Rheumatology Unit, University of Messina, Italy.
Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
Clin Exp Rheumatol. 2019 Jul-Aug;37(4):649-655. Epub 2019 Feb 11.
To determine the incidence of serious infections (SIs) among the spondyloarthropathy (SpA) patients from the "Gruppo Italiano per lo Studio delle Early Arthritis" (GISEA) registry and treated with tumour necrosis factor (TNF) inhibitors (TNFIs), and to identify the factors associated with the development of the infections.
This observational study on 3321 GISEA-registered SpA patients collected real-world demographic and clinical data relating to their biological drug treatments. The overall incidence of infections was analysed by type of SpA.
A total of 3321 SpA patients (1731 males, 52.2%; mean age 47±13 years; median disease duration 3 years, interquartile range [IQR] 0-8) were eligible for inclusion in the analysis. Two hundred and fifty-nine patients experienced at least one of 391 microbiologically diagnosed SIs, 32% of which were recorded during the first 12 months of treatment. The overall incidence of SIs was 43.9/1000 patient-years of follow-up (95% confidence interval [CI] 39.6-48.4): 29.9/1000 (95% CI 23.1-38.1) among those treated with adalimumab (ADA); 36.1/1000 (95% CI 30.0-43.1) among those treated with etanercept (ETN); and 61.4/1000 (95% CI 53.3-70.5) among those treated with infliximab (INF). The highest incidence was observed among the patients with psoriatic arthritis (PsA), but the difference was statistically significant only in comparison with the patients with undifferentiated SpA (p=0.002), whose incidence of SIs was also lower than in the patients with ankylosing spondylitis (AS) (p=0.034). Multivariate models showed that the number of comorbidities (hazard ratio [HR] 1.29, 95%CI 1.2-1.4; p<0.001), age at the start of TNFi treatment (HR 0.99, 95%CI 0.97-0.99; p=0.030), steroid use (HR 1.40, 95%CI 1.1-1.8; p=0.012) and male sex (HR 0.72, 95%CI 0.5-0.9; p=0.012) were all statistically significant predictors of infection. The factors independently associated with a lower risk of SIs were the use of ETN (HR 0.52, 95%CI 0.4-0.7; p<0.001) or ADA (HR 0.59, 95%CI 0.4-0.8; p=0.002) rather than INF.
The incidence of SIs was higher among patients with PsA or AS than among those with undifferentiated SpA, and among patients treated with INF than among those treated with ADA or ETN. Male sex, steroid use and the number of comorbidities were all factors predictive of SIs.
确定“意大利早期关节炎研究组”（GISEA）登记的脊柱关节炎（SpA）患者使用肿瘤坏死因子（TNF）抑制剂（TNFIs）治疗后严重感染（SIs）的发生率，并确定与感染发生相关的因素。
本项针对 3321 名 GISEA 登记的 SpA 患者的观察性研究收集了与生物药物治疗相关的真实世界人口统计学和临床数据。通过 SpA 类型分析感染的总体发生率。
共纳入 3321 名 SpA 患者（男性 1731 名，占 52.2%；平均年龄 47±13 岁；中位疾病持续时间 3 年，四分位距[IQR] 0-8）进行分析。259 名患者至少经历过 391 次微生物学确诊的 SIs，其中 32%发生在治疗的头 12 个月内。SIs 的总体发生率为 43.9/1000 患者年（95%可信区间[CI] 39.6-48.4）：阿达木单抗（ADA）治疗组为 29.9/1000（95%CI 23.1-38.1）；依那西普（ETN）治疗组为 36.1/1000（95%CI 30.0-43.1）；英夫利昔单抗（INF）治疗组为 61.4/1000（95%CI 53.3-70.5）。在患有银屑病关节炎（PsA）的患者中观察到最高的发病率，但与未分化 SpA 患者相比，差异仅具有统计学意义（p=0.002），且其 SIs 发生率也低于强直性脊柱炎（AS）患者（p=0.034）。多变量模型显示，合并症数量（风险比[HR] 1.29，95%CI 1.2-1.4；p<0.001）、TNFi 治疗开始时的年龄（HR 0.99，95%CI 0.97-0.99；p=0.030）、皮质类固醇的使用（HR 1.40，95%CI 1.1-1.8；p=0.012）和男性（HR 0.72，95%CI 0.5-0.9；p=0.012）均为感染的统计学显著预测因素。使用 ETN（HR 0.52，95%CI 0.4-0.7；p<0.001）或 ADA（HR 0.59，95%CI 0.4-0.8；p=0.002）而非 INF 治疗与 SIs 风险降低独立相关。
与未分化 SpA 患者相比，PsA 或 AS 患者的 SIs 发生率更高，与 ADA 或 ETN 治疗相比，INF 治疗的 SIs 发生率更高。男性、皮质类固醇的使用和合并症数量都是 SIs 的预测因素。
