Clinical and Imaging Efficacy of Infliximab in HLA-B27-Positive Patients With Magnetic Resonance Imaging-Determined Early Sacroiliitis
Clinical and Imaging Efficacy of Infliximab in HLA-B27-Positive Patients With Magnetic Resonance Imaging-Determined Early Sacroiliitis
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DOI：
10.1002/art.24408
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发表时间：
2009-04-01
影响因子：
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通讯作者：
Emery, Paul
中科院分区：
文献类型：
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作者：
Barkham, Nick;Keen, Helen I.;Emery, Paul
目标。通过临床和MRI评估，评价英夫利昔单抗治疗hla - b27阳性的磁共振成像（MRI）确定的早期骶髂炎患者的疗效。40例新近发病的炎症性背痛患者，根据Calin标准、HLA-B27阳性、巴斯强直性脊柱炎疾病活动指数（BASDAI）测量的临床疾病活动性、疼痛和早晨僵硬以及磁共振成像（MRI）确定的骶髂关节骨水肿，以双盲方式随机分配，在0、2、6和12周接受英夫利昔单抗5 mg/kg或安慰剂。在基线和16周时进行MRI扫描，并由2名观察者（对扫描顺序和治疗组不知情）使用利兹评分系统进行评分。临床评估包括BASDAI，巴斯强直性脊柱炎功能指数（BASFI），强直性脊柱炎生活质量（ASQoL）仪器，强直性脊柱炎国际工作组评估标准（ASAS）改善和炎症标志物。从第0周到第16周，英夫利昔单抗治疗的患者与安慰剂治疗的患者相比，MRI总评分的平均下降幅度更大（P = 0.033）。平均而言，英夫利昔单抗组有更多的病变消退（P < 0.001），而安慰剂组有更多的新病变出现（P = 0.004）。与安慰剂组相比，英夫利昔单抗组在第0周至第16周的BASDAI （P = 0.002）、BASH （P = 0.004）和ASQoL （P = 0.007）评分方面的改善也明显更大。在英夫利昔单抗治疗的患者中，分别有61%、44%和56%的患者达到了asa标准的40%改善、asa标准的20%改善和ASAS部分缓解。英夫利昔单抗耐受性良好，未观察到严重不良事件。英夫利昔单抗是早期骶髂炎的有效治疗方法，可在第16周减少疾病活动。这项研究首次表明，英夫利昔单抗可有效减少mri确定的早期轴型脊柱炎患者疾病活动性的临床和影像学证据。
Objective. To evaluate the efficacy of infliximab in HLA-B27-positive patients with magnetic resonance imaging (MRI)-determined early sacroiliitis, using both clinical and MRI assessments.Methods. Forty patients with recent-onset inflammatory back pain, as assessed by the Calin criteria, HLA-B27 positivity, clinical disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), pain and morning stiffness, and magnetic resonance imaging (MRI)-determined sacroiliac joint bone edema were randomized in a double-blind manner to receive infliximab 5 mg/kg or placebo at 0, 2, 6, and 12 weeks. MRI scans were performed at baseline and 16 weeks and scored by 2 observers (blinded to both the order of the scans and to treatment group), using the Leeds scoring system. Clinical assessments included the BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL) instrument, the ASsessment in Ankylosing Spondylitis International Working Group criteria (ASAS) for improvement, and markers of inflammation.Results. The mean reduction in the total MRI score from week 0 to week 16 was significantly greater in infliximab-treated patients compared with placebo-treated patients (P = 0.033). On average, significantly more lesions resolved in the infliximab group (P < 0.001), while significantly more new lesions developed in the placebo group (P = 0.004). Significantly greater improvement in the infliximab group versus the placebo group was also observed for changes from week 0 to week 16 in the BASDAI (P = 0.002), BASH (P = 0.004), and ASQoL (P = 0.007) scores. Responses according to the ASAS criteria for 40% improvement, the ASAS criteria for 20% improvement in 5 of 6 domains, and ASAS partial remission were achieved by 61%, 44%, and 56% of infliximab-treated patients, respectively. Infliximab was well tolerated, and no serious adverse events were observed.Conclusion. Infliximab was an effective therapy for early sacroilitis, providing a reduction in disease activity by week 16. This study is the first to show that infliximab is effective for reducing clinical and imaging evidence of disease activity in patients with MRI-determined early axial spondylarthritis.