IF 3.5 3区 医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2025-02-01 Epub Date: 2025-02-04 DOI:10.1007/s13555-024-01320-y
Jonathan I Silverberg, Eric L Simpson, Andrew E Pink, Stephan Weidinger, Gary Chan, Pinaki Biswas, Claire Clibborn, Erman Güler
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引用次数: 0

摘要

简介JADE DARE试验(NCT04345367)的初步结果表明,在减轻中度至重度特应性皮炎(AD)的体征和症状方面,阿昔替尼优于杜比鲁单抗。这项事后分析采用不同的反应定义,评估了阿罗西替尼对中重度特应性皮炎患者的疗效和安全性:数据包括JADE DARE中接受过杜比鲁单抗治疗的患者,这些患者在参加正在进行的JADE EXTEND试验(NCT03422822)时改用阿罗西替尼200毫克。在这项分析中,JADE DARE 第 26 周的各种反应标准是根据研究者总体评估 (IGA)、湿疹面积和严重程度指数 (EASI)、瘙痒峰值数字评定量表 (PP-NRS) 和皮肤科生活质量指数 (DLQI) 评分或反应临时定义的。根据患者在 JADE DARE 第 26 周达到的各种反应标准,在 JADE EXTEND 第 12 周进行疗效分析。将 JADE DARE 第 26 周的 EASI 评分以及 EASI 和 PP-NRS 与基线相比的百分比变化与 EXTEND 第 12 周的相应评分和百分比变化进行比较。对安全性进行了评估:在 JADE DARE 的 365 例杜比鲁单抗治疗患者中,有 316 例参加了 JADE EXTEND,其中 312 例接受了阿罗西替尼 200 毫克治疗。在DARE第26周,大多数对IGA、EASI、PP-NRS和DLQI有反应的患者在改用阿罗西替尼治疗12周后仍有反应,而相当一部分对IGA、EASI、PP-NRS或DLQI无反应的患者在改用阿罗西替尼治疗后获得了反应。在EXTEND第12周观察到的EASI评分较低,EASI和PP-NRS评分与基线相比的百分比变化较大;在DARE第26周观察到的EASI评分较低,EASI和PP-NRS评分与基线相比的百分比变化较大。未观察到新的安全性信号:临床试验注册:临床试验注册:Clinicaltrials.gov:临床试验注册:Clinicaltrials.gov:NCT04345367(JADE DARE)和NCT03422822(JADE EXTEND)。
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Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE.

Introduction: Primary results of the JADE DARE trial (NCT04345367) demonstrated that abrocitinib was superior to dupilumab in reducing the signs and symptoms of moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with moderate-to-severe AD who were responders or nonresponders to dupilumab using various definitions of response.

Methods: Data included dupilumab-treated patients from JADE DARE who switched to abrocitinib 200 mg when enrolled in the ongoing JADE EXTEND trial (NCT03422822). For this analysis, various response criteria at Week 26 of JADE DARE were defined post hoc based on Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) scores or responses. Efficacy was analyzed at Week 12 of JADE EXTEND based on patients' fulfillment of the various response criteria at Week 26 of JADE DARE. EASI scores and percentage changes from baseline in EASI and PP-NRS at Week 26 in JADE DARE were compared with the corresponding scores and percentage changes at Week 12 in EXTEND. Safety was assessed.

Results: Of 365 dupilumab-treated patients in JADE DARE, 316 were enrolled in JADE EXTEND and 312 received abrocitinib 200 mg. Most dupilumab responders for IGA, EASI, PP-NRS, and DLQI at DARE Week 26 maintained their responses 12 weeks after switching to abrocitinib, while a considerable proportion of IGA, EASI, PP-NRS, or DLQI dupilumab nonresponders gained response after switching to abrocitinib. Lower EASI scores and greater percentage changes from baseline in EASI and PP-NRS scores were observed with abrocitinib at EXTEND Week 12 than with dupilumab at DARE Week 26. No new safety signals were observed.

Conclusion: Abrocitinib 200 mg may be an effective treatment option for patients with moderate-to-severe AD who do not achieve an optimal response with dupilumab treatment.

Clinical trial registration: Clinicaltrials.gov: NCT04345367 (JADE DARE) and NCT03422822 (JADE EXTEND).

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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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