Roflumilast Cream 0.05% Phase 3 INTEGUMENT-PED Trial Results in Children with Atopic Dermatitis Presented at AAD Meeting

Arcutis Biotherapeutics, a biopharmaceutical firm, has reported promising results from its pivotal Phase 3 study on roflumilast cream for treating atopic dermatitis in children aged 2 to 5. The study, known as INTEGUMENT-PED, demonstrated that the steroid-free cream, when applied once daily, led to significant improvements in the condition from the first week of treatment. Notably, 25.4% of the children achieved the primary endpoint of IGA Success, a measure indicating clear or almost clear skin, by the fourth week. This compares favorably to just 10.7% in the control group.

The results also showed that 39.4% of the children using roflumilast cream experienced at least a 75% improvement in their Eczema Area and Severity Index (EASI-75) by the end of the study, a stark contrast to the 20.6% in the control group. Furthermore, the cream was well-tolerated, with a low incidence of adverse events, and no significant issues with local skin tolerability were reported.

Lawrence F. Eichenfield, a dermatology and pediatrics professor at UC San Diego School of Medicine, emphasized the importance of balancing efficacy, tolerability, and safety in treating pediatric patients. He noted that the roflumilast cream's formulation, which does not disrupt the skin barrier, is beneficial for young children and eases caregivers' concerns.

Patrick Burnett, Arcutis' chief medical officer, expressed satisfaction with the study's findings, highlighting the cream's rapid reduction in itch within 24 hours of application and its significant improvement in skin clearance by the first week. He also pointed out the cream's favorable safety profile and its potential to meet an unmet need for safe and effective treatments for young children with atopic dermatitis.

The INTEGUMENT-PED trial enrolled 652 children with mild to moderate atopic dermatitis, applying the cream once daily for four weeks without the use of other skin products on the treatment sites. The primary endpoint was the achievement of IGA Success, with multiple secondary endpoints evaluated, including the proportion of subjects attaining an EASI-75 reduction by the fourth week.

Roflumilast cream is a topical phosphodiesterase-4 (PDE4) inhibitor, a class of drugs known for their anti-inflammatory properties. It is formulated as a non-greasy, quick-absorbing cream that does not contain common sensitizing ingredients. The cream is also under review by the FDA for the treatment of plaque psoriasis in patients aged 6 and older.

Arcutis Biotherapeutics is dedicated to developing innovative treatments for immune-mediated dermatological conditions, with a robust pipeline targeting various inflammatory skin diseases. The company's commitment to addressing persistent patient challenges in dermatology is evident through its growing portfolio of FDA-approved products and ongoing clinical programs.