Daily tapinarof use leads to 75% improvements in Eczema Area and Severity Index scores

Key takeaways:

• Tapinarof is a steroid-free topical treatment targeting atopic dermatitis.
• Patients saw statistically significant improvements in itch with treatment.
• Adverse events were mostly mild to moderate.

WASHINGTON — Treatment with 1% tapinarof cream led to symptom improvements for most patients with atopic dermatitis, according to a poster presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.

These improvements were consistent across disease severity and age subgroups, Philip M. Brown, MD, JD, chief medical officer at Dermavant Sciences, and colleagues wrote.

The company also has submitted a supplemental new drug application to the FDA for its 1% tapinarof cream, named Vtama, targeting topical treatment of AD among patients aged 2 years and older.

Alternative treatment

“Topical therapies for AD remain an area of unmet medical need, particularly in children,” Brown told Healio. “Conventional topical treatment options may not offer long-term relief, due to limitations on where they can be used on the body and for how long.”

Philip M. Brown

If used over an extended period, Brown continued, some treatments may be challenging. Also, he said, application might be physically uncomfortable, feeling greasy and thick, and these treatments may not be easily absorbed.

Treatment for AD depends on the severity of the condition as well, Brown added.

“When it comes to finding topical treatments that yield results patients are looking for, many people with AD go through a period of trial and error, and even still may not find a treatment that works for them,” he said.

“There remains a need for well-tolerated, steroid-free topical treatment options that provide relief of symptoms, such as itch, and are safe to be used anywhere on the body long-term,” he added.

Brown called tapinarof cream a steroid-free, first-in-class aryl hydrocarbon receptor (AhR) agonist in development for adults and children aged as young as 2 years with AD.

“This makes it suitable for sensitive areas of the skin that are affected, such as the face, groin and underarms,” he said.

If approved by the FDA, he said, tapinarof has the potential to be a meaningful steroid-free, cosmetically elegant topical option that could provide long-term disease management.

Study results

The phase 3 ADORING 1 (n = 407) and ADORING 2 (n = 406) randomized controlled trials included patients aged 2 years and older with AD treated with 1% tapinarof cream or vehicle once daily for 8 weeks.

“In the identical phase 3 ADORING 1 and ADORING 2 studies, Vtama cream demonstrated highly statistically significant improvements compared to vehicle in the validated Investigator Global Assessment for Atopic Dermatitis scores of 0 (clear skin) or 1 (almost clear skin) with at least a two-grade improvement from baseline at week 8, the primary endpoint,” Brown said.

In ADORING 1, 55.8% of the treatment group and 22.9% of the vehicle group achieved an improvement of 75% or more in their Eczema Area and Severity Index (EASI 75) score from baseline through week 8 (P < .0001).

Similarly, 59.1% of the treatment group and 21.2% of the vehicle group achieved EASI 75 from baseline through week 8 in ADORING 2 (P < .0001).

Proportions of patients who achieved EASI 75 were similar for patients with moderate AD at baseline, including 58.8% and 59.9% of the treatment groups and 25.7% and 24.3% of the vehicle groups in ADORING 1 and 2, respectively.

The patients with severe AD at baseline also had similar EASI 75 outcomes in both ADORING 1 (54.5% vs. 6.9%) and ADORING 2 (69.3% vs. 7.6%).

Proportions experiencing improvements were similar when stratified by age group as well. Among patients aged 2 to 6 years, these included 72.1% and 68.1% of the treatment groups and 17% and 24.8% of the vehicle groups in ADORING 1 and 2, respectively.

The subgroup of patients aged 7 to 11 years included 52.1% and 55.3% of patients in the treatment groups and 28% and 35.1% of patients in the vehicle groups achieving EASI 75 in ADORING 1 and 2, respectively.

Patients aged 12 to 17 years included 54.3% and 68.1% in the treatment groups and 24.5% and 13.5% in the vehicle groups achieving EASI 75 in ADORING 1 and 2, respectively.

Adults aged 18 years and older achieving EASI 75 included 52.5% and 49.2% in the treatment groups and 26.2% and 15.1% in the vehicle groups in ADORING 1 and 2, respectively.

Brown called these improvements “highly statistically significant,” with “consistent, clinically meaningful efficacy across disease severity and age subgroups.”

Also, the researchers found statistically significant improvements in itch as assessed by a four-point or greater improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score among those patients aged 12 years and older.

The most common adverse events reported in the studies included folliculitis, headache and nasopharyngitis, with no new safety or tolerability signals of concern, Brown said.

“Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events,” Brown said.

Conclusions, next steps

Based on these results, the researchers said that treatment with 1% tapinarof cream once a day demonstrated efficacy that was consistent and clinically meaningful regardless of the severity of the disease or the age of the patient.

“If approved by the U.S. FDA, Vtama cream would be a first-in-class, AhR-targeting topical treatment that can be used in adults and children 2 years of age or older with AD in any range of the disease severity spectrum,” Brown said.

Dermavant’s ADORING 3 open-label, long-term extension trial exploring the long-term effects of the treatment is underway as well.

Reference:

• Dermavant submits supplemental new drug application (sNDA) to FDA for Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. https://www.dermavant.com/dermavant-submits-supplemental-new-drug-application-snda-to-fda-for-vtama/. Published Feb. 14, 2024. Accessed Feb. 21, 2024.