Non-Invasive Serological Monitoring for Crohn's Disease Post-Operative Recurrence.

Abstract

Crohn's disease recurs after intestinal resection. This study evaluated accuracy of a new blood test, the Endoscopic Healing Index (EHI), in monitoring for disease recurrence. Patients enrolled in the prospective POCER study (NCT00989560) underwent a post-operative colonoscopic assessment at 6 (2/3 of patients) and 18 months (all patients) post bowel resection using the Rutgeerts Score (recurrence ≥i2). Serum was assessed at multiple timepoints for markers of endoscopic healing using the EHI, and paired with the Rutgeerts endoscopic score as the reference standard. 131 patients provided 437 serum samples, which were paired with endoscopic assessments available in 94 patients (30 with recurrence) at 6 months and 107 patients (44 with recurrence) at 18 months. The median EHI at 6 months was significantly lower in patients in remission (Rutgeerts <i2) than those with recurrence; P = 0.033. The AUROC for EHI to detect recurrence at 6 months was comparable to that of fecal calprotectin (0.712 vs 0.779, P = 0.414). EHI of ≤20 at 6 months had a negative predictive value of 75.7% (95% CI 58.8 - 88.2), and sensitivity of 70% (95% CI 50.6 - 85.3) for detecting recurrence. Combining all time points, an EHI ≤20 had a negative predictive value of 70.3%. Changes in EHI significantly associated with changes in Rutgeerts scores over the 18 months. The non-invasive multi-marker EHI has sufficient accuracy to be used to monitor for post-operative Crohn's disease recurrence. A monitoring strategy that combines EHI with ileo-colonoscopy, with or without fecal calprotectin, should now be prospectively tested.