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在一项真实世界注册研究(PROSE)中开始使用度普利尤单抗治疗的成年特应性皮炎患者的基线人口统计学、严重程度和负担

Baseline Demographics and Severity and Burden of Atopic Dermatitis in Adult Patients Initiating Dupilumab Treatment in a Real-World Registry (PROSE).

作者信息

Bagel Jerry, Nguyen Tien Q, Lima Hermenio, Jain Neal, Pariser David M, Hsu Sylvia, Yosipovitch Gil, Zhang Haixin, Chao Jingdong, Bansal Shikha, Chen Zhen, Richman Daniel, Korotzer Andrew, Ardeleanu Marius

机构信息

Eczema Treatment Center of New Jersey, East Windsor, NJ, USA.

The First OC Dermatology, Fountain Valley, CA, USA.

出版信息

Dermatol Ther (Heidelb). 2022 Jun;12(6):1417-1430. doi: 10.1007/s13555-022-00742-w. Epub 2022 May 20.

Abstract

INTRODUCTION

Dupilumab was initially approved in 2017 as the first biologic therapy for atopic dermatitis (AD). We characterized adults with AD initiating dupilumab in a real-world setting in the USA/Canada.

METHODS

PROSE is an ongoing, longitudinal, prospective, observational, multicenter registry of patients with AD initiating dupilumab per country-specific prescribing information. We report baseline data (day of first dupilumab injection) for patients enrolled from April 2018 through July 2019.

RESULTS

Among 315 patients (mean age 42.5 years, 55.2% female), the median AD duration was 17.0 years; 65.4% reported a history of type 2 inflammatory comorbidities (e.g., allergic rhinitis, asthma), and 93.3% reported treatment(s) for AD in the previous year, including topical corticosteroids (90.8%), systemic corticosteroids (36.2%), and nonsteroidal systemic therapies (14.0%). In total, 89.2% had an Overall Disease Severity score of 3 (moderate) or 4 (severe). Other mean disease severity scores included the following: Eczema Area and Severity Index 16.9 (range 0-72), body surface area affected 26.8%, Patient-Oriented Eczema Measure 18.5 (range 0-28), Dermatology Life Quality Index 12.7 (range 0-30), and pruritus Numerical Rating Scale score 6.9 (range 0-10).

CONCLUSION

Patients initiating dupilumab have longstanding moderate-to-severe AD with significant disease burden and frequent type 2 comorbidities.

GOV IDENTIFIER

NCT03428646.

摘要

引言

度普利尤单抗于2017年首次获批,是首个用于治疗特应性皮炎(AD)的生物疗法。我们对美国/加拿大现实环境中开始使用度普利尤单抗的成年AD患者进行了特征描述。

方法

PROSE是一项正在进行的、纵向、前瞻性、观察性、多中心注册研究,纳入依据各国特定处方信息开始使用度普利尤单抗的AD患者。我们报告了2018年4月至2019年7月入组患者的基线数据(首次注射度普利尤单抗的日期)。

结果

在315例患者中(平均年龄42.5岁,55.2%为女性),AD的中位病程为17.0年;65.4%的患者报告有2型炎症性合并症病史(如过敏性鼻炎、哮喘),93.3%的患者报告在前一年接受过AD治疗,包括外用糖皮质激素(90.8%)、全身性糖皮质激素(36.2%)和非甾体类全身治疗(14.0%)。总体而言,89.2%的患者总体疾病严重程度评分为3(中度)或4(重度)。其他平均疾病严重程度评分如下:湿疹面积和严重程度指数为16.9(范围0 - 72),受累体表面积为26.8%,患者导向性湿疹评估为18.5(范围0 - 28),皮肤病生活质量指数为12.7(范围0 - 30),瘙痒数字评定量表评分为6.9(范围0 - 10)。

结论

开始使用度普利尤单抗的患者患有长期的中度至重度AD,疾病负担较重且常有2型合并症。

政府标识符

NCT03428646

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