Introduction: Certolizumab pegol (CZP) is an Fc-free PEGylated TNF-α inhibitor approved for the treatment of psoriatic arthritis (PsA) and plaque psoriasis in many countries. It demonstrated favorable results in PsA in terms of improvement in peripheral arthritis, dactylitis, and enthesitis in a phase III trial (RAPID-PSA) and in real-life experiences. Recently, three phase III randomized clinical trials (CIMPASI-1, CIMPASI-2, CIMPACT) showed significant and sustained improvements in signs and symptoms of moderate-to-severe plaque psoriasis as well as in quality of life parameters as compared to placebo and etanercept.Areas covered: We reviewed the structure and the mechanism of action of CZP, and critically analyzed data from clinical trials and real-life, concerning its efficacy and safety in all aspects of the psoriatic disease. We designed a comprehensive literature search on this topic, by a review of published articles in indexed international journals up until 31 July 2019.Expert opinion: CZP demonstrated positive results in several domains of psoriatic disease, also in patients previously exposed to other TNF-α inhibitors and in patients receiving re-treatment after treatment interruption. The peculiar chemical structure, along with its well-established efficacy and safety, support CZP as the drug of choice in specific subgroups of patients with psoriatic disease, in particular patients with comorbidities and pregnant or breastfeeding female patients.

中文翻译：

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Certolizumab pegol用于治疗牛皮癣性关节炎和斑块状牛皮癣。

简介：Certolizumab聚乙二醇（CZP）是一种无Fc的聚乙二醇化TNF-α抑制剂，在许多国家/地区已被批准用于治疗牛皮癣关节炎（PsA）和斑块状牛皮癣。在III期临床试验（RAPID-PSA）和现实生活中，就改善外周关节炎，齿根炎和皮炎而言，PsA取得了令人满意的结果。最近，三项III期随机临床试验（CIMPASI-1，CIMPASI-2，CIMPACT）显示，与安慰剂和依那西普相比，中重度斑块状牛皮癣的体征和症状以及生活质量参数均得到了显着且持续的改善覆盖范围：我们审查了CZP的结构和作用机理，并严格分析了来自临床试验和现实生活的数据，涉及其在银屑病疾病各个方面的功效和安全性。我们通过回顾截至2019年7月31日在国际索引期刊上发表的文章，针对这一主题设计了全面的文献检索专家意见：CZP在银屑病的多个领域均显示出阳性结果，此前曾接触过其他TNF-α的患者也是如此抑制剂和治疗中断后接受重新治疗的患者。独特的化学结构及其公认的功效和安全性支持CZP作为银屑病患者特定亚组（尤其是合并症患者和孕妇或哺乳期女性患者）的首选药物。CZP在银屑病的多个领域，以前曾接触过其他TNF-α抑制剂的患者以及在治疗中断后接受重新治疗的患者中均显示出阳性结果。独特的化学结构及其公认的功效和安全性支持CZP作为银屑病患者特定亚组（尤其是合并症患者和孕妇或哺乳期女性患者）的首选药物。CZP在银屑病的多个领域显示了积极的结果，在先前接触过其他TNF-α抑制剂的患者以及治疗中断后接受重新治疗的患者中也显示出阳性结果。独特的化学结构及其公认的功效和安全性支持CZP作为银屑病患者特定亚组（尤其是合并症患者和孕妇或哺乳期女性患者）的首选药物。