Pediatric AD: Tapinarof Cream 1% Delivers Clear Skin and Reduced Burden

In the pivotal ADORING 1 and 2 phase 3 trials, tapinarof cream 1% (VTAMA, Organon) showed consistent and statistically significant efficacy across all pediatric age groups in children with atopic dermatitis (AD), with benefits extending to sleep and family impact outcomes.

Across the two multicenter, randomized, double-blind, vehicle-controlled trials, 813 patients in the US and Canada were enrolled, including more than 80% aged 2 to 17 years. At baseline, approximately 87% to 90% had moderate disease severity (vIGA-AD™ score of 3), and the mean Eczema Area and Severity Index (EASI) scores indicated moderate to severe AD.

Children treated with once-daily tapinarof cream achieved significantly higher rates of vIGA-AD™ response at Week 8 (clear or almost clear skin with ≥2-grade improvement) compared to vehicle in both trials: 45.4% vs 13.9% in ADORING 1 and 46.4% vs 18.0% in ADORING 2 (P < .0001 for both). Efficacy was consistent across pediatric age groups. For example, among children 2–6 years old, response rates were 61.8% with tapinarof vs 7.5% with vehicle in ADORING 1, and 50.0% vs 17.0% in ADORING 2.

Secondary endpoints also favored tapinarof. EASI 75 (≥75% improvement from baseline) response rates were significantly higher in the active treatment arms: 55.8% vs 22.9% (ADORING 1) and 59.1% vs 21.2% (ADORING 2), with consistent outcomes across pediatric age groups. In addition, tapinarof significantly reduced mean body surface area (BSA) affected at Week 8 compared to vehicle (e.g., –9.4% vs –3.2% in ADORING 1; P < .0001).

Tapinarof was well tolerated in both studies. The most common treatment-emergent adverse events (TEAEs) were mild or moderate, including folliculitis, headache, and nasopharyngitis. Discontinuation rates due to TEAEs were low and numerically lower in the tapinarof groups compared to vehicle. Local tolerability was favorable, including when applied to sensitive skin areas, as reported by patients, caregivers, and investigators.

“Tapinarof cream 1% QD monotherapy demonstrated significant and clinically meaningful efficacy in children aged 2–17 years with AD across multiple clinical measures,” the authors concluded. “Tapinarof is a once-daily, non-steroidal cream with no restrictions on duration, extent, or location of use, and without the need for long-term maintenance therapy”.