Roflumilast for Treatment of Pediatric Atopic Dermatitis

Children with atopic dermatitis who received roflumilast treatment in the Integument PED trial showed steady improvement over time, with response rates that continued to increase throughout extended treatment periods. At 4 weeks, 25% of patients achieved IGA success compared with 11% with vehicle alone, whereas nearly 40% reached EASI-75 improvement. The medication’s sophisticated vehicle formulation provides excellent moisturizing properties, making even the placebo cream beneficial for patients with atopic dermatitis.

The long-term extension study revealed remarkable durability of response, with 73% of patients achieving EASI-75 improvement after 56 weeks of continued treatment, demonstrating response rates that rival systemic medications. This progressive improvement suggests that roflumilast may help restore skin barrier function and reduce underlying inflammation with sustained use. The medication’s ability to maintain and even enhance effectiveness over extended periods makes it particularly valuable for long-term management of chronic atopic dermatitis in children.

Patients and families appreciate roflumilast’s excellent tolerability profile, with 96.8% of users reporting good application site tolerance, essentially matching the vehicle-only group. The medication avoids common concerns associated with other treatments, including the black box warnings of Janus kinase inhibitors and the folliculitis seen with tapinarof. Additionally, roflumilast’s formulation excludes propylene glycol, making it suitable for children with contact allergies to this common topical medication ingredient, although more nonsteroidal options with similar allergen-free formulations would benefit patients with multiple sensitivities.