{"title":"局部治疗特应性皮炎的临床疗效和安全性的系统文献综述和网络meta分析。","authors":"Hiroyuki Murota, Takeshi Nakahara, Xinyu Wang, Miyuki Matsukawa, Hiroe Takeda, Tomohiro Kondo, Kentaro Yamato","doi":"10.1007/s13555-025-01390-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>In Japan, atopic dermatitis (AD) is one of the most common skin diseases, with the number of patients steadily increasing in recent years. Thus, it is crucial to assess the efficacy and safety of currently existing and recently introduced new treatments.</p><p><strong>Methods: </strong>A systematic literature review (SLR) and network meta-analysis (NMA) was conducted to evaluate the clinical efficacy and safety of existing standard topical therapies and new topical treatments for AD. Medline, Embase, Cochrane, and ICHUSHI were used to select studies. The Eczema Area and Severity Index (EASI) score and Investigator Global Assessment (IGA) score were efficacy outcomes, whereas any serious adverse events (AEs), acne, and skin infections were safety outcomes. A Bayesian multiple treatment NMA with fixed effects was performed. Odds ratio with 95% credible interval (CrI) was used to compare the outcomes of different topical medications including placebo for AD.</p><p><strong>Results: </strong>A total of 11 randomised controlled trials (RCTs) conducted in adult patients with varying degrees of AD severity were selected for NMA. The systematic review showed improvement in EASI scores with difamilast 0.3% and 1% and tacrolimus 0.1% as well as in IGA score success rates with difamilast 1%, delgocitinib 3%, and tacrolimus 0.1%. According to NMA, at week 4, difamilast 1% twice daily (BID) showed a significant improvement in the IGA score and percent EASI score change from baseline versus placebo; however, compared to other comparators, point estimates numerically favoured difamilast 1% but were not statistically significant. Difamilast 1% BID showed a significantly lower incidence of acne than delgocitinib 0.3% BID. There was no statistically significant difference in the incidence of serious AEs, acne, and skin infections compared to placebo or other comparators.</p><p><strong>Conclusion: </strong>This study establishes the efficacy and safety of current topical treatment options and recently marketed delgocitinib and difamilast ointments for AD in Japan.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Systematic Literature Review and Network Meta-Analysis of Clinical Efficacy and Safety of Topical Treatments for Patients with Atopic Dermatitis.\",\"authors\":\"Hiroyuki Murota, Takeshi Nakahara, Xinyu Wang, Miyuki Matsukawa, Hiroe Takeda, Tomohiro Kondo, Kentaro Yamato\",\"doi\":\"10.1007/s13555-025-01390-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>In Japan, atopic dermatitis (AD) is one of the most common skin diseases, with the number of patients steadily increasing in recent years. Thus, it is crucial to assess the efficacy and safety of currently existing and recently introduced new treatments.</p><p><strong>Methods: </strong>A systematic literature review (SLR) and network meta-analysis (NMA) was conducted to evaluate the clinical efficacy and safety of existing standard topical therapies and new topical treatments for AD. Medline, Embase, Cochrane, and ICHUSHI were used to select studies. The Eczema Area and Severity Index (EASI) score and Investigator Global Assessment (IGA) score were efficacy outcomes, whereas any serious adverse events (AEs), acne, and skin infections were safety outcomes. A Bayesian multiple treatment NMA with fixed effects was performed. Odds ratio with 95% credible interval (CrI) was used to compare the outcomes of different topical medications including placebo for AD.</p><p><strong>Results: </strong>A total of 11 randomised controlled trials (RCTs) conducted in adult patients with varying degrees of AD severity were selected for NMA. The systematic review showed improvement in EASI scores with difamilast 0.3% and 1% and tacrolimus 0.1% as well as in IGA score success rates with difamilast 1%, delgocitinib 3%, and tacrolimus 0.1%. According to NMA, at week 4, difamilast 1% twice daily (BID) showed a significant improvement in the IGA score and percent EASI score change from baseline versus placebo; however, compared to other comparators, point estimates numerically favoured difamilast 1% but were not statistically significant. Difamilast 1% BID showed a significantly lower incidence of acne than delgocitinib 0.3% BID. There was no statistically significant difference in the incidence of serious AEs, acne, and skin infections compared to placebo or other comparators.</p><p><strong>Conclusion: </strong>This study establishes the efficacy and safety of current topical treatment options and recently marketed delgocitinib and difamilast ointments for AD in Japan.</p>\",\"PeriodicalId\":11186,\"journal\":{\"name\":\"Dermatology and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-03-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13555-025-01390-6\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01390-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Systematic Literature Review and Network Meta-Analysis of Clinical Efficacy and Safety of Topical Treatments for Patients with Atopic Dermatitis.
Introduction: In Japan, atopic dermatitis (AD) is one of the most common skin diseases, with the number of patients steadily increasing in recent years. Thus, it is crucial to assess the efficacy and safety of currently existing and recently introduced new treatments.
Methods: A systematic literature review (SLR) and network meta-analysis (NMA) was conducted to evaluate the clinical efficacy and safety of existing standard topical therapies and new topical treatments for AD. Medline, Embase, Cochrane, and ICHUSHI were used to select studies. The Eczema Area and Severity Index (EASI) score and Investigator Global Assessment (IGA) score were efficacy outcomes, whereas any serious adverse events (AEs), acne, and skin infections were safety outcomes. A Bayesian multiple treatment NMA with fixed effects was performed. Odds ratio with 95% credible interval (CrI) was used to compare the outcomes of different topical medications including placebo for AD.
Results: A total of 11 randomised controlled trials (RCTs) conducted in adult patients with varying degrees of AD severity were selected for NMA. The systematic review showed improvement in EASI scores with difamilast 0.3% and 1% and tacrolimus 0.1% as well as in IGA score success rates with difamilast 1%, delgocitinib 3%, and tacrolimus 0.1%. According to NMA, at week 4, difamilast 1% twice daily (BID) showed a significant improvement in the IGA score and percent EASI score change from baseline versus placebo; however, compared to other comparators, point estimates numerically favoured difamilast 1% but were not statistically significant. Difamilast 1% BID showed a significantly lower incidence of acne than delgocitinib 0.3% BID. There was no statistically significant difference in the incidence of serious AEs, acne, and skin infections compared to placebo or other comparators.
Conclusion: This study establishes the efficacy and safety of current topical treatment options and recently marketed delgocitinib and difamilast ointments for AD in Japan.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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