Post-hoc safety/efficacy analyses from pediatric delgocitinib atopic dermatitis trials.

Abstract

Background: Delgocitinib ointment is usually recommended for use in children at a concentration of 0.25%. However, there are no clear criteria for dosing, except that a 0.5% formulation may also be used, depending on symptom severity. Treatment of atopic dermatitis is based on combinations of topical corticosteroids, tacrolimus ointment, and delgocitinib ointment, but there are no reports on the safety of delgocitinib ointment when used in combination with other drugs.

Methods: This is a post-hoc analysis of data from two delgocitinib ointment trials with pediatric atopic dermatitis patients. The efficacy and safety of the 0.25% and 0.5% formulations were compared. Efficacy and safety were evaluated after up to 4 and 56 weeks of treatment, respectively. The safety of delgocitinib ointment when used in combination with topical corticosteroids and/or tacrolimus ointment was investigated.

Results: The dose-response relationship was examined according to baseline disease severity. The proportions of subjects with mild disease who achieved cumulative investigator's global assessment of 0 (clear) or 1 (almost clear) were 46.2% (0.25% ointment), 71.4% (0.5% ointment), and 7.7% (vehicle). For subjects with moderate to severe disease, the corresponding proportions were 19.0%, 20.0%, and 0.0%, respectively. No overall differences were seen in the safety profiles of the 0.25% and 0.5% delgocitinib ointment doses, or in the safety profiles of the two doses relating to disease severity or to concomitant use of topical corticosteroids and/or tacrolimus ointment.

Conclusions: These analyses indicate that after up to 4 weeks of treatment, delgocitinib 0.5% ointment may be more effective than the 0.25% dose for mild atopic dermatitis, and that after up to 56 weeks of treatment, delgocitinib is well tolerated in a pediatric trial population when used as prescribed in combination with topical corticosteroids and/or tacrolimus ointment.