阿布昔替尼治疗中重度特应性皮炎疗效与安全性的系统评价与meta分析

Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis:a systematic review and meta-analysis

目的系统评价阿布昔替尼治疗中重度特应性皮炎(AD)的疗效与安全性。方法检索PubMed、Cochrane Library、Web of Science、Embase、中国知网、维普、万方数据库,检索时间为各数据库建库至2022年6月,筛选阿布昔替尼治疗AD的临床随机对照试验研究,对纳入的研究进行质量评价,使用RevMan 5.4对结局指标进行meta分析。结果共纳入5篇文献,1825例中重度AD患者,其中试验组1387例(阿布昔替尼治疗),对照组438例(给予安慰剂)。meta分析结果显示:第12周时试验组达到研究者整体评分(IGA)=0或1[RR=3.02,95%CI(2.26~4.02),P<0.001]、湿疹面积及严重程度指数缓解75%[RR=2.89,95%CI(2.17~3.85),P<0.001]、峰值瘙痒数值评定量表(PP-NRS)得分较基线改善≥4分[RR=2.32,95%CI(1.88~2.87),P<0.001]的患者百分比均明显高于对照组;试验组治疗期不良事件(TEAE)发生率明显高于对照组[RR=1.16,95%CI(1.07~1.25),P<0.001],而两组间严重不良事件(SAE)发生率无明显差异[RR=0.66,95%CI(0.37~1.17),P=0.160]。所有纳入研究的偏倚风险评估均为低风险。结论阿布昔替尼对中重度AD患者有益,且不良反应可耐受。

Objective To systematically assess the efficacy and safety of abrocitinib in the treatment of moderate-to-severe atopic dermatitis(AD).Methods PubMed,Cochrane Library,Web of Science,Embase,China national knowledge infrastructure,VIP,and Wanfang databases were searched from the establishment of each database to June 2022 to screen the clinical randomized controlled trials of abrocitinib for the treatment of AD.The quality of included studies were evaluated,and meta-analysis of outcomes was performed using RevMan5.4 software.Results A total of five articles were included,including 1825 patients with moderate to severe AD.There were 1387 patients in the experimental group(treated with abrocitinib)and 438 patients in the control group(given placebo).Meta-analysis showed that the percentages of patients with an investigator global assessment(IGA)score=0 or 1[RR=3.02,95%CI(2.26-4.02),P<0.001],a at least 75%relief in the eczema area and severity index[RR=2.89,95%CI(2.17-3.85),P<0.001],an improvement of the peak pruritus numerical rating scale(PP-NRS)score≥4 from baseline[RR=2.32,95%CI(1.88-2.87),P<0.001]in the experimental group at 12 weeks were significantly higher than those in the control group.The incidence of treatment emergent adverse events(TEAE)in the experimental group was significantly higher than that in the control group[RR=1.16,95%CI(1.07-1.25),P<0.001],while there was no significant difference in serious adverse events(SAE)between the two groups[RR=0.66,95%CI(0.37-1.17),P=0.160].All included studies were assessed as low risk of bias.Conclusion Abrocitinib is beneficial in patients with moderate to severe AD,and adverse effects are well tolerated.