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.

Abstract

In 2 pivotal phase 3 trials, tapinarof demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis. Assess skin clearance rates, duration of treatment-free intervals, and safety of tapinarof in a phase 3 open-label extension trial. 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. Seven hundred twenty-eight 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%). Open-label; treatment-free interval potentially underestimated. 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.