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

35 Citations (Scopus)

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

Fingerprint

Crohn Disease
Multicenter Studies
Magnetic Resonance Spectroscopy
Clinical Trials
Inflammation
Ileum
Patient Selection
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

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. / 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.

In: Alimentary Pharmacology and Therapeutics, Vol. 43, No. 1, 01.01.2016, p. 61-72.

Research output: Contribution to journalArticle

Coimbra, AJF, Rimola, J, O'Byrne, S, Lu, TT, Bengtsson, T, De Crespigny, A, Luca, D, Rutgeerts, P, Bruining, DH, Fidler, JL, Sandborn, WJ, Santillan, CS, Higgins, PDR, Al-Hawary, MM, Vermeire, S, Vanbeckevoort, D, Vanslembrouck, R, Peyrin-Biroulet, L, Laurent, V, Herrmann, KA & 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, vol. 43, no. 1, pp. 61-72. https://doi.org/10.1111/apt.13453
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. / 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. In: Alimentary Pharmacology and Therapeutics. 2016 ; Vol. 43, No. 1. pp. 61-72.
@article{83605e75e304478f83ce479ecb8c40cb,
title = "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: 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.",
author = "Coimbra, {A. J F} and J. Rimola and S. O'Byrne and Lu, {T. T.} and T. Bengtsson and {De Crespigny}, A. and D. Luca and P. Rutgeerts and Bruining, {D. H.} and Fidler, {J. L.} and Sandborn, {W. J.} and Santillan, {C. S.} and Higgins, {P. D R} and Al-Hawary, {M. M.} and S. Vermeire and D. Vanbeckevoort and R. Vanslembrouck and L. Peyrin-Biroulet and V. Laurent and Herrmann, {K. A.} and J. Panes",
year = "2016",
month = "1",
day = "1",
doi = "10.1111/apt.13453",
language = "English (US)",
volume = "43",
pages = "61--72",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "1",

}

TY - JOUR

T1 - 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

AU - Coimbra, A. J F

AU - Rimola, J.

AU - O'Byrne, S.

AU - Lu, T. T.

AU - Bengtsson, T.

AU - De Crespigny, A.

AU - Luca, D.

AU - Rutgeerts, P.

AU - Bruining, D. H.

AU - Fidler, J. L.

AU - Sandborn, W. J.

AU - Santillan, C. S.

AU - Higgins, P. D R

AU - Al-Hawary, M. M.

AU - Vermeire, S.

AU - Vanbeckevoort, D.

AU - Vanslembrouck, R.

AU - Peyrin-Biroulet, L.

AU - Laurent, V.

AU - Herrmann, K. A.

AU - Panes, J.

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84951907744&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84951907744&partnerID=8YFLogxK

U2 - 10.1111/apt.13453

DO - 10.1111/apt.13453

M3 - Article

C2 - 26548868

AN - SCOPUS:84951907744

VL - 43

SP - 61

EP - 72

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

SN - 0269-2813

IS - 1

ER -