中国耳鼻咽喉头颈外科2026，Vol.33Issue(5)：265-271,287,8.DOI:10.16066/j.1672-7002.2026.05.005
司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的疗效:基于生物标志物的亚组分析
Efficacy of stapokibart in chronic rhinosinusitis with nasal polyps:A biomarker-based subgroup analysis of CROWNS-2
摘要
Abstract
OBJECTIVE Aimed to evaluate the efficacy of stapokibart in patients with CRSwNP stratified by baseline inflammatory biomarker levels.METHODS This post hoc analysis was based on data from the multicenter,randomized,double-blind,placebo-controlled phase 3 CROWNS-2 study.Patients were stratified according to baseline biomarker levels,including peripheral blood and tissue eosinophil counts,serum total immunoglobulin E,serum thymus and activation-regulated chemokine,and plasma eotaxin-3 levels.The efficacy of stapokibart was assessed across different biomarker-defined subgroups.RESULTS In subgroups stratified by the median baseline level of each biomarker,stapokibart significantly reduced nasal polyp scores compared with placebo after 24 weeks of treatment[all P values(vs.placebo)<0.0001].In addition,stapokibart significantly improved symptom-related outcomes,including nasal congestion,loss of smell,University of Pennsylvania smell identification test scores,and total nasal symptom scores,as well as Lund-Mackay CT scores and quality-of-life scores,compared with placebo across all biomarker subgroups[all P values(vs.placebo)<0.05].In terms of the onset of action,clinical responses were observed earlier in patients with higher baseline biomarker levels,whereas patients with lower baseline levels experienced a relatively delayed onset but still achieved significant clinical benefits.CONCLUSION Stapokibart provides significant clinical benefits for patients with CRSwNP across different biomarker levels.The onset of action is associated with biomarker levels,suggesting that biomarkers may help guide individualized treatment.关键词
鼻窦炎/鼻息肉/司普奇拜单抗/生物标志物/亚组分析Key words
Sinusitis/Nasal Polyps/stapokibart/biomarker/subgroup analysis引用本文复制引用
闫冰,靳泽怡,王成硕,张罗..司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的疗效:基于生物标志物的亚组分析[J].中国耳鼻咽喉头颈外科,2026,33(5):265-271,287,8.基金项目
国家自然科学基金(82471135、82025010、82171108) （82471135、82025010、82171108）
首都卫生发展科研专项(2022-1-1091) （2022-1-1091）
