Atopic dermatitis (AD) patients aged 2 and older who used tapinarof cream, 1% (Vtama, Dermavant) showed “early, significant, and meaningful” improvements in itch and sleep, according to results from the ADORING 1 and ADORING 2 trials presented at the 2024 American College of Allergy, Asthma and Immunology Annual Meeting in Boston, MA.

Specifically, 31.4% and 33.0% of patients treated with tapinarof cream, 1% in ADORING 1 and ADORING 2, respectively, achieved no-to-minimal itch on the Peak Pruritus Numerical Rating Scale (PP-NRS≤1) at Week 8 compared to those receiving versus vehicle. Results were statistically significant at Week 1, with continued improvement through Week 8, the studies showed.

Similarly, sleep improvements with tapinarof cream 1% were statistically significant for patients ≥12 years old and <12 years old versus vehicle at Week 8, with statistical significance achieved at Week 1, the earliest assessment.

Tapinarof cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. The U.S. Food and Drug Administration (FDA) has accepted Dermavant’s supplemental new drug application (sNDA) for tapinarof cream 1% for the treatment of AD in adults and children aged 2 and older. The FDA’s Prescription Drug User Fee Act (PDUFA) date is expected in the fourth quarter of 2024.

“In the ADORING 1 and ADORING 2 trials, VTAMA cream demonstrated an early, significant, and meaningful achievement of no-to-minimal itch and improvement in sleep, for patients with atopic dermatitis” says Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of the CLEAR Eczema Center, at the Oregon Health & Science University in Portland, OR, in a news release. “Itch frequently causes sleep disturbance in patients with atopic dermatitis, which can be especially burdensome for young patients and their families. In the ADORING pivotal trials, VTAMA cream demonstrated significant itch reduction and sleep improvement, in patients with atopic dermatitis, versus vehicle and was well-tolerated in both adults and children down to two years of age. Subject to FDA approval, VTAMA cream could become a compelling new treatment option for atopic dermatitis patients, most of whom regard itch as one of the most bothersome symptoms of their disease.”

In the ADORING pivotal trials, adults and children (n=813) were randomized to tapinarof cream, 1% or vehicle once daily for eight weeks. In ADORING 1 and ADORING 2, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA–AD) success, defined as vIGA-AD=0 or 1 and ≥2-grade improvement from baseline at Week 8, was achieved by 45% and 46% of patients on tapinarof cream, 1% vs. 14% and 18% of patients on vehicle, respectively. The most common adverse reactions (incidence ≥1%) in patients treated with tapinarof cream 1% were folliculitis, nasopharyngitis, headache, asthma, and influenza.

For the study, PP-NRS data was used to assess pruritus relief. Sleep improvement was assessed by asking “Over the last week, on how many nights has your/your child’s sleep been disturbed because of eczema?” on the Patient Oriented Eczema Measure (POEM), using a 5-point scale.

A Deeper Data Dive into ADORING 1 and ADORING 2

There was a statistically significant improvement in sleep, achievement of no-to-minimal itch (PP-NRS≤1) and mean weekly PP-NRS<2 targets were observed as early as Week 1 with continued improvement observed through Week 8 in AD patients with treated with tapinarof cream, 1% cream versus vehicle.

The proportion of patients with AD achieving no-to-minimal itch was statistically significantly higher in tapinarof cream, 1% groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 31.4% vs. 17.4% and 33.0% vs. 14.0%.

The proportion of patients with atopic dermatitis achieving PP-NRS<2 was statistically significantly higher in tapinarof cream 1% groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 48.1% vs. 28.4% and 46.8% vs. 19.6%.

Sleep improvement reached statistical significance with tapinarof cream 1% versus vehicle at Week 1, the earliest assessment, and continued through Week 8 in a pooled analyses for ADORING 1 and ADORING 2 in both patients with atopic dermatitis aged 2-11 years and ≥12 years: -1.7 vs. -1.0 and -1.4 vs. -0.8.