Arcutis Publishes Phase 3 Results of ZORYVE® Cream for Atopic Dermatitis in JAMA Dermatology

Arcutis Biotherapeutics, Inc., a biopharmaceutical company specializing in immuno-dermatology, announced the publication of positive results from two Phase 3 studies in JAMA Dermatology. These studies evaluated ZORYVE® (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in both adults and children aged six and older. The FDA approved ZORYVE cream in July 2024 for this indication, and it is now available in pharmacies across the United States.

The INTEGUMENT-1 and INTEGUMENT-2 studies demonstrated that ZORYVE cream led to significant improvements across multiple efficacy endpoints. Approximately 31% of individuals treated with ZORYVE cream achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at Week 4, compared to just 14% for the vehicle. This measure reflects a substantial improvement in the condition, with effectiveness noted as early as Week 1 of treatment.

One of the most notable outcomes was the rapid reduction in itch, the most bothersome symptom of AD. Significant improvements in itch severity were observed within 24 hours of the first application, as measured by the Worst Itch-Numeric Rating Scale (WI-NRS). Over 30% of individuals treated with ZORYVE cream achieved WI-NRS Success at Week 4, compared to around 12%-20% for the vehicle. WI-NRS Success is defined as a reduction of at least 4 points on the 0-10 scale for those who had a baseline score of 4 or higher.

In addition to relieving itch, ZORYVE cream significantly reduced the Eczema Area and Severity Index (EASI) scores, with more than 40% of treated individuals achieving a 75% reduction (EASI-75) at Week 4, compared to around 20% for the vehicle. These improvements in EASI scores were also seen as early as Week 1.

ZORYVE cream was well tolerated, exhibiting a low incidence of Treatment Emergent Adverse Events (TEAEs). At all time points, 95% of patients treated with ZORYVE cream reported no signs of irritation at the application site, and over 90% experienced no sensation or only mild sensation at the application site.

Eric Simpson, MD, MCR, FAAD, Professor of Dermatology at Oregon Health & Science University and lead author of the publication, emphasized the cream's ability to provide rapid and significant itch relief without disrupting the skin barrier. This is a crucial factor for AD treatment, given the chronic and burdensome nature of the disease, which often leads to reduced quality of life and sleep disturbances.

Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis, highlighted the robust efficacy of ZORYVE cream in rapidly relieving AD symptoms, particularly itch. He noted that as a safe and well-tolerated once-daily cream, ZORYVE offers a new treatment option for individuals living with AD and their caregivers.

AD is a chronic, relapsing inflammatory skin disease affecting millions in the United States, manifesting as a red, itchy rash that can appear anywhere on the body. ZORYVE, a steroid-free topical phosphodiesterase-4 (PDE4) inhibitor, is approved for treating AD, seborrheic dermatitis, and plaque psoriasis. PDE4 is an enzyme that regulates the production of inflammatory mediators in the skin.

Currently, ZORYVE cream 0.15% is approved for treating mild to moderate AD in individuals aged six and older, while ZORYVE cream 0.3% is approved for treating plaque psoriasis. Additionally, ZORYVE foam 0.3% is available for the treatment of seborrheic dermatitis in individuals aged nine and older. Arcutis is also evaluating a lower dose of roflumilast cream for younger children and has completed a clinical development program for a foam formulation to treat scalp and body psoriasis.