학술대회 발표 연제 초록

학술대회 발표 연제 초록

발표형식 : 구연채택	접수번호 - 990053 RHOP 7-2
STAPOKIBART RAPIDLY IMPROVES SYMPTOMS IN PATIENTS WITH SEVERE CHRONIC RHINOSINUSITIS WITH NASAL POLYPS: A POST-HOC ANALYSIS OF THE PHASE 3 CROWNS-2 TRIAL
1 DEP. OF OTOLARYNGOLOGY, HEAD AND NECK SURGERY, BEIJING TONGREN HOSP., CAPITAL MEDICAL UNIV., BEIJING, CHINA, 2 BEIJING INSTITUTE OF OTOLARYNGOLOGY, BEIJING LABORATORY OF ALLERGIC DISEASES, BEIJING KEY LABORATORY OF NASAL DISEASES, KEY LABORATORY OF OTOLARYNGOLOGY HEAD AND NECK SURGERY, MINISTRY OF EDUCATION, CAPITAL MEDICAL UNIV., BEIJING, CHINA, 3 DEP. OF PATHOLOGY, BEIJING TONGREN HOSP., CAPITAL MEDICAL UNIV., BEIJING, CHINA, 4 BEIJING KEY LABORATORY OF HEAD AND NECK MOLECULAR DIAGNOSTIC PATHOLOGY, BEIJING, CHINA, 5 OTOLARYNGOLOGY DEP., THE FIRST PEOPLES HOSP., FOSHAN, CHINA, 6 DEP. OF OTORHINOLARYNGOLOGY, HEAD AND NECK SURGERY, TIANJIN UNION MEDICAL CENTER, TIANJIN, CHINA, 7 DEP. OF OTOLARYNGOLOGY-HEAD AND NECK SURGERY, SHENGJING HOSP. OF CHINA MEDICAL UNIV., SHENYANG, CHINA, 8 DEP. OF OTORHINOLARYNGOLOGY, HEAD AND NECK SURGERY, THE SECOND HOSP. OF SHANXI MEDICAL UNIV., TAIYUAN, CHINA, 9 DEP. OF OTORHINOLARYNGOLOGY, ZIBO CENTRAL HOSP., ZIBO, CHINA, 10 DEP. OF OTORHINOLARYNGOLOGY, HEAD AND NECK SURGERY, WEST CHINA HOSP. SICHUAN UNIV., CHENGDU, CHINA, 11 DEP. OF OTORHINOLARYNGOLOGY HEAD AND NECK SURGERY, SHANDONG PROVINCIAL ENT HOSP., SHANDONG UNIV., JINAN, CHINA, 12 DEP. OF OTOLARYNGOLOGY, HEAD AND NECK SURGERY, HENAN PROVINCIAL PEOPLES HOSP., PEOPLES HOSP. OF ZHENGZHOU UNIV., PEOPLES HOSP. OF HENAN UNIV., ZHENGZHOU, CHINA, 13 DEP. OF OTORHINOLARYNGOLOGY, HEAD AND NECK SURGERY, YANTAI YUHUANGDING HOSP., QINGDAO UNIV., YANTAI, CHINA, 14 SHANDONG PROVINCIAL CLINICAL RESEARCH CENTRE FOR OTORHINOLARYNGOLOGIC DISEASES, YANTAI, CHINA, 15 DEP. OF ENT, SHENZHEN SECOND PEOPLES HOSP., SHENZHEN, CHINA, 16 DEP. OF OTORHINOLARYNGOLOGY, UNION HOSP., TONGJI MEDICAL COLLEGE, HUAZHONG UNIV. OF SCIENCE AND TECHNOLOGY, WUHAN, CHINA, 17 DEP. OF OTOLARYNGOLOGY, HOSP. OF CHENGDU UNIV. OF TRADITIONAL CHINESE MEDICINE, CHENGDU, CHINA, 18 DEP. OF OTORHINOLARYNGOLOGY AND HEAD NECK SURGERY, THE FIRST AFFILIATED HOSP. OF NANCHANG UNIV., NANCHANG, CHINA, 19 DEP. OF OTOLARYNGOLOGY, TONGJI HOSP., SCHOOL OF MEDICINE, TONGJI UNIV., SHANGHAI, CHINA, 20 DEP. OF ALLERGY, TONGJI HOSP., SCHOOL OF MEDICINE, TONGJI UNIV., SHANGHAI, CHINA, 21 DEP. OF OTORHINOLARYNGOLOGY, HEAD AND NECK SURGERY, THE FIRST AFFILIATED HOSP. OF CHONGQING MEDICAL UNIV., CHONGQING, CHINA, 22 DEP. OF OTORHINOLARYNGOLOGY, HEAD AND NECK SURGERY, CHONGQING GENERAL HOSP., CHONGQING, CHINA, 23 DEP. OF OTOLARYNGOLOGY, RENJI HOSP., SHANGHAI JIAO TONG UNIV. SCHOOL OF MEDICINE, SHANGHAI, CHINA, 24 DEP. OF OTOLARYNGOLOGY-HEAD & NECK SURGERY, SHANGHAI SIXTH PEOPLES HOSP. AFFILIATED TO SHANGHAI JIAO TONG UNIV. SCHOOL OF MEDICINE, SHANGHAI, CHINA, 25 DEP. OF OTOLARYNGOLOGY HEAD AND NECK SURGERY, SICHUAN PROVINCIAL PEOPLES HOSP., SCHOOL OF MEDICINE, UNIV. OF ELECTRONIC SCIENCE AND TECHNOLOGY OF CHINA, CHENGDU, CHINA, 26 KEYMED BIOSCIENCES (CHENGDU) CO., LTD, CHENGDU, CHINA, 27 DEP. OF ALLERGY, BEIJING TONGREN HOSP., CAPITAL MEDICAL UNIV., BEIJING, CHINA.
JINGYU JIANG, JINGYU JIANG1, SHEN SHEN1, 2, BING YAN1, 2, MING WANG1, 2, DI WU1, 2, YINGSHI PIAO3, 4, JUN TANG5, XIANGLI YANG6, ZHIWEI CAO7, JINMEI XUE8, WEN LIU9, SHIXI LIU10, LI SHI11, GUANGKE WANG12, XICHENG SONG13,14, YONGTIAN LU15, JIANJUN CHEN16, LUYUN JIANG17, JING YE18, SHAOQING YU19,20, YUCHENG YANG21, HONGYAN FANG22, JIPING LI23, HAIBO SHI24, JIANGANG FAN25, HONGYUE YAN26, HAIFEI WANG26, BO CHEN26, CHENGSHUO WANG1, 2, LUO ZHANG1, 2, 27
목적: Chronic rhinosinusitis with nasal polyps (CRSwNP) often leads to uncontrolled nasal symptoms and impaired quality of life. Stapokibart, a novel humanized monoclonal IL-4Rα antibody, has been approved for the treatment of CRSwNP in China. In the phase 3 CROWNS-2 trial (NCT05436275), nasal congestion score (NCS) and total symptom score (TSS) were significantly improved with stapokibart compared to placebo at the first post-treatment evaluation (week 4). This post-hoc analysis aimed to assess the early onset of stapokibart among patients with severe CRSwNP based on daily individual rhinosinusitis symptom scores. 방법:Eligible participants in CROWNS-2 were randomly assigned to subcutaneous stapokibart 300 mg or placebo (1:1) every 2 weeks (Q2W) for 24 weeks, in addition to mometasone furoate nasal spray. Outcomes analyzed in this study were the changes from baseline in daily NCS, TSS, and loss-of- smell score, and the proportion of patients achieving NCS improvement of at least 0.5 (meaningful change threshold) and at least 1 within two weeks of treatment initiation. 결과:In CROWNS-2, 90 patients received stapokibart and 89 received placebo. At D4 post- treatment initiation, change from baseline in NCS was significantly greater in the stapokibart group than the placebo group (p=0.0302). Consistently, a significantly higher proportion of patients in the stapokibart group achieved NCS improvement of at least 0.5 (25.6% vs. 11.2%, p=0.0148) and of at least 1 (15.6% vs. 4.5%, p=0.0140) than the placebo group at D4. Of note, TSS was significantly improved in the stapokibart group versus the placebo group as early as D1 post treatment initiation (p=0.0465). Loss-of-smell score was significantly improved in the stapokibart group versus the placebo group since D5 (p=0.0272). 결론:Stapokibart led to rapid improvements in individual rhinosinusitis symptoms in patients with severe CRSwNP.