K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.
Dermatologikum Berlin, Berlin, Germany.
J Eur Acad Dermatol Venereol. 2019 Jun;33(6):1098-1106. doi: 10.1111/jdv.15400. Epub 2019 Mar 5.
Efficacy of tildrakizumab for plaque psoriasis was demonstrated in randomized, placebo-controlled trials.
To consolidate tildrakizumab efficacy results by pooling data.
Data (N = 2081) from tildrakizumab 100 mg, tildrakizumab 200 mg and placebo groups in three trials were pooled.
Proportions of Psoriasis Area and Severity Index (PASI) 75 responders at week 12 were better with tildrakizumab 100 mg (62.3%) and tildrakizumab 200 mg (64.8%) vs. placebo (5.6%; P < 0.0001) and for PASI 90, PASI 100 and Physician's Global Assessment (PGA) 'clear' or 'minimal' vs. placebo (P < 0.0001). Responses increased from weeks 12 to 28. Week 12 PASI and PGA responses to tildrakizumab vs. placebo were numerically greater in patients with lower vs. higher bodyweight and were better with tildrakizumab 200 mg than tildrakizumab 100 mg for patients with higher bodyweight. Week 12 PASI 75 responses vs. placebo with tildrakizumab 100 mg were similar between patients with (55.0%) or without (56.7%) prior biologics. PASI 90, PASI 100 and PGA responses were generally higher in patients without prior biologics. Week 8 PASI 50 response predicted PASI 90 response.
Pooled data confirmed the efficacy of tildrakizumab for moderate-to-severe plaque psoriasis.
替拉珠单抗治疗斑块状银屑病的疗效已在随机、安慰剂对照试验中得到证实。
通过汇总数据来巩固替拉珠单抗的疗效结果。
汇总了三项试验中替拉珠单抗 100mg、200mg 组和安慰剂组的 2081 例数据。
替拉珠单抗 100mg(62.3%)和 200mg(64.8%)组在第 12 周的银屑病面积和严重程度指数(PASI)75 应答者比例优于安慰剂组(5.6%;P<0.0001),且在第 12 周时,PASI 90、PASI 100 和医生整体评估(PGA)“清除”或“最小”的应答者比例优于安慰剂组(P<0.0001)。应答反应从第 12 周增加到第 28 周。第 12 周时,与安慰剂相比,体重较低的患者接受替拉珠单抗治疗时,PASI 和 PGA 的应答率均高于替拉珠单抗治疗时,且体重较高的患者接受替拉珠单抗 200mg 治疗时的应答率优于替拉珠单抗 100mg 治疗。第 12 周时,与安慰剂相比,体重较低的患者接受替拉珠单抗 100mg 治疗时,PASI 75 应答率相似(55.0%)或更高(56.7%)。PASI 90、PASI 100 和 PGA 的应答率在无既往生物制剂治疗的患者中通常更高。第 8 周 PASI 50 应答可预测 PASI 90 应答。
汇总数据证实了替拉珠单抗治疗中重度斑块状银屑病的疗效。