Delgocitinib shows long-term safety, efficacy in pediatric atopic dermatitis

Delgocitinib ointment was associated with improved efficacy over placebo in pediatric patients with moderate atopic dermatitis through 56 weeks of follow-up, according to a study.

While the topical janus kinase (JAK) inhibitor delgocitinib 0.5% ointment is approved for adults in Japan, there are questions about its efficacy in pediatric populations with atopic dermatitis (AD), according to Hidemi Nakagawa, MD, PhD, of Jikei University School of Medicine in Tokyo, and colleagues.

The trial was conducted in two parts. The first part consisted of a 4-week double-blind period in which 137 patients aged 2 to 15 years were randomly assigned delgocitinib 0.25% ointment or vehicle ointment in a 1:1 ratio. There were 69 patients in the active therapy group and 68 received placebo.

Sixty-two patients on active therapy and 48 patients in the vehicle group completed part one, while seven on active therapy and 19 in the vehicle group entered part two early due to worsening AD. One patient in the vehicle group was withdrawn from the study.

Part two was a 52-week extension analysis in which all patients received delgocitinib in a 0.25% or 0.5% formulation based on the patient’s disease condition and the investigator’s discretion. Results showed that 118 patients overall completed part two.

Baseline data showed that half of the patients overall had moderate AD as defined by modified Eczema Area and Severity Index score. Change in this score served as the primary endpoint.

Results from part one showed a least-squares mean percent change from baseline in the mEASI score of –39.3% in the delgocitinib arm and +10.9% in the vehicle arm (P < .001).

Also, 50.7% of patients (35 of 69) in the study drug group and just 17.6% of patients (12 of 68) in the vehicle group achieved mEASI-50. An mEASI-75 score was reached by 37.7% of patients (26 of 69) in the delgocitinib arm but just 4.4% (3 of 68) of those receiving vehicle.

These trends persisted through week 56 for delgocitinib, with 73.6% of patients (39 of 53) from the active therapy arm in part one reaching mEASI-50 and 52.8% (28 of 53) reaching mEASI-75. In addition, among patients treated with vehicle in part one, 52-week results showed that 70.5% (43 of 61) reached mEASI-50 and 52.5% (32 of 61) reached mEASI-75.

Safety data showed that most adverse events were mild and unrelated to delgocitinib in either part of the study.

The researchers stressed that data could be limited by the fact that only Japanese patients were included, and that there was no control group in the second phase of the study.

“Delgocitinib ointment was effective and well tolerated when applied to Japanese pediatric patients with AD for up to 56 weeks,” the researchers wrote.