全身磁共振成像在中轴型脊柱关节炎中的应用：阿达木单抗安慰剂对照试验中骶髂、脊柱和肌腱附着点炎症的改善。
Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab.
机构信息
From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, and Department of Clinical Biochemistry, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen; Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Frederiksberg; Department of Radiology, Copenhagen University Hospital Herlev, Herlev; Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte, Hellerup; Department of Rheumatology, Zealand University Hospital, Køge; Odense Patient Data Explorative Network (OPEN), Odense University Hospital/Institute of Clinical Research, Odense, Denmark; Department of Diagnostic Imaging, Sheba Medical Center (affiliated with the Sackler School of Medicine, Tel Aviv University), Ramat Gan, Israel.
S. Krabbe, MD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen; M. Østergaard, MD, PhD, DMSc, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen; I. Eshed, MD, Department of Diagnostic Imaging, Sheba Medical Center; I.J. Sørensen, MD, PhD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen; B. Jensen, MD, Center for Rheumatology and Spine Diseases, Frederiksberg Hospital; J.M. Møller, Radiographer, Department of Radiology, Copenhagen University Hospital Herlev; L. Balding, MD, Department of Radiology, Copenhagen University Hospital Herlev; O.R. Madsen, MD, PhD, DMSc, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte; K. Asmussen, MD, PhD, Center for Rheumatology and Spine Diseases, Frederiksberg Hospital; G. Eng, MD, PhD, Department of Rheumatology, Zealand University Hospital Køge; N.R. Jørgensen, MD, PhD, DMSc, Department of Clinical Biochemistry, Rigshospitalet, and OPEN, Odense University Hospital/Institute of Clinical Research; S.J. Pedersen, MD, PhD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Gentofte.
出版信息
J Rheumatol. 2018 May;45(5):621-629. doi: 10.3899/jrheum.170408. Epub 2018 Feb 15.
OBJECTIVE
To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA).
METHODS
An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.0 despite treatment with nonsteroidal antiinflammatory drugs and a clinical indication for tumor necrosis factor inhibitor treatment. Patients were randomized to subcutaneous ADA 40 mg or placebo every other week for 6 weeks; thereafter, all patients received ADA. Conventional MRI and WBMRI were performed at weeks 0, 6, 24, and 48. The primary WBMRI endpoint was the proportion of patients with an improvement in WBMRI total inflammation index above the smallest detectable change (SDC) at Week 6.
RESULTS
The primary WBMRI endpoint (improvement of SDC > 2.3) was met in 11 (44%) patients in the ADA group and 3 (13%) patients in the placebo group (p = 0.025, Fisher's exact test). The primary conventional MRI endpoint, the minimally important change in Spondyloarthritis Research Consortium of Canada Spine MRI Inflammation Index at Week 6, was achieved by 9 (36%) patients in the ADA group and 4 (17%) patients in the placebo group (p = 0.20). The primary clinical endpoint, BASDAI reduction > 50% or 2.0 at Week 24, was attained by 32 (65%) patients.
CONCLUSION
ADA provided significant reductions in WBMRI indices of peripheral, axial, and whole-body inflammation in patients with axSpA. WBMRI is promising for objective assessment and monitoring of peripheral and axial disease activity in future clinical trials.
目的
研究阿达木单抗（ADA）是否能降低中轴型脊柱关节炎（axSpA）患者附着点、外周关节、骶髂关节、脊柱和全身的全身磁共振成像（WB-MRI）炎症指标。
方法
这是一项由研究者发起的、随机、安慰剂对照、双盲、48 周随访试验，纳入了 49 名 BASDAI≥4.0 的 axSpA 患者，这些患者尽管接受了非甾体抗炎药治疗且有肿瘤坏死因子抑制剂治疗的临床指征，但仍存在疾病活动。患者被随机分配至 ADA 40mg 或安慰剂组，每两周皮下注射一次，共 6 周；此后所有患者均接受 ADA 治疗。在第 0、6、24 和 48 周进行常规 MRI 和 WB-MRI。主要的 WB-MRI 终点是在第 6 周时达到 WB-MRI 总炎症指数改善超过最小可检测变化（SDC）的患者比例。
结果
ADA 组有 11 名（44%）患者和安慰剂组有 3 名（13%）患者达到主要的 WB-MRI 终点（SDC>2.3）（p=0.025，Fisher 确切概率法）。ADA 组有 9 名（36%）患者和安慰剂组有 4 名（17%）患者达到 Spondyloarthritis Research Consortium of Canada 脊柱 MRI 炎症指数的 6 周时最小临床重要变化这一主要常规 MRI 终点（p=0.20）。ADA 组有 32 名（65%）患者达到 24 周时 BASDAI 降低≥50%或 2.0 的主要临床终点。
结论
ADA 可显著降低 axSpA 患者的 WB-MRI 外周、中轴和全身炎症指标。WB-MRI 有望在未来临床试验中用于客观评估和监测外周和中轴疾病活动。
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