Roflumilast improves skin clearance in patients with AD

Treatment with topical roflumilast cream 0.15% demonstrates a significant improvement in vIGA-AD* score, achieving a clear or almost clear status, in patients with mild-to-moderate atopic dermatitis (AD), according to the pooled analysis of the phase III INTEGUMENT-1/2 studies presented at ACAAI 2023.

Roflumilast is a once-daily, nonsteroidal treatment being investigated in creams and foam formulations for psoriasis, which has already been approved by the FDA, seborrheic dermatitis, and AD, said lead author Dr Lawrence Eichenfield from Rady’s Children’s Hospital-San Diego, University of California San Diego, California, US.

These two identical, multicentre, phase III trials involved 1,337 patients aged ≥6 years with AD who had an Eczema Area and Severity Index (EASI) score of ≥5 and a vIGA-AD score of 2 (mild) or 3 (moderate) at baseline. Participants were randomized to apply roflumilast cream 0.15% (n=884) or vehicle cream (n=453) once daily for 4 weeks.

At week 4, 31.3 percent of the roflumilast-treated patients achieved the primary endpoint of vIGA-AD success (defined as clear or almost clear vIGA-AD with a ≥2-grade improvement from baseline) compared with 14.1 percent of the vehicle-treated patients (p<0.0001). [ACAAI 2023, abstract P284]

Significantly more roflumilast recipients also achieved a vIGA-AD score of 0 (clear) or 1 (almost clear) than the vehicle recipients at week 4 (41.1 percent vs 21.4 percent; p<0.0001).

A significantly higher percentage of patients who received roflumilast also had a 75-percent reduction in EASI score (42.7 percent vs 20.6 percent; p<0.0001) and a ≥4-point improvement in WI-NRS** (31.9 percent vs 16.6 percent; p<0.0001) at week 4 vs those on vehicle cream.

In addition, roflumilast improved itching as early as 24 hours after the first application compared with the vehicle cream, said lead author Dr Lawrence Eichenfield from Rady’s Children’s Hospital-San Diego, University of California San Diego, California, US.

In terms of safety, both the roflumilast and vehicle groups showed a low incidence of treatment-emergent adverse events (TEAEs), serious AEs, and TEAEs leading to treatment discontinuation, Eichenfield noted.

“Overall, once-daily, nonsteroidal roflumilast cream 0.15% significantly improved AD … across multiple efficacy endpoints while demonstrating favourable safety and tolerability in these two phase III trials,” Eichenfield concluded.