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意大利一项为期 28 周的回顾性研究:真实世界中古塞库单抗、里莎鲁单抗和替西珠单抗的间接比较。

Real-world practice indirect comparison between guselkumab, risankizumab, and tildrakizumab: results from an Italian 28-week retrospective study.

机构信息

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

出版信息

J Dermatolog Treat. 2022 Sep;33(6):2813-2820. doi: 10.1080/09546634.2022.2081655. Epub 2022 May 29.

DOI:10.1080/09546634.2022.2081655
PMID:35603992
Abstract

BACKGROUND

Guselkumab, tildrakizumab, and risankizumab, acting on interleukin(IL)23 axis, have been recently approved for psoriasis management. However, real-life data regarding their comparison are scant.

OBJECTIVES

The aim of our real life study was to perform an indirect efficacy and safety comparison among anti-IL23s, particularly focusing on difficult-to-treat areas.

METHODS

A 2-year single-center retrospective observational study was performed enrolling moderate-to-severe psoriasis patients treated with anti-IL23. For each patient, clinical and demographical data were collected at baseline and at week4, week16, and week28. PASI, BSA, NAPSI, and specific BSA regarding difficult to treat areas were evaluated.

RESULTS

One hundred and fifty patients were included in the study: 63 (42%) received guselkumab, 21 (14%) tildrakizumab, and 66 (44%) risankizumab. The three groups were comparable for age, sex, and disease severity, only differing for psoriasis duration, psoriatic arthritis prevalence (higher in guselkumab), and previous systemic treatment failure (lower for tildrakizumab). Mean PASI and BSA significantly reduced from baseline up to week 28 without significant differences among the 3 drugs (reduction of 95-97.3% for PASI and 94.8-96.7% for BSA). No significant differences were registered for PASI75, 90, or 100 responses, in particular, PASI100 was reached by 73.4-85% of patients. As regards difficult-to-treat areas, all the drugs displayed a high efficacy, with significant differences registered only for the rapidity of action on palmoplantar psoriasis.

CONCLUSIONS

Our 28-weeks study demonstrated a comparable efficacy and safety profile for all anti-IL23, with guselkumab and risankizumab appearing slightly faster than tildrakizumab particularly on palmoplantar lesions in the short-term.What is already known about this topic?The interleukins (IL) 23/17 axis seems to play a key role in psoriasis management.Guselkumab, tildrakizumab, and risankizumab, selectively blocking the IL23 signaling, have been recently approved for psoriasis management.Real-world data regarding different anti-IL23 comparisons are scant.What does this study add?Our 28-weeks study showed that there were not any significant differences in terms of efficacy and safety between each anti-IL-23 apart from palmoplantar area where guselkumab and risankizumab showed higher efficacy.Globally risankizumab and guselkumab appeared slightly faster than tildrakizumab.Guselkumab, tildrakizumab, and risankizumab are valid weapons for psoriasis management, also for difficult-to-treat areas (scalp, nails, genitalia, lower limbs, and palmo-plantar area).

摘要

背景

古塞库单抗、替度鲁单抗和瑞莎珠单抗通过作用于白细胞介素(IL)23 轴,最近已被批准用于治疗银屑病。然而,关于它们的比较的真实数据很少。

目的

我们的真实研究旨在对抗-IL23 药物进行间接疗效和安全性比较,特别是关注治疗困难区域。

方法

这是一项为期 2 年的单中心回顾性观察研究,纳入了接受抗-IL23 治疗的中重度银屑病患者。对于每位患者,在基线和第 4、16 和 28 周收集临床和人口统计学数据。评估 PASI、BSA、NAPSI 和特定于治疗困难区域的 BSA。

结果

该研究纳入了 150 名患者:63 名(42%)接受古塞库单抗治疗,21 名(14%)接受替度鲁单抗治疗,66 名(44%)接受瑞莎珠单抗治疗。三组患者的年龄、性别和疾病严重程度相当,仅在银屑病病程、银屑病关节炎患病率(古塞库单抗组较高)和既往全身治疗失败方面存在差异(替度鲁单抗组较低)。从基线到第 28 周,PASI 和 BSA 均显著降低,三种药物之间无显著差异(PASI 降低 95-97.3%,BSA 降低 94.8-96.7%)。PASI75、90 或 100 反应的登记无显著差异,特别是 73.4-85%的患者达到了 PASI100。至于治疗困难区域,所有药物均显示出较高的疗效,仅在掌跖银屑病的起效速度上存在差异。

结论

我们 28 周的研究表明,所有抗-IL23 药物的疗效和安全性相似,古塞库单抗和瑞莎珠单抗的起效速度略快于替度鲁单抗,尤其是在短期治疗掌跖病变方面。

关于这个主题已知的是什么?白细胞介素(IL)23/17 轴似乎在银屑病的治疗中起关键作用。古塞库单抗、替度鲁单抗和瑞莎珠单抗通过选择性阻断 IL23 信号通路,最近已被批准用于治疗银屑病。关于不同抗-IL23 药物比较的真实世界数据很少。

这项研究增加了什么?我们的 28 周研究表明,除了掌跖区域外,古塞库单抗和瑞莎珠单抗显示出更高的疗效,抗 IL-23 之间在疗效和安全性方面没有任何显著差异。古塞库单抗、替度鲁单抗和瑞莎珠单抗的起效速度略快于替度鲁单抗,全球范围内,古塞库单抗和瑞莎珠单抗的起效速度略快于替度鲁单抗。古塞库单抗、替度鲁单抗和瑞莎珠单抗是治疗银屑病的有效武器,也可用于治疗困难区域(头皮、指甲、生殖器、下肢和掌跖区域)。

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