Safety, efficacy, and pharmacokinetics of delgocitinib ointment in infants with atopic dermatitis: A phase 3, open-label, and long-term study
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- Nakagawa Hidemi
- The Jikei University School of Medicine
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- Igarashi Atsuyuki
- Department of Dermatology, NTT Medical Center Tokyo
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- Saeki Hidehisa
- Department of Dermatology, Nippon Medical School
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- Kabashima Kenji
- Department of Dermatology, Graduate School of Medicine, Kyoto University
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- Tamaki Tomomi
- Pharmaceutical Division, Japan Tobacco Inc.
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- Kaino Hironobu
- Pharmaceutical Division, Japan Tobacco Inc.
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- Miwa Yasushi
- Pharmaceutical Division, Japan Tobacco Inc.
抄録
<p>Background: Delgocitinib ointment, a topical Janus kinase inhibitor, is used as treatment of patients with atopic dermatitis (AD) aged ≥2 years in Japan. Although initiating appropriate and early treatment upon the onset of AD in childhood is important, the safety and efficacy of delgocitinib ointment in infants with AD have not been established.</p><p>Methods: This phase 3 study was conducted from October 2020 to June 2022 (number JapicCTI-205412). Eligible Japanese infants with AD aged 6 to <24 months received 0.25% or 0.5% of delgocitinib ointment twice daily for 52 weeks in an open-label uncontrolled manner. Topical corticosteroids were allowed to apply for worsening AD during the treatment period at the investigators' discretion.</p><p>Results: A total of 22 infants were enrolled. Adverse events (AEs) were reported in 21 (95.5%) infants and were mostly mild. No treatment-related AEs were reported. The Modified Eczema Area and Severity Index (mEASI) score continuously decreased until week 4, and the score reduction was maintained until week 52. The mean percent changes in the mEASI score from baseline were −73.5% at week 4, −81.7% at week 28, and −81.9% at week 52. Delgocitinib was not detected in the plasma of most infants (68.2%–95.2%).</p><p>Conclusions: Delgocitinib ointment is well tolerated and effective for up to 52 weeks when applied to Japanese infants with AD.</p>
収録刊行物
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- Allergology International
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Allergology International 73 (1), 137-142, 2024
一般社団法人日本アレルギー学会
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詳細情報 詳細情報について
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- CRID
- 1390580405831180800
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- ISSN
- 14401592
- 13238930
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- Crossref
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- 抄録ライセンスフラグ
- 使用不可