Tildrakizumab与安慰剂或服用依那西普治疗慢性斑块性银屑病(重现1和重现2):结果,来自两个随机对照,3期试验。

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帝国K, Papp KA, Blauvelt轮胎SK,辛克莱R,萨奇D, Nograles K,梅塔,Cichanowitz N,李问刘K, La Rosa C,绿色的年代,金博AB

Tildrakizumab与安慰剂或服用依那西普治疗慢性斑块性银屑病(重现1和重现2):结果,来自两个随机对照,3期试验。

柳叶刀》。2017年7月15日,390 (10091):276 - 288。doi: 10.1016 / s0140 - 6736 (17) 31279 - 5。Epub 2017年6月6日。

PubMed ID

28596043 (在PubMed

]

文摘

背景:Tildrakizumab高亲和性,人性化,IgG1 kappa抗体针对白介素23 p19代表了发展慢性斑块性银屑病的治疗策略。先前的研究表明临床改善抑制白介素23 p19。我们做了两个第三阶段试验调查tildrakizumab是否优于安慰剂和服用依那西普治疗慢性斑块性银屑病。方法:我们做了两三个部分,平行组,双盲、随机对照研究,重现1(118个网站在澳大利亚、加拿大、日本、英国和美国)和重现2(在132网站在欧洲,以色列和美国)。参与者18岁或以上,严重慢性斑块性银屑病(身体表面积参与> / = 10%,内科医生的全球评估(PGA)评分> / = 3,和银屑病面积和严重程度指数(PASI)评分> / = 12)是随机(通过交互式语音和网络响应系统)tildrakizumab 200毫克,tildrakizumab 100毫克或安慰剂重现1(2:2:1),或者tildrakizumab 200毫克,tildrakizumab 100毫克,安慰剂,或者服用依那西普50毫克(2:2:1:2)。随机是由地区和分层的体重(90公斤)和以前接触生物制剂治疗牛皮癣。调查中,参与者,研究人员对集团也不分配和保持蒙蔽,直到完成研究。指定的药物是相同的外观和包装。Tildrakizumab皮下接种周0和4在第1部分和第2部分在第16周(周12和16的参与者re-randomised Tildrakizumab安慰剂;道了两次每周2的第1部分中重现,一次每周在co-primary端点)。第2部分患者的比例实现PASI 75和PGA响应(得分为0或1 > / = 2年级得分减少从基线)在第12周。 Safety was assessed in the all-participants-as-treated population, and efficacy in the full-analysis set. These trials are registered with ClinicalTrials.gov, numbers NCT01722331 (reSURFACE 1) and NCT01729754 (reSURFACE 2). These studies are completed, but extension studies are ongoing. FINDINGS: reSURFACE 1 ran from Dec 10, 2012, to Oct 28, 2015. reSURFACE 2 ran from Feb 12, 2013, to Sept 28, 2015. In reSURFACE 1, 772 patients were randomly assigned, 308 to tildrakizumab 200 mg, 309 to tildrakizumab 100 mg, and 155 to placebo. At week 12, 192 patients (62%) in the 200 mg group and 197 patients (64%) in the 100 mg group achieved PASI 75, compared with 9 patients (6%) in the placebo group (p<0.0001 for comparisons of both tildrakizumab groups vs placebo). 182 patients (59%) in the 200 mg group and 179 patients (58%) in the 100 mg group achieved PGA responses, compared with 11 patients (7%) in the placebo group (p<0.0001 for comparisons of both tildrakizumab groups vs placebo). In reSURFACE 2, 1090 patients were randomly assigned, 314 to tildrakizumab 200 mg, 307 to tildrakizumab 100 mg, 156 to placebo, and 313 to etanercept. At week 12, 206 patients (66%) in the 200 mg group, and 188 patients (61%) in the 100 mg group achieved PASI 75, compared with 9 patients (6%) in the placebo group and 151 patients (48%) in the etanercept group (p<0.0001 for comparisons of both tildrakizumab groups vs placebo; p<0.0001 for 200 mg vs etanercept and p=0.0010 for 100 mg vs etanercept). 186 patients (59%) in the 200 mg group, and 168 patients (59%) [corrected] in the 100 mg group achieved a PGA response, compared with 7 patients (4%) in the placebo group and 149 patients (48%) in the etanercept group (p<0.0001 for comparisons of both tildrakizumab groups vs placebo; p=0.0031 for 200 mg vs etanercept and p=0.0663 for 100 mg vs etanercept). Serious adverse events were similar and low in all groups in both trials. One patient died in reSURFACE 2, in the tildrakizumab 100 mg group; the patient had alcoholic cardiomyopathy and steatohepatitis, and adjudication was unable to determine the cause of death. INTERPRETATION: In two phase 3 trials, tildrakizumab 200 mg and 100 mg were efficacious compared with placebo and etanercept and were well tolerated in the treatment of patients with moderate-to-severe chronic plaque psoriasis. FUNDING: Merck & Co.

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药物

Tildrakizumab