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| STAPOKIBART REDUCES PREDICTED NEED FOR SURGERY IN PATIENTS WITH CHRONIC
RHINOSINUSITIS WITH NASAL POLYPS |
| 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. |
| YI ZHOU,
YI ZHOU1, 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
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¸ñÀû: Repeat sinus surgery is often required for patients with chronic
rhinosinusitis with nasal polyps (CRSwNP) refractory to medical
intervention. Stapokibart, a novel anti-IL-4R¥á monoclonal antibody,
has recently received its approval for the treatment of adults with
severe uncontrolled CRSwNP in China. This post-hoc study aimed to
evaluate the effect of stapokibart treatment on reduced need for
surgery in patients with CRSwNP. ¹æ¹ý:In the phase 3 CROWNS-2 study (NCT05436275), eligible patients were
randomized to receive subcutaneous stapokibart 300 mg or placebo (1:1)
every 2 weeks for 24 weeks, in addition to daily mometasone furoate
nasal spray. Reduced need for surgery through week 24 was defined as
patients achieving a Nasal Polyps Score of less than or equal to 4
(each nostril of less than or equal to 2) and a Sinonasal Outcome
Test-22 improvement of at least 8.9 points (the minimum clinically
important difference). The probability of reduced need for surgery by
week 24 was assessed with the Cox proportional hazards model. The
between-group difference in the proportion of patients with reduced
need for surgery at week 24 was estimated using logistic regression. °á°ú:A total of 179 patients received at least one dose of stapokibart (n =
90) or placebo (n = 89). Of which, 64.4% (58/90) and 62.9% (56/89),
respectively, had previously undergone sinus surgery. During the 24-week
treatment period, patients treated with stapokibart experienced an over
three-fold higher probability of reduced need for surgery (HR (95% CI):
4.4 (2.8-7.0), P < 0.001). At week 24, the proportion of patients with
reduced need for surgery was significantly higher in the stapokibart
group compared to placebo (68.9% vs 13.5%, OR (95% CI): 18.3 (7.9-42.2),
P <0.001). °á·Ð:Stapokibart significantly reduced the predicted need of further sinus
surgery in patients with CRSwNP. |
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