Visvanathan S, Wagner C, Marini J C, Baker D, Gathany T, Han J, van der Heijde D, Braun J
Centocor Research and Development, Inc., Malvern, PA, USA.
Ann Rheum Dis. 2008 Apr;67(4):511-7. doi: 10.1136/ard.2007.071605. Epub 2007 Jul 20.
To evaluate the relationship between biomarker levels and disease activity and the spinal inflammation detected by magnetic resonance imaging (MRI) in patients with ankylosing spondylitis (AS).
Patients with AS were randomly assigned in a 3:8 ratio to receive infusions of placebo or 5 mg/kg infliximab at weeks 0, 2, 6, 12 and 18. Sera were collected for biomarker analysis at weeks 0, 2 and 24 and were analysed for levels of interleukin-6 (IL-6), vascular endothelial growth factor (VEGF) and C-reactive protein (CRP). Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores and pre- and post-gadolinium T1 and short tau inversion recovery MRIs were collected at baseline and week 24.
Significantly greater reductions in IL-6, VEGF and CRP were observed at weeks 2 and 24 in the infliximab group compared with the placebo group (all p<0.001). Baseline IL-6 levels >7.38 pg/ml and CRP levels >1.5 mg/dl were associated with increased rates of clinical response after 24 weeks. Multiple regression analyses showed that reductions from baseline to week 2 in IL-6, but not CRP or VEGF, were significantly associated with reductions in MRI activity and BASDAI scores from baseline to week 24 in the infliximab group (p<0.001).
Significant reductions in IL-6, VEGF and CRP were observed with infliximab compared with placebo. High levels of baseline IL-6 and CRP were associated with clinical response after infliximab treatment. Early reductions in IL-6 were significantly associated with improvements in disease activity and the spinal inflammation detected by MRI.
评估强直性脊柱炎（AS）患者生物标志物水平与疾病活动度以及磁共振成像（MRI）检测到的脊柱炎症之间的关系。
将AS患者按3:8的比例随机分组，在第0、2、6、12和18周接受安慰剂或5 mg/kg英夫利昔单抗输注。在第0、2和24周采集血清进行生物标志物分析，检测白细胞介素-6（IL-6）、血管内皮生长因子（VEGF）和C反应蛋白（CRP）水平。在基线和第24周收集巴斯强直性脊柱炎疾病活动指数（BASDAI）评分以及钆增强前后的T1加权像和短tau反转恢复序列MRI。
与安慰剂组相比，英夫利昔单抗组在第2周和第24周时IL-6、VEGF和CRP的降低更为显著（均p<0.001）。基线IL-6水平>7.38 pg/ml和CRP水平>1.5 mg/dl与24周后临床缓解率增加相关。多元回归分析显示，英夫利昔单抗组中，从基线到第2周IL-6水平的降低与从基线到第24周MRI活动度和BASDAI评分的降低显著相关，而CRP或VEGF水平的降低则无此相关性（p<0.001）。
与安慰剂相比，英夫利昔单抗治疗可使IL-6、VEGF和CRP水平显著降低。基线IL-6和CRP水平较高与英夫利昔单抗治疗后的临床缓解相关。早期IL-6水平的降低与疾病活动度改善以及MRI检测到的脊柱炎症改善显著相关。
