Nonsteroidal cream brings early relief in atopic dermatitis itch

In children and adults with moderate-to-severe atopic dermatitis (AD), applying tapinarof cream 1% helps reduce itch within 24 hours, according to the results of the phase III trials ADORING 1 and 2.

In both trials, tapinarof produced greater reductions in PP-NRS scores compared with vehicle as early as 24 hours after initial application in ADORING 1 (–1.2 vs –0.9) and day 2 in ADORING 2 (–1.6 vs –1.4). Daily PP-NRS scores continued to decrease with tapinarof vs vehicle through the first 2 weeks (day 14: –3.0 vs –2.0 and –2.9 vs –1.8, respectively) and through week 8. [EADV 2023, abstract 6579]

Likewise, the changes in mean weekly PP-NRS scores were also clinically meaningful and significantly better for patients treated with tapinarof than for those treated with vehicle, with the reductions occurring as early as week 1, both in ADORING 1 (–2.0 vs –1.2; p<0.0001) and 2 (–2.0 vs –1.3; p=0.0010). Significantly greater reductions in mean PP-NRS scores with tapinarof vs vehicle were recorded for all weekly visits through week 8 (ADORING 1: –4.1 vs –2.6; ADORING 2; –4.1 vs –2.4; p<0.0001 for both).

ADORING 1 (n=407, mean age 15.6 years, 48.2 percent men) and 2 (n=406, mean age 16.5 years, 43.1 percent men) were two identical, double-blind, vehicle-controlled trials, wherein patients with moderate-to-severe AD who were at least 2 years of age had been randomly assigned to receive tapinarof cream 1% or vehicle once daily for 8 weeks.

The included patients had a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of ≥3, Eczema Area and Severity Index (EASI) score of ≥6, and body surface area involvement of 5–35 percent. At baseline, mean Peak Pruritus-Numerical Rating Scale (PP-NRS) scores were 6.7 and 6.8 in ADORING 1 and 2, respectively.

As for the safety of tapinarof, lead study investigator Dr Eric Simpson of Oregon Health & Science University in Portland, Oregon, US, noted that the medication was well tolerated.

Treatment-emergent adverse events (TEAEs) were mild to moderate in severity and consistent with previous trials. The most common TEAEs were folliculitis, headache, and nasopharyngitis in both ADORING 1 and 2.

Rates of discontinuation due to adverse events were low, with fewer patients in the tapinarof than in the vehicle arm, Simpson added.

Nonsteroidal topical AhR agonist

A first-in-class, nonsteroidal topical aryl hydrocarbon receptor (AhR) agonist, tapinarof is approved by the Food and Drug Administration for the treatment of plaque psoriasis in adults. Tapinarof normalizes the skin barrier through the upregulation of skin barrier proteins (eg, filaggrin, loricrin, hornerin, and involucrin) and reduces oxidative stress.

The findings of ADORING 1 and 2 suggest that tapinarof cream rapidly reduces pruritus in AD patients, including those as young as 2 years, according to Simpson. This is a boon for patients, given that “pruritus is the most bothersome symptom [of AD], with a significant negative impact on quality of life.”

Sustained relief from core AD symptoms, such as pruritus, is a key factor in disease management, he continued.

“Tapinarof … has the potential to be used without restrictions on duration of use, extent of body surface area treated, or sites of application,” Simpson said.