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一项真实世界观察性研究:度普利尤单抗治疗结节性痒疹成人患者的疗效。

A real-world observational study of dupilumab treatment in adult patients with prurigo nodularis.

机构信息

Department of Dermatology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Disease, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China.

Department of Dermatology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Disease, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China.

出版信息

An Bras Dermatol. 2023 Jul-Aug;98(4):440-448. doi: 10.1016/j.abd.2022.09.008. Epub 2023 Mar 23.

Abstract

BACKGROUND

Prurigo nodularis (PN) is a chronic inflammatory skin condition that has a significant unmet needs for effective treatment options.

OBJECTIVE

To assess the efficacy and safety of dupilumab in adult patients with PN refractory to traditional therapies.

METHODS

This ongoing, real-life study examined dupilumab treatment in 8 adult patients diagnosed with PN for at least 6 months. The included patients were prescribed 300 mg dupilumab biweekly for at least 16 weeks. Efficacy was the primary outcome by means of multiple standardized scale measurements while safety was also reported.

RESULTS

PN patients treated with dupilumab showed notable clinical improvement. After 16 weeks of dupilumab treatment, the mean Investigator Global Assessment (IGA) score reduced from 3.75 to 1.50. Patients mean Numerical Rating Scale Itch Intensity (NRSI), Dermatology Life Quality Index (DLQI), and Hospital Anxiety and Depression Scale (HADS) ratings reduced from 8.625, 15.13, and 14.50 to 1.563, 4.625, and 1.000 respectively. The majority of the patients (87.5%) reported dupilumab as effective while no adverse events have been reported.

STUDY LIMITATIONS

This study was limited to a small cohort of adult PN patients and a short-time observation period.

CONCLUSIONS

Dupilumab is effective and tolerable in adult PN patients with significant improvement in skin lesions, itching, and quality of life.

摘要

背景

结节性痒疹(PN)是一种慢性炎症性皮肤病,其有效治疗方法存在重大未满足的需求。

目的

评估度普利尤单抗治疗对传统疗法难治的成人 PN 患者的疗效和安全性。

方法

本正在进行的真实世界研究检查了 8 名至少被诊断为 PN 6 个月的成年患者接受度普利尤单抗治疗的情况。纳入的患者接受了至少 16 周、每两周 300mg 的度普利尤单抗治疗。主要疗效终点是通过多种标准化量表测量的,同时还报告了安全性。

结果

接受度普利尤单抗治疗的 PN 患者表现出明显的临床改善。在接受度普利尤单抗治疗 16 周后,研究者整体评估(IGA)评分从 3.75 降至 1.50。患者的数字评分瘙痒强度(NRSI)、皮肤病生活质量指数(DLQI)和医院焦虑抑郁量表(HADS)评分分别从 8.625、15.13 和 14.50 降至 1.563、4.625 和 1.000。大多数患者(87.5%)认为度普利尤单抗有效,且无不良反应报告。

研究局限性

本研究仅限于一小部分成人 PN 患者和较短的观察期。

结论

度普利尤单抗对成人 PN 患者有效且耐受良好,可显著改善皮肤病变、瘙痒和生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/172c/10334323/d51addc8f41b/gr1.jpg

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