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抗肿瘤坏死因子-α疗法在非放射学轴性脊柱关节炎患者中的疗效及药物留存率:一项来自瑞典南部的观察性队列研究

Efficacy and drug survival of anti-tumour necrosis factor-alpha therapies in patients with non-radiographic axial spondyloarthritis: an observational cohort study from Southern Sweden.

作者信息

Gulfe A, Kapetanovic M C, Kristensen L E

机构信息

Department of Clinical Sciences, Lund, Section of Rheumatology, Lund University , Sweden.

出版信息

Scand J Rheumatol. 2014;43(6):493-7. doi: 10.3109/03009742.2014.918173. Epub 2014 Aug 22.

Abstract

OBJECTIVES

To evaluate the efficacy and drug survival of anti-tumour necrosis factor (anti-TNF) therapy in non-radiographic axial spondyloarthritis (nr-axSpA) patients treated in clinical practice in Southern Sweden.

METHOD

In this cohort study we prospectively included 112 patients with nr-axSpA and high disease activity as well as inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) receiving their first course of anti-TNF therapy. Patients fulfilling modified New York criteria for ankylosing spondylitis (AS) were excluded. The Assessment of SpondyloArthritis International Society (ASAS) criteria for axial SpA were fulfilled by 77% (n = 86) of the included patients.

RESULTS

At baseline, the median age of the cohort was 38 years, 59% were males, 79% of the patients had imaging suggestive of sacroiliitis (primarily inflammation on magnetic resonance imaging, MRI), 71% were HLA-B27 positive, and the median disease duration was 6 years and 10 months. At 6 months of follow-up, the median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) decreased from 5.6 to 3.2 (p = 0.002), the Bath Ankylosing Spondylitis Functional Index (BASFI) decreased from 3.9 to 1.8 (p = 0.005), and C-reactive protein (CRP) level decreased from 4.4 to 1.7 mg/L (p = 0.001). After 1 year of treatment the Kaplan-Meier estimated drug survival was 76%, and at 2 years of follow-up this value decreased to 65%. Patients with inflammatory MRI findings at baseline had significantly better drug survival [hazard ratio (HR) 0.24, 95% confidence interval (CI) 0.10-0.55, p = 0.001]. Male sex was also associated with higher drug survival (HR 0.45, 95% CI 0.24-0.85, p = 0.011). CRP level at baseline was not associated with drug survival.

CONCLUSIONS

Anti-TNF treatment of patients with nr-axSpA in clinical practice resulted in reduced BASDAI and BASFI scores and good drug survival. The results from this study suggest that male gender and positive imaging at baseline are associated with a favourable treatment course.

摘要

目的

评估在瑞典南部临床实践中接受治疗的非放射学中轴型脊柱关节炎(nr-axSpA)患者使用抗肿瘤坏死因子(抗TNF)疗法的疗效和药物留存率。

方法

在这项队列研究中,我们前瞻性纳入了112例nr-axSpA且疾病活动度高、对非甾体抗炎药(NSAIDs)反应不佳或不耐受的患者,他们接受首个疗程的抗TNF治疗。符合改良纽约标准的强直性脊柱炎(AS)患者被排除。纳入患者中有77%(n = 86)符合脊柱关节炎国际协会(ASAS)中轴型脊柱关节炎标准。

结果

基线时,队列的中位年龄为38岁,59%为男性,79%的患者影像学提示骶髂关节炎(主要是磁共振成像,MRI显示炎症),71%为HLA-B27阳性,中位病程为6年10个月。随访6个月时,中位巴斯强直性脊柱炎疾病活动指数(BASDAI)从5.6降至3.2(p = 0.002),巴斯强直性脊柱炎功能指数(BASFI)从3.9降至1.8(p = 0.005),C反应蛋白(CRP)水平从4.4降至1.7 mg/L(p = 0.001)。治疗1年后,Kaplan-Meier估计的药物留存率为76%,随访2年时该值降至65%。基线时MRI有炎症表现的患者药物留存率显著更高[风险比(HR)0.24,95%置信区间(CI)0.10 - 0.55,p = 0.

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