Coimbra A J F, Rimola J, O'Byrne S, Lu T T, Bengtsson T, de Crespigny A, Luca D, Rutgeerts P, Bruining D H, Fidler J L, Sandborn W J, Santillan C S, Higgins P D R, Al-Hawary M M, Vermeire S, Vanbeckevoort D, Vanslembrouck R, Peyrin-Biroulet L, Laurent V, Herrmann K A, Panes J
Genentech, Inc., South San Francisco, CA, USA.
Hospital Clínic de Barcelona, Catalonia, Spain.
Aliment Pharmacol Ther. 2016 Jan;43(1):61-72. doi: 10.1111/apt.13453. Epub 2015 Nov 9.
Reliable tools for patient selection are critical for clinical drug trials.
To evaluate a consensus-based, standardised magnetic resonance enterography (MRE) protocol for selecting patients for inclusion in Crohn's disease (CD) multicenter clinical trials.
This study recruited 20 patients [Crohn's Disease Activity Index (CDAI) scores: <150 (n = 8); 150-220 (n = 4); 220-450 (n = 8)], to undergo ileocolonoscopy and two MREs (with and without colonic contrast) within a 14-day period. Procedures were scored centrally using, Magnetic Resonance Index of Activity (MaRIA), and both Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simplified Endoscopic Score (SES-CD).
37 MREs were acquired. Both MREs were evaluable in 16 patients for calculation of test-retest and inter-reader reliability scores. The MaRIA scores for the terminal ileum had excellent test-retest and inter-reader reliability, with correlations >0.9. The proximal ileum showed strong within-reader agreement (0.90-0.96), and fair between-reader agreement (0.59-0.72). MRE procedures were tolerable. MaRIA scores correlated with CDEIS and SES-CD (0.63 and 0.71), but not with CDAI (0.34). MRE identified 3 patients with intra-abdominal complications, who would otherwise have been included in clinical trials. Furthermore, both MRE and ileocolonoscopy identified active bowel wall inflammation in 2 patients with CDAI <150, and none in 1 patient with CDAI > 220. Data quality was good/excellent in 85% of scans, and fair or better in 96%.
Magnetic resonance enterography of high-quality and reproducibility was feasible in a global multi- centre setting, with evidence for improved selectivity over CDAI and ileocolonoscopy in identifying appropriate CD patients for inclusion in therapeutic intervention trials.
可靠的患者选择工具对临床药物试验至关重要。
评估一种基于共识的标准化磁共振小肠造影（MRE）方案，用于选择纳入克罗恩病（CD）多中心临床试验的患者。
本研究招募了20名患者[克罗恩病活动指数（CDAI）评分：<150（n = 8）；150 - 220（n = 4）；220 - 450（n = 8）]，在14天内接受回结肠镜检查和两次MRE检查（一次有结肠对比剂，一次无结肠对比剂）。使用活动磁共振指数（MaRIA）以及克罗恩病内镜严重程度指数（CDEIS）和简化内镜评分（SES - CD）对检查结果进行集中评分。
共获取了37次MRE检查结果。16名患者的两次MRE检查结果均可用于计算重测信度和阅片者间信度得分。末段回肠的MaRIA评分具有出色的重测信度和阅片者间信度，相关性>0.9。近端回肠显示阅片者内一致性较强（0.90 - 0.96），阅片者间一致性一般（0.59 - 0.72）。MRE检查过程耐受性良好。MaRIA评分与CDEIS和SES - CD相关（分别为0.63和0.71），但与CDAI不相关（0.34）。MRE检查发现3例有腹腔内并发症的患者，否则这些患者可能会被纳入临床试验。此外，MRE和回结肠镜检查均发现2例CDAI <150的患者存在肠壁活动性炎症，而1例CDAI > 220的患者未发现。85%的扫描数据质量为良好/优秀，96%为中等或更好。
高质量且可重复的磁共振小肠造影在全球多中心环境中是可行的，有证据表明在识别适合纳入治疗干预试验的CD患者方面，其选择性优于CDAI和回结肠镜检查。
