个人中心| | 帮助
高级检索
当前位置： 首页 > 详情页

A multicenter, randomized, double-blinded, placebo-controlled, phase Ⅲ study evaluating the efficacy and safety of Xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis

| 认领 | 导出 | |

文献详情

资源类型：
Pubmed体系：
作者：
Cai Lin[1] * ; Jiang Congjun[2] ; Zhang Guoqiang[3] ; Fang Hong[4] ; Wang Jinyan[5] ; Li Yumei[6] ; Xu Hui[6] ; Xiao Rong[7] ; Ding Yangfeng[8] ; Huang Kun[9] ; Zhang Chunlei[10] ; Zhang Litao[11] ; Chen Bin[12] ; Duan Xinsuo[13] ; Pan Weili[14] ; Han Guangming[15] ; Chen Rongyi[16] ; Liu Lunfei[17] ; Zhang Shoumin[18] ; Tao Juan[19] ; Pang Xiaowen[20] ; Yu Jianbin[21] ; Wang Huiping[22] ; Zhao Yi[23] ; Li Chengxin[24] ; Kang Xiaojing[25] ; Qin Lanying[26] ; Zhu Xiaofang[27] ; Su Juan[28] ; Li Shanshan[29] ; Yang Chunjun[30] ; Feng Wenli[31] ; Lei Tiechi[32] ; Jiang Shan[32] ; Fang Ruihua[33] ; Lin Mao[34] ; Lu Qianjin[35] ; Xu Chunxing[36] ; Wang Wei[37] ; Zhang Jianzhong[1] ;
机构： [1]Department of Dermatology, Peking University People's Hospital, Beijing, China. [2]Department of Dermatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China. [3]Department of Dermatology, The First Hospital of Hebei Medical University, Shijiazhuang, China. [4]Department of Dermatology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. [5]Department of Dermatology, Ningbo No.2 Hospital, Ningbo, China. [6]Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, China. [7]Department of Dermatology, The Second Xiangya Hospital of Central South University, Changsha, China. [8]Department of Dermatology, Shanghai Skin Disease Hospital/Skin Disease Hospital of Tongji University, Shanghai, China. [9]Department of Dermatology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [10]Department of Dermatology, Peking University Third Hospital, Beijing, China. [11]Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China. [12]Department of Dermatology, Sir Run Run Hospital of Nanjing Medical University, Nanjing, China. [13]Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, China. [14]Department of Dermatology, Zhejiang Provincial People's Hospital/People's Hospital of Hangzhou Medical College, Hangzhou, China. [15]Department of Rheumatology, Dermatology Hospital of Southern Medical University/Guangdong Provincial Dermatology Hospital, Guangzhou, China. [16]Department of Dermatology, Dermatology Hospital of Southern Medical University/Guangdong Provincial Dermatology Hospital, Guangzhou, China. [17]Department of Dermatology, The Forth Affiliated Hospital Zhejiang University School of Medicine, Yiwu, China. [18]Department of Dermatology, Henan Provincial People's Hospital, Zhengzhou, China. [19]Department of Dermatology, Union Hospital Tongji Medical College Huazhong University of Scinece and Technology, Wuhan, China. [20]Department of Dermatology, Air Force Medical center, PLA, Beijing, China. [21]Department of Dermatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [22]Department of Dermatology, Tianjin Medical University General Hospital, Tianjin, China. [23]Department of Dermatology, Beijing Tsinghua Changgung Hospital, Beijing, China. [24]Department of Dermatology, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing, China. [25]Department of Dermatology, Xinjiang Uiger Municipal People's Hospital, Wulumuqi, China. [26]Department of Dermatology, Cangzhou People's Hospital, Cangzhou, China. [27]Department of Dermatology, Northern Jiangsu People's Hospital, Yangzhou, China. [28]Department of Dermatology, Xiangya Hospital Central South University, Changsha, China. [29]Department of Dermatology, The First Bethune Hospital of Jilin University, Changchun, China. [30]Department of Dermatology, The Second Hospital of Anhui Medical University, Hefei, China. [31]Department of Dermatology, Second Hospital of Shanxi Medical University, Taiyuan, China. [32]Department of Dermatology, Renmin Hospital of Wuhan University/Hubei General Hospital, Wuhan, China. [33]Department of Dermatology, Guangzhou First People's Hospital, Guangzhou, China. [34]Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, China. [35]Department of Dermatology, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College, Nanjing, China. [36]Department of Dermatology, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, Changzhou, China. [37]Chongqing Genrix Biopharmaceutical Co., Ltd, Chongqing, China.
出处：
DOI： 10.1093/bjd/ljae062
ISSN：

摘要：
Xeligekimab is a fully human monoclonal antibody that selectively neutralizes IL-17A and had shown potential efficacy in preliminary trials.To 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 extending the treatment schedule to GR1501 every 4 weeks for further 40 weeks. Efficacy was assessed by evaluating the Physician's Global Assessment (PGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75/90/100 improvement. The safety profile was also evaluated.At week 12, The PASI 75/90/100 were achieved in 90.7%/74.4%/30.2%% patients in GR1501 group compared with 8.6%/1.4%/0% patients in placebo group, respectively. The PGA 0/1 were achieved in 74.4% patients of GR1501 group and 3.6% patients in placebo group, respectively. The PASI 75 and PGA 0/1 maintained until week 52. No unexpected adverse events were observed.Xeligekimab showed high efficacy and is well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

基金：
Supported by Chongqing Genrix Biopharmaceutical Co., Ltd, Chongqing
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 皮肤病学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 皮肤病学
第一作者：
第一作者机构： [1]Department of Dermatology, Peking University People's Hospital, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Cai Lin,Jiang Congjun,Zhang Guoqiang,et al.A multicenter, randomized, double-blinded, placebo-controlled, phase Ⅲ study evaluating the efficacy and safety of Xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis[J].The British Journal Of Dermatology.2024,doi:10.1093/bjd/ljae062.
APA：
Cai Lin,Jiang Congjun,Zhang Guoqiang,Fang Hong,Wang Jinyan...&Zhang Jianzhong.(2024).A multicenter, randomized, double-blinded, placebo-controlled, phase Ⅲ study evaluating the efficacy and safety of Xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis.The British Journal Of Dermatology,,
MLA：
Cai Lin,et al."A multicenter, randomized, double-blinded, placebo-controlled, phase Ⅲ study evaluating the efficacy and safety of Xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis".The British Journal Of Dermatology .(2024)

资源点击量：2018 今日访问量：0 总访问量：645 更新日期：2024-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 广东省中医院 技术支持：重庆聚合科技有限公司 地址：广州市越秀区大德路111号