Once-Daily Roflumilast Cream Delivers Lasting Benefits in Atopic Dermatitis: Study Shows
USA: A subgroup analysis published in The Journal of Allergy and Clinical Immunology reports that roflumilast cream may provide sustained improvement in patients with atopic dermatitis, including those who also have other allergic conditions. The findings suggest that the once-daily topical therapy could help control disease symptoms while potentially lowering the need for long-term corticosteroid use.
Atopic dermatitis (AD) commonly coexists with other allergic conditions such as Asthma, Allergic Rhinitis, and food allergies. These disorders are often treated with corticosteroids, increasing the risk of cumulative steroid exposure. Researchers therefore investigated whether roflumilast cream, a topical phosphodiesterase-4 inhibitor, could provide sustained disease control in patients with AD who also have other atopic conditions.
The analysis was led by Bob Geng from the UCSD School of Medicine in collaboration with investigators from Allergy & Asthma Medical Group & Research Center and Rady Children's Hospital. Researchers analyzed data from the INTEGUMENT open-label extension study that followed earlier randomized trials evaluating roflumilast cream in AD.
Patients who completed the INTEGUMENT-1, INTEGUMENT-2, or INTEGUMENT-PED trials were eligible to enter the extension study and continue treatment for up to 52 weeks. Participants aged six years and older applied roflumilast cream 0.15% once daily, while children aged two to five years used a 0.05% formulation.
Treatment effectiveness was assessed using the validated Investigator Global Assessment for AD (vIGA-AD) and the Worst Itch Numeric Rating Scale (WI-NRS). The study included patients with various coexisting allergic conditions, including upper airway or ocular allergies, lower airway diseases such as asthma, food or gastrointestinal allergies, and systemic hypersensitivity reactions.
Key Findings:
- After 52 weeks of treatment, nearly half of the patients achieved clear or almost clear skin along with meaningful improvement in disease severity.
- Comparable response rates were observed across patient groups with different allergic comorbidities.
- More than half of the participants reported clinically meaningful reductions in itch intensity.
- A substantial proportion of patients achieved minimal or no itch during the study period.
- Significant improvements were also observed in the Eczema Area and Severity Index scores.
- Treatment benefits were similar among patients with no additional atopic conditions, one additional condition, or multiple allergic comorbidities.
According to the researchers, these findings indicate that roflumilast cream can effectively improve both skin symptoms and itching in patients with atopic dermatitis, even when other allergic diseases are present. The therapy may therefore provide an alternative approach for long-term management of AD while helping to limit cumulative corticosteroid exposure.
Reference: https://www.jacionline.org/article/S0091-6749(25)01247-3/fulltext
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