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TOPLINE:

Treatment with tapinarof cream 1%, approved for psoriasis, improved disease severity and pruritus scores in adults and children with moderate to severe atopic dermatitis (AD) and was well-tolerated in phase 3 trials.

METHODOLOGY:

• In two phase 3 pivotal trials, ADORING 1 and 2, 813 adults and children with moderate to severe AD in the United States and Canada aged 2 years and older (80% were younger than 18 years) were randomly assigned in a 2:1 ratio to topical tapinarof, a nonsteroidal, topical aryl hydrocarbon receptor agonist, or vehicle cream once daily.
• All participants were required to have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3, an Eczema Area and Severity Index (EASI) score ≥ 6, and 5%-35% body surface area involvement at screening and baseline.
• The primary efficacy endpoint was the proportion of patients with a vIGA-AD score of 0 (clear) or 1 (almost clear) and an improvement of at least two grades from baseline to week 8.
• At least a 75% improvement in the EASI score (EASI75), patient-reported outcomes such as pruritus improvement, and safety were also assessed.

TAKEAWAY:

• At week 8, a higher proportion of patients receiving tapinarof vs vehicle achieved a vIGA-AD response in the ADORING 1 (45.4% vs 13.9%) and 2 (46.4% vs 18.0%; P < .0001 for both) trials.
• Similarly, a higher proportion of patients in the tapinarof vs vehicle arms achieved an EASI75 response in both the trials (55.8% vs 22.9% and 59.1% vs 21.2%, respectively; P < .0001 for both).
• Patient-reported pruritus improved with tapinarof among patients aged 12 years and older and those younger than 12 years in both the trials.
• Common treatment-emergent adverse events with tapinarof included folliculitis, headache, and nasopharyngitis. Adverse event–related discontinuation rates were lower in the tapinarof group.

IN PRACTICE:

"Tapinarof potentially fills a gap in the treatment armamentarium for a highly effective, nonsteroidal topical that can be used down to 2 years of age without restrictions on the severity of disease, duration of use, total BSA [body surface area] treated, or sites of application," the authors wrote.

SOURCE:

This study, led by Jonathan I. Silverberg, MD, PhD, MPH, professor of dermatology, The George Washington University, Washington, DC, was published online on May 20, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The study did not assess long-term efficacy.

DISCLOSURES:

The study was supported by Dermavant Sciences. Several authors reported receiving honoraria, grants, and fees; serving on the advisory board or as principal investigators; or having other ties with multiple pharmaceutical companies, including Dermavant. Five authors reported being employees of Dermavant with stock options.