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Delgocitinib ointment: a clinical study in pediatric patients with atopic dermatitis

Published online: August 16, 2019

Atopic dermatitis (AD) is a pruritic, eczematous dermatitis, and a higher prevalence of AD is seen in children than in adults. Various cytokines, which are associated with the pathology of AD, exert their biological effects via the Janus kinase (JAK)–signal transducer and activator of transcription pathway. Several JAK inhibitors are currently under development for the treatment of AD. Topical delgocitinib, a novel JAK inhibitor, had been shown to be clinically effective in adult patients with AD. However, the efficacy of topical delgocitinib remained unclear in pediatric patients with AD.

In a recently published article in The Journal of Allergy and Clinical Immunology (JACI), Nakagawa and colleagues report the results of a phase 2 clinical study of delgocitinib ointment in pediatric patients with AD. In this clinical study, Japanese patients aged 2 through 15 years with AD were randomized to receive 0.25% or 0.5% delgocitinib ointment, or the vehicle ointment twice daily for 4 weeks.

The authors found that the modified Eczema Area and Severity Index scores (an index for measuring the clinical signs of eczema) in both delgocitinib groups were significantly reduced compared with that in the vehicle group at the end of treatment. The least-squares mean percentage changes from baseline were –54.2% in the 0.25% group and –61.8% in the 0.5% group, versus –4.8% in the vehicle group. Similarly, all the other efficacy parameters, including the Investigator’s Global Assessment and pruritus scores, in both delgocitinib groups were significantly improved compared with those in the vehicle group. Adverse events in both delgocitinib groups were mild in severity, and no serious adverse events were reported.

The authors found that delgocitinib ointment improved clinical signs and symptoms in pediatric patients with AD and was well tolerated. To the author’s knowledge, this is the first clinical study demonstrating the efficacy and safety of topical JAK inhibitors in pediatric patients with AD. Their findings indicate that delgocitinib ointment can be a promising therapeutic option for pediatric patients with AD.

The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.