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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 Lishao Guo

作者单位

¹³13 Department of Dermatology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia 750000, China ^{7 6 Department of Dermatology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China 1919 Department of Dermatology and Venereal Diseases, The First Affiliated Hospital of University of South China, Hengyang, Hunan 421001, China 1818 Department of Dermatology, Union Hospital Tongji Medical Collage Huazhong University of Science and Technology, Wuhan, Hubei 430022, China Department 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, China Department of Dermatology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710004, China 4 Department of Dermatology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang 830001, China Department of Dermatology, Wuxi People's Hospital of Wuxi City, Wuxi, Jiangsu 214023, China 1616 Department of Dermatology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China 1212 Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China 1010 Department of Dermatology, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang 310014, China 2 9 8 Department of Dermatology, Beijing Tsinghua Changgung Hospital, Beijing 102218, China 5 1111 Department of Dermatology, The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan 453100, China 1717 Department of Dermatology, Yuebei People's Hospital, Shaoguan, Guangdong 512026, China 1515 Department of Dermatology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China 3 1414 Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, Hebei 067000, China Department of Dermatology, The Second Hospital of Jilin University, Changchun, Jilin 130041, China 1 Department of Dermatology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shaanxi 710032, China 2020 Shenzhen Kangzhe Biotechnology Co., Ltd., Shenzhen, Guangdong 518052, China. Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong 510091, China}

刊名

Chinese Medical Journal

年份

2024

卷号

Vol.137 No.10

页码

1190-1198

ISSN

0366-6999

摘要

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 to receive subcutaneous tildrakizumab 100 mg o...更多

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 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 response rate at week 12. Results:. At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates , 40.72, 62.13]; P <0.001) and Physician's Global Assessment 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 and maintained up to 52 weeks . Most treatment-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.收起

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