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特应性皮炎全身和生物疗法2期及3期试验中的安慰剂反应——一项系统评价和荟萃分析

Placebo response in phase 2 and 3 trials of systemic and biological therapies for atopic dermatitis-a systematic review and meta-analysis.

作者信息

Andreasen T H, Christensen M O, Halling A-S, Egeberg A, Thyssen J P

机构信息

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.

Copenhagen Research Group for Inflammatory Skin, CORGIS, Hellerup, Denmark.

出版信息

J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1143-1150. doi: 10.1111/jdv.16163. Epub 2020 Feb 9.

DOI:10.1111/jdv.16163
PMID:31856331
Abstract

A growing number of clinical trials of biological and systemic therapies have been conducted within adult atopic dermatitis (AD). No study has yet examined and meta-analysed the pooled placebo response in AD. We performed a systematic review and meta-analysis to examine the placebo response in clinical trials evaluating the effect of systemic and biological therapies in adult AD and compared it to results from clinical trials in psoriasis. Two screeners independently searched the databases ClinicalTrials.gov, Embase, Pubmed and Web of Science. A total of 2058 articles were identified, of which 78 were full-text reviewed. Overall, 25 trials were included in the qualitative analysis, of which 24 were further included in the quantitative analysis. At 12-week follow-up, EASI50, EASI75 and EASI90 placebo responses were 39.9% [95% confidence interval (CI), 36.7-43.2], 20.9% (95% CI, 18.2-23.8) and 9.0% (95% CI, 6.7-11.6), respectively. At week 12, the pooled proportion of placebo-treated AD patients that obtained EASI50, EASI75 and EASI90 was significantly higher than the pooled proportion of placebo-treated psoriasis patients obtaining PASI50, PASI75 and PASI90 (P < 0.05). Our findings emphasize the fluctuating nature of AD and show that correct and consistent use of topical treatments strongly reduces disease severity.

摘要

越来越多针对成人特应性皮炎(AD)的生物疗法和全身疗法的临床试验已经开展。然而,尚无研究对AD中的合并安慰剂反应进行考察和荟萃分析。我们进行了一项系统评价和荟萃分析,以研究在评估全身疗法和生物疗法对成人AD疗效的临床试验中的安慰剂反应,并将其与银屑病临床试验的结果进行比较。两名筛选人员独立检索了ClinicalTrials.gov、Embase、Pubmed和Web of Science数据库。共识别出2058篇文章,其中78篇进行了全文审阅。总体而言,25项试验纳入了定性分析,其中24项进一步纳入了定量分析。在12周随访时,EASI50、EASI75和EASI90的安慰剂反应分别为39.9%[95%置信区间(CI),36.7 - 43.2]、20.9%(95%CI,18.2 - 23.8)和9.0%(95%CI,6.7 - 11.6)。在第12周时,达到EASI50、EASI75和EASI90的接受安慰剂治疗的AD患者的合并比例显著高于达到PASI50、PASI75和PASI90的接受安慰剂治疗的银屑病患者的合并比例(P < 0.05)。我们的研究结果强调了AD的波动性,并表明正确且一致地使用局部治疗可显著降低疾病严重程度。

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