1. Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children.
- Author
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Simpson, Eric, Hebert, Adelaide, Browning, John, Serrao, Rocco, Sofen, Howard, Brown, Philip, Piscitelli, Stephen, Rubenstein, David, and Tallman, Anna
- Subjects
Atopic dermatitis ,Family impact ,Patient-reported outcomes ,Quality of life ,Sleep improvement ,Tapinarof cream 1% once daily ,Topical aryl hydrocarbon receptor agonist - 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), Childrens 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
- Published
- 2025