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

Document Type

Conference Proceeding

Publication Date

4-1-2024

Publication Title

Journal of Managed Care and Specialty Pharmacy

Keywords

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

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

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