Oddgeir Selaas, H. H. Nordal, A. Halse, J. Brun, R. Jonsson, K. Brokstad
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引用次数: 9
Abstract
Objective. The aim of this study was to investigate the clinical effect and serum markers in a cohort of rheumatoid arthritis patients with moderate to high disease activity, participating in an open clinical phase IV study conducted in Norway between 2001 and 2003 receiving infliximab treatment. Method. A total of 39 patients were studied, with a mean age of 54 years and 12-year disease duration. The analyses were performed using serum from patients at four assessment time points: baseline and 3, 6, and 12 months after starting treatment with infliximab. A wide variety of clinical data was collected and disease activity of 28 joints and Simple Disease Activity Index were calculated. The joint erosion was determined by X-ray imaging and the Sharp/van der Heijde score was determined. Serum analysis included multiplex immunoassays for 12 cytokines, 5 matrix metalloproteases, and 2 VEGFs. Results. The majority of the RA patients in this study had initially moderate to high disease activity and the infliximab treatment reduced the disease activity significantly and also reduced any further joint destruction and improved disease status. Most of the serum levels of cytokines and metalloproteases remained unchanged during the course of the study, and we were unable to detect changes in TNF-α in serum. Serum levels of IL-6 and VEGF-A decreased significantly after initiation of infliximab treatment. Conclusion. The serum levels of IL-6 and VEGF-A may be promising disease markers as they vary with disease progression. The clinical significance of these findings is yet to be determined and has to be confirmed in future clinical trials before being applied in the clinics.
目标。本研究的目的是调查2001年至2003年在挪威进行的一项开放临床IV期研究中,接受英夫利昔单抗治疗的中度至高度疾病活动性类风湿关节炎患者的临床疗效和血清标志物。方法。39例患者被纳入研究,平均年龄54岁,病程12年。分析使用患者在四个评估时间点的血清进行:基线和开始使用英夫利昔单抗治疗后的3、6和12个月。收集各种临床资料,计算28个关节的疾病活动性和简单疾病活动性指数。通过x射线成像确定关节侵蚀,并测定Sharp/van der Heijde评分。血清分析包括12种细胞因子、5种基质金属蛋白酶和2种vegf的多重免疫分析。结果。本研究中的大多数RA患者最初具有中度至高度的疾病活动性,英夫利昔单抗治疗显著降低了疾病活动性,也减少了任何进一步的关节破坏,改善了疾病状态。在研究过程中,大多数血清细胞因子和金属蛋白酶水平保持不变,我们无法检测血清中TNF-α的变化。开始英夫利昔单抗治疗后血清IL-6和VEGF-A水平显著下降。结论。血清IL-6和VEGF-A水平随着疾病进展而变化,可能是有希望的疾病标志物。这些发现的临床意义尚待确定,在应用于临床之前,必须在未来的临床试验中得到证实。