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乌帕替尼在吸烟的中度至重度特应性皮炎患者中的安全性和有效性:一项为期2年的真实世界多中心研究。

Safety and Effectiveness of Upadacitinib in Patients with Moderate-to-Severe Atopic Dermatitis Who Smoke: a 2-Year Real-Life Multicenter Study.

作者信息

Leo Francesco, Ortoncelli Michela, Cascio Ingurgio Ruggero, Galli Benedetta, Grigolato Laura, Paganini Claudia, Maurelli Martina, Di Brizzi Eugenia Veronica, Lauletta Giuseppe, Barei Francesca, Fiasconaro Chiara Anna, Casale Alloa Marta, Guanti Mario Bruno, Gori Niccolò, Chiricozzi Andrea, Napolitano Maddalena, Patruno Cataldo, Galluzzo Marco, Rossi Mariateresa, Balato Anna, Ferrucci Silvia Mariel, Marzano Angelo Valerio, Pezzolo Elena, Foti Caterina, Girolomoni Giampiero, Gargiulo Luigi, Narcisi Alessandra, Quaglino Pietro, Ribero Simone, Mastorino Luca

机构信息

Dermatology Section, Department of Medical Sciences, Dermatology Clinic, University of Turin, Via Cherasco 23, 10121, Torino, Italy.

Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.

出版信息

Am J Clin Dermatol. 2025 May;26(3):425-435. doi: 10.1007/s40257-025-00926-y. Epub 2025 Feb 24.

Abstract

BACKGROUND

Atopic dermatitis (AD) is a chronic inflammatory skin condition that significantly impairs the quality of life. Recent advancements in systemic therapies, such as Janus kinase (JAK) inhibitors, offer very effective new treatment options. However, concerns regarding potential adverse events, including cardiovascular and thromboembolic risk, have emerged from clinical studies and call for further real-life investigations. This has highlighted the need to establish specific risk categories, such as tobacco smokers.

OBJECTIVE

This study aims to evaluate the safety and effectiveness of upadacitinib, a JAK1 inhibitor, in patients who smoke with moderate-to-severe AD over a 2-year treatment period, comparing outcomes with patients who do not smoke.

PATIENTS AND METHODS

A retrospective multicenter study was conducted across 12 dermatology departments in Italy, including 375 patients treated with upadacitinib. The presence and intensity of smoking habits as well as effectiveness scores and safety data were collected.

RESULTS

Patients who smoke accounted for 36.8% of the sample. Two thromboembolic events in patients who do not smoke were recorded in the 2-year (median follow up of 52.6 weeks) observation period. The most common adverse event was acneiform eruption (12.4% of patients after 104 weeks). No significant differences related to safety emerged regarding the presence or absence of a smoking habit. Drug survival was very high with no differences between the two cohorts (83.5% after 104 weeks for patients who smoke).

CONCLUSIONS

This study suggests that upadacitinib is a safe and effective treatment for moderate-to-severe AD in presence of tobacco smoke, with no significant differences in safety or effectiveness compared with patients who do not smoke.

摘要

背景

特应性皮炎(AD)是一种慢性炎症性皮肤病,严重影响生活质量。系统性疗法的最新进展,如 Janus 激酶(JAK)抑制剂,提供了非常有效的新治疗选择。然而,临床研究中出现了对潜在不良事件的担忧,包括心血管和血栓栓塞风险,这需要进一步的实际调查。这凸显了建立特定风险类别(如吸烟者)的必要性。

目的

本研究旨在评估 JAK1 抑制剂乌帕替尼在中度至重度 AD 吸烟者中进行 2 年治疗期的安全性和有效性,并与不吸烟者的结果进行比较。

患者和方法

在意大利的 12 个皮肤科进行了一项回顾性多中心研究,包括 375 例接受乌帕替尼治疗的患者。收集吸烟习惯的存在和强度以及有效性评分和安全数据。

结果

吸烟者占样本的 36.8%。在 2 年(中位随访 52.6 周)观察期内,记录到 2 例不吸烟者发生血栓栓塞事件。最常见的不良事件是痤疮样皮疹(104 周后 12.4%的患者)。吸烟习惯的有无在安全性方面未出现显著差异。药物留存率非常高,两组之间无差异(吸烟者 104 周后为 83.5%)。

结论

本研究表明,乌帕替尼对有吸烟情况的中度至重度 AD 是一种安全有效的治疗方法,与不吸烟者相比,安全性和有效性无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/76ea/12085314/2b98014484db/40257_2025_926_Fig1_HTML.jpg

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