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度普利尤单抗治疗中国结节性痒疹的有效性和安全性:一项多中心观察性研究

Effectiveness and Safety of Dupilumab for Prurigo Nodularis in China: A Multicentric and Observational Study.

作者信息

Zhao Zuotao, Song Xiaoting, Shang Yuanyuan, Liu Lijuan, Zheng Rui, Xia Jianxin, Liu Qiang, Hao Guodong, Li Jie, Geng Songmei, An Jingang, Wang Qiang, Liu Xiaoyan, Tang Jianping, Xiao Yizhu, Zhang Litao

机构信息

Department of Dermatology, Tianjin Institute of Integrative Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.

Department of Dermatology and Venerology, Peking University First Hospital, Beijing, China.

出版信息

Allergy. 2025 May;80(5):1428-1435. doi: 10.1111/all.16478. Epub 2025 Jan 21.

Abstract

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.

摘要

背景

度普利尤单抗治疗难治性结节性痒疹(PN)患者的疗效和安全性在临床试验中已得到充分证实,但缺乏关于其在真实世界环境中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月期间开始使用度普利尤单抗治疗、在中国10家医院进行至少16周随访的中重度PN患者。我们使用瘙痒峰值数字评定量表(PP-NRS)、PN的研究者整体评估(IGA)以及成人或儿童皮肤病生活质量指数(DLQI/CDLQI)来评估疾病控制状态和生活质量损害,并监测不良事件以评估安全性。

结果

共纳入73例PN患者(女性33例,男性40例;平均年龄45.9±21.5岁)。12周时84.9%的患者在PP-NRS中实现了≥4分的具有临床意义的改善(PP-NRS4)。达到IGA 0/1的患者百分比在12周和16周时分别从0%显著增加到37.0%和46.6%。患者报告的生活质量结果显示有显著改善,从基线时的16.6±6.8降至12周时的7.2±4.9,16周时为6.4±4.5。度普利尤单抗的安全性良好,有1例患者报告出现干眼。

结论

在真实世界环境中,度普利尤单抗可有效改善PN患者的瘙痒、结节性皮损及生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1f8/12105062/ec1b306ad03a/ALL-80-1428-g002.jpg

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