53949 Tapinarof Cream 1% Once Daily was Well Tolerated for the Treatment of Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis Across Two Pivotal Phase 3 Trials
Recommended Citation
Stein-Gold L, Del Rosso J, Ehst BD, Zirwas MJ, Green LJ, Brown PM, Tallman AM, Rubenstein DS, Piscitelli SC. 53949 Tapinarof Cream 1% Once Daily was Well Tolerated for the Treatment of Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis Across Two Pivotal Phase 3 Trials. J Am Acad Dermatol 2024; 91(3):AB321.
Document Type
Conference Proceeding
Publication Date
9-1-2024
Publication Title
J Am Acad Dermatol
Abstract
Tapinarof cream 1% once daily (QD) demonstrated significant efficacy versus vehicle in adults and children down to 2 years of age with moderate to severe atopic dermatitis (AD) in the pivotal phase 3 ADORING 1 and 2 trials. Here, we report local tolerability results for tapinarof cream. In ADORING 1 and 2, patients were randomized 2:1 to tapinarof cream or vehicle QD for 8 weeks. Tolerability was evaluated using patient- and investigator-assessed Local Tolerability Scale (LTS) scores on a 5-point scale (range 0-4; 0=none to 4=severe). Investigators also assessed irritation scores for sensitive/intertriginous skin areas. 407 and 406 patients (>80% aged <18 years) were randomized. Mean baseline, pre-treatment LTS scores were similar in tapinarof and vehicle groups across trials (patient-assessed overall scores, 1.0-1.9; investigator-assessed overall scores, 0.3-0.6). Tapinarof was well tolerated with patients reporting none (LTS=0) or slight (LTS=1) local burning/stinging and itching, with improvement from baseline. At Week 8, mean LTS scores with tapinarof cream were 0.2-0.4 (burning/stinging) and 0.6-0.8 (itching) across trials. Investigator-assessed mean LTS scores across tapinarof groups also showed no irritation (dryness/erythema/peeling) with improvement from baseline at Week 8: mean scores were 0.2 and 0.1 in ADORING 1 and 2, respectively. Across sensitive and intertriginous areas, mean scores were 0-0.3 and 0-0.1. Tapinarof cream 1% QD had favorable patient- or investigator-assessed local tolerability, including on sensitive and intertriginous skin, in adults and children down to 2 years of age with moderate to severe AD. Improvements from baseline with tapinarof were possibly due to skin barrier repair.
Volume
91
Issue
3
First Page
AB321
