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在3期JADE COMPARE研究中,使用阿布昔替尼治疗时中重度特应性皮炎体征/症状按身体部位改善的速度

Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study.

作者信息

Alexis Andrew, de Bruin-Weller Marjolein, Weidinger Stephan, Soong Weily, Barbarot Sebastien, Ionita Ileana, Zhang Fan, Valdez Hernan, Clibborn Claire, Yin Natalie

机构信息

Weill Cornell Medical College, New York, NY, USA.

University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

Dermatol Ther (Heidelb). 2022 Mar;12(3):771-785. doi: 10.1007/s13555-022-00694-1. Epub 2022 Mar 17.

Abstract

INTRODUCTION

Atopic dermatitis (AD) can affect multiple body regions and is especially burdensome when involving exposed skin areas. Rapid, effective treatment of AD across body regions remains an unmet need, particularly for difficult-to-treat areas such as the head and neck area. We investigated the temporal and regional patterns of clinical improvement in AD with the use of abrocitinib, an orally available Janus kinase 1 selective inhibitor under development for the treatment of moderate-to-severe AD.

METHODS

We performed a post hoc analysis of data from JADE COMPARE, a phase 3, multicenter, randomized, double-blind, double-dummy trial that evaluated the efficacy and safety of abrocitinib 200 mg once daily, abrocitinib 100 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, and placebo in adult patients with moderate-to-severe AD who were concomitantly receiving medicated topical therapy. Assessments included the Eczema Area and Severity Index (EASI) and SCORing Atopic Dermatitis (SCORAD) index.

RESULTS

With abrocitinib 200 mg, time to ≥ 75% improvement in EASI (EASI-75) occurred at a median of 29 days across body regions, including the head and neck region. With abrocitinib 100 mg, EASI-75 response was achieved at a median of 30-32 days for the trunk and lower limbs, and at 56-57 days for the head and neck region and upper limbs. With dupilumab, EASI-75 response was achieved at a median of 43 days for the trunk and 57 days for other regions. EASI body region scores significantly improved with abrocitinib 200 mg and 100 mg versus placebo at week 2 (p < 0.0001 for all comparisons). Improvements with abrocitinib were maintained up to week 16.

CONCLUSIONS

Rapid and persistent improvement in AD across all body regions was observed with abrocitinib treatment. Abrocitinib may be useful in patients with AD that affects difficult-to-treat anatomical areas or who require a rapid response.

TRIAL REGISTRATION

Clinicaltrials.gov identifier: NCT03720470.

摘要

引言

特应性皮炎(AD)可累及身体多个部位,当累及暴露皮肤区域时,负担尤为沉重。在全身各部位快速、有效地治疗AD仍然是未被满足的需求,尤其是对于头颈部等难治部位。我们使用阿布昔替尼(一种正在开发用于治疗中度至重度AD的口服可用的Janus激酶1选择性抑制剂),研究了AD临床改善的时间和区域模式。

方法

我们对JADE COMPARE试验的数据进行了事后分析,这是一项3期、多中心、随机、双盲、双模拟试验,评估了每日一次200mg阿布昔替尼、每日一次100mg阿布昔替尼、每2周皮下注射300mg度普利尤单抗和安慰剂在中度至重度AD成年患者中的疗效和安全性,这些患者同时接受药物局部治疗。评估包括湿疹面积和严重程度指数(EASI)和特应性皮炎评分(SCORAD)指数。

结果

使用200mg阿布昔替尼时,全身各部位(包括头颈部)达到EASI改善≥75%(EASI-75)的时间中位数为29天。使用100mg阿布昔替尼时,躯干和下肢达到EASI-75反应的时间中位数为30 - 32天,头颈部和上肢为56 - 57天。使用度普利尤单抗时,躯干达到EASI-75反应的时间中位数为43天,其他部位为57天。在第2周时,与安慰剂相比,200mg和100mg阿布昔替尼的EASI身体区域评分显著改善(所有比较p < 0.0001)。阿布昔替尼的改善持续至第16周。

结论

使用阿布昔替尼治疗可观察到AD在全身各部位快速且持续的改善。阿布昔替尼可能对影响难治解剖部位或需要快速反应的AD患者有用。

试验注册

Clinicaltrials.gov标识符:NCT03720470。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7806/8940992/67df9aeb32c5/13555_2022_694_Fig1_HTML.jpg

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