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一项针对银屑病-IL PSO(意大利银屑病概况)部分缓解者从优特克单抗转换为古塞库单抗的3年多中心研究。

A 3-Year Multicentric Study on Switching from Ustekinumab to Guselkumab in Partial Responders with Psoriasis-IL PSO (Italian Landscape Psoriasis).

作者信息

Valenti Mario, Ibba Luciano, Cascio Ingurgio Ruggero, Malagoli Piergiorgio, Carugno Andrea, Campoli Marco, Carrera Carlo G, Gaiani Francesca M, Strippoli Davide, Mola Federica, Marzano Angelo V, Zerbinati Nicola, Minuti Anna, Costanzo Antonio, Narcisi Alessandra

机构信息

Dermatology Unit, IRCCS Humanitas Research Hospital, Via Alessandro Manzoni, 56, Rozzano, Milan, Italy.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

出版信息

Dermatol Ther (Heidelb). 2024 Nov;14(11):2987-2997. doi: 10.1007/s13555-024-01270-5. Epub 2024 Oct 13.

DOI:10.1007/s13555-024-01270-5
PMID:39397217
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11557789/
Abstract

INTRODUCTION

Guselkumab, a human monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), has shown efficacy in psoriasis and psoriatic arthritis. However, long-term real-world data on its effectiveness in patients with inadequate response to ustekinumab are limited. This study investigates guselkumab's long-term effectiveness and safety in patients with psoriasis with partial response to ustekinumab.

METHODS

We performed a retrospective multicentric study analyzing data of patients with psoriasis from seven Italian hospitals between January 2021 and May 2024. The study included 169 patients who switched from ustekinumab to guselkumab. Primary endpoints were Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, and absolute PASI ≤ 2. Site-specific Physician Global Assessment (PGA) scores were also collected for difficult-to-treat areas.

RESULTS

The study included 169 patients. After 3 years of treatment, PASI 75, PASI 90 and PASI 100 were achieved by 88.4%, 55.8%, and 32.6% of patients, respectively. Site-specific PGA showed significant improvements, especially in the scalp and genital areas. After 3 years of treatment, no significant impact of higher body mass index (BMI) or cardiometabolic comorbidities on guselkumab effectiveness was detected. No severe adverse events were reported during the study period.

CONCLUSIONS

In our study, guselkumab provided significant long-term effectiveness and safety in patients partially responsive to ustekinumab, improving both PASI score and site-specific PGA and confirming its potential use for patients with psoriasis switching from ustekinumab.

摘要

引言

古塞库单抗是一种靶向白细胞介素-23(IL-23)p19亚基的人源单克隆抗体,已在银屑病和银屑病关节炎中显示出疗效。然而,关于其对乌司奴单抗反应不足的患者有效性的长期真实世界数据有限。本研究调查了古塞库单抗在对乌司奴单抗部分反应的银屑病患者中的长期有效性和安全性。

方法

我们进行了一项回顾性多中心研究,分析了2021年1月至2024年5月期间来自意大利七家医院的银屑病患者数据。该研究纳入了169名从乌司奴单抗转换为古塞库单抗的患者。主要终点为银屑病面积和严重程度指数(PASI)改善75%、改善90%、改善100%以及绝对PASI≤2。还收集了难治部位的特定部位医师整体评估(PGA)评分。

结果

该研究纳入了169名患者。治疗3年后,分别有88.4%、55.8%和32.6%的患者实现了PASI改善75%、改善90%和改善100%。特定部位的PGA显示出显著改善,尤其是在头皮和生殖器部位。治疗3年后,未检测到较高体重指数(BMI)或心血管代谢合并症对古塞库单抗有效性有显著影响。研究期间未报告严重不良事件。

结论

在我们的研究中,古塞库单抗在对乌司奴单抗部分反应的患者中提供了显著的长期有效性和安全性,改善了PASI评分和特定部位的PGA,并证实了其对从乌司奴单抗转换的银屑病患者的潜在用途。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/30cd1460e4d6/13555_2024_1270_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/89e5a07b358f/13555_2024_1270_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/958a55a67571/13555_2024_1270_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/632d1f6de1e5/13555_2024_1270_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/30cd1460e4d6/13555_2024_1270_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/89e5a07b358f/13555_2024_1270_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/958a55a67571/13555_2024_1270_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/632d1f6de1e5/13555_2024_1270_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4448/11557789/30cd1460e4d6/13555_2024_1270_Fig4_HTML.jpg

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