Delgocitinib ointment in pediatric patients with atopic dermatitis: a phase 3, randomized, double-blind, vehicle-controlled study and a subsequent open-label, long-term study.
Delgocitinib 0.5% ointment, a topical JAK inhibitor, has been approved for adult patients with atopic dermatitis (AD) in Japan.To evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD.In part 1, a 4-week double-blind period, Japanese patients aged 2 through 15 years were randomized in a 1:1 ratio to delgocitinib 0.25% ointment or vehicle ointment. Eligible patients entered part 2, a 52-week extension period, to receive 0.25% or 0.5% delgocitinib ointment.At initiation of study, approximately half of the patients had moderate AD. At the end of treatment in part 1, the least-squares mean percent change from baseline in modified Eczema Area and Severity Index score, the primary efficacy endpoint, was significantly greater for delgocitinib ointment than for vehicle (-39.3% vs +10.9%, P < .001). In part 2, the improvements in AD were also seen through week 56. Most adverse events were mild and unrelated to delgocitinib across the study periods.Only Japanese patients were included. In part 2, no control group was included, and rescue therapy was allowed.Delgocitinib ointment was effective and well tolerated when applied to Japanese pediatric patients with AD for up to 56 weeks.
Authors: Hidemi Nakagawa, Osamu Nemoto, Atsuyuki Igarashi, Hidehisa Saeki, Kenji Kabashima, Manabu Oda, Takeshi Nagata