Tam Lai-Shan, Shang Qing, Kun Emily W, Lee Ka-Lai, Yip Man-Lung, Li Martin, Li Tena K, Zhu Tracy Y, Pui Michelle O, Li Edmund K, Yu Cheuk-Man
Rheumatology (Oxford). 2014 Jun;53(6):1065-74. doi: 10.1093/rheumatology/ket469.
Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS.
A randomized, double-blind, placebo-controlled pilot study was performed in which AS patients were treated with golimumab (n = 20) and placebo (n = 21) for 12 months. Patients from the placebo group who failed to achieve a 20% response to Assessment of SpondyloArthritis international Society criteria (ASAS20) at 6 months received open-label golimumab. Intima-media thickness (IMT), pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline, 6 and 12 months.
At 6 months, 11/20 (55%) and 3/21 (14%) patients from the golimumab and placebo groups achieved an ASAS20 response, respectively (P = 0.006). There was no significant difference in the change of the vascular parameters between the two groups. In the placebo group, significantly greater progression of the mean IMT [from 0.51 mm (S.D. 0.07) at baseline to 0.53 mm (S.D. 0.08) at 6 months, P = 0.044] and PWV (from 12.2 m/s (S.D. 1.6) at baseline to 12.6 m/s (S.D. 1.3), P = 0.028] were observed. There was a trend towards progression of the mean IMT in the golimumab group (P = 0.099) but the maximum IMT, PWV and AIx remained unchanged. At 12 months the changes in vascular parameters were similar between the early and delayed (or no) golimumab groups.
Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS. Arterial dysfunction may be prevented by golimumab over a period of 6 months, probably because of effective suppression of inflammation.
clinicaltrials.gov (NCT01212653)
我们的目的是确定与安慰剂相比，戈利木单抗在预防强直性脊柱炎（AS）患者动脉粥样硬化和动脉僵硬度方面的疗效。
进行了一项随机、双盲、安慰剂对照的试点研究，其中AS患者接受戈利木单抗治疗（n = 20）和安慰剂治疗（n = 21），为期12个月。安慰剂组中在6个月时未达到国际脊柱关节炎协会评估标准（ASAS20）20%反应的患者接受开放标签的戈利木单抗治疗。在基线、6个月和12个月时测量内膜中层厚度（IMT）、脉搏波速度（PWV）和增强指数（AIx）。
在6个月时，戈利木单抗组和安慰剂组分别有11/20（55%）和3/21（14%）的患者达到ASAS20反应（P = 0.006）。两组血管参数的变化无显著差异。在安慰剂组中，观察到平均IMT有显著进展[从基线时的0.51 mm（标准差0.07）增加到6个月时的0.53 mm（标准差0.08），P = 0.044]以及PWV有显著进展[从基线时的12.2 m/s（标准差1.6）增加到12.6 m/s（标准差1.3），P = 0.028]。戈利木单抗组平均IMT有进展趋势（P = 0.099），但最大IMT、PWV和AIx保持不变。在12个月时，早期和延迟（或未使用）戈利木单抗组之间血管参数的变化相似。
未控制的炎症可能导致AS患者的IMT和PWV显著进展。戈利木单抗可能通过有效抑制炎症在6个月内预防动脉功能障碍。
clinicaltrials.gov（NCT01212653）
