New Data: ZORYVE® (Roflumilast) Cream 0.15% Improves Atopic Dermatitis Across Skin Types

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company, has unveiled promising new pooled subgroup analysis results from its Phase 3 INTEGUMENT-1 and -2 trials. These trials revealed that ZORYVE cream 0.15% significantly improved the signs and symptoms of atopic dermatitis (AD) across diverse racial, ethnic, and skin type groups. The findings were presented at the European Academy of Dermatology & Venereology Congress in Amsterdam, held from September 25-28, 2024.

The data demonstrated that by Week 4, higher percentages of patients treated with ZORYVE achieved Validated Investigator Global Assessment for AD (vIGA-AD) Success compared to those treated with a vehicle, across all racial and ethnic groups. Specifically, ZORYVE-treated patients showed notable improvements in disease clearance and itch reduction, without significant variation based on race (White: 32.3% vs. 13.3%; Black or African American: 25.8% vs. 11.5%; Asian: 33.7% vs. 21.8%; Others: 33.2% vs. 13.7%) or ethnicity (Hispanic or Latino: 32.9% vs. 16.5%; Not Hispanic or Latino: 31.1% vs 13.8%). Similar efficacy was observed across Fitzpatrick skin types, which classify skin reaction to sunlight from type I (pale white skin) to type VI (dark brown or black skin).

Dr. Vimal H. Prajapati of the University of Calgary commented on the significance of these findings, emphasizing that the consistency in efficacy, safety, and tolerability of ZORYVE across different subgroups is reassuring. This consistency is crucial given the varied clinical presentation of AD among different skin types and ethnicities. The results suggest that ZORYVE can offer effective and well-tolerated relief for diverse patient groups.

In terms of itch reduction, ZORYVE-treated patients exhibited greater improvements on the Worst Itch-Numeric Rating Scale (WI-NRS), defined as a ≥4-point improvement in patients aged 12 and older with a baseline WI-NRS score of ≥4, at Week 4. Again, the results were consistent across all subgroups, including various racial and ethnic groups (White: 33.5% vs. 16.5%; Black or African American: 30.6% vs. 21.0%; Asian: 25.4% vs. 7.9%; Others: 34.3% vs. 22.7%) and Fitzpatrick skin types (I–III: 35.5% vs. 15.0%; IV–VI: 27.3% vs. 18.2%).

Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer of Arcutis, highlighted that ZORYVE cream's formulation was designed with all AD patients in mind. He expressed satisfaction with the Phase 3 INTEGUMENT study results, which confirmed ZORYVE’s consistent effectiveness and safety across diverse demographics. Burnett stressed the importance of clinical data representing global diversity to ensure that therapies like ZORYVE can meet the needs of all patients.

The trials also reported a low incidence of Treatment Emergent Adverse Events (TEAEs) for both ZORYVE and vehicle-treated patients, with a comparable safety profile across all subgroups. Common adverse reactions included headache, nausea, application site pain, diarrhea, and vomiting.

The INTEGUMENT-1 and INTEGUMENT-2 trials are double-blind, vehicle-controlled studies that evaluate the safety and efficacy of ZORYVE cream 0.15% in treating atopic dermatitis. ZORYVE, a next-generation topical phosphodiesterase-4 (PDE4) inhibitor, is approved by the U.S. FDA for treating mild to moderate atopic dermatitis and plaque psoriasis in patients aged six years and older.

Atopic dermatitis, a common type of eczema, affects millions of children and adults in the United States. It is a chronic, relapsing inflammatory skin disease with genetic predispositions, presenting as intensely itchy rashes that vary in appearance based on age and environmental factors.

Arcutis remains committed to addressing the urgent needs of individuals with immune-mediated dermatological conditions through innovative therapies. The company’s expanding portfolio includes multiple FDA-approved products targeting various inflammatory skin conditions.