The Crohn’s Disease Activity Index, a scoring index including patient-reported outcomes, has known limitations for measuring intestinal inflammatory disease burden.
Non-invasive markers of inflammation could prove more accurate than patient-reported outcomes.
Regulatory authorities are exploring the use of patient-reported outcomes and endoscopic data as co-primary end points in clinical trials.
Dr Jennifer Jones and colleagues of Canada assessed the predictive ability of individual components of the Crohn’s Disease Activity Index, along with biomarker concentrations, to create models for predicting endoscopic disease activity.
Between 2004 and 2006, 164 patients with established Crohn’s disease undergoing clinically indicated ileocolonoscopy were recruited.
|The number of liquid stools correlated with the Simple Endoscopic Score–Crohn’s Disease|
|Inflammatory Bowel Diseases|
Individual Crohn’s Disease Activity Index variables and fecal calprotectin were selected to explore their predictive accuracy for endoscopic disease activity, with the Simple Endoscopic Score–Crohn’s Disease as the outcome variable.
The researchers found the number of liquid stools, abdominal pain, hematocrit, fecal calprotectin, and high-sensitivity C-reactive protein correlated significantly with the Simple Endoscopic Score–Crohn’s Disease.
For the prediction of Simple Endoscopic Score–Crohn’s Disease, the area under the curve was 0.81, with 63% and 88% sensitivity and specificity, for the patient-reported outcomes+ model, compared with a 0.56 area under the curve, with 61% and 55%, respectively, for the patient-reported outcomes model.
The team revealed the patient-reported outcomes+ model to be superior in the prediction of endoscopically active disease.
Dr Jones's team concludes, "The inclusion of biomarkers significantly improved predictive accuracy for endoscopic disease activity compared with patient-reported outcomes-exclusive models."