Two pivotal phase III trials show that a once-daily application of tapinarof cream 1% yields rapid treatment response ? as indicated by the vIGA-AD™×BSA* composite score ? in individuals with moderate-to-severe atopic dermatitis (AD).

The vIGA-AD™×BSA may provide a sensitive and simple measure of treatment response in clinical practice, has been shown to correlate with EASI** score, and is less time-consuming to perform than EASI. [J Am Acad Dermatol 2020;82:1187-1194; Br J Dermatol 2022;186:496-507]

“[In this] prespecified vIGA-AD™×BSA analyses from ADORING 1 and 2 … tapinarof cream 1% QD demonstrated rapid and statistically significant improvements in vIGA-AD™×BSA composite scores from week 1 through week 8 in adults and children down to 2 years of age with AD,” said the investigators.

The improvements in mean percent vIGA-AD™×BSA were significantly greater with tapinarof vs vehicle in both ADORING 1 (?30.4 percent vs ?13.9 percent) and 2 (?34.1 percent vs ?12.5 percent) as early as week 1 and persisted through week 8 (?72.5 percent vs ?38.8 percent and ?76 percent vs ?35 percent, respectively; p<0.0001 for all).

This treatment effect favouring tapinarof over vehicle was also seen in terms of mean change in vIGA-AD™×BSA from baseline across both trials at weeks 1 (?15 vs ?5.1 [ADORING 1] and ?19 vs ?6 [ADORING 2]) and 8 (?37.6 vs ?15.8 and ?41.9 vs ?20.5, respectively; p<0.0001 for all).

Week 2 improvement in 3yo

Of note, a 3-year-old patient with moderate AD at baseline (vIGA-AD™ 3) achieved the primary endpoint at week 4. The baseline vIGA-AD™×BSA score of 39 dropped to 10 at week 2 and plummeted to 2 by week 4, which persisted through week 8.

Itch at baseline, as reported by the parent/caregiver, was deemed severe based on the PP-NRS*** score of 9. “[The] reduction in itch surpassed the minimal clinically important ≥4-point improvement by week 2, and no-to-minimal itch (PP-NRS ≤1) was achieved at weeks 4 through 8,” the researchers said.

Consistent efficacy across all clinical outcome measures

Treatment-emergent adverse events (TEAEs) were mostly mild or moderate, the most common being folliculitis, headache, and nasopharyngitis. Study discontinuation rates due to TEAEs were lower with tapinarof vs vehicle in both ADORING 1 (1.9 percent vs 3.6 percent) and 2 (1.5 percent vs 3 percent).

In this analysis, 813 participants (n=407 and 406 from ADORING 1 and 2, respectively) were randomized 2:1 to tapinarof cream 1% or vehicle QD for 8 weeks. Eighty percent of the overall cohort were aged 2?17 years. The mean age was 15.6 years in ADORING 1 and 16.5 years in ADORING 2. About 55 percent of participants were female.

At baseline, nearly 90 percent of patients in ADORING 1 had a vIGA-AD™ score of 3 (moderate); the corresponding percentage in ADORING 2 was 84 percent. Across trials and treatment arms, the mean EASI score was 12.2?13.5, mean BSA affected was 15.8?17.7, and mean vIGA-AD™×BSA was 51.1?56.1.

The initial results of both ADORING trials have reflected the superior efficacy of tapinarof cream 1% QD over vehicle, with all primary and secondary endpoints achieved. [J Am Acad Dermatol 2024:91:457-465] The current findings align with the initial efficacy analysis and patient-reported outcomes. [Dermatol Ther (Heidelb) 2025;15:111-124]

“[Taken together,] tapinarof cream 1% QD demonstrated consistent, robust efficacy across all measures, including vIGA-AD™, EASI75**, and vIGA-AD™×BSA in adults and children with AD,” noted the investigators.

“Tapinarof is a highly effective, nonsteroidal topical treatment option for patients down to 2 years of age with AD that can be used without restrictions on duration of use, extent of BSA treated, or application site,” they concluded.