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性别对早期银屑病关节炎模式及临床反应的影响:来自意大利前瞻性SIRENA研究的真实世界数据

The Impact of Sex on the Pattern and Clinical Response of Early Psoriatic Arthritis: Real-life Data from the Italian Prospective SIRENA Study.

作者信息

Favalli Ennio G, Luchetti Gentiloni Michele M, Selmi Carlo, Ramonda Roberta, Grembiale Rosa D, Dagna Lorenzo, D'Angelo Salvatore, Gerli Roberto, Foti Rosario, Ciccia Francesco, Guggino Giuliana, Franceschini Franco, Chimenti Maria S, Rossini Maurizio, Lubrano Ennio, Frediani Bruno, Marelli Silvia, Zabotti Alen

机构信息

Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Via Gaetano Pini, 9, 20122, Milan, Italy.

Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy.

出版信息

Rheumatol Ther. 2025 Jul 25. doi: 10.1007/s40744-025-00787-1.

Abstract

INTRODUCTION

Limited data are available on sex differences in the disease characteristics, burden and treatment outcomes of early psoriatic arthritis (PsA). The "Spondyloarthritis Italian Registry: Evidence from a National Pathway" (SIRENA) study is a prospective, observational, Italian study conducted in 23 Rheumatology sites on patients with recent diagnosis of spondyloarthritis and naïve to any disease-modifying antirheumatic drugs (DMARDs).

METHODS

The study included 203 patients with early PsA, observed per clinical practice, who were studied regarding the influence of sex on the disease presentation and the likelihood of achieving minimal disease activity (MDA). Clinical and patient-reported outcome (PRO) measures were collected at both study entry and each follow-up visit until 24 months. Treatment was assigned by the treating rheumatologist based on standard clinical practice.

RESULTS

At baseline, 87% of patients with PsA received systemic treatment, mainly with conventional (49%) or biological (25%) DMARDs. Twenty-three of 158 (15%) patients were already in MDA status at study entry: this percentage increased to 55% (n = 83/150) at 6 months and 75% (n = 73/97) at 24 months. MDA was more frequent in males at baseline (20.0% vs. 8.2% in females, p = 0.036) and throughout the study. Significant improvements in clinical measures and PROs were reported in both sexes at all follow-up visits, but PRO scores were significantly worse in females at baseline and at most endpoints. Increasing age, male sex, new PsA diagnosis, mono-/oligoarticular involvement, low (≤ 14) Disease Activity index for PSoriatic Arthritis (DAPSA) and low Health Assessment Questionnaire Disability Index (HAQ-DI) values showed potential associations with MDA achievement at 6 months in univariate analysis, but this was not significant in the multivariate model.

CONCLUSION

In patients with PsA naïve to DMARDs, sex considerably influences the clinical characteristics and outcomes.

TRIAL REGISTRATION NUMBER

NCT03131661.

摘要

引言

关于早期银屑病关节炎(PsA)的疾病特征、负担及治疗结局的性别差异,现有数据有限。“脊柱关节炎意大利注册研究:来自国家路径的证据”(SIRENA)是一项前瞻性、观察性的意大利研究,在23个风湿病学中心开展,研究对象为近期诊断为脊柱关节炎且未使用过任何改善病情抗风湿药物(DMARDs)的患者。

方法

该研究纳入了203例早期PsA患者,按照临床实践进行观察,研究性别对疾病表现及达到最小疾病活动度(MDA)可能性的影响。在研究入组时及直至24个月的每次随访时收集临床和患者报告结局(PRO)指标。治疗由主治风湿病医生根据标准临床实践进行安排。

结果

基线时,87%的PsA患者接受了全身治疗,主要使用传统(49%)或生物(25%)DMARDs。158例患者中有23例(15%)在研究入组时已处于MDA状态:该比例在6个月时增至55%(n = 83/150),在24个月时增至75%(n = 73/97)。在基线时及整个研究过程中,MDA在男性中更为常见(男性为20.0%,女性为8.2%,p = 0.036)。在所有随访中,两性的临床指标和PROs均有显著改善,但女性在基线及大多数终点时的PRO评分显著更差。在单因素分析中,年龄增加、男性、新发PsA诊断、单/寡关节受累、低(≤14)银屑病关节炎疾病活动指数(DAPSA)及低健康评估问卷残疾指数(HAQ-DI)值显示与6个月时达到MDA存在潜在关联,但在多变量模型中无显著性。

结论

在未使用过DMARDs的PsA患者中,性别对临床特征和结局有显著影响。

试验注册号

NCT03131661。

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