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培戈洛珠单抗治疗银屑病:真实世界数据。

Certolizumab pegol in the treatment of psoriasis: Real-life data.

机构信息

Dermatology Department, Izmir Bozyaka Training and Research Hospital, Izmir, Turkey.

出版信息

Dermatol Ther. 2021 May;34(3):e14929. doi: 10.1111/dth.14929. Epub 2021 Mar 10.

DOI:10.1111/dth.14929
PMID:33665940
Abstract

Certolizumab pegol (CZP), the only Fc-free, PEGylated anti-tumor necrosis factor biologic agent. This study aims to investigate the effect and safety of CZP in moderate-to-severe chronic plaque psoriasis. We performed a retrospective observational analysis of the moderate-to-severe psoriasis patients under ceratolizumab pegol therapy. Primer endpoints were efficacy of CZP, defined as statistically significant improvement of Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA), and clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) in the 24 week of therapy. Secondary endpoints were safety of CZP especially during COVID-19 pandemic. Fifty-six moderate-to-severe psoriasis patients treated with CZP were evaluated retrospectively. We observed a rapid and significant reduction of PASI, PGA, and cDAPSA scores in W4. After loading dose, we observed loss of clinical efficacy of CZP in eight patients and optimized therapy by increasing the dosing of CZP. Dose escalation of CZP permitted the achievement and long-term maintenance of clinical improvement in these patients. We compare the clinical efficacy of CZP between naive and patients who has been treated with other biologic agents. There were no statistical differences in efficacy between these two groups. No side effects were observed during CZP treatment. There were no cases of death from COVID-related disease in our study population or patients hospitalized for COVID-19 related disease. Our results demonstrate that CZP is an effective and safe therapeutic option for patients with moderate-to-severe chronic plaque psoriasis.

摘要

注射用培塞利珠单抗(CZP)是唯一一种无 Fc 段、聚乙二醇化的抗肿瘤坏死因子生物制剂。本研究旨在探讨 CZP 在中重度慢性斑块型银屑病患者中的疗效和安全性。我们对接受培塞利珠单抗治疗的中重度银屑病患者进行了回顾性观察性分析。主要终点是 CZP 的疗效,定义为治疗 24 周时银屑病面积和严重程度指数(PASI)、医生整体评估(PGA)和关节炎临床疾病活动指数(cDAPSA)的统计学显著改善。次要终点是 CZP 的安全性,特别是在 COVID-19 大流行期间。我们回顾性评估了 56 例接受 CZP 治疗的中重度银屑病患者。我们观察到在 W4 时 PASI、PGA 和 cDAPSA 评分迅速显著降低。在负荷剂量后,我们观察到 8 例患者 CZP 的临床疗效丧失,并通过增加 CZP 的剂量来优化治疗。增加 CZP 的剂量允许这些患者实现并长期维持临床改善。我们比较了 CZP 在初治和已接受其他生物制剂治疗的患者中的疗效。两组患者在疗效方面无统计学差异。在 CZP 治疗期间未观察到不良反应。在我们的研究人群或因 COVID-19 相关疾病住院的患者中,没有因 COVID 相关疾病死亡的病例。我们的结果表明,CZP 是中重度慢性斑块型银屑病患者的一种有效且安全的治疗选择。

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