Background: A model has been developed to predict the risk of patients with Crohn's disease experiencing a disease related complication . Although the model was validated retrospectively in additional patient cohorts, it had not been tested prospectively to determine if high-risk patients actually experience more complications than those with predicted low-risk disease. The aim of this study was to determine the proportion of patients experiencing Crohn's disease related complications stratified by predicted risk category.
Methods: Patients with Crohn's disease are being prospectively recruited from 15 medical practices across the US (8 academic, 7 community based). To meet inclusion criteria, all patients have to be within 15 years of diagnosis, without any current or prior disease complications, not currently on immunomodulators or biologics but considered a candidate for these treatments by their provider. Upon study entry, based on serologic and genetic testing, disease phenotype and demographic information, an individualized risk profile is generated for each subject using the validated risk prediction tool, PROSPECT . PROSPECT predicts a patient's risk of developing a complication (stricture or fistula) or progression to surgery over the next 3 years. We report clinical outcomes after the first year of follow-up.
Results: 154 patients have been recruited in total, of which 122 patients have been followed for 6 months, 91 for 1 year, and 28 for 2 years. Median age of patients is 31 (range 18–69) and 55% of patients are women. 18% of patients were predicted to have a low risk of developing disease related complications, 57% at moderate risk, and 25% were predicted to be at high risk. Overall, 21 patients experienced complications and 6 progressed to surgery. 10/21 complications occurred within 6 months of enrollment and 19/21 occurred within one year of enrollment. Among patients that experienced complications, 10% were predicted to be at low risk of developing a complication; 50% were at moderate risk and 40% were predicted to be at high risk. Of all patients predicted to be at low risk, 10.0% developed a complication; of all patients at moderate risk, 15.2% had a complication; and of all patients at high risk, 26.7% had a complication.
Conclusions: The PROSPECT tool predicted that over 80% patients with Crohn's disease are at moderate to high risk of disease related complications within 3 years. Within the first year of follow-up, as predicted, more patients at moderate to high risk developed disease related complications compared to those at low risk.
 Siegel CA, et al. AP&T 2015.