53928 Tapinarof Cream 1% Once Daily: Interim Analysis of ADORING 3 Phase 3 Long-term Extension Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis
Recommended Citation
Bissonnette R, Stein-Gold L, Kircik L, Eichenfield LF, Hong H, Papp KA, Tallman AM, Piscitelli SC, Rubenstein DS, Brown PM, Silverberg JI. 53928 Tapinarof Cream 1% Once Daily: Interim Analysis of ADORING 3 Phase 3 Long-term Extension Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis. J Am Acad Dermatol 2024; 91(3):AB88.
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 and was well-tolerated in adults and children down to 2 years of age with moderate to severe atopic dermatitis (AD) in two pivotal phase 3 trials (ADORING 1 and 2). Here, we present baseline characteristics and outcomes from the prespecified interim analysis of ADORING 3, the long-term extension trial assessing safety and efficacy of up to 48-weeks’ open-label tapinarof. 728 patients enrolled in ADORING 3, representing a large, diverse AD population comprising a high proportion (91%) of eligible patients from the pivotal ADORING trials, 28 patients from a 4-week maximal usage pharmacokinetic trial, and an additional 76 tapinarof-naive patients aged 2-17 years with various disease severities (mild; or moderate or worse with body surface area [BSA] ≥40%), who were ineligible for preceding trials. The majority of patients in ADORING 3 were pediatric; 26.6% were aged 2-6 years; 27.1% 7-11 years; 29.3% 12-17 years; and 17.0% were adults. Overall, 46.6% were male, 52.6% White, 11.1% Asian, 30.1% Black/African American, and 4.4% other race categories. Patients with AD present different phenotypes and treatment responses. A high proportion of primarily pediatric patients elected to rollover from previous trials, and the diverse population enrolled in ADORING 3 is representative across the broad spectrum of disease severity, BSA affected (up to 95%), and demographics. No new safety signals were reported with long-term treatment in this interim analysis. The full analysis in 2024 will report further safety and efficacy data with tapinarof cream 1% QD.
Volume
91
Issue
3
First Page
AB88
