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阿泊替尼治疗治疗难治性特应性皮炎患者的真实世界疗效。

Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis.

机构信息

Department of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.

出版信息

J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2537-2542. doi: 10.1111/jdv.19378. Epub 2023 Aug 2.

DOI:10.1111/jdv.19378
PMID:37478296
Abstract

BACKGROUND

Abrocitinib is a JAK-1 selective inhibitor registered for the treatment of moderate-to-severe atopic dermatitis (AD). Although efficacy and safety have been shown in phase 3 clinical trials, data on real-world patients with a treatment history of advanced systemics are scarce.

OBJECTIVES

The objective of the study was to evaluate the effectiveness and safety of abrocitinib treatment in patients with difficult-to-treat AD in daily practice.

METHODS

In this prospective observational single-centre study, all AD patients who started abrocitinib treatment in the context of standard care between April 2021 and December 2022 were included. Effectiveness was assessed using clinician- and patient-reported outcome measures. Adverse events were evaluated.

RESULTS

Forty-one patients were included. The majority (n = 30; 73.2%) had failed (ineffectiveness) on other targeted therapies, including JAK inhibitors (n = 14, 34%) and biologics (n = 16, 39%). Abrocitinib treatment resulted in a significant decrease in disease severity during a median follow-up period of 25 weeks (IQR 16-34). Median EASI score at baseline decreased from 14.7 (IQR 10.4-25.4) to 4.0 (IQR 1.6-11.4) at last review (p < 0.001). Median NRS itch decreased from 7.0 (IQR 5-8) to 3.0 (IQR 1-2) at last review (p < 0.001). The most frequently reported AEs included gastrointestinal symptoms (27.6%), acne (20.7%) and respiratory tract infections (17.2%). 16 (39%) patients discontinued abrocitinib treatment due to ineffectiveness, AEs or both (41.2%, 41.2% and 11.8%, respectively).

CONCLUSION

Abrocitinib can be an effective treatment for patients with moderate-to-severe AD in daily practice, including non-responders to other targeted therapies.

摘要

背景

阿巴西普是一种 JAK-1 选择性抑制剂,已注册用于治疗中重度特应性皮炎(AD)。尽管在 3 期临床试验中已显示出疗效和安全性,但关于具有先进系统治疗史的真实世界患者的数据却很少。

目的

本研究的目的是评估阿巴西普治疗日常实践中治疗困难的 AD 患者的有效性和安全性。

方法

在这项前瞻性观察性单中心研究中,纳入了 2021 年 4 月至 2022 年 12 月期间在标准治疗背景下开始阿巴西普治疗的所有 AD 患者。使用临床医生和患者报告的结局测量来评估疗效。评估不良事件。

结果

共纳入 41 例患者。大多数患者(n=30;73.2%)在其他靶向治疗中失败(无效),包括 JAK 抑制剂(n=14,34%)和生物制剂(n=16,39%)。在中位随访 25 周(IQR 16-34)期间,阿巴西普治疗可显著降低疾病严重程度。基线时 EASI 评分中位数从 14.7(IQR 10.4-25.4)降至最后一次评估时的 4.0(IQR 1.6-11.4)(p<0.001)。NRS 瘙痒评分中位数从 7.0(IQR 5-8)降至最后一次评估时的 3.0(IQR 1-2)(p<0.001)。最常报告的 AE 包括胃肠道症状(27.6%)、痤疮(20.7%)和呼吸道感染(17.2%)。16 例(39%)患者因无效、AE 或两者均因停止阿巴西普治疗(分别为 41.2%、41.2%和 11.8%)。

结论

阿巴西普在日常实践中可有效治疗中重度 AD 患者,包括对其他靶向治疗无应答的患者。

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