Magnetic resonance enterography is feasible and reliable in multicenter clinical trials in patients with Crohn's disease, and may help select subjects with active inflammation

Abstract : Background Reliable tools for patient selection are critical for clinical drug trials. Aim To evaluate a consensus-based, standardised magnetic resonance enterography (MRE) protocol for selecting patients for inclusion in Crohn's disease (CD) multicenter clinical trials. Methods 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). Results 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%. Conclusions 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.
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Alimentary Pharmacology & Therapeutics (Suppl), 2016, 43 (1), pp.61 - 72. 〈10.1111/apt.13453〉
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https://hal.univ-lorraine.fr/hal-01663714
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Soumis le : jeudi 14 décembre 2017 - 11:42:48
Dernière modification le : lundi 23 avril 2018 - 15:53:34

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J. Coimbra, J. Rimola, S. O'Byrne, T. Lu, T. Bengtsson, et al.. Magnetic resonance enterography is feasible and reliable in multicenter clinical trials in patients with Crohn's disease, and may help select subjects with active inflammation. Alimentary Pharmacology & Therapeutics (Suppl), 2016, 43 (1), pp.61 - 72. 〈10.1111/apt.13453〉. 〈hal-01663714〉

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