Background

Certolizumab pegol, the only Fc-free, PEGylated anti–tumor 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.

中文翻译：

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Certolizumab pegol用于治疗慢性斑块状牛皮癣：来自2期3期，多中心，随机，双盲，安慰剂对照研究（CIMPASI-1和CIMPASI-2）的48周结果

背景

Certolizumab pegol是唯一不含Fc，聚乙二醇化的抗肿瘤坏死因子的生物制剂，在具有中度至重度慢性斑块状牛皮癣的成人2期研究中显示出临床上有意义的改善，表明正风险-收益平衡。

客观的

在3期研究中评估certolizumab与安慰剂的疗效和安全性。

方法

每2周将中度至重度慢性斑块状牛皮癣患者按2：2：1随机分配至certolizumab 400 mg，certolizumab 200 mg或安慰剂。在第16周时，通过牛皮癣区域和严重性指数降低50％的接受certolizumab治疗的患者继续治疗直至第48周。主要终点是第16周的缓解率，定义为牛皮癣区域和严重性指数降低75％，以及医师的整体评估0 / 1（清晰/几乎清晰）且≥2分的改进。通过紧急治疗不良事件评估安全性。

结果

两种剂量的塞妥珠单抗与安慰剂相比，第16周的终点显着更高，并且反应一直持续到第48周。对于大多数测量，塞妥珠单抗400 mg的改善在数值上更大。没有发现意外的安全信号。

局限性

没有活动的比较器。

结论

每两周使用certolizumab 400 mg或200 mg的治疗与中度至重度牛皮癣的显着改善和临床上有意义的改善相关。400毫克剂量可以提供额外的临床益处。安全性与治疗类别一致。