Phase 3 results show Vtama rapidly reduces itch in children, adults with atopic dermatitis
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Key takeaways:
- As early as day 1, Vtama-treated patients saw an up to 1.6-point reduction in pruritus.
- By week 8, pruritus scores had decreased by 4.1 points in Vtama groups vs. up to 2.6 points in vehicle groups (P < .0001).
Dermavant Sciences has announced new “highly favorable” phase 3 pruritus data for Vtama cream for the treatment of moderate to severe atopic dermatitis in adults and children aged as young as 2 years, according to a press release.
Eric Simpson, professor of dermatology at the School of Medicine at Oregon Health & Science University, presented the study findings at the European Academy of Dermatology and Venereology Congress in Berlin.
“Itch remains the most burdensome and prevalent symptom of atopic dermatitis (AD), negatively impacting the quality of life not only for the patients, but also their families,” Simpson told Healio. “There remains a need for a topical option for these patients, particularly the pediatric population, that can provide rapid reduction in itch relief with sustained efficacy.”
The new pruritus data from the identical, double-blind, vehicle-controlled, phase 3 ADORING 1 (n = 407) and ADORING 2 (n = 406) trials showed that Vtama (tapinarof) cream 1%, a nonsteroidal formulation, rapidly reduced itch in adults and children with AD.
In the studies, patients were randomly assigned 2:1 to Vtama cream or vehicle to be applied twice daily for 8 weeks.
As early as day 1, a greater reduction in Peak Pruritus-Numeric Rating Scale (PP-NRS) scores was seen in patients treated with Vtama compared with vehicle in both ADORING 1 (–1.2 vs. –0.9) and ADORING 2 (–1.6 vs. –1.4). According to the study abstract, these improvements continued through the first 2 weeks (ADORING 1, –3 vs. –2; ADORING 2, –2.9 vs. –1.8) and through week 8 in both trials.
In the first assessment of PP-NRS scores at week 1, Vtama-treated patients exhibited a 2-point reduction compared with a 1.2-point reduction among vehicle-treated patients in ADORING 1 (P < .0001). Similar results were seen in ADORING 2 among the Vtama and vehicle groups (–2.0 vs. –1.3; P = .001).
By week 8, PP-NRS scores had decreased by 4.1 points in both ADORING 1 and ADORING 2 Vtama groups, whereas patients treated with vehicle saw smaller reductions of 2.6 points and 2.4 points, respectively (P < .0001).
Vtama is currently FDA-approved for the treatment of plaque psoriasis in adults. If approved for AD, Vtama could become “a potential first-line topical treatment for both atopic dermatitis and plaque psoriasis, thereby serving as a two-in-one treatment option,” Simpson told Healio.
“Tapinarof has already brought about a shift in the treatment approach for plaque psoriasis, and I am eager to learn more about how it could benefit atopic dermatitis patients in the long run, and potentially simplify the treatment landscape by providing nonsteroidal options that are both safe and effective,” Simpson added.
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Simpson E. Rapid and early onset of itch relief with tapinarof cream 1% once daily in two pivotal phase 3 trials in adults and children down to 2 years of age with moderate to severe atopic dermatitis. Presented at: EADV Congress; Oct. 11-14, 2023; Berlin.
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