Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-07 DOI:10.1007/s13555-024-01318-6

Eric L Simpson, Adelaide A Hebert, John Browning, Rocco T Serrao, Howard Sofen, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman

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引用次数: 0

Abstract

Introduction: Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2.

Methods: In ADORING 1 and 2, 813 patients were randomized to tapinarof or vehicle QD for 8 weeks. PROs were assessed using the Dermatology Life Quality Index (DLQI), Children's Dermatology Life Quality Index (CDLQI), Infants' Dermatitis Quality of Life Index (IDQOL), Dermatitis Family Impact Questionnaire (DFI), and Patient Oriented Eczema Measure (POEM).

Results: Mean baseline DLQI, CDLQI, IDQOL, and DFI scores indicated that the impact on families and patients' quality of life (QoL) of AD was moderate to very large. Mean POEM scores indicated moderate to severe AD symptoms at baseline. Tapinarof improved QoL versus vehicle across all endpoints at week 8: DLQI, - 6.2 vs - 3.5 (P = 0.0031) and - 5.5 vs - 3.5 (P = 0.0028); DFI, - 5.6 vs - 2.9 (P < 0.0001) and - 5.6 vs - 3.8 (P = 0.0037), in ADORING 1 and 2, respectively. Similar improvements in CDLQI and IDQOL were reported with tapinarof versus vehicle. Tapinarof also significantly improved CDLQI, DFI, and POEM sleep subdomain scores versus vehicle. POEM scores also improved with tapinarof versus vehicle: ≥ 12 years, - 9.4 vs - 5.3 and - 10.6 vs - 3.6 (both P < 0.0001); < 12 years, - 11.4 vs - 5.7 (P < 0.0001), and - 10.8 vs - 7.3 (P = 0.0005).

Conclusions: Tapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD.

Trial registration: Clinical Trials.gov identifier: NCT05014568; NCT05032859.

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在成人和儿童的两项3期特应性皮炎试验中，Tapinarof改善了患者和家属的结局和睡眠。

Tapinarof是一种正在开发的用于治疗特应性皮炎（AD）的局部芳烃受体（AhR）激动剂。在两项3期试验（ADORING 1和ADORING 2）中，tapinarof霜1%每日一次（QD）显示出显著的疗效，并且在2岁以下AD患者中具有良好的耐受性。在这里，我们评估了患者报告的结果（PROs），包括家庭影响，在ADORING 1和2中使用tapinarof。方法：在ADORING 1和2组中，813例患者随机接受tapinarof或车辆QD治疗，为期8周。采用皮肤病学生活质量指数（DLQI）、儿童皮肤病学生活质量指数（CDLQI）、婴儿皮炎生活质量指数（IDQOL）、皮炎家庭影响问卷（DFI）和患者导向湿疹量表（POEM）对PROs进行评估。结果：平均基线DLQI、CDLQI、IDQOL和DFI评分表明，AD对家庭和患者生活质量（QoL）的影响是中等到非常大的。平均POEM评分在基线时显示中度至重度AD症状。在第8周，Tapinarof改善了所有终点的生活质量，DLQI分别为- 6.2 vs - 3.5 （P = 0.0031）和- 5.5 vs - 3.5 (P = 0.0028)；结论：从第1周（最早评估）到第8周，Tapinarof显著改善了所有专业人员的生活质量，包括睡眠和家庭影响，无论年龄。Tapinarof是一种每日一次的非甾体软膏，可迅速改善2岁以下AD患者的症状、睡眠和生活质量。试验注册：Clinical Trials.gov标识符：NCT05014568；NCT05032859。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.