For pediatric patients with atopic dermatitis (AD), delgocitinib ointment is effective and well tolerated, according to a study published in the October issue of the Journal of the American Academy of Dermatology.

Hidemi Nakagawa, M.D., Ph.D., from the Jikei University School of Medicine in Tokyo, and colleagues examined the efficacy and safety of delgocitinib ointment in pediatric AD. The study included two parts: a four-week double-blind period in which Japanese patients aged 2 through 15 years were randomly assigned to delgocitinib 0.25 percent ointment or vehicle ointment in a 1:1 ratio and a 52-week extension period. Eligible patients received 0.25 or 0.5 percent delgocitinib ointment in part 2.

The researchers found that about half of the patients had moderate AD at initiation of the study. The least-squares mean percent change from baseline in modified Eczema Area and Severity Index score was significantly greater for delgocitinib ointment versus vehicle at the end of treatment in part 1 (−39.3 versus 10.9 percent). Improvements in AD were seen through week 56 in part 2. Across the study periods, most adverse events were mild and unrelated to delgocitinib.

"Overall, delgocitinib ointment was well tolerated in pediatric patients with AD over the treatment period," the authors write. "No new safety concerns with delgocitinib ointment emerged in pediatric patients with AD."

Several authors disclosed financial ties to pharmaceutical companies, including Leo Pharma, the manufacturer of delgocitinib. The study was funded by Japan Tobacco Inc. and Torii Pharmaceutical Co.

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