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

A. J F Coimbra, J. Rimola, S. O'Byrne, T. T. Lu, T. Bengtsson, A. De Crespigny, D. Luca, P. Rutgeerts, D. H. Bruining, J. L. Fidler, W. J. Sandborn, C. S. Santillan, P. D R Higgins, M. M. Al-Hawary, S. Vermeire, D. Vanbeckevoort, R. Vanslembrouck, L. Peyrin-Biroulet, V. Laurent, K. A. HerrmannJ. Panes

Research output: Contribution to journalArticle

41 Scopus citations

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: 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 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.

Original languageEnglish (US)
Pages (from-to)61-72
Number of pages12
JournalAlimentary Pharmacology and Therapeutics
Volume43
Issue number1
DOIs
StatePublished - Jan 1 2016

ASJC Scopus subject areas

  • Pharmacology (medical)

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    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., ... Panes, J. (2016). 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 and Therapeutics, 43(1), 61-72. https://doi.org/10.1111/apt.13453