Loading…

A multicentre randomized double-blind placebo-controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis

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.BACKGROUNDXeligekimab (GR1501) is a fully human monoclonal antibody that selectively neutralizes...

Full description

Saved in:
Bibliographic Details
Published in:British journal of dermatology (1951) 2024-08, Vol.191 (3), p.336-343
Main Authors: Cai, Lin, Jiang, Congjun, Zhang, Guoqiang, Fang, Hong, Wang, Jinyan, Li, Yumei, Xu, Hui, Xiao, Rong, Ding, Yangfeng, Huang, Kun, Zhang, Chunlei, Zhang, Litao, Chen, Bin, Duan, Xinsuo, Pan, Weili, Han, Guangming, Chen, Rongyi, Liu, Lunfei, Zhang, Shoumin, Tao, Juan, Pang, Xiaowen, Yu, Jianbin, Wang, Huiping, Zhao, Yi, Li, Chengxin, Kang, Xiaojing, Qin, Lanying, Zhu, Xiaofang, Su, Juan, Li, Shanshan, Yang, Chunjun, Feng, Wenli, Lei, Tiechi, Jiang, Shan, Fang, Ruihua, Lin, Mao, Lu, Qianjin, Xu, Chunxing, Wang, Wei, Zhang, Jianzhong
Format: Article
Language:English
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.BACKGROUNDXeligekimab (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.To evaluate the efficacy and safety of xeligekimab in Chinese patients with moderate-to-severe psoriasis.OBJECTIVESTo evaluate the efficacy and safety of xeligekimab in Chinese patients with moderate-to-severe psoriasis.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.METHODSA 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.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.RESULTSAt 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.Xeligekimab showed high efficacy and was well tolerated in Chinese patients with moderate-to
ISSN:0007-0963
1365-2133
1365-2133
DOI:10.1093/bjd/ljae062