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 - 29/06/21

Doi : 10.1016/j.jaad.2021.06.014

Hidemi Nakagawa, MD, PhD ^a, Osamu Nemoto, MD, PhD ^b, Atsuyuki Igarashi, MD, PhD ^c, Hidehisa Saeki, MD, PhD ^d, Kenji Kabashima, MD, PhD ^e, Manabu Oda, MS ^f,^⁎ , Takeshi Nagata, MS ^f
^a Jikei University School of Medicine, Tokyo, Japan
^b Kojinkai Sapporo Skin Clinic, Hokkaido, Japan
^c Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan
^d Department of Dermatology, Nippon Medical School, Tokyo, Japan
^e Department of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
^f Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan

^∗Correspondence to: Manabu Oda, MS, Pharmaceutical Division, Japan Tobacco Inc, 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, 103-0023 Japan.Pharmaceutical DivisionJapan Tobacco Inc4-1, Nihonbashi-Honcho 3-chomeChuo-ku, Tokyo103-0023Japan

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Abstract

Background

Delgocitinib 0.5% ointment, a topical Janus kinase inhibitor, has been approved in Japan for adult patients with atopic dermatitis (AD).

Objective

To evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD.

Methods

Part 1 of this study was a 4-week double-blind period in which Japanese patients aged 2 through 15 years were randomized in a 1:1 ratio to delgocitinib 0.25% ointment or vehicle ointment. Part 2 was a 52-week extension period. Eligible patients entered part 2 to receive 0.25% or 0.5% delgocitinib ointment.

Results

At the initiation of the 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, improvements in AD were also seen through week 56. Most adverse events were mild and unrelated to delgocitinib across the study periods.

Limitations

Only Japanese patients were included. In part 2, no control group was included and rescue therapy was allowed.

Conclusion

Delgocitinib ointment was effective and well tolerated when applied to Japanese pediatric patients with AD for up to 56 weeks.

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Key words : atopic dermatitis, delgocitinib, eczema, Janus kinase, JAK inhibitor, JTE-052, ointment, pediatric patients, pruritus, skin barrier, topical therapy

Abbreviations used : AD, AE, EASI, EOT, IGA, JAK, mEASI

Plan

Efficacy and safety evaluations

Safety and tolerability

Pharmacokinetics

Discussion

Conclusion

	Funding sources: Funded by Japan Tobacco Inc and Torii Pharmaceutical Co, Ltd. Japan Tobacco Inc contributed to the study design, data collection, analysis, and data interpretation and provided medical writing assistance for this manuscript. All authors made the decision to submit the manuscript for publication.
	Presented some of the data reported in this article at the AAD VMX 2021, April 23-25, 2021.
	IRB approval status: Study-related documents, including the study protocol and informed consent forms, were reviewed and approved by Hoshikuma Dermatology∙Allergy Clinic IRB, Sugiura Clinic IRB, Asai Dermatology IRB, Chiba University IRB, Kanagawa Children's Medical Center IRB, National Center for Child Health and Development IRB, and Shimane University IRB.
	Reprints not available from the authors.