Abstract
The selection of the best patients who may benefit from therapeutic de-escalation (TDE) and how to monitor them is a concern and a clinical challenge in inflammatory bowel diseases (IBD). The role of faecal calprotectin (Fcal) remains poorly investigated in these situations. We aimed to assess Fcal level before TDE as predictor of clinical relapse and to evaluate serial measurements of Fcal to predict clinical relapse after TDE. From a prospectively maintained database, we enrolled all IBD patients in clinical remission, with Fcal measured within 8 weeks before therapeutic de-escalation. TDE was defined as decrease of dose or increase of interval between two infusions/injections or medication discontinuation or replacement by a medication that is traditionally earlier in a “step-up” approach to IBD management (5-ASA < immunosuppressants < biologics). Clinical relapse was defined as reappearance of clinical manifestations (HBI > 4 or SCCAI > 2 with sub-score > 1 for at least one item among stool frequency and rectal bleeding) leading to therapeutic intensification, hospitalisation or IBD-related surgery. Overall, 160 IBD patients were included (Table 1). Baseline characteristics of the 160 patients with inflammatory bowel disease enrolled in this study. Results of univariate and multivariate analyses investigating the predictors of clinical relapse after therapeutic de-escalation. Using a ROC curve, Fcal >100 µg/g was the best threshold to predict clinical relapse after TDE (AUC = 0.84; Se = 0.76; Spe = 0.86; PPV = 0.77; NPV = 0.85). In multivariate analysis, clinical remission > 6 months before TDE (HR 0.57[0.33–0.99]; p = 0.044) was associated with decreased risk of relapse while current steroids medication (HR = 1.67[1.00–2.79]; p < 0.0001) was a risk factor. Fcal > 100 µg/g was predictive of clinical relapse (HR = 3.96[2.47–6.35]; p < 0.0001) in the whole cohort but also in patients with anti-TNF agents (n = 85 patients; p < 0.0001), anti-integrins (n = 32; p = 0.003), no biologics (n = 43; p = 0.049) or attempting to discontinue steroids (n = 37; p = 0.001). One patient (1/98) and 7 patients (7/88, 8.0%) with baseline Fcal < 100 µg/g relapsed within 3 months and 6 months, respectively. 74 Fcal measurements were performed in 52 patients after TDE. Monitoring Fcal > 200 µg/g (AUC = 0.96; se = 0.93, spe = 0.93, PPV = 0.78, NPV = 0.98) was highly predictive of clinical relapse in multivariate analysis (HR = 31.8[3.5–289.4], p = 0.002). Only two relapses (2/45, 4.4%) occurred within 6 months while Fcal < 200 µg/g. Fcal level is highly accurate to predict and monitor the risk of relapse after TDE in IBD patients. Fcal should be measured 3 months after TDE and then every 6 months. The Fcal level appears to be useful for prediction of steroid dependency.
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