比美吉珠单抗治疗银屑病:一项真实世界环境下评估短期和中期疗效及安全性的单中心研究。

Bimekizumab in psoriasis: a monocentric study evaluating short- and mid-term effectiveness and safety profile in a real-world setting.

机构信息

Department of Dermatology-Venereology, Medical School, National and Kapodistrian University of Athens, "A. Sygros" Hospital for Skin and Venereal Diseases, Athens, Greece.

出版信息

Arch Dermatol Res. 2024 Apr 25;316(5):133. doi: 10.1007/s00403-024-02868-7.

Abstract

INTRODUCTION

Bimekizumab is a humanized monoclonal IgG1 antibody with a unique mechanism of action, as it inhibits both IL17A and IL17F molecules. This dual inhibition is thought to be responsible for its high efficacy in treating chronic plaque psoriasis with rapid onset of action in Randomized Controlled Trials (RCTs). Concerning safety, oral candidiasis was one of the most common drug-related adverse events, commonly mild-to-moderate in severity. Although data from RCTs supporting this efficacy and safety profile of bimekizumab is numerous, results from the real-world setting concerning short- and mid-term treatment effectiveness and safety profile are limited.

MATERIALS AND METHODS

An observational, retrospective, monocentric study was conducted at the Psoriasis Outpatient Unit of "A. Sygros" Hospital for Skin and Venereal Diseases, in Athens, Greece, which included 61 adult patients with moderate-to-severe skin psoriasis, who received at least one dosage of bimekizumab.

RESULTS

At week 4, 65.7% achieved PASI75, 45.7% PASI90, and 32.4% PASI100. After 16 weeks of treatment, 92.3/76.9/66.7% of the patients achieved PASI75/90/100, respectively. Increased BMI, previous treatment with another IL-17 inhibitor, or previous exposure to another biologic did not seem to influence the possibility of achieving PASI90 and PASI100 at week 16 of bimekizumab treatment in this cohort. Six (9.8%) cases of possibly drug-related AEs were reported, from which four incidences of oral candidiasis.

CONCLUSION

Our results confirm that this IL17A/F inhibitor is highly effective, with a tolerability profile similar to the one expected from RCTs.

摘要

简介

Bimekizumab 是一种人源化单克隆 IgG1 抗体,具有独特的作用机制,因为它可以抑制 IL17A 和 IL17F 两种分子。这种双重抑制作用被认为是其在治疗慢性斑块型银屑病方面具有高效性的原因,并且在随机对照试验(RCT)中具有快速的作用。关于安全性,口腔念珠菌病是最常见的药物相关不良事件之一,通常为轻度至中度。尽管 RCT 中有大量数据支持 bimekizumab 的这种疗效和安全性,但关于短期和中期治疗效果和安全性的真实世界数据有限。

材料和方法

在希腊雅典的“A. Sygros”皮肤病和性病医院的银屑病门诊单位进行了一项观察性、回顾性、单中心研究,该研究纳入了 61 名患有中重度皮肤银屑病的成年患者,他们至少接受了一次 bimekizumab 治疗。

结果

在第 4 周,65.7%的患者达到 PASI75,45.7%的患者达到 PASI90,32.4%的患者达到 PASI100。治疗 16 周后,92.3/76.9/66.7%的患者分别达到 PASI75/90/100。在该队列中,BMI 增加、先前接受另一种 IL-17 抑制剂治疗或先前暴露于另一种生物制剂似乎并不影响 bimekizumab 治疗 16 周时达到 PASI90 和 PASI100 的可能性。报告了 6 例(9.8%)可能与药物相关的 AEs,其中 4 例为口腔念珠菌病。

结论

我们的结果证实,这种 IL17A/F 抑制剂具有高度疗效,且耐受性与 RCT 中预期的相似。

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