中重度特应性皮炎患者服用1%地拉米司特和地戈西替尼0.5%的疗效和安全性的匹配调整间接比较研究

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2024-10-01 Epub Date: 2024-10-04 DOI:10.1007/s13555-024-01282-1
Takeshi Nakahara, Hiroyuki Murota, Miyuki Matsukawa, Hiroe Takeda, Yilong Zhang, Tomohiro Kondo
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引用次数: 0

摘要

背景:特应性皮炎(AD)是一种慢性疾病,在日本的发病率越来越高。在日本进行的 2 期和 3 期临床试验证明,地拉米司特和德尔戈西替尼都是治疗特应性皮炎的新型外用药物,具有良好的疗效和安全性。然而,目前还没有头对头的试验来比较它们的疗效和安全性。本研究旨在确定中重度AD患者的严重程度比例,并采用匹配调整间接比较法(MAIC)比较地拉米司特和德戈西替尼在中重度AD患者中的临床疗效和安全性:方法:纳入了地拉米司特和德戈西替尼治疗AD的3期临床试验。这些试验设计相似,但基线人群特征不同。使用锚定MAIC来调整基线特征并计算临床结果。主要结果是通过湿疹面积和严重程度指数(EASI)确定AD患者比例的严重程度分级,次要结果包括比较地拉米司特和德戈西替尼的其他临床疗效和安全性:从地法米司特试验中选取了340例患者(地法米司特和安慰剂各170例)进行分析,从德戈西替尼试验中选取了158例患者(德戈西替尼106例;安慰剂52例)进行分析。将地法米司特试验的患者与德尔戈西替尼试验的患者进行配对后,有效样本量(ESS)减少到原来地法米司特患者(治疗/安慰剂)的32.7%-43.3%。第4周时,根据EASI评分,地拉米司特组的ESS与delgocitinib组相比,在AD严重程度分期分布方面没有统计学意义上的显著差异。此外,两种治疗方法在改良EASI(mEASI)评分、mEASI 50和75评分以及安全性结果方面也没有发现明显差异:锚定MAIC分析表明,在日本,地拉司特治疗与delgocitinib一样,都是治疗中重度AD患者的有效选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Difamilast 1% and Delgocitinib 0.5% in Patients with Moderate-to-Severe Atopic Dermatitis.

Background: Atopic dermatitis (AD) is a chronic condition with an increasing incidence in Japan. Difamilast and delgocitinib are both new topical drugs for AD proven to be efficacious and safe in phases 2 and 3 clinical trials in Japan. However, there are no head-to-head trials comparing their efficacy and safety. The aim of this study was to determine the proportion of patients by severity and compare the clinical efficacy and safety of difamilast with delgocitinib among patients with moderate-to-severe AD using a matching-adjusted indirect comparison (MAIC).

Methods: Phase 3 clinical trials of difamilast and delgocitinib for treating AD were included. The trials had similar designs but differed in baseline population characteristics. Anchored MAIC was used to align the baseline characteristics and calculate clinical outcomes. The primary outcome was to determine severity stages of the proportion of patients with AD through Eczema Area and Severity Index (EASI), while the secondary outcome included comparing other clinical efficacy and safety of difamilast with delgocitinib.

Results: A total of 340 patients were selected (170 each received difamilast and placebo) from the difamilast trial, with 158 (106 received delgocitinib; 52 received placebo) from the delgocitinib trial for the analysis. After matching patients from the difamilast trial with those from the delgocitinib trial, the effective sample sizes (ESS) reduced to 32.7-43.3% of the original difamilast (treatment/placebo) patients. At week 4, the ESS in the difamilast group demonstrated no statistically significant differences in the distribution of AD severity stages, as per EASI scores, compared with the delgocitinib group. In addition, no significant differences were found in modified EASI (mEASI) scores, mEASI 50 and 75 scores, and safety outcomes between the two treatments.

Conclusions: The anchored MAIC analysis indicates that difamilast treatment, like delgocitinib, is a useful option for the treatment of patients with moderate-to-severe AD in Japan.

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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
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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