Skin Clearance, Duration of Treatment-free Interval, and Safety of Tapinarof Cream 1% Once Daily: Results from ADORING 3, a 48-week Phase 3 Open-label Extension Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis.
Academic Article
Overview
abstract
BACKGROUND: In two pivotal phase 3 trials, tapinarof demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis. OBJECTIVE: Assess skin clearance rates, duration of treatment-free intervals, and safety of tapinarof in a phase 3 open-label extension trial. METHODS: Patients from the ADORING 1 and 2 pivotal phase 3 trials, a 4-week maximal usage pharmacokinetics trial, and tapinarof-naive patients received tapinarof for up to 48 weeks. Treatment was based on Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) score. Patients with vIGA-AD™≥1 received tapinarof until vIGA-AD™=0. Patients achieving vIGA-AD™=0 discontinued tapinarof and were monitored for treatment-free interval. Patients with vIGA-AD™≥2 were re-treated until vIGA-AD™=0. RESULTS: 728 patients enrolled. Overall, 51.9% achieved vIGA-AD™=0, and 81.6% achieved vIGA-AD™=0 or 1 at least once. After first achieving complete clearance and discontinuing treatment, the mean first treatment-free interval was 79.8 consecutive days. Tapinarof was well tolerated, with no new safety signals. Most-frequent adverse events were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). LIMITATIONS: Open-label; treatment-free interval potentially underestimated. CONCLUSION: Tapinarof was well tolerated and resulted in high skin clearance rates that were maintained off-therapy and consistent safety in patients down to age 2 years.
