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
Keywords
tapinarof, adolescent, adult, African American, age, atopic dermatitis, body surface, Caucasian, child, conference abstract, controlled study, cream, drug therapy, female, human, long term care, major clinical study, male, multicenter study, pediatric patient, pharmacokinetics, phase 3 clinical trial, phenotype, randomized controlled trial, severity of illness index, side effect, treatment response
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
