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意大利基于疾病的中轴型和外周型脊柱关节炎注册研究:西雷娜研究

An Italian Disease-Based Registry of Axial and Peripheral Spondyloarthritis: The SIRENA Study.

作者信息

Zabotti Alen, Luchetti Michele Maria, Selmi Carlo Francesco, Ramonda Roberta, Grembiale Rosa Daniela, Dagna Lorenzo, D'Angelo Salvatore, Cafaro Giacomo, De Vita Salvatore, Felicetti Mara, Marelli Silvia, Frigerio Daniela, Favalli Ennio Giulio

机构信息

Rheumatology Clinic, Department of Medical Area, University of Udine, Academic Hospital S. Maria della Misericordia, Udine, Italy.

Clinica Medica, Dipartimento Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Ancona, Italy.

出版信息

Front Med (Lausanne). 2021 Sep 22;8:711875. doi: 10.3389/fmed.2021.711875. eCollection 2021.

Abstract

Data about the clinical presentation and management of early and mild spondyloarthritis (SpA) are limited. The objective of this study was to describe the baseline characteristics of disease-modifying antirheumatic drug (DMARD)-naïve patients with axial or peripheral SpA. The Spondyloarthritis Italian Registry: Evidence from a National Pathway (SIRENA) study is an ongoing, Italian, multicenter, prospective registry of patients with a first or newly confirmed diagnosis of SpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria. To be included, patients had to be naïve to conventional, targeted, and biological DMARDs for SpA. Patients were enrolled between June 2017 and June 2019 and classified into groups according to disease presentation: predominantly axial or peripheral manifestations. The study is ongoing, and patients are being followed for 2 years, with an evaluation every 6 months according to clinical practice. Differences in baseline demographics, lifestyle, and clinical characteristics between axial and peripheral SpA were evaluated. In this study, 350 patients were enrolled, of which 123 (35.1%) were axial and 227 (64.9%) were peripheral patients. Patients with axial SpA were significantly younger at enrollment (median age: 44 vs. 53 years), had significantly more anxiety/depression (13 vs. 2.6%), and expressed higher disease activity compared to patients with peripheral SpA. Patients with peripheral SpA had significantly more cardiometabolic disorders (33 vs. 18.7%), skin psoriasis (65.2 vs. 21.1%), and nail psoriasis (35.5 vs. 17.1%) than patients with axial SpA. Dactylitis, enthesitis, and fibromyalgia were observed, respectively, in 17.6, 51.2, and 5.7% of patients with axial SpA and 24.3, 40, and 3.1% of patients with peripheral SpA. In both disease groups, women tended to report depression, joint tenderness, and higher disease activity more frequently than their male counterparts. At inclusion, a new diagnosis of SpA was performed in 58% of axial and 77% of peripheral patients, with a median time from symptom onset to diagnosis of 36 and 24 months, respectively. At baseline, most patients with axial SpA (77%) started a biological DMARD, while over half of the peripheral patients started a conventional DMARD. Based on a well-characterized clinical registry of SpA, we provided real-world insights on the clinical features of DMARD-naïve SpA patients, pointing out major differences between axial and peripheral disease in terms of clinical characteristics and treatment pattern. Future prospective evaluations within the SIRENA study will improve knowledge on SpA and contribute to defining the best therapeutic approach.

摘要

关于早期和轻度脊柱关节炎(SpA)临床表现及治疗的数据有限。本研究的目的是描述未使用改善病情抗风湿药物(DMARD)的轴向或外周SpA患者的基线特征。意大利脊柱关节炎注册研究:来自国家路径的证据(SIRENA)是一项正在进行的意大利多中心前瞻性注册研究,纳入首次或新确诊的符合国际脊柱关节炎评估协会(ASAS)标准的SpA患者。纳入的患者必须未使用过用于SpA的传统、靶向和生物DMARD。患者于2017年6月至2019年6月入组,并根据疾病表现分为以下组:主要为轴向或外周表现。该研究正在进行中,对患者进行为期2年的随访,根据临床实践每6个月进行一次评估。评估了轴向和外周SpA患者在基线人口统计学、生活方式和临床特征方面的差异。在本研究中,共纳入350例患者,其中123例(35.1%)为轴向SpA患者,227例(64.9%)为外周SpA患者。轴向SpA患者入组时明显更年轻(中位年龄:44岁对53岁),焦虑/抑郁发生率明显更高(13%对2.6%),与外周SpA患者相比疾病活动度更高。外周SpA患者的心脏代谢紊乱(33%对18.7%)、皮肤银屑病(65.2%对21.1%)和指甲银屑病(35.5%对17.1%)明显多于轴向SpA患者。轴向SpA患者和外周SpA患者中,指(趾)炎、附着点炎和纤维肌痛的发生率分别为17.6%、51.2%、5.7%和24.3%、40%、3.1%。在两个疾病组中,女性比男性更频繁地报告抑郁、关节压痛和更高的疾病活动度。纳入时,58%的轴向SpA患者和77%的外周SpA患者为新诊断的SpA,从症状出现到诊断的中位时间分别为36个月和24个月。基线时,大多数轴向SpA患者(77%)开始使用生物DMARD,而超过一半的外周SpA患者开始使用传统DMARD。基于一个特征明确的SpA临床注册研究,我们提供了未使用DMARD的SpA患者临床特征的真实世界见解,指出了轴向和外周疾病在临床特征和治疗模式方面的主要差异。SIRENA研究未来的前瞻性评估将增进对SpA的了解,并有助于确定最佳治疗方法。

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