The identical phase 3 trials ADORING 1 (NCT05014568) and 2 (NCT05032859) investigated tapinarof as a treatment for AD. Included were 813 adult and paediatric participants aged 2 years or older1. The mean age of the participants was about 16 years with over 20% in the age group 2–6 years. Most participants (83.7–90.4%) had moderate disease (vIGA-AD 3), and all others had vIGA-AD 4. They were treated for over 8 weeks with either once daily tapinarof cream 1% or vehicle.
After 2 months, significantly higher proportions of participants in the tapinarof arms in both studies reached the primary endpoint of 0/1 in vIGA-AD: 45.4% and 46.4% vs 13.9% and 18.0% on placebo (P<0.0001 for both comparisons). Similarly, the results for the secondary endpoint of EASI75 in ADORING 1 and 2 were 55.8% vs 22.9% (P<0.0001) and 59.1% vs 21.2% (P<0.0001). In addition, a ≥4-point decrease on the Peak Pruritus Numerical Rating Scale (PP-NRS) was detected in favour of tapinarof in both trials: 55.8% vs 34.2% (P=0.0366) and 52.8% vs 24.1% (P=0.0015).
Folliculitis, headache, and nasopharyngitis were the most common adverse events with a rate of ≥5%. Dr Jonathan Silverberg (The George Washington University School of Medicine and Health Sciences, Washington DC, USA) described the study drug as overall well-tolerated with a predictable safety profile, also referring to existing large experience from the already FDA-approved indication for psoriasis.
“The take-home message is that tapinarof is a novel non-steroidal topical medication that has the potential to be used for the treatment of atopic dermatitis in patients down to 2 years without restrictions on duration, extent, or sites of application,” Dr Silverberg concluded.