Department of Dermatology, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, 210029, China.
Naunyn Schmiedebergs Arch Pharmacol. 2024 Jul;397(7):4657-4662. doi: 10.1007/s00210-024-02971-6. Epub 2024 Feb 15.
Given the lack of head-to-head studies of novel non-steroidal molecule topical therapies in mild-to-moderate atopic dermatitis (AD), network meta-analyses (NMAs) can provide comparative efficacy and safety data for clinical decision-making. In this NMA, we performed a literature search until 01 March 2023 for eligible studies written in English using databases, including PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov. Only double-blind randomized clinical trials (RCTs) with topical Ruxolitinib, Crisaborole, or Tapinarof versus vehicle for patients with mild-to-moderate AD were included. Baseline and follow-up data were extracted. Efficacy was evaluated using Investigator's Global Assessment (IGA) achieving "clear" or "almost clear," with 2 points or more improvement from baseline at the end of treatment, referred to as "IGA success." For binary outcomes, we analyzed in random-effects Bayesian NMA consistency models to compare the efficacy of these 3 topical therapies by odds ratio (OR) with 95% credibility interval (CrI). Overall, 10 phase 2 or phase 3 RCTs were identified, which included 4010 patients with mild to moderate AD. Compared with the topical vehicle control, all these 3 treatments had higher response rate of "IGA success" at the end of trial (Ruxolitinib 1.5% b.i.d: OR, 11.94; 95%CrI, 6.28-23.15; Crisaborole 2% b.i.d: OR, 2.08; 95%CrI, 1.46-3.52; Tapinarof 1% b.i.d: OR, 2.64; 95%CrI, 0.75-9.70). Notably, Ruxolitinib 1.5% b.i.d. had the highest probability of achieving "IGA success" in ranking analysis (Rank 1, SUCRA = 0.75) and lower risk of AE (Rank 8, SUCRA = 0.22). Besides, there was no difference in treatment-related adverse events between 3 therapies. Heterogeneity was not significant across studies.
由于缺乏新型非甾体类分子局部治疗轻度至中度特应性皮炎(AD)的头对头研究,网络荟萃分析(NMA)可为临床决策提供比较疗效和安全性数据。在这项 NMA 中,我们使用包括 PubMed、EMBASE、Cochrane 图书馆和 ClinicalTrials.gov 在内的数据库,对截至 2023 年 3 月 1 日的英文文献进行了检索,以确定合格的研究。仅纳入了比较局部用芦可替尼、克立硼罗或他克莫司与赋形剂治疗轻度至中度 AD 患者的双盲随机对照临床试验(RCT)。提取基线和随访数据。采用研究者全球评估(IGA)评估疗效,治疗结束时达到“清除”或“几乎清除”,与基线相比改善 2 分或更多,称为“IGA 成功”。对于二分类结局,我们在随机效应贝叶斯 NMA 一致性模型中进行分析,以比值比(OR)和 95%可信区间(CrI)比较这 3 种局部治疗的疗效。总体而言,确定了 10 项 2 期或 3 期 RCT,共纳入 4010 例轻度至中度 AD 患者。与局部赋形剂对照相比,所有这些治疗在试验结束时 IGA 成功的反应率更高(芦可替尼 1.5%,每日 2 次:OR,11.94;95%CrI,6.28-23.15;克立硼罗 2%,每日 2 次:OR,2.08;95%CrI,1.46-3.52;他克莫司 1%,每日 2 次:OR,2.64;95%CrI,0.75-9.70)。值得注意的是,在排序分析中,芦可替尼 1.5%,每日 2 次的 IGA 成功概率最高(排名 1,SUCRA=0.75),AE 风险最低(排名 8,SUCRA=0.22)。此外,3 种治疗方法之间的治疗相关不良事件无差异。各研究间的异质性不显著。