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Tapinarof 1% topical cream showed greater efficacy than the control in adults and children as young as age 2 years with atopic dermatitis (AD). The cream also provided safe and faster-acting relief of pruritus than did the control treatment.

Those were the bottom-line findings of two phase 2 randomized controlled trials, the results of which appeared in .

A total of 813 patients were randomized to receive either tapinarof or the control treatment. In both of the 8-week trials, significantly superior scores emerged for tapinarof compared with vehicle treatment on both the Validated Investigator Global Assessment for Atopic Dermatitis (45.4% vs 13.9% and 46.4% vs 18.0%, respectively) and EASI-75 (55.8% vs 22.9% and 59.1% vs 21.2%, respectively) scales.

The investigations were conducted mainly by researchers from the U.S. and Canada. The following excerpts have been edited for length and clarity.

What was the impetus behind these randomized controlled trials?

Due to the burden and heterogeneity of AD, there is a need for safe, efficacious, nonsteroidal, topical therapies that can be used by all patients, including very young children, without the limitations of current topical medications.

Only one topical medication, a calcineurin inhibitor, is currently approved to treat severe AD, and it is restricted to second-line, short-duration use. Tapinarof is a nonsteroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults and is currently under investigation for the treatment of plaque psoriasis in children.

In children and adults with moderate-to-severe AD, tapinarof cream 1% once daily previously demonstrated efficacy versus vehicle. Additionally, tapinarof increases cytoprotective antioxidant responses that reduce oxidative stress in AD.

In the current paper, investigators reported results from ADORING 1 and ADORING 2, two double-blind, randomized, vehicle-controlled phase 3 trials assessing the efficacy and safety of tapinarof cream 1% in adults and children with AD down to age 2.

What were the investigations' principal findings?

Daily tapinarof 1% cream demonstrated statistically significant and clinically meaningful efficacy in the treatment of AD compared with vehicle on the primary endpoint in adults and children down to age 2. Statistically significant and clinically meaningful efficacy in favor of tapinarof was confirmed across key secondary endpoints, including pruritus.

Tapinarof was well tolerated by the young patients, demonstrating a favorable and safety profile consistent with previous trials in both AD and plaque psoriasis.

What are the key details around safety findings?

Common treatment-emergent adverse events (TEAE) were few and included folliculitis, headache, and nasopharyngitis. Most TEAEs were mild or moderate and were not associated with significant discontinuation rates. There were few serious TEAEs and none were considered treatment-related. Trial discontinuation rates due to any AEs were lower with tapinarof than vehicle (1.9% vs 3.6% in the first trial, 1.5% vs 3.0% in the second trial, respectively).

While rates of headache were generally low and not considered treatment-related by investigators, it is possible that variations in the incidence of headache across groups may be treatment related.

What are the key take-home messages for dermatologists?

Tapinarof potentially fills a gap in the treatment armamentarium for a highly effective, nonsteroidal topical that can be used in young children without restrictions on the severity of disease, duration of use, or sites of application.

In the foreseeable future, while rapid improvements in AD were demonstrated in 8 weeks, the long-term extension trial, ADORING 3, will assess the efficacy and safety of tapinarof cream in AD across the spectrum of severity, including patients with mild or more severe AD. Eligible participants from the first two trials who enrolled in ADORING 3 will be evaluated for up to 48 weeks.