详情页 - 首都医科大学附属北京同仁医院知识库

当前位置：首页 > 详情页

Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: The CROWNS-2 Randomized Clinical Trial

文献详情

资源类型：

Pubmed体系：

收录情况： ◇ 自然指数

作者：

机构： [1]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. [4]Department of Pathology, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [5]Beijing Key Laboratory of Head and Neck Molecular Diagnostic Pathology, Beijing, China. [6]Otolaryngology Department, First People's Hospital of Foshan, Foshan, China. [7]Department of Otorhinolaryngology, Head and Neck Surgery, Tianjin Union Medical Center, Tianjin, China. [8]Department of Otolaryngology-Head and Neck Surgery, Shengjing Hospital of China Medical University, Shenyang, China. [9]Department of Otorhinolaryngology, Head and Neck Surgery, Second Hospital of Shanxi Medical University, Taiyuan, China. [10]Department of Otorhinolaryngology, Zibo Central Hospital, Zibo, China. [11]Department of Otorhinolaryngology, Head and Neck Surgery, West China Hospital Sichuan University, Chengdu, China. [12]Department of Otorhinolaryngology Head and Neck Surgery, Shandong Provincial ENT Hospital, Shandong University, Jinan, China. [13]Department of Otolaryngology, Head and Neck Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, China. [14]Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China. [15]Shandong Provincial Clinical Research Centre for Otorhinolaryngologic Diseases, Yantai, China. [16]Department of ENT, Shenzhen Second People's Hospital, Shenzhen, China. [17]Department of Otorhinolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [18]Department of Otolaryngology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. [19]Department of Otorhinolaryngology and Head Neck Surgery, First Affiliated Hospital of Nanchang University, Nanchang, China. [20]Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. [21]Department of Allergy, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. [22]Department of Otorhinolaryngology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [23]Department of Otorhinolaryngology, Head and Neck Surgery, Chongqing General Hospital, Chongqing, China. [24]Department of Otolaryngology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [25]Department of Otolaryngology-Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China. [26]Department of Otolaryngology, Head and Neck Surgery, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. [27]Keymed Biosciences (Chengdu) Co Ltd, Chengdu, China. [28]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China.

出处：

DOI：

ISSN：

摘要：

Chronic rhinosinusitis with nasal polyps causes severe symptoms and impaired quality of life. Stapokibart is a novel monoclonal antibody that targets interleukin 4Rα.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.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.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.Co-primary end points were changes from baseline in nasal polyp score (meaningful change threshold [MCT] ≥1 point) and nasal congestion score (MCT ≥0.5 points) at week 24 in all patients and in the population with eosinophilia.Among 180 patients randomized, 179 (mean age, 45 [SD, 12.9] years; 61 [34.1%] women) received at least 1 treatment dose (n = 90 for stapokibart; n = 89 for placebo). In the overall population, the least-squares (LS) mean change in nasal polyp score from baseline to week 24 in the stapokibart vs placebo groups was -2.6 vs -0.3 points, respectively, (LS mean difference, -2.3; 95% CI, -2.6 to -1.9; P < .001); in the population with eosinophilia, the change was -3.0 vs -0.4 points, respectively (LS mean difference, -2.5; 95% CI, -2.9 to -2.1; P < .001). The LS mean change in nasal congestion score from baseline to week 24 in the stapokibart vs placebo groups was -1.2 vs -0.5 points, respectively, in the overall population (LS mean difference, -0.7; 95% CI, -0.9 to -0.5; P < .001) and -1.3 vs -0.5 points, respectively, in the population with eosinophilia (LS mean difference, -0.8; 95% CI, -1.0 to -0.6; P < .001). Serious adverse events were rare (2.2% in the stapokibart group vs 1.1% in the placebo group). Higher rates of arthralgia (7.8% vs 0%) and hyperuricemia (5.6% vs 1.1%) were reported with stapokibart vs placebo, respectively.Among patients with severe chronic rhinosinusitis with nasal polyps treated with a daily intranasal corticosteroid, stapokibart reduced polyp size and severity of nasal symptoms at 24 weeks.ClinicalTrials.gov Identifier: NCT05436275.

基金：

语种：

PubmedID：

中科院(CAS)分区：

出版当年[2025]版：

大类 | 1 区

医学

小类 | 1 区医学：内科

最新[2025]版：

大类 | 1 区

医学

小类 | 1 区医学：内科

第一作者：

第一作者机构： [1]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China.

共同第一作者：

通讯作者：

通讯机构： [1]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. [28]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China.

推荐引用方式(GB/T 7714)：

APA：

MLA：