Tapinarof improves itch, sleep quality for children, adults with atopic dermatitis

Key takeaways:

• Tapinarof cream 1% showed low discontinuation rates.
• The cream has no restriction of use.
• Tapinarof patients have significantly better outcomes compared with vehicle patients.

BOSTON — Daily tapinarof cream 1% improved weekly itch outcomes and sleep in patients with atopic dermatitis and pruritus, according to an abstract presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

“Atopic dermatitis is a very itchy condition,” Dareen D. Siri, MD, FAAAAI, FACAAI, allergist at Midwest Allergy Sinus Asthma, said during her presentation.

“A substantial impact of itch in terms of health-related quality of life is that it also affects sleep. Sleep deprivation certainly has many ramifications in terms of families, the patients themselves and many other things that are either short term or long term that are impactful for the patient,” she continued.

Tapinarof (Vtama, Dermavant Sciences) is a nonsteroidal, topical aryl hydrocarbon receptor agonist. Tapinarof 1% cream is currently approved to treat plaque psoriasis in adults. It has no restriction on duration, location or extent of use, according to Siri.

The ADORING 1 and 2 trials are identically designed, phase 3, double-blind, randomized, vehicle-controlled trials that aimed to identify itch outcomes and sleep improvement with tapinarof cream 1% in patients aged 2 years or older.

The ADORING 1 trial included 407 patients randomly assigned 2:1 to once-daily tapinarof (n = 270; mean age, 15.6 years) or vehicle (n = 137; mean age, 15.6 years). ADORING 2 had 406 patients also randomly assigned 2:1 to once-daily tapinarof (n = 271; mean age, 16.4 years) or vehicle (n = 135; mean age, 16.7 years). The double-blind treatment study duration spanned 8 weeks.

Inclusion criteria consisted of patients diagnosed with atopic dermatitis with a validated Investigator Global Assessment for Atopic Dermatitis score of at least 3 and an Eczema Area and Severity Index score of at least 6 with body surface area (BSA) involvement between 5% and 35%.

Siri discussed post hoc endpoints, which included achieving an itch-free state, defined as no to minimal itch, with a mean weekly PP-NRS score of less than 1, a mean weekly PP-NRS score of less than 2 and improvement in sleep. Study authors noted that the study population consisted of 80.4% pediatric patients aged 2 to 17 years and that mean baseline PP-NRS scores were 6.5 to 6.9 and similar across all groups.

In ADORING 1, the proportion of patients in week 8 that achieved an itch-free state was 31.4% in the tapinarof group compared with 17.4% in the vehicle group (P = .0072). In ADORING 2, the proportion of patients that achieved an itch-free state from baseline was 33% in the tapinarof group compared with 14% in the vehicle group (P = .0003).

The achievement of a mean weekly PP-NRS score of less than 2 at week 8 in the ADORING 1 trial was seen in 48.1% of patients in the tapinarof group compared with 28.4% in the vehicle group (P = .0006). In ADORING 2, a score of less than 2 appeared in 46.8% of patients in the tapinarof group and 19.6% of patients in the vehicle group (P < .0001).

In terms of safety, treatment-related adverse events were mostly mild or moderate. The most common were folliculitis, headache and nasopharyngitis. Discontinuation of the trial was lower in the tapinarof vs. vehicle group (ADORING 1: 1.9% vs. 3.6%; ADORING 2: 1.5% vs. 3%, respectively).

“One-percent cream monotherapy demonstrated early significant and meaningful achievement of that stringent, mean weekly itch outcomes of an itch-free state, which is no to minimal itch, with a PP-NRS of less than 1 or equal to 1 and improvement in sleep in adults and children down to 2 years of age,” Siri said.

She emphasized that tapinarof was very well tolerated and adverse events were mostly mild to moderate. There were low discontinuation rates, demonstrating a predictable safety profile.

“This once-daily non-corticosteroid cream rapidly improves itch and sleep in patients down to 2 years of age and is not associated with any restriction in terms of duration of use, extent of BSA treated or site of application,” she said.