Arcutis Biotherapeutics, Inc. announced new individual patient response data showing the vast majority of individuals (91.5%) treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index (EASI) in 4 weeks. New pooled analyses from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) were presented at the 2024 Winter Clinical Dermatology Conference ? Hawaii held January 12-17, 2024, in Honolulu, HI. Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis.

At Week 4, a statistically significant greater percentage of patients achieved a 50% reduction in EASI scores (EASI-50), with 69.2% of patients treated with roflumilast cream compared to 44.4% of those treated with vehicle (pPoster Details Roflumilast Cream 0.15% in Patients With Atopic Dermatitis: Individual Patient EASI Responses: Pooled INTEGUMENT 1 and INTEGUMENT 2 Phase 3 Trials Simpson, E et al. AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. It is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation.

This reaction produces a red, itchy rash, most frequently occurring on the face, arms, and legs, and in some cases covers half of the body or more. Roflumilast cream is a next generation topical phosphodiesterase-4 (PDE4) inhibitor. PDE4 ?

an established target in dermatology ? is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®) is approved by the Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.

Investigational roflumilast cream was evaluated at lower doses for atopic dermatitis: 0.15% for adults and children 6 years of age and older and 0.05% for children aged 2 to 5 years. Roflumilast cream 0.15% is under review at the FDA for the treatment of adults and children 6 years of age and older with a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024. Roflumilast cream is uniquely formulated as a non-greasy emollient cream that absorbs quickly and does not disrupt the skin barrier.

In addition, roflumilast cream does not include sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances. ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. The most common adverse reactions (=1%) include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).