Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)
Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)
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DOI：
10.1016/j.jaad.2018.04.012
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发表时间：
2018-08-01
影响因子：
13.8
通讯作者：
Reich, Kristian
中科院分区：
文献类型：
--
作者：
Gottlieb, Alice B.;Blauvelt, Andrew;Reich, Kristian
背景资料：Certolizumab pegol是唯一一种不含Fc的聚乙二醇化抗肿瘤坏死因子生物制剂，在中重度慢性斑块状银屑病成人的2期研究中显示出具有临床意义的改善，提示积极的风险-获益平衡。目的：在3期研究中评估Certolizumab与安慰剂相比的疗效和安全性。1至certolizumab 400 mg、certolizumab 200 mg或安慰剂，每2周一次。在第16周，certolizumab治疗患者的银屑病面积和严重程度指数降低50%，并继续治疗至第48周。共同主要终点是第16周应答率，定义为银屑病面积和严重程度指数降低75%，医生总体评估为0/1（清除/几乎清除）和改善≥ 2分。安全性评估治疗后出现的不良事件。结果：第16周的终点显着更大的两个剂量的赛妥珠单抗与安慰剂，并通过48周的反应保持。对于大多数指标，赛妥珠单抗400 mg组的改善在数值上更大。没有意外的安全性信号被identified.Limitation：没有积极comparator.Conclusion：无论是certolizumab 400 mg或200 mg每2周治疗与显着和临床意义的改善中重度银屑病。400 mg剂量可提供额外的临床获益。安全性特征与治疗类别一致。
Background: Certolizumab pegol, the only Fc-free, PEGylated antietumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis.Objective: Assess certolizumab efficacy and safety versus placebo in phase 3 studies.Methods: Patients with moderate-to-severe chronic plaque psoriasis were randomized 2: 2: 1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear) and >= 2-point improvement. Safety was assessed by treatment-emergent adverse events.Results: Week-16 endpoints were significantly greater for both doses of certolizumab versus placebo, and the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified.Limitation: There was no active comparator.Conclusion: Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.