Roflumilast Delivers Speedy Improvement, Significant Itch Reduction in Younger Pediatric Patients: Lawrence F. Eichenfield, MD

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The introduction of roflumilast 0.05% cream (Zoryve; Arcutis Biotherapeutics) for the treatment of atopic dermatitis in patients aged 2 to 5 years addresses a significant clinical need in pediatric dermatology. Atopic dermatitis is incredibly common in pediatrics, and while treatment for adult patients often involves topical corticosteroids (TCS), there may perhaps be too much concern among parents and clinicians regarding their use in pediatric patients.

Concerns about long-term use of TCS are legitimate, but "topical steroid addiction or withdrawal syndrome" is very uncommon in pediatrics, explained According to Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California San Diego and chief of pediatric dermatology at Rady Children's Hospital San Diego.

Still, this necessity created a clinical need for effective topical nonsteroids. These ideal nonsteroidal treatments should be anti-inflammatory, help alleviate the itch of atopic dermatitis, and be suitable for use in different care regimens, potentially allowing for longer periods of use.

Roflumilast 0.05% cream, a phosphodiesterase 4 inhibitor, was approved by the FDA on October 6, having been specifically designed for children aged 2 to 5 years. This formulation of the water-based cream involves the drug sitting in the lipid layer and intercalating in the skin. There is no limitation in body surface area that can be treated.

The clinical studies leading to this approval—INTEGUMENT-PED (NCT04845620), INTEGUMENT-OLE (NCT04804605), and a phase 1 pharmacokinetic study—were vehicle control studies. The children included had mild to moderate eczema and a body surface area involvement at baseline averaging about 22%. A high body surface area involvement, even in milder disease, is not uncommon in younger children with atopic dermatitis, explained Eichenfield in an interview with The American Journal of Managed Care^® about this approval.

The clinical studies demonstrated speedy improvements in atopic dermatitis. Compared with the vehicle group, these improvements were statistically significant. Specifically, about a quarter of the children using the active treatment achieved the outcome of clear or almost clear skin, coupled with at least a 2-step improvement in their atopic dermatitis. This is notably superior to the 11% of the vehicle group who achieved the same outcome measures. Furthermore, other metrics, such as achieving 75% improvement via the Eczema Area and Severity Index, also showed excellent results.