Dermavant Shares Positive Safety and Efficacy Data From Analysis of ADORING Program for Atopic Dermatitis

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Dermavant Sciences announced recently additional positive safety and efficacy data from its phase 3 development program, ADORING, of tapinarof (Vtama) cream, 1% in adults and children as young as 2 years of age with atopic dermatitis (AD).

The ADORING 1 and 2 identical phase 3 trials evaluated and demonstrated the efficacy and safety of tapinarof in this indication. ADORING 3, an ongoing, open-label, long-term extension study, consists of 728 patients who previously completed the ADORING 1 and 2 trials, or the Maximal Usage Pharmacokinetics study. The study is exploring the cream's safety and efficacy for a duration of up to 48 weeks.

In this interim analysis of the ADORING 3 study, Dermavant reports that efficacy continued to improve beyond the 8-week mark. In total, 51.2% of patients, or 373 individuals, achieved complete disease clearance as determined by a vIGA-AD score of 0.

Furthermore, 73% of patients (n=519) achieved a vIGA-AD score of clear or almost clear with at least 2-grades of improvement. Even more so, 92.3% of patients (n=656) achieved at least a 1-point improvement in vIGA-AD scoring.

Eczema Area and Severity Index (EASI) scores also improved. Approximately 80.7% (n=574) of patients achieved EASI75.

Regarding itch, an average reduction was reported as early as 24 hours after tapinarof cream application, with 77.9% (n=218) of patients who had presented with a Peak Pruritus Numeric Rating Scale (PP-NRS) score of equal to or greater than 4 achieving a minimum 4-point PP-NRS score reduction.

Tapinarof cream was also well-tolerated among patients with no new safety signals reported. Adverse events were predominantly mild to moderate in nature, with no serious events related to treatment reported. The discontinuation rate attributed to adverse events was low at 2.6%.

“Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population. The integrated analysis data from the ADORING development program are particularly encouraging as they show a high level of efficacy in a diverse patient population, including patients down to 2 years of age, who are in need of a treatment option such as VTAMA cream that has demonstrated a positive safety and tolerability profile and potential long-term disease control in the ADORING studies,” said Eric Simpson, MD, MCR, in a press release. Simpson is the Frances J. Storrs Medical Dermatology professor and director of CLEAR Eczema Center at the Oregon Health & Science University.

“If approved for the treatment of atopic dermatitis, VTAMA cream’s efficacy and safety profile combined with its rapid onset of itch reduction, the most common symptom of atopic dermatitis, could provide an important new treatment option for not only patients suffering from the disease but also for their caregivers and the healthcare professionals treating them," he said.

Currently, tapinarof has been approved by the US Food and Drug Administration (FDA) for the treatment of plaque psoriasis. The same strength and formulation of tapinarof cream is being studied by the ADORING development program.

Reference

Dermavant Sciences. Dermavant announces positive data from the ADORING phase 3 development program in atopic dermatitis with VTAMA (tapinarof) cream, 1% in adults and children as young as 2 years old. BioSpace. Published January 11, 2024. Accessed January 11, 2024. https://www.biospace.com/article/releases/dermavant-announces-positive-data-from-the-adoring-phase-3-development-program-in-atopic-dermatitis-with-vtama-tapinarof-cream-1-percent-in-adults-and-children-as-young-as-2-years-old/