patients in the xeligekimab group vs. 8.6%, 1.4% and 0% of patients in the placebo group, respectively. PGA 0/1 was achieved in 74.4% patients in the xeligekimab group and 3.6% of patients in the placebo group. PASI 75 and PGA 0/1 were maintained until week 52. No unexpected adverse events were recorded. Conclusions Xeligekimab showed high efficacy and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.