{"title":"Dupilumab在中国治疗结节性痒疹的有效性和安全性:一项多中心观察性研究。","authors":"Zuotao Zhao,Xiaoting Song,Yuanyuan Shang,Lijuan Liu,Rui Zheng,Jianxin Xia,Qiang Liu,Guodong Hao,Jie Li,Songmei Geng,Jingang An,Qiang Wang,Xiaoyan Liu,Jianping Tang,Yizhu Xiao,Litao Zhang","doi":"10.1111/all.16478","DOIUrl":null,"url":null,"abstract":"BACKGROUND\r\nThe efficacy and safety of dupilumab in patients with refractory prurigo nodularis (PN) is well established in clinical trials, but there is a lack of multicenter data regarding its effectiveness and safety in real-world settings.\r\n\r\nMETHODS\r\nPatients with moderate-to-severe PN who initiated dupilumab treatment between July 2023 and January 2024, with a follow-up period of at least 16 weeks at 10 hospitals in China were included. We used peak pruritus numeric rating scale (PP-NRS), investigator global assessment (IGA) for PN, and dermatology life quality index for adults or children (DLQI/CDLQI) to assess disease control status and quality of life impairment, and monitored adverse events to assess the safety.\r\n\r\nRESULTS\r\nA total of 73 PN patients (33 female, 40 male; mean age 45.9 ± 21.5 years) were included. A clinically meaningful improvement of ≥ 4 points in PP-NRS (PP-NRS4) was achieved in 84.9% of patients at Week 12. The percentage of patients achieving IGA 0/1 significantly increasing from 0% to 37.0% and 46.6% at Week 12 and 16, respectively. Patient-reported quality of life outcomes showed substantial improvement, with decreasing from 16.6 ± 6.8 at baseline to 7.2 ± 4.9 at Week 12, 6.4 ± 4.5 at Week 16. The safety profile of dupilumab was favorable, with one patient reporting dry eyes.\r\n\r\nCONCLUSION\r\nDupilumab can effectively improve the pruritus, nodular lesions and quality of life for PN in real-world settings.","PeriodicalId":122,"journal":{"name":"Allergy","volume":"74 1","pages":""},"PeriodicalIF":12.6000,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and Safety of Dupilumab for Prurigo Nodularis in China: A Multicentric and Observational Study.\",\"authors\":\"Zuotao Zhao,Xiaoting Song,Yuanyuan Shang,Lijuan Liu,Rui Zheng,Jianxin Xia,Qiang Liu,Guodong Hao,Jie Li,Songmei Geng,Jingang An,Qiang Wang,Xiaoyan Liu,Jianping Tang,Yizhu Xiao,Litao Zhang\",\"doi\":\"10.1111/all.16478\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"BACKGROUND\\r\\nThe efficacy and safety of dupilumab in patients with refractory prurigo nodularis (PN) is well established in clinical trials, but there is a lack of multicenter data regarding its effectiveness and safety in real-world settings.\\r\\n\\r\\nMETHODS\\r\\nPatients with moderate-to-severe PN who initiated dupilumab treatment between July 2023 and January 2024, with a follow-up period of at least 16 weeks at 10 hospitals in China were included. We used peak pruritus numeric rating scale (PP-NRS), investigator global assessment (IGA) for PN, and dermatology life quality index for adults or children (DLQI/CDLQI) to assess disease control status and quality of life impairment, and monitored adverse events to assess the safety.\\r\\n\\r\\nRESULTS\\r\\nA total of 73 PN patients (33 female, 40 male; mean age 45.9 ± 21.5 years) were included. A clinically meaningful improvement of ≥ 4 points in PP-NRS (PP-NRS4) was achieved in 84.9% of patients at Week 12. The percentage of patients achieving IGA 0/1 significantly increasing from 0% to 37.0% and 46.6% at Week 12 and 16, respectively. Patient-reported quality of life outcomes showed substantial improvement, with decreasing from 16.6 ± 6.8 at baseline to 7.2 ± 4.9 at Week 12, 6.4 ± 4.5 at Week 16. The safety profile of dupilumab was favorable, with one patient reporting dry eyes.\\r\\n\\r\\nCONCLUSION\\r\\nDupilumab can effectively improve the pruritus, nodular lesions and quality of life for PN in real-world settings.\",\"PeriodicalId\":122,\"journal\":{\"name\":\"Allergy\",\"volume\":\"74 1\",\"pages\":\"\"},\"PeriodicalIF\":12.6000,\"publicationDate\":\"2025-01-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/all.16478\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/all.16478","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
Effectiveness and Safety of Dupilumab for Prurigo Nodularis in China: A Multicentric and Observational Study.
BACKGROUND
The efficacy and safety of dupilumab in patients with refractory prurigo nodularis (PN) is well established in clinical trials, but there is a lack of multicenter data regarding its effectiveness and safety in real-world settings.
METHODS
Patients with moderate-to-severe PN who initiated dupilumab treatment between July 2023 and January 2024, with a follow-up period of at least 16 weeks at 10 hospitals in China were included. We used peak pruritus numeric rating scale (PP-NRS), investigator global assessment (IGA) for PN, and dermatology life quality index for adults or children (DLQI/CDLQI) to assess disease control status and quality of life impairment, and monitored adverse events to assess the safety.
RESULTS
A total of 73 PN patients (33 female, 40 male; mean age 45.9 ± 21.5 years) were included. A clinically meaningful improvement of ≥ 4 points in PP-NRS (PP-NRS4) was achieved in 84.9% of patients at Week 12. The percentage of patients achieving IGA 0/1 significantly increasing from 0% to 37.0% and 46.6% at Week 12 and 16, respectively. Patient-reported quality of life outcomes showed substantial improvement, with decreasing from 16.6 ± 6.8 at baseline to 7.2 ± 4.9 at Week 12, 6.4 ± 4.5 at Week 16. The safety profile of dupilumab was favorable, with one patient reporting dry eyes.
CONCLUSION
Dupilumab can effectively improve the pruritus, nodular lesions and quality of life for PN in real-world settings.
期刊介绍:
Allergy is an international and multidisciplinary journal that aims to advance, impact, and communicate all aspects of the discipline of Allergy/Immunology. It publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors, and correspondences. The journal accepts articles based on their scientific merit and quality.
Allergy seeks to maintain contact between basic and clinical Allergy/Immunology and encourages contributions from contributors and readers from all countries. In addition to its publication, Allergy also provides abstracting and indexing information. Some of the databases that include Allergy abstracts are Abstracts on Hygiene & Communicable Disease, Academic Search Alumni Edition, AgBiotech News & Information, AGRICOLA Database, Biological Abstracts, PubMed Dietary Supplement Subset, and Global Health, among others.