乌纳奇珠单抗治疗中重度慢性斑块状银屑病的疗效和安全性：一项随机、双盲、安慰剂对照的3期试验。
Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial.
作者信息
Yan Kexiang, Li Fuqiu, Bi Xiaodong, Han Ling, Zhang Zhenghua, Chen Rixin, Li Yuye, Zhang Litao, Wang Xiaohua, Li Linfeng, Lu Jianyun, Xu Ai'e, Yang Sen, Lu Yan, Sun Jianfang, Li Zhiming, Zhu Xiaohong, Jiang Meiying, Zhang Siping, Wang Wenqing, Li Yanling, Meng Zudong, Li Hongyi, Mou Kuanhou, Han Xiuping, Li Shanshan, Chen Aijun, Li Xin, Liu Donghua, Zhang Chunlei, Ji Chao, Wang Yu, Cheng Hao, Cui Xiaojing, Yao Xiaoyan, Bai Xiaoyan, Dong Guangchao, Xu Jinhua
机构信息
Department of Dermatology, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
Department of Dermatology, The Second Hospital of Jilin University, Changchun, China.
出版信息
J Am Acad Dermatol. 2025 Jan;92(1):92-99. doi: 10.1016/j.jaad.2024.09.031. Epub 2024 Sep 26.
BACKGROUND
Vunakizumab, a novel anti-interleukin-17A antibody, has shown promising efficacy for moderate-to-severe plaque psoriasis in a phase 2 trial.
OBJECTIVE
We conducted a double-blind, randomized phase 3 trial (NCT04839016) to further evaluate vunakizumab in this population.
METHODS
Six hundred ninety 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 every 4 weeks 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.
RESULTS
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 < .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.
LIMITATIONS
Chinese subjects only; no active comparator.
CONCLUSION
Vunakizumab demonstrated robust clinical response at week 12 and through week 52, with good tolerability in moderate-to-severe plaque psoriasis.
背景
Vunakizumab是一种新型抗白细胞介素-17A抗体，在一项2期试验中对中度至重度斑块状银屑病显示出有前景的疗效。
目的
我们进行了一项双盲、随机3期试验（NCT04839016），以在该人群中进一步评估Vunakizumab。
方法
690名受试者被随机分组（2:1），在第0、2、4和8周接受240mg Vunakizumab或安慰剂治疗。在第12周，接受安慰剂治疗的受试者换用240mg Vunakizumab（第12、14、16周，此后每4周一次）。共同主要终点为第12周时银屑病面积和严重程度指数评分（PASI 90）较基线改善≥90%以及静态医师整体评估评分为0/1（sPGA 0/1）。
结果
在第12周时，Vunakizumab组显示出更高的PASI 90（76.8%对0.9%）和sPGA 0/1（71.8%对0.4%）缓解率，以及更高的PASI 75（93.6%对4.0%）、PASI 100（36.6%对0.0%）和sPGA 0（38.2%对0.0%）缓解率（与安慰剂相比，所有双侧P<0.0001）。持续使用Vunakizumab至第52周疗效得以维持。0.9%接受Vunakizumab治疗的受试者发生了可能与治疗相关的严重不良事件。
局限性
仅纳入中国受试者；无活性对照药。
结论
Vunakizumab在第12周以及至第52周期间均显示出强劲的临床反应，在中度至重度斑块状银屑病中耐受性良好。
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