The DermatologistFDA Approves Roflumilast Cream 0.15% for Treatment of Atopic Dermatitis in Adults and Children Aged 6 and Older

Phosphodiesterase-4 Inhibition in Atopic Dermatitis: A Novel Approach with Potential Implications for Other Inflammatory Skin Conditions

The FDA has approved roflumilast cream 0.15% for treating mild to moderate atopic dermatitis in adults and children aged 6 and older. This once-daily, steroid-free topical medication, which acts as a phosphodiesterase-4 inhibitor, offers rapid relief, significant itch reduction, and long-term disease control. The approval is based on robust clinical trial data demonstrating efficacy and safety in more than 1,300 patients.

Key Points:

• Roflumilast cream 0.15% is now FDA-approved for mild to moderate atopic dermatitis in patients 6 years and older
• The treatment is a once-daily, steroid-free topical medication
• Approval is based on INTEGUMENT-1 and INTEGUMENT-2 Phase 3 trials involving 1,337 participants
• Primary endpoint achievement: 32.0% and 28.9% of participants reached vIGA-AD score of clear or almost clear at week 4 vs. 15.2% and 12.0% in vehicle groups
• Approximately 40% of treated participants achieved vIGA-AD score of clear or almost clear at week 4, with significant improvement observed as early as week 1
• Rapid itch improvement noted within 24 hours of first application, and more than 30% of participants achieved ≥4-point reduction in Worst Itch-Numeric Rating Scale score
• More than 40% of participants reached EASI-75 at week 4
• INTEGUMENT-OLE long-term study showed efficacy and safety over 56 weeks
• Median duration of disease control: 281 days for participants who achieved clear status and switched to twice-weekly application
• 66.2% of participants achieved EASI-75 at week 56 in the long-term study
• Most common adverse events: headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%)
• Roflumilast cream 0.15% is expected to be available by the end of July 2024

Atopic dermatitis (AD) is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States. (National Eczema Association)

More in Pediatric Dermatology