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Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, placebo-controlled phase 3 trial

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机构： [1]Huashan Hospital Affiliated to Fudan University, Shanghai, China. [2]The Second Hospital of Jilin University, Changchun, China. [3]Nanyang First People's Hospital, Nanyang, China. [4]The First Affiliated Hospital of Kunming Medical University, Kunming, China. [5]Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China. [6]Dermatology Hospital, Southern Medical University, Guangzhou, China. [7]Beijing Friendship Hospital, Beijing, China. [8]Third Xiangya Hospital, Central South University, Changsha, China. [9]Hangzhou Third Hospital, Hangzhou, China. [10]Anhui Medical University First Affiliated Hospital, Hefei, China. [11]Jiangsu Province Hospital, Nanjing, China. [12]Dermatology Hospital, Chinese Academy of Medical Sciences, Nanjing, China. [13]The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. [14]Wuxi Second People's Hospital, Wuxi, China. [15]The Second Affiliated Hospital of Nanchang University, Nanchang, China. [16]Anhui Provincial Hospital, Hefei, China. [17]The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [18]The Second Hospital of Hebei Medical University, Shijiazhuang, China. [19]Shiyan Renmin Hospital, Shiyan, China. [20]Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. [21]The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China. [22]Shengjing Hospital, China Medical University, Shenyang, China. [23]The First Hospital of Jilin University, Changchun, China. [24]The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [25]Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. [26]The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [27]Peking University Third Hospital, Beijing, China. [28]The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. [29]The Affiliated Hospital of Guizhou Medical University, Guizhou, China. [30]Sir Run Run Shaw Hospital ZheJiang University School of Medicine, Hangzhou, China. [31]Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. [32]Huashan Hospital Affiliated to Fudan University, Shanghai, China. Electronic address: xjhhsyy@163.com.

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关键词： Plaque psoriasis Clinical trial Psoriasis Area and Severity Index anti-IL-17A biologics quality of life

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Vunakizumab, a novel anti-IL-17A antibody, has showed promising efficacy for moderate-to-severe plaque psoriasis in a phase 2 trial.We conducted a double-blind, randomized phase 3 trial (NCT04839016) to further evaluate vunakizumab in this population.690 subjects were randomized (2:1) to receive vunakizumab 240 mg or placebo at weeks 0, 2, 4 and 8. At week 12, subjects on placebo were switched to vunakizumab 240 mg (weeks 12, 14, 16 and q4w thereafter). The co-primary endpoints were ≥90% improvement from baseline in the psoriasis area-and-severity index score (PASI 90) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.At week 12, the vunakizumab group showed higher PASI 90 (76.8% vs 0.9%) and sPGA 0/1 (71.8% vs 0.4%) response rates, as well as higher PASI 75 (93.6% vs 4.0%), PASI 100 (36.6% vs 0.0%) and sPGA 0 (38.2% vs 0.0%) response rates (all two-sided P<0.0001 vs placebo). Efficacy was maintained through week 52 with continuous vunakizumab. Possible treatment-related serious adverse events occurred in 0.9% of vunakizumab-treated subjects.Chinese subjects only; no active comparator.Vunakizumab demonstrated robust clinical response at week 12 and through week 52, with good tolerability in moderate-to-severe plaque psoriasis.Copyright © 2024. Published by Elsevier Inc.

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大类 | 1 区

医学

小类 | 1 区皮肤病学

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Q1 DERMATOLOGY

影响因子： 12.8 最新[2023版] 11.5 最新五年平均 0 出版当年[2025版] 0 出版当年五年平均 0 出版前一年[2024版]

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第一作者机构： [1]Huashan Hospital Affiliated to Fudan University, Shanghai, China.

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Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, placebo-controlled phase 3 trial

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