Efficacy and safety of delgocitinib ointment in combination with topical corticosteroids for remission induction in pediatric patients with atopic dermatitis: A 4-week, randomized, open-label, parallel-group study in Japan

BACKGROUND: Delgocitinib ointment is a non-steroidal Janus kinase inhibitor approved for atopic dermatitis (AD). To address limitations of topical corticosteroids (TCS)-such as reduced adherence and efficacy due to the complexity of anatomical location-based potency adjustments, and patient reluctance to use high-ranked TCS-this study investigated the potential of combining delgocitinib ointment with a medium-ranked TCS (Japanese guideline) to induce remission in pediatric AD patients. METHODS: Eligible Japanese AD patients aged 2 to under 16 years were randomized in a 1:1 ratio to receive either delgocitinib-TCS combination therapy or TCS monotherapy for 4 weeks in an open-label, parallel-group design. Assessments included Eczema Area and Severity Index (EASI), Numeric Rating Scale (NRS), Patient-Oriented Eczema Measure (POEM), and Validated Investigator's Global Assessment (vIGA) for efficacy, and adverse events (AEs) for safety. The study was registered with the Japan Registry of Clinical Trials (jRCTs031240119). RESULTS: Eighty-three and 84 pediatric AD patients received delgocitinib combination therapy and TCS monotherapy, respectively, and showed 71.74% and 60.03% reductions in EASI score after up to 4 weeks of treatment (primary endpoint). The delgocitinib combination group demonstrated a statistically significant 11.71% greater reduction compared to the TCS monotherapy group (p = 0.0383). The adverse drug reactions (ADRs) observed in the delgocitinib combination group were expected local events, and no notable safety concerns were identified with the addition of delgocitinib to TCS therapy. CONCLUSIONS: The combination of delgocitinib ointment and TCS is considered a promising novel therapeutic option for remission induction in pediatric patients with moderate to severe AD.