Tapinarof Cream 1% Rapidly Improves Mild to Severe Plaque Psoriasis

Howard Sofen, MD

Credit: DrSofen.com

Patients with plaque psoriasis, including in intertriginous areas and genitalia, treated with tapinarof cream 1% had rapid, clinical meaningful efficacy beginning at week 2, according to research presented at the 2023 Fall Clinical Dermatology Conference.¹

“Topical corticosteroids, while efficacious for the treatment of psoriasis, are associated with adverse events (AEs), including acne, rosacea, perioral dermatitis, facial erythema, hirsutism, skin thinning and atrophy, ecchymosis, striae, in addition to the risk of systemic AEs, which can limit their use,” wrote a team of investigators led by Howard Sofen, MD, associated with the David Geffen University of California, Los Angeles (UCLA) School of Medicine.

Because of this risk, topical corticosteroids are generally used intermittently. Additionally, AEs are more likely to occur in groin or genital involvement due to the thinner skin and direct occlusion in these areas. Therefore, nonsteroidal topical treatment options, such as tapinarof cream 1%, are important. These nonsteroidal options offer minimal systemic absorption, no risk of systemic AEs, and have no restrictions regarding extent of use, duration, and application site.

The phase 4, open-label, multicenter trial enrolled adult patients with mild to severe plaque psoriasis in intertriginous areas to evaluate the efficacy and safety of tapinarof cream 1% once daily. Patients received the treatment for 12 weeks, followed by a 1-week follow-up period. Eligible patients had an intertriginous Physician Global Assessment (iPGA) score of ≥2 and ≥3 months of stable disease in intertriginous areas.

The primary endpoint was iPGA response at week 12, which was defined as the proportion of patients with an iPGA score of 0 or 1 and ≥2-grade improvement from baseline. Other endpoints were the time to achieve completely clear intertriginous skin and complete disease clearance by visit. The Static Physician’s Global Assessment of Genitalia (sPGA-G) response was defined as the proportion of participants who were able to achieve a 0/1 score with a ≥2-grade improvement from baseline. Tolerability was evaluated using the Local Tolerability Scale (LTS) and LTS-external genitalia scores, and safety assessments determined the incidence, duration, and frequency of treatment-emergent adverse events (TEAEs).

A total of 34 patients were enrolled in the trial, with a mean age of 54.1 years, 58.8% were male, and 64.7% had a baseline iPGA score of 3, indicating moderate severity. Most (82.4%) patients completed the 13-week study period.

At week 12, 82.8% (n = 24/29) of patients achieved the primary endpoint of iPGA response, with the median time to achieve response reported as 6 days. Additionally, 65.5% (n = 19/29) achieved complete disease clearance at the end of the trial. Results were maintained in 64.3% of patients after treatment discontinuation (week 13). All patients with intertriginous psoriasis in the genital area achieved an sPGA-G response at week 4, which was maintained through week 12.

The drug was generally well tolerated, with investigators observing improvements from baseline scores throughout the trial. No irritation was reported for the genitalia specifically for most patients, and the majority of subjects had no irritation for all intertriginous areas.

TEAEs were consistent with those observed in previous trials and most were categorized as mild or moderate. Only 1 patient discontinued treatment due to an AE.

“Tapinarof cream 1% once daily is a highly effective, nonsteroidal topical treatment option for patients with mild to severe plaque psoriasis, with no restrictions on extent, duration, or location of use, including in sensitive and intertriginous areas,” investigators concluded.

References

1. ^{Sofen H, Tyring S, Marchese Johnson S, Guenthner S, et al. Efficacy of Tapinarof Cream 1% Once Daily for the Treatment of Mild to Severe Intertriginous Plaque Psoriasis. Presented at: Fall Clinical Dermatology 2023 Conference. Las Vegas, NV. October 19 – 22, 2023.}