Development and External Validation of a Predictive Model for Postoperative Recurrence of Crohn's Disease in the Biologic Era

Abstract

Background & aims: Ileocolonic resection remains common in Crohn's disease (CD) despite increasing biologic use. The aim of this study was to identify risk factors for postoperative recurrence and to assess prophylactic biologic therapy effectiveness in relation to risk factors.

Methods: This prospective multicentre study included adults with CD undergoing ileocolonic resection (ICR). The primary endpoint was endoscopic recurrence (modified Rutgeerts score ≥i2b) within the year following surgery. Factors associated with endoscopic recurrence were identified using a logistic regression model. A composite time-to-event endpoint was defined for long-term follow-up based on clinical, endoscopic, and/or imaging data. An external validation of our predictive model was performed in 2 independent international cohorts.

Results: Among 632 patients (median disease duration, 7.8 years), 78% had prior biologic exposure; 44% received postoperative biologic prophylaxis. Endoscopic recurrence occurred in 237 patients (37.5%). In multivariable model, risk factors included: male sex (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.38-2.83), active smoking (OR, 2.37; 95% CI, 1.56-3.62), previous ICR (OR, 1.78; 95% CI, 1.13-2.82), previous exposure to 1 (OR, 2.15; 95% CI, 1.37-3.42) or more than 1 biologic (OR, 2.41; 95% CI, 1.39-4.22). Biologic prophylaxis significantly reduced recurrence risk (OR, 0.31; 95% CI, 0.20-0.45), independently of these risk factors. A predictive nomogram based on multivariable analysis achieved an area under the receiver operating characteristic curve of 0.72, with similar performance in external cohorts. Clinically significant recurrence, observed in 22.9%, 36.5%, and 53.2% at 3, 5, and 10 years, was associated with severity of early endoscopic recurrence.

Conclusions: Postoperative recurrence risk can be estimated using a model based on clinical factors. Biologic prophylaxis is highly effective in preventing early endoscopic recurrence, regardless of risk profile.

Clinicaltrials: gov, Number: NCT03458195.

Keywords: Biologic Therapies; Crohn’s Disease; Endoscopic Recurrence; Ileocolonic Surgery; Prophylaxis.