Summary: Dermavant Sciences presented data from phase 3 trials of VTAMA cream, a topical treatment for atopic dermatitis (eczema), showing significant improvements in itch relief and sleep for patients as young as 2 years old. The studies demonstrated early and lasting effects, with many patients achieving no-to-minimal itch and improved sleep as early as the first week of treatment. VTAMA cream was also well-tolerated, showing potential as a new treatment option pending FDA approval.
Key Takeaways:
- Early Itch and Sleep Improvement: VTAMA cream significantly reduced itch and improved sleep as early as week one, with benefits continuing through week eight in patients with moderate to severe atopic dermatitis.
- Higher Itch-Relief Success Rates: In the trials, 45-46% of patients using VTAMA achieved no-to-minimal itch at week eight, compared to 14-18% in the control group.
- Potential New Treatment Option: Pending FDA approval, VTAMA cream may offer a well-tolerated, effective treatment for atopic dermatitis, addressing common symptoms like persistent itch and sleep disturbance.
Dermavant Sciences, a biopharmaceutical company developing and commercializing therapeutics in immuno-dermatology, presented data on the achievement of no-to-minimal itch and sleep improvement in patients with atopic dermatitis (eczema) as young as 2 years old at the American College of Allergy, Asthma, and Immunology Annual Meeting.
The data presented were generated from Dermavant’s phase 3 ADORING 1 and ADORING 2 pivotal trials studying VTAMA cream, 1% in patients with moderate to severe atopic dermatitis as young as 2 years old.
In the ADORING pivotal trials, adults and children (n=813) were randomized to VTAMA cream or vehicle once daily for eight weeks. In ADORING 1 and ADORING 2, The 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 VTAMA cream versus 14% and 18% of patients on vehicle, respectively.
The most common adverse reactions in patients treated with VTAMA cream were folliculitis, nasopharyngitis, headache, asthma, and influenza. Peak Pruritus Numerical Rating Scale (PP-NRS) data, a patient-reported outcome, were used to assess itch relief. Sleep improvement was assessed using question two, (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 five-point scale.
Results:
- 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 (first assessment) with continued improvement observed through week 8 in patients with atopic dermatitis treated with VTAMA cream versus vehicle.
- The proportion of patients with atopic dermatitis achieving no-to-minimal itch was statistically significantly higher in VTAMA cream 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 VTAMA cream groups compared with vehicle as early as week 1 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 VTAMA cream versus vehicle at week 1 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.
“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 a release. “Itch frequently causes sleep disturbance in patients with atopic dermatitis, which can be especially burdensome for young patients and their families.”
He continues in a release, “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.”
ADORING is Dermavant’s phase 3 atopic dermatitis clinical development program for VTAMA (tapinarof) cream, 1%, which consists of ADORING 1 and ADORING 2, as well as ADORING 3, a 48-week open-label, long-term extension study.
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