Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps

作者：Shen Shen, Bing Yan, Ming Wang, Di Wu, Yingshi Piao, Jun Tang, Xiangli Yang, Zhiwei Cao, Jinmei Xue, Wenwen Liu, Shixi Liu, Li Shi, Guangke Wang, Xicheng Song, Yongtian Lu, Jianjun Chen, Luyun Jiang, Jing Ye, Shaoqing Yu, Yucheng Yang, Hongyan Fang, Jiping Li, Haibo Shi, Jiangang Fan, Hongyue Yan, Haifei Wang, Bo Chen, Chengshuo Wang, Luo Zhang, CROWNS-2 Study Investigators, Lijia Wan, Guolin Tan, Yi Yang, Shiyin Ma, Lizhong Su, Xuezhong Li, Yongle Li, Fang Quan, Mingliang Xiang, Yan Jiang, Gang He, Chang Lin, Xiaoyong Ren, Liyan Ni, Xiaoping Gao, Jiusheng Chu, Ruixia Ma, Zhihai Xie, Bing Guan, Shui‐Hong Zhou, Lijian Zhang, Xin Wei, Zhichun Huang, Qingshan Jiang, Xin Wang, Li Zhu, Zian Xiao, Lei Cheng, Kai Wang, Qingqing Yu, Jing Pan, Yuxiao Du, Xiaoqiu Chen, Rui Dong, Shi‐Ping Sun, Feng Liu, Shengyang Liu, Pengfei Ba, Yu Zhang, Xiaobin Wang, Shan Chen, Yan Xie, Qing Luo, Ling Jin, Xia Ke, Junwei Xiong, Ji Xu, Weitian Zhang, Qinxuan Gu, Wei Ni, Wei Li, Xia Gong, Junjie Zhang, Weiming Hu, Shuang Gu, Zhiqi Ma, Huajing Li, Yilin Shen, Longgang Yu, Ding-qiang Huang, Yuanteng Xu, Bin Sun, Xuejun Liu, Hui Shao, Yanyun Liu, Le Wang, Shumin Xie, Haihong Chen, Zhuoqin Han, Jing Zheng, Lifen Wang, Ming Xu, Yusheng Wang, Jinhong Li, Junjie Zeng, Meiping Lu, Yancheng Xu, Qinna Zhang, Xiaowen Zhang · 发表于：JAMA · 年份：2025 · DOI：10.1001/jama.2025.12515 · 被引用次数：23 · 研究领域：Sinusitis and nasal conditions、Allergic Rhinitis and Sensitization、Cystic Fibrosis Research Advances

Importance: Chronic rhinosinusitis with nasal polyps causes severe symptoms and impaired quality of life. Stapokibart is a novel monoclonal antibody that targets interleukin 4Rα. Objective: To assess the efficacy and safety of stapokibart as an add-on treatment to intranasal corticosteroids in patients with severe uncontrolled chronic rhinosinusitis with nasal polyps. Design, Setting, and Participants: From August 9, 2022, to April 28, 2023, this randomized, double-blind, phase 3 clinical trial, conducted at 51 hospitals in China, enrolled adult patients with chronic rhinosinusitis with nasal polyps who had a history of systemic corticosteroid use or sinonasal surgery and a bilateral nasal polyp score of 5 or greater (on a scale of 0-8) and a weekly mean nasal congestion score of 2 or greater (on a scale of 0-3). Eosinophilic chronic rhinosinusitis with nasal polyps was defined as blood eosinophils of 6.9% or greater (without asthma) or 3.7% or greater (with asthma) or an eosinophil count of 55 per high-power field or greater or 27% or greater in nasal polyp tissue. Patient follow-up was completed on June 25, 2024. Interventions: Four weeks after initiation of mometasone furoate nasal spray, 100 µg in each nostril daily, patients were randomized to receive subcutaneous stapokibart, 300 mg, or placebo (1:1) every 2 weeks for 24 weeks. Both groups then received stapokibart for 28 weeks. Main Outcomes and Measures: Co-primary end points were changes from baseline in nasal polyp ...