Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients:A12-week randomized placebo-controlled phase Ⅲ trial with long-term extensionOACSTPCDMEDLINE
Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients:A12-week randomized placebo-controlled phase Ⅲ trial with long-term extension
Background:There is a need for effective and safe therapies for psoriasis that provide sustained benefits.The 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 patients. Methods: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 4.Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12,16,and every 12 weeks thereafter.Patients in the tildrakizumab group continued with tildrakizumab at week 16,and every 12 weeks until week 52.The primary endpoint was the Psoriasis Area and Severity Index(PASI 75)response rate at week 12. Results: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];P＜0.001)and Physician's Global Assessment(60.9％[67/110]vs.10.0％[11/110];difference,49.1％[95％CI,38.64,59.62];P＜0.001)compared to placebo.PASI 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 trcatment-emergent adverse events were mild and not related to tildrakizumab. Conclusion:Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis. Trial registration:ClinicalTrials.gov,NCT05108766.
Chen Yu;Weili Pan;Zhongwei Tian;Jinhua Xu;Zhenghua Zhang;Nan Yu;Xinsuo Duan;Shuping Guo;Qing Sun;Weiquan Li;Juan Tao;Songmei Geng;Zhijun Liu;Yuanyuan Yin;Gang Wang;Bin Yang;Yunhua Deng;Fuqiu Li;Xiaojing Kang;Mingye Bi;Furen Zhang;Yi Zhao
Department of Dermatology,Xijing Hospital,The Fourth Military Medical University,Xi'an,Shaanxi 710032,ChinaDepartment of Dermatology,Zhejiang Provincial People's Hospital,Hangzhou,Zhejiang 310014,ChinaDepartment of Dermatology,The First Affiliated Hospital of Xinxiang Medical College,Xinxiang,Henan 453100,ChinaDepartment of Dermatology,Huashan Hospital Affiliated to Fudan University,Shanghai 200040,ChinaDepartment of Dermatology,General Hospital of Ningxia Medical University,Yinchuan,Ningxia 750000,ChinaDepartment of Dermatology,Affiliated Hospital of Chengde Medical University,Chengde,Hebei 067000,ChinaDepartment of Dermatology,The First Hospital of Shanxi Medical University,Taiyuan,Shanxi 030001,ChinaDepartment of Dermatology,Qilu Hospital of Shandong University,Jinan,Shandong 250012,ChinaDepartment of Dermatology,Yuebei People's Hospital,Shaoguan,Guangdong 512026,ChinaDepartment of Dermatology,Union Hospital Tongji Medical Collage Huazhong University of Science and Technology,Wuhan,Hubei 430022,ChinaDepartment of Dermatology,The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an,Shaanxi 710004,ChinaDepartment of Dermatology and Venereal Diseases,The First Affiliated Hospital of University of South China,Hengyang,Hunan 421001,ChinaShenzhen Kangzhe Biotechnology Co.,Ltd.,Shenzhen,Guangdong 518052,ChinaDepartment of Dermatology,Dermatology Hospital of Southern Medical University,Guangzhou,Guangdong 510091,ChinaDepartment of Dermatology,Tongji Hospital,Huazhong University of Science and Technology,Wuhan,Hubei 430030,ChinaDepartment of Dermatology,The Second Hospital of Jilin University,Changchun,Jilin 130041,ChinaDepartment of Dermatology,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi,Xinjiang 830001,ChinaDepartment of Dermatology,Wuxi People's Hospital of Wuxi City,Wuxi,Jiangsu 214023,ChinaDepartment of Dermatology,Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology,Shandong First Medical University &Shandong Academy of Medical Sciences,Jinan,Shandong 250022,ChinaDepartment of Dermatology,Beijing Tsinghua Changgung Hospital,Beijing 102218,China
TildrakizumabInterleukin 23Plaque psoriasisChineseRandomized controlled trial
《中华医学杂志（英文版）》 2024 (010)
1190-1198 / 9
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