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。

IF 12.6 1区 医学 Q1 ALLERGY
Allergy Pub Date : 2025-01-21 DOI:10.1111/all.16478
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
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引用次数: 0

摘要

dupilumab治疗难治性结节性痒疹(PN)的有效性和安全性在临床试验中得到了很好的证实,但在现实环境中缺乏关于其有效性和安全性的多中心数据。方法纳入2023年7月至2024年1月期间在中国10家医院接受杜匹单抗治疗的中重度PN患者,随访期至少16周。我们使用瘙痒峰数值评定量表(PP-NRS)、研究者全球评估量表(IGA)和成人或儿童皮肤病学生活质量指数(DLQI/CDLQI)来评估疾病控制状况和生活质量损害,并监测不良事件以评估安全性。结果共73例PN患者,其中女性33例,男性40例;平均年龄45.9±21.5岁)。在第12周,84.9%的患者在PP-NRS (PP-NRS4)方面达到了具有临床意义的≥4分的改善。在第12周和第16周,达到IGA 0/1的患者比例分别从0%显著增加到37.0%和46.6%。患者报告的生活质量结果显着改善,从基线的16.6±6.8下降到第12周的7.2±4.9,第16周的6.4±4.5。dupilumab的安全性是有利的,有一名患者报告眼睛干涩。结论杜匹单抗可有效改善PN患者的瘙痒、结节性病变和生活质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.
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来源期刊
Allergy
Allergy 医学-过敏
CiteScore
26.10
自引率
9.70%
发文量
393
审稿时长
2 months
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.
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