乌司奴单抗改善中、重度斑块状银屑病患者健康相关生活质量和临床疗效观察

发布时间：2018-06-02 16:49

  本文选题：银屑病 + 乌司奴单抗　； 参考：《临床皮肤科杂志》2014年09期

【摘要】：目的:评估乌司奴单抗对中国3期、双盲、安慰剂对照临床(LOTUS)研究患者健康相关生活质量(HRQoL)的影响。方法:共322例患者,在第0周和第4周随机接受乌司奴单抗45mg(n=160)或安慰剂(n=162);第12周和第16周安慰剂组交叉使用乌司奴单抗,而乌司奴单抗组则在第16周继续使用乌司奴单抗。第12周HRQoL终点包括皮肤病生活质量指数(DLQI)评分较基线的变化、单个DLQI域的变化、DLQI评分为0分或1分的患者比例以及获得有临床意义DLQI改善(评分降低≥5分)的患者比例。结果:乌司奴单抗治疗患者12周时DLQI评分较基线的改善(-9.3分)显著优于安慰剂组(-1.9分)(P0.001)。同样,乌司奴单抗治疗后DLQI≤1分的患者比例显著高于安慰剂组(42.6%vs 10.7%,P0.001),乌司奴单抗组和安慰剂组治疗后分别有71.5%和29.6%的患者DLQI降低≥5分(P均0.001)。乌司奴单抗治疗患者12周时单个DLQI域与安慰剂相比显著改善(P0.001)。乌司奴单抗组DLQI的改善在治疗28周内持续存在。交叉接受乌司奴单抗的安慰剂组患者,与最初随机接受乌司奴单抗治疗的患者相比,HRQoL改善程度类似。结论:乌司奴单抗显著改善了中国中至重度斑块状银屑病患者的HRQoL。
[Abstract]:Aim: to evaluate the effects of Ulinumab on health related quality of life (HRQoL) in Chinese phase 3, double blind, placebo controlled clinical trials. Methods: a total of 322 patients were randomly assigned to Ulinumab 45mgnn160) or placebo 162g at week 0 and week 4, and Ulinumab was cross-used in the 12th and 16th week placebo group, while Ulinumab was continued in the Ulinumab group at the 16th week. The end point of HRQoL at the 12th week included the change of the quality of life index (DLQI) score of dermatology compared with the baseline, the proportion of patients with a single DLQI domain with a DLQI score of 0 or 1, and the proportion of patients with clinically significant DLQI improvement (score reduction 鈮，

本文编号：1969480