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GLOBOSTAD 长期观察性研究中的成人和青少年特应性皮炎的基线人口统计学、合并症、治疗模式和负担。

Baseline Demographics, Comorbidities, Treatment Patterns and Burden of Atopic Dermatitis in Adults and Adolescents from the GLOBOSTAD Long-Term Observational Study.

机构信息

Dermatology Department, University of Brescia, Brescia, Italy.

Department of Dermatology and Venereology, Faculty Hospital and Medical Faculty of Charles University, Hradec Králové, Czech Republic.

出版信息

Adv Ther. 2023 Dec;40(12):5366-5382. doi: 10.1007/s12325-023-02644-5. Epub 2023 Oct 6.

Abstract

INTRODUCTION

Insights into real-world treatment of atopic dermatitis (AD) are relevant to clinical decision making. The aim of this analysis was to characterize patients who receive dupilumab for AD in a real-world setting.

METHODS

The GLOBOSTAD registry is an ongoing, longitudinal, prospective, observational study of patients with AD who receive dupilumab according to country-specific prescribing information. We report baseline characteristics, comorbidities and treatment patterns for patients enrolled from July 11, 2019 to March 31, 2022. Analyses are descriptive; no formal statistical comparisons were performed.

RESULTS

Nine hundred fifty-two adults and adolescents were enrolled in GLOBOSTAD. Patients had a high disease burden before starting dupilumab: (mean [standard deviation]) percent body surface area affected (44.8 [24.42]), Eczema Area and Severity Index total score (24.8 [12.95]), SCORing Atopic Dermatitis total score (60.5 [16.34]), Patient-Oriented Eczema Measure total score (19.7 [6.37]) and Dermatology Life Quality Index total score (13.7 [7.02]). Overall, 741 (77.8%) patients reported ≥ 1 type 2 inflammatory comorbidities, most frequently allergic rhinitis (492 [51.7%]), asthma (323 [33.9%]), food allergy (294 [30.9%]) or another allergy (274 [28.8%]). In the previous 12 months, 310 (32.6%) patients had received systemic non-steroidal immunosuppressants and 169 (17.8%) systemic corticosteroids; 449 (47.2%) had received topical corticosteroids, most commonly potent topical corticosteroids; 141 (14.8%) had received topical calcineurin inhibitors and 32 (3.4%) ultraviolet therapy. Most (713 [74.9%]) patients started dupilumab because of prior treatment failure.

CONCLUSION

Patients enrolled in GLOBOSTAD demonstrated considerable multidimensional burden of disease across AD signs, symptoms and quality of life despite previous use of systemic and non-systemic AD treatments.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT03992417. Video Abstract.

摘要

简介

了解特应性皮炎(AD)的真实世界治疗情况有助于临床决策。本分析的目的是描述在真实环境中接受度普利尤单抗治疗的 AD 患者的特征。

方法

GLOBOSTAD 登记处是一项正在进行的、纵向的、前瞻性、观察性研究,纳入了根据国家特定处方信息接受度普利尤单抗治疗的 AD 患者。我们报告了 2019 年 7 月 11 日至 2022 年 3 月 31 日期间入组患者的基线特征、合并症和治疗模式。分析为描述性的,未进行正式的统计学比较。

结果

GLOBOSTAD 共纳入 952 名成人和青少年患者。患者在开始度普利尤单抗治疗前疾病负担较高:(平均值[标准差])体表面积受累百分比(44.8[24.42])、湿疹面积和严重程度指数总评分(24.8[12.95])、SCORing 特应性皮炎总评分(60.5[16.34])、患者导向湿疹测量总评分(19.7[6.37])和皮肤病生活质量指数总评分(13.7[7.02])。总体而言,741 名(77.8%)患者报告有≥1 种 2 型炎症性合并症,最常见的是过敏性鼻炎(492 名[51.7%])、哮喘(323 名[33.9%])、食物过敏(294 名[30.9%])或其他过敏(274 名[28.8%])。在过去 12 个月中,310 名(32.6%)患者接受过全身非甾体类免疫抑制剂治疗,169 名(17.8%)患者接受过全身皮质类固醇治疗;449 名(47.2%)患者接受过局部皮质类固醇治疗,最常见的是强效局部皮质类固醇;141 名(14.8%)患者接受过局部钙调磷酸酶抑制剂治疗,32 名(3.4%)患者接受过紫外线治疗。大多数(713 名[74.9%])患者因先前治疗失败而开始接受度普利尤单抗治疗。

结论

尽管先前使用过 AD 的全身和非全身治疗,但 GLOBOSTAD 入组患者的 AD 体征、症状和生活质量的多维疾病负担仍相当大。

临床试验注册

ClinicalTrials.gov 标识符 NCT03992417。视频摘要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3038/10611842/98e4381a74fe/12325_2023_2644_Fig1_HTML.jpg

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