risankizumab治疗中重度斑块状银屑病疗效与安全性的系统评价

Effect and safety of risankizumab for treatment of moderate-to-severe plaque psoriasis: a systematic review

目的评价risankizumab治疗中重度斑块状银屑病的疗效与安全性。方法计算机检索PubMed、Embase、Cochrane Library、中国知网、维普、万方等数据库及临床试验网站,检索时间均为建库至2019年10月,纳入risankizumab与安慰剂或阳性对照药比较的随机对照试验(RCT),并使用Stata16软件进行Meta分析。结果纳入6个RCT共1 880例患者。疗效指标中,risankizumab组的银屑病皮损面积和严重程度指数评分较基线下降≥90%的患者例数(PASI 90)均显著优于安慰剂组(RR=25.85,95%CI:14.22~46.97,P=0.000)和乌司奴单抗组(RR=1.66,95%CI:1.43~1.93,P=0.000);且risankizumab组的静态医师全面评估评分为0或1的患者例数(sPGA 0/1)均显著优于安慰剂组(RR=11.97,95%CI:8.27~17.32,P=0.000)和乌司奴单抗组(RR=1.36,95%CI:1.22~1.50,P=0.000)。在总不良事件发生率方面,risankizumab与安慰剂或乌司奴单抗间均无显著差异(P> 0.05)。结论当前证据显示,risankizumab在治疗中重度斑块状银屑病方面优于安慰剂和乌司奴单抗。

AIM To evaluate the effect and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis. METHODS The database of PubMed, Embase, Cochrane Library, CNKI, Wanfang, VIP database and Clinicaltrials.gov were retrieved with computer from their establishment to October 2019 for searching randomized controlled trials(RCTs)comparing the plaque psoriasis treatment effect between risankizumab and placebo/positive controls. Meta-analysis of the data was performed by Stata 16 software. RESULTS Six RCTs with a total of 1 880 patients were included. The results of meta-analysis indicated that the proportion of patients who achieved 90% reduction or more from baseline of Psoriasis Area and Severity Index(PASI 90)in the risankizumab group was significantly superior than that in the placebo group(RR = 25.85, 95%CI: 14.22 to 46.97, P = 0.000)and the ustekinumab group(RR = 1.66, 95%CI: 1.43 to 1.93, P = 0.000). The proportion of patients in a static Physician’s Global Assessment who score of 0 or 1(sPGA 0/1)in the risankizumab group was significantly better than that in the placebo group(RR = 11.97, 95%CI: 8.27 to 17.32, P = 0.000)and the ustekinumab group(RR = 1.36, 95%CI: 1.22 to 1.50, P = 0.000). Moreover, there was no significant difference about the rates of total adverse events between the risankizumab group and placebo or ustekinumab group(P > 0.05). CONCLUSION Current evidence shows that risankizumab is superior to both placebo and ustekinumab in treating moderate-to-severe plaque psoriasis.