{"title":"德尔戈西替尼软膏对特应性皮炎婴儿的安全性、有效性和药代动力学：一项三期开放标签长期研究","authors":"Hidemi Nakagawa , Atsuyuki Igarashi , Hidehisa Saeki , Kenji Kabashima , Tomomi Tamaki , Hironobu Kaino , Yasushi Miwa","doi":"10.1016/j.alit.2023.04.003","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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></div><div><h3>Methods</h3><p>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></div><div><h3>Results</h3><p>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></div><div><h3>Conclusions</h3><p>Delgocitinib ointment is well tolerated and effective for up to 52 weeks when applied to Japanese infants with AD.</p></div>","PeriodicalId":48861,"journal":{"name":"Allergology International","volume":"73 1","pages":"Pages 137-142"},"PeriodicalIF":6.2000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1323893023000412/pdfft?md5=26844f544c915b33b1bc538aa274f8ac&pid=1-s2.0-S1323893023000412-main.pdf","citationCount":"2","resultStr":"{\"title\":\"Safety, efficacy, and pharmacokinetics of delgocitinib ointment in infants with atopic dermatitis: A phase 3, open-label, and long-term study\",\"authors\":\"Hidemi Nakagawa , Atsuyuki Igarashi , Hidehisa Saeki , Kenji Kabashima , Tomomi Tamaki , Hironobu Kaino , Yasushi Miwa\",\"doi\":\"10.1016/j.alit.2023.04.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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></div><div><h3>Methods</h3><p>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></div><div><h3>Results</h3><p>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></div><div><h3>Conclusions</h3><p>Delgocitinib ointment is well tolerated and effective for up to 52 weeks when applied to Japanese infants with AD.</p></div>\",\"PeriodicalId\":48861,\"journal\":{\"name\":\"Allergology International\",\"volume\":\"73 1\",\"pages\":\"Pages 137-142\"},\"PeriodicalIF\":6.2000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1323893023000412/pdfft?md5=26844f544c915b33b1bc538aa274f8ac&pid=1-s2.0-S1323893023000412-main.pdf\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergology International\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1323893023000412\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergology International","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1323893023000412","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 2
摘要
背景德尔戈西替尼软膏是一种局部Janus激酶抑制剂，在日本被用于治疗年龄≥2岁的特应性皮炎（AD）患者。尽管在儿童 AD 发病时尽早开始适当的治疗非常重要，但德尔戈西替尼软膏对 AD 婴儿的安全性和有效性尚未确定。符合条件的6至24个月大的日本AD婴儿在开放标签、无对照的情况下接受0.25%或0.5%的delgocitinib软膏治疗，每天两次，为期52周。在治疗期间，如果AD病情恶化，研究人员可酌情使用局部皮质类固醇激素。21名婴儿（95.5%）出现了不良反应（AEs），大部分为轻微不良反应。未报告与治疗相关的不良反应。改良湿疹面积和严重程度指数（mEASI）评分在第4周前持续下降，降分幅度一直保持到第52周。与基线相比，第4周mEASI评分的平均变化百分比为-73.5%，第28周为-81.7%，第52周为-81.9%。大多数婴儿（68.2%-95.2%）的血浆中未检测到地尔戈西替尼。
Safety, efficacy, and pharmacokinetics of delgocitinib ointment in infants with atopic dermatitis: A phase 3, open-label, and long-term study
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.
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.
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%).
Conclusions
Delgocitinib ointment is well tolerated and effective for up to 52 weeks when applied to Japanese infants with AD.
期刊介绍：
Allergology International is the official journal of the Japanese Society of Allergology and publishes original papers dealing with the etiology, diagnosis and treatment of allergic and related diseases. Papers may include the study of methods of controlling allergic reactions, human and animal models of hypersensitivity and other aspects of basic and applied clinical allergy in its broadest sense.
The Journal aims to encourage the international exchange of results and encourages authors from all countries to submit papers in the following three categories: Original Articles, Review Articles, and Letters to the Editor.
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