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

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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 (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 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.

abstractsBackground::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 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.

作者 Yu Chen ^[1] Geng Songmei ^[2] Yang Bin ^[3] Deng Yunhua ^[4] Li Fuqiu ^[5] Kang Xiaojing ^[6] Bi Mingye ^[7] Zhang Furen ^[8] Zhao Yi ^[9] Pan Weili ^[10] Tian Zhongwei ^[11] Xu Jinhua ^[12] Zhang Zhenghua ^[12] Yu Nan ^[13] Duan Xinsuo ^[14] Guo Shuping ^[15] Sun Qing ^[16] Li Weiquan ^[17] Tao Juan ^[18] Liu Zhijun ^[19] Yin Yuanyuan ^[20] Wang Gang ^[1] 学术成果认领

作者单位 Department of Dermatology, Xijing Hospital, The Fourth Military Medical University, Xi’an, Shaanxi 710032, China ^[1] Department of Dermatology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi 710004, China ^[2] Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong 510091, China ^[3] Department of Dermatology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China ^[4] Department of Dermatology, The Second Hospital of Jilin University, Changchun, Jilin 130041, China ^[5] Department of Dermatology, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang 830001, China ^[6] Department of Dermatology, Wuxi People’s Hospital of Wuxi City, Wuxi, Jiangsu 214023, China ^[7] Department of Dermatology, Shandong Provincial Hospital for Skin Diseases amp; Shandong Provincial Institute of Dermatology and Venereology, Shandong First Medical University amp; Shandong Academy of Medical Sciences, Jinan, Shandong 250022, China ^[8] Department of Dermatology, Beijing Tsinghua Changgung Hospital, Beijing 102218, China ^[9] Department of Dermatology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang 310014, China ^[10] Department of Dermatology, The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan 453100, China ^[11] Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China ^[12] Department of Dermatology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia 750000, China ^[13] Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, Hebei 067000, China ^[14] Department of Dermatology, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China ^[15] Department of Dermatology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China ^[16] Department of Dermatology, Yuebei People’s Hospital, Shaoguan, Guangdong 512026, China ^[17] Department of Dermatology, Union Hospital Tongji Medical Collage Huazhong University of Science and Technology, Wuhan, Hubei 430022, China ^[18] Department of Dermatology and Venereal Diseases, The First Affiliated Hospital of University of South China, Hengyang, Hunan 421001, China ^[19] Shenzhen Kangzhe Biotechnology Co., Ltd., Shenzhen, Guangdong 518052, China ^[20]

关键词 Tildrakizumab Interleukin 23 Plaque psoriasis Chinese Randomized controlled trial Tildrakizumab Interleukin 23 Plaque psoriasis Chinese Randomized controlled trial

栏目名称 Original Article

DOI 10.1097/CM9.0000000000002873

发布时间 2025-03-04