Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab -: Results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study
Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab -: Results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study
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DOI：
10.1002/art.21790
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发表时间：
2006-05-01
影响因子：
--
通讯作者：
van der Heijde, D
中科院分区：
文献类型：
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作者：
Braun, J;Landewé, R;van der Heijde, D
Objective.确定抗肿瘤坏死因子α（TNF α）在减少强直性脊柱炎（AS）体征和症状方面的作用是否与磁共振成像（MRI）检测到的脊柱炎症减少一致。在基线和第24周，对参与多中心、随机、双盲、安慰剂对照研究的AS患者采集了脊柱的钆前和钆后T1和STIR MR图像。患者以8：3的比例随机分配，在第0、2和6周接受英夫利西单抗（5 mg/kg）或安慰剂输注，然后每6周输注一次。由2名对治疗分配和图像时间顺序不知情的阅片者独立获得和评估MR图像。英夫利西单抗组共有194例患者，安慰剂组共有72例患者在基线和第24周时具有可评价的图像。通过MRI评估，约80%的患者在基线时至少有1处活动性脊柱病变。6个月后，接受英夫利西单抗治疗的患者MRI活动评分的改善（平均值5.02，中位数2.72）显著高于接受安慰剂治疗的患者（平均值0.60，中位数0.0）（P < 0.001）。在接受英夫利西单抗治疗的大多数患者中，无论基线活动如何，脊柱炎症几乎完全消退。接受英夫利西单抗治疗的AS患者通过MRI检测显示脊柱炎症减少，而接受安慰剂治疗的患者显示持续性炎症性脊柱炎。
Objective. To determine whether the effects of anti-tumor necrosis factor alpha (TNF alpha) in reducing the signs and symptoms of ankylosing spondylitis (AS) coincide with a reduction in spinal inflammation as detected by magnetic resonance imaging (MRI).Methods. Pre- and postgadolinium T1 and STIR MR images of the spine were acquired at baseline and at week 24 in patients with AS who participated in a multicenter, randomized, double-blind, placebo-controlled study. Patients were randomly assigned at an 8:3 ratio to receive infusions of infliximab (5 mg/kg) or placebo at weeks 0, 2, and 6 and then every 6 weeks thereafter. MR images were obtained and evaluated independently by 2 readers who were blinded to the treatment allocation and time sequence of the images.Results. A total of 194 patients in the infliximab group and 72 patients in the placebo group had evaluable images at baseline and week 24. About 80% of the patients had at least 1 active spinal lesion at baseline, as assessed by MRI. The improvement in the MRI Activity Score after 6 months was significantly greater in the patients who received infliximab (mean 5.02, median 2.72) than in those who received placebo (mean 0.60, median 0.0) (P < 0.001). Almost complete resolution of spinal inflammation was seen in most patients who received infliximab, irrespective of baseline activity.Conclusion. Patients with AS who received infliximab therapy showed a decrease in spinal inflammation as detected by MRI, whereas those who received placebo showed persistent inflammatory spondylitis.