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Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study - 13/03/20

Doi : 10.1016/j.jaad.2019.12.015 
Hidemi Nakagawa, MD, PhD a, Osamu Nemoto, MD, PhD b, Atsuyuki Igarashi, MD, PhD c, Hidehisa Saeki, MD, PhD d, Hironobu Kaino, MS e, Takeshi Nagata, MS e,
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 Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan 

Reprint requests: Takeshi Nagata, MS, Pharmaceutical Division, Japan Tobacco Inc, Torii Nihonbashi Bldg 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, 103-0023 Japan.Pharmaceutical DivisionJapan Tobacco IncTorii Nihonbashi Bldg 4-1, Nihonbashi-Honcho 3-chome, Chuo-kuTokyo103-0023Japan

Abstract

Background

Previous studies showed the potential effectiveness of delgocitinib ointment, a novel topical Janus kinase inhibitor, in atopic dermatitis (AD).

Objective

This study aimed to evaluate the efficacy and safety of delgocitinib 0.5% ointment.

Methods

In part 1, a 4-week double-blind period, Japanese patients aged 16 years or older with moderate or severe AD were randomly assigned in a 2:1 ratio to delgocitinib 0.5% ointment or vehicle ointment. Eligible patients entered part 2, a 24-week extension period, to receive delgocitinib 0.5% ointment.

Results

At the end of treatment in part 1, the least-squares mean percent changes from baseline in the modified Eczema Area and Severity Index score, the primary efficacy endpoint, were significantly greater in the delgocitinib group than in the vehicle group (-44.3% vs 1.7%, P < .001). The improvement in modified Eczema Area and Severity Index score was maintained in part 2. Most adverse events were mild and unrelated to delgocitinib across the study periods.

Limitations

Only Japanese patients were included. The vehicle-controlled period lasted only 4 weeks. In part 2, topical corticosteroids were allowed for the treatment of worsening of AD.

Conclusion

Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.

Le texte complet de cet article est disponible en PDF.

Key words : Atopic dermatitis, delgocitinib, eczema, inflammation, JAK inhibitor, Janus kinase, JTE-052, ointment, pruritus, QOL, skin barrier, topical therapy

Abbreviation used : AD, AE, BSA, EASI, EOT, IGA, IL, JAK, mEASI, mEASI-50, mEASI-75, NRS, STAT, Th


Plan


 Funding sources: Supported by Japan Tobacco Inc. Japan Tobacco Inc. contributed to the study design, data collection, analysis, and interpretation of the data and provided medical writing assistance for the manuscript. All authors made the decision to submit the manuscript for publication.
 Disclosure: Dr Nakagawa received consulting fees and/or speaker honoraria from AbbVie, Eisai, Eli Lilly Japan, Janssen, Japan Tobacco Inc, Kyowa Hakko Kirin, LEO Pharma, Maruho, Novartis, Tanabe Mitsubishi, Torii Pharmaceutical, and UCB Japan. Dr Nemoto received advisory board honoraria and/or speaker honoraria from Japan Tobacco Inc., Kyowa Hakko Kirin, LEO Pharma, and Maruho. Dr Igarashi received advisory board honoraria, consulting fees, or speaker honoraria from AbbVie, Eli Lilly Japan, Japan Tobacco Inc, Maruho, Novartis, Sanofi, and Torii Pharmaceutical and received research grants from AbbVie, Eli Lilly Japan, Japan Tobacco Inc, Novartis, and Sanofi. Dr Saeki received advisory board honoraria and/or speaker honoraria from Japan Tobacco Inc, Kyorin Pharmaceutical, Kyowa Hakko Kirin, Maruho, Taiho Pharma, Tanabe Mitsubishi, and Torii Pharmaceutical and received research grants from AbbVie, Japan Tobacco Inc, LEO Pharma, Maruho, Otsuka Pharmaceutical, and Sanofi. Mr Kaino and Mr Nagata are employees of Japan Tobacco Inc.
 The results of part 1 of the study were presented at the 2019 American Academy of Dermatology Annual Meeting in Washington, DC, on March 1-2, 2019.
 IRB approval status: Study-related documents, including the study protocol and informed consent forms, were reviewed by the Sugiura Clinic IRB on April 4, 2017, Atago Dermatology Clinic IRB on April 28, 2017, Osaka University Hospital IRB on March 28, 2017, Tokyo Teishin Hospital IRB on April 19, 2017, and Jichi Medical University Hospital IRB on April 28, 2017. The conduct of the study was approved for all the study sites.


© 2019  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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