Tapinarof cream 1% once daily: Interim analysis of ADORING 3 phase 3 long-term extension trial in adults and children down to age 2 years with atopic dermatitis
Recommended Citation
Bissonnette R, Stein Gold LF, Kircik L, Eichenfield LF, Chih-Ho Hong H, Papp KA, Tallman AM, Piscitelli SC, Rubenstein DS, Brown PM, Silverberg JI. Tapinarof cream 1% once daily: Interim analysis of ADORING 3 phase 3 long-term extension trial in adults and children down to age 2 years with atopic dermatitis. Journal of Managed Care and Specialty Pharmacy 2024; 30(4-a):S89.
Document Type
Conference Proceeding
Publication Date
4-1-2024
Publication Title
Journal of Managed Care and Specialty Pharmacy
Abstract
BACKGROUND: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy vs vehicle and was well tolerated in adults and children aged 2 years or older with atopic dermatitis (AD) in 2 pivotal phase 3 trials (ADORING 1 and 2). OBJECTIVE: To 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 cream 1% QD for adults and children with AD. METHODS: Patients completing the 8-week ADORING 1 and 2 trials, 4-week maximal usage pharmacokinetics trial, and direct-enrollers were eligible for 48-weeks' open-label treatment with tapinarof cream 1% QD. RESULTS: A total of 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 pharmacokinetics trial, and an additional 76 tapinarofnaive patients aged 2-17 years with various disease severities (mild; or moderate or worse with body surface area ≥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. CONCLUSIONS: Patients with AD present with 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, body surface area 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
30
Issue
4-a
First Page
S89
