A prospective evaluation of the predictive value of faecal calprotectin in quiescent Crohn's disease

Background: The faecal calprotectin (FC) test is a non-invasive marker for gastrointestinal inflammation. Aim: To determine whether higher FC levels in individuals with quiescent Crohn's disease are associated with clinical relapse over the ensuing 12 months. Methods: A single centre prospective study was undertaken in Crohn's disease patients in clinical remission attending for routine review. The receiver operating characteristic (ROC) curve for the primary endpoint of clinical relapse by 12 months, based on FC at baseline, was calculated. Kaplan-Meier curves of time to relapse were based on the resulting optimal FC cutoff for predicting relapse. Results: Of 97 patients recruited, 92 were either followed up for 12 months without relapsing, or reached the primary endpoint within that period. Of these, 10 (11 had relapsed by 12 months. The median FC was lower for non-relapsers, 96?g/g (IQR 39-237), than for relapsers, 414?g/g (IQR 259-590), (p=0.005). The area under the ROC curve to predict relapse using FC was 77.4 An optimal cutoff FC value of 240?g/g to predict relapse of quiescent Crohn's had sensitivity of 80.0% and specificity of 74.4 Negative predictive value was 96.8% and positive predictive value was 27.6 FC?240mug/g was associated with likelihood of relapse 5.7 (95% CI 1.9-17.3) times higher within 2.3 years than lower values (p=0.002). Conclusions: In this prospective dataset, FC appears to be a useful, non-invasive tool to help identify quiescent Crohn's disease patients at a low risk of relapse over the ensuing 12 months. FC of 240?g/g was the optimal cutoff in this cohort.