Dermavant Shares Positive Phase 4 Data for Tapinarof 1% in Adults With Plaque Psoriasis of the Head and Neck

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Dermavant Sciences recently announced positive phase 4 data from its open label trial of tapinarof (VTAMA) cream 1% in adult patients with plaque psoriasis affecting the head and neck.

The DMVT-505-4002 (NCT05789576) study, which was open label and conducted at multiple study centers, enrolled 31 patients, with 58.1% presenting with psoriasis of the scalp, 35.5% with psoriasis of the face, and 6.5% with psoriasis of the neck.

After 12 weeks of once-daily tapinarof cream 1% application, 88.5% of patients achieved a Physician Global Assessment (tPGA) score of 0 or 1, indicative of complete or almost complete clearance. Additionally, 88.5% of patients achieved a 2-point or greater improvement in tPGA score from baseline.

In some patients, tapinarof cream 1% demonstrated rapid efficacy with improvements noted in as early as 1 week, or a median of 4 weeks among all patients.

The study also met secondary endpoints of complete clearance of the target lesion, which was achieved by 80.8% of patients, and an equal to or greater than 75% reduction in Psoriasis Area and Severity Index (PASI75) as early as 1 week into treatment. Furthermore, 70% of patients achieved a 4-point or greater reduction in Peak Pruritus-Numeric Rating Scale scoring by week 12.

Investigators also reported significant improvements to patients' overall quality of life, with the majority of patients also agreeing that tapinarof cream 1% was not greasy, was easy to apply, and quickly absorbed into the skin.

No new safety signals were reported, with the most common adverse reactions among patients being contact dermatitis, seborrheic keratosis, folliculitis, headache, and sinusitis.

“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body. In this Phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability, and cosmetic elegance of VTAMA cream even when used in hair bearing areas such as the head and neck region,” said Philip Brown, MD, JD, Chief Medical Officer at Dermavant, in a press release.

This phase 4 data expands upon data from Dermavant's phase 3 PSOARING 1 and PSOARING 2 studies, which involved a total of 1,025 adult patients with plaque psoriasis.

After 12 weeks of treatment with tapinarof cream 1%, 36% and 40% of patients in the PSOARING 1 and 2 studies achieved a PGA success rate, respectively. This is compared to 6% of patients receiving a placebo achieving the same success.

Read Dermatology Times' previous coverage of the PSOARING studies here.

“Plaque psoriasis is a chronic condition with a significant negative impact on patients’ quality of life. The scalp region, in particular, is one of the most difficult areas to treat. Many currently available treatment options fail to offer sustained long-term relief due to lack of practical applicability to certain body areas and limitations on the duration of use,” said G. Michael Lewitt, MD, FAAD, in the press release. “The impressive levels of efficacy achieved by VTAMA cream in the open-label trial, where 80% of adult patients achieved complete clearance of the target lesion, is highly encouraging for both patients with plaque psoriasis and their healthcare providers. Importantly, 58% of patients enrolled in the trial had a target plaque psoriasis lesion in the scalp region, and as assessed by both the investigators and the patients in the trial, VTAMA cream demonstrated favorable tolerability even when applied in hair bearing affected areas; making it a versatile and cosmetically elegant treatment option for plaque psoriasis that can be used anywhere on the affected body areas, including the most sensitive areas as well the scalp, head, and neck areas.”

Reference

Dermavant Sciences. Dermavant Announces Positive Results from Phase 4 Open Label Trial of VTAMA tapinarof Cream 1 for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults. December 6, 2023. Accessed December 7, 2023. https://www.dermavant.com/dermavant-announces-positive-results-from-phase-4-open-label-trial-of-vtama-tapinarof-cream-1-for-the-treatment-of-plaque-psoriasis-in-the-head-and-neck-region-in-adults/