Background

Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.

Objective

Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis.

Methods

Patients were randomized 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks. Certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 were re-randomized to certolizumab or placebo for 32 weeks. The primary endpoint was responder rate (≥75% reduction in psoriasis area and severity index) versus placebo (primary analysis) and etanercept (secondary analysis) at Week 12; secondary endpoints included responder rates on various measures versus placebo at Weeks 12, 16, and 48. Safety was assessed by treatment-emergent adverse events.

Results

All endpoints were significantly greater for certolizumab versus placebo with the greatest response seen with 400 mg. Certolizumab 400 mg was superior to and 200 mg was noninferior to etanercept. Adverse events were consistent with the anti-tumor necrosis factor class.

Limitations

Single-blind etanercept.

Conclusion

Both certolizumab regimens improved psoriasis symptoms with greater response at the higher dose. No new safety signals were observed.

中文翻译：

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Certolizumab Pegol治疗慢性斑块状牛皮癣：第3阶段，多中心，随机，双盲，依那西普和安慰剂对照研究（CIMPACT）的48周结果

背景

用无Fc，聚乙二醇化，抗肿瘤坏死因子的生物体certolizumab聚乙二醇进行的2期牛皮癣研究显示出有意义的临床活性。

客观的

评估西妥珠单抗在中重度慢性斑块状牛皮癣成人中的安全性和有效性。

方法

患者被随机分3：3：1：3接受certolizumab 400 mg，200 mg或安慰剂，每2周治疗16周，或依那西普50 mg每周两次，持续12周。在第16周时，银屑病面积和严重性指数降低≥75％的接受Certolizumab治疗的患者被重新随机分配至certolizumab或安慰剂治疗32周。主要终点指标是在第12周时相对于安慰剂（主要分析）和依那西普（次要分析）的缓解率（牛皮癣面积和严重程度指数降低≥75％）；次要终点包括在第12、16和48周时各种措施与安慰剂的缓解率。通过治疗紧急不良事件评估安全性。

结果

与安慰剂相比，塞妥珠单抗的所有终点均显着更高，400 mg的应答最大。Certolizumab 400 mg优于依那西普，而200 mg不逊于依那西普。不良事件与抗肿瘤坏死因子类别一致。

局限性

单盲依那西普。

结论

两种certolizumab方案均可以改善牛皮癣症状，并在较高剂量时反应更大。没有观察到新的安全信号。