The U.S. Food and Drug Administration (FDA) has approved tapinarof cream, 1% (Vtama, Organon) for atopic dermatitis (AD) in adults and pediatric patients aged 2  and up.

Tapinarof cream, 1% is a novel aryl hydrocarbon reception agonist that can be used once daily in patients with mild, moderate, and severe disease as well as those who are experiencing acute and chronic exacerbations.In May 2022, the FDA approved tapinarof cream, 1% for the treatment of plaque psoriasis in adults.

The Data Behind the Approval

In the ADORING pivotal studies, tapinarof cream, 1% demonstrated a statistically significant difference vs. vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) in moderate to severe patients as young as 2 years old with AD,

The difference between patients who received tapinarof cream, 1% and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age.

The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%).

ADORING 3, a 48-week open-label, long-term extension study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were VTAMA cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria.

In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with tapinarof cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with tapinarof cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with tapinarof cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8.

Experts React

“VTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease,” says Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program, in a news release. “Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream.”

“The safety profile of VTAMA cream is extremely favorable, and the maximal usage pharmacokinetic study demonstrated it is minimally systemically absorbed,” says Leigh Ann Pansch, MSN, FNP-BC, DCNP, the Clinical Director of Education at DOCS Dermatology in Cincinnati, OH. “I personally find this approval to be game-changing!  Given [the cream’s] utility in all stages and phases of AD, I plan to use this for most of my patients who suffer with this disease; regardless of other, additional therapy.”

She adds,  “I look at VTAMA cream as a toolkit for flares for all my AD patients who are at least 2 years of age and I look forward to offering patients a safe and effective treatment that is steroid-free and can be used longer than two weeks.  “