Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients:A 12-week randomized placebo-controlled phase III trial with long-term extension

作     者：Chen Yu Songmei Geng Bin Yang Yunhua Deng Fuqiu Li Xiaojing Kang Mingye Bi Furen Zhang Yi Zhao Weili Pan Zhongwei Tian Jinhua Xu Zhenghua Zhang Nan Yu Xinsuo Duan Shuping Guo Qing Sun Weiquan Li Juan Tao Zhijun Liu Yuanyuan Yin Gang Wang Chen Yu;Songmei Geng;Bin Yang;Yunhua Deng;Fuqiu Li;Xiaojing Kang;Mingye Bi;Furen Zhang;Yi Zhao;Weili Pan;Zhongwei Tian;Jinhua Xu;Zhenghua Zhang;Nan Yu;Xinsuo Duan;Shuping Guo;Qing Sun;Weiquan Li;Juan Tao;Zhijun Liu;Yuanyuan Yin;Gang Wang

作者机构：Department of DermatologyXijing HospitalThe Fourth Military Medical UniversityXi’anShaanxi 710032China Department of DermatologyThe Second Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxi 710004China Department of DermatologyDermatology Hospital of Southern Medical UniversityGuangzhouGuangdong 510091China Department of DermatologyTongji HospitalHuazhong University of Science and TechnologyWuhanHubei 430030China Department of DermatologyThe Second Hospital of Jilin UniversityChangchunJilin 130041China Department of DermatologyPeople’s Hospital of Xinjiang Uygur Autonomous RegionUrumqiXinjiang 830001China Department of DermatologyWuxi People’s Hospital of Wuxi CityWuxiJiangsu 214023China Department of DermatologyShandong Provincial Hospital for Skin Diseases&Shandong Provincial Institute of Dermatology and VenereologyShandong First Medical University&Shandong Academy of Medical SciencesJinanShandong 250022China Department of DermatologyBeijing Tsinghua Changgung HospitalBeijing 102218China Department of DermatologyZhejiang Provincial People’s HospitalHangzhouZhejiang 310014China Department of DermatologyThe First Affiliated Hospital of Xinxiang Medical CollegeXinxiangHenan 453100China Department of DermatologyHuashan Hospital Affiliated to Fudan UniversityShanghai 200040China Department of DermatologyGeneral Hospital of Ningxia Medical UniversityYinchuanNingxia 750000China Department of DermatologyAffiliated Hospital of Chengde Medical UniversityChengdeHebei 067000China Department of DermatologyThe First Hospital of Shanxi Medical UniversityTaiyuanShanxi 030001China Department of DermatologyQilu Hospital of Shandong UniversityJinanShandong 250012China Department of DermatologyYuebei People’s HospitalShaoguanGuangdong 512026China Department of DermatologyUnion Hospital Tongji Medical Collage Huazhong University of Science and TechnologyWuhanHubei 430022China Department of Dermatology and Venereal DiseasesThe First Affiliated Hospital of University of South ChinaHengyangHunan 421001China Shenzhen Kangzhe Biotechnology Co.Ltd.ShenzhenGuangdong 518052China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2024年第137卷第10期

页      面：1190-1198页

核心收录：

学科分类：1002[医学-临床医学] 100206[医学-皮肤病与性病学] 10[医学] 

基　　金：Shenzhen Kangzhe Pharmaceutical Co.  Ltd 

主　　题：Tildrakizumab Interleukin 23 Plaque psoriasis Chinese Randomized controlled trial 

摘      要：Background:There is a need for effective and safe therapies for psoriasis that provide sustained *** aim of this study was to assess the efficacy and safety of tildrakizumab,an anti-interleukin-23p19 monoclonal antibody,for treating moderate-to-severe plaque psoriasis in Chinese ***:In this multi-center,double-blind,phase III trial,patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned(1:1)to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and *** initially assigned to placebo were switched to receive tildrakizumab at weeks 12,16,and every 12 weeks *** in the tildrakizumab group continued with tildrakizumab at week 16,and every 12 weeks until week *** primary endpoint was the Psoriasis Area and Severity Index(PASI 75)response rate at week ***:At week 12,tildrakizumab demonstrated significantly higher PASI 75 response rates(66.4%[73/110]vs.12.7%[14/110];difference,51.4%[95%confidence interval(CI),40.72,62.13];P0.001)and Physician’s Global Assessment(60.9%[67/110]vs.10.0%[11/110];difference,49.1%[95%CI,38.64,59.62];P0.001)compared to *** 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups,reaching maximal efficacy after 28 weeks(86.8%[92/106]vs.82.4%[89/108])and maintained up to 52 weeks(91.3%[95/104]vs.87.4%[90/103]).Most treatment-emergent adverse events were mild and not related to ***:Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque *** registration:***,NCT05108766.