Funded by a grant from the David Telling Charitable Trust.
Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials?†
Article first published online: 23 JAN 2012
Copyright © 2012 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 18, Issue 11, pages 2056–2062, November 2012
How to Cite
Dhanda, A. D., Creed, T. J., Greenwood, R., Sands, B. E. and Probert, C. S. (2012), Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials?. Inflamm Bowel Dis, 18: 2056–2062. doi: 10.1002/ibd.22879
- Issue published online: 15 OCT 2012
- Article first published online: 23 JAN 2012
- Manuscript Accepted: 19 DEC 2011
- Manuscript Received: 13 DEC 2011
- ulcerative colitis;
- Mayo score;
- clinical disease activity
There is no gold standard index in the measurement of ulcerative colitis (UC) disease activity in clinical trials. Mucosal healing has been described as an important clinical endpoint requiring endoscopic assessment, which is unpleasant for the patient and may hamper recruitment to trials. The aim of this study was to determine whether endoscopy is necessary in the assessment of UC disease activity and whether a noninvasive disease activity index (partial Mayo score) could be used to predict the Mayo score.
In all, 149 subjects with moderate to severe UC enrolled in a clinical trial were assessed using total and partial Mayo scores. Histologic assessment of biopsies was performed. A regression model was constructed to predict total Mayo score from the partial Mayo score and histology score from the Mayo score. A Bland–Altman test of agreement was performed.
The partial Mayo score correlated closely with the total Mayo score at week 4 (rho = 0.97) and week 8 (rho = 0.98). The model to predict total from partial Mayo score showed excellent correlation (rho = 0.97) and good agreement with the total Mayo score at week 4 and the week 8 validation set (rho = 0.97) and accurately classified disease severity (kappa = 0.82). The model to predict histology score from the Mayo score correlated only moderately with the actual histology score at week 4 (rho = 0.59) and week 8 (rho = 0.36).
The Mayo score can be accurately predicted from the partial Mayo score. A noninvasive index can replace the Mayo score in future clinical trials. (Inflamm Bowel Dis 2012;)