Accuracy of Consecutive Fecal Calprotectin Measurements to Predict Relapse in Inflammatory Bowel Disease Patients Under Maintenance With Anti-TNF Therapy: A Prospective Longitudinal Cohort Study.

BACKGROUND AND GOAL: Predicting relapse in inflammatory bowel disease (IBD) patients could allow early changes in therapy. We aimed at evaluating the accuracy of consecutive fecal calprotectin (FC) measurements to predict flares in IBD patients under maintenance treatment with anti-tumor necrosis factor (TNF) drugs. STUDY: A prospective longitudinal cohort study with 16-month follow-up period was designed. IBD patients in clinical remission for at least 6 months under anti-TNF therapy were included. FC was quantified at 4-month intervals for 1 year, and patients were clinically evaluated for relapse at 2-month intervals. Diagnostic accuracy of FC for predicting relapse was evaluated by receiver-operating characteristic curve analysis. RESULTS: In total, 95 of 106 included patients finalized the study and were analyzed (median age 44 y, 50.5% female, 75% with Crohn's disease). A total of 30 patients (31.6%) had a relapse over follow-up. FC concentration was significantly higher in patients who relapsed (477 µg/g) than in patients who maintained in remission (65 µg/g) (P<0.005). The optimal cutoff to predict remission was 130 µg/g (negative predictive value of 100%), and 300 µg/g to predict relapse (positive predictive value of 78.3%). CONCLUSIONS: FC is a good predictor of clinical relapse and a particularly good predictor of remission over the following 4 months in patients with IBD on maintenance therapy with anti-TNF drugs. FC levels <130 µg/g is consistently associated with maintained disease remission, whereas concentrations >300 µg/g allow predicting relapse with a high probability at any time over the following 4 months.

Fecal Calprotectin as Predictor of Relapse in Patients With Inflammatory Bowel Disease Under Maintenance Infliximab Therapy.

BACKGROUND AND GOALS: Predicting relapse in Inflammatory Bowel Disease (IBD) could allow for early changes of treatment. Close monitoring of fecal calprotectin (FC) could be useful to predict relapse in IBD. Aim of the study was to evaluate the predictive value of a rapid FC test to predict flares in patients with IBD under maintenance therapy with Infliximab. STUDY: A prospective observational cohort study was designed. IBD patients in clinical remission under maintenance Infliximab therapy were included. FC was measured using a rapid test on a stool sample obtained within 24 hours before Infliximab infusion. Clinical examination was performed 2 months after that infusion. RESULTS: Fifty-three patients were included (52.8% female). Thirty-three patients (62.3%) had Crohn's disease and 20 (37.7%) had ulcerative colitis. All patients were in remission at inclusion. After 2 months, 41 patients (77.4%) remained in clinical remission and 12 (22.6%) presented a relapse. FC (mean±SD) in relapsing and not-relapsing disease was 332±168 and 110±163 µg/g, respectively (P<0.005). A FC concentration>160 µg/g had a sensitivity of 91.7%, and specificity of 82.9% to predict relapse. CONCLUSIONS: In IBD patients under Infliximab maintenance therapy, high FC levels allow predicting relapse within the following 2 months. Long-term remission is associated with low calprotectin levels. Further studies are required to confirm these results.

Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab.

BACKGROUND AND AIM: Predicting relapse in Crohn's disease (CD) patients by measuring non-invasive biomarkers could allow for early changes of treatment. Data are scarce regarding the utility of monitoring calprotectin to predict relapse. The aim of the study was to evaluate the predictive value of a rapid test of faecal calprotectin (FC) to predict for flares in CD patients on maintenance treatment with adalimumab (ADA). METHODS: A prospective, observational cohort study was designed. Inclusion criteria were CD patients in clinical remission on a standard dose of ADA therapy. Fresh FC was measured using a rapid test. RESULTS: Thirty patients were included (median age 38 years, 56.7% female). After the 4 months follow-up, 70.0% patients remained in clinical remission and 30.0% had a relapse. FC concentration at inclusion was significantly higher in those patients who relapsed during the follow-up (625 µg/g) compared to those who stayed in remission (45 µg/g). The optimal cut-off for FC to predict relapse was 204 µg/g. The area under the receiver-operating characteristic curve was 0.968. Sensitivity, specificity, positive, and negative predictive value of FC to predict relapse were 100%, 85.7%, 74.1%, and 100%, respectively. CONCLUSION: In CD patients on ADA maintenance therapy, FC levels measured with a rapid test allow relapse over the following months to be predicted with high accuracy. Low FC levels exclude relapse within at least 4 months after testing, whereas high levels are associated with relapse in three out of every four patients.

Influence of alexithymia on health-related quality of life in inflammatory bowel disease: are there any related factors?

OBJECTIVE: Alexithymia is a personality trait characterized by difficulty to perceive and express emotions. Previous studies have indicated a high prevalence of alexithymia in patients with inflammatory bowel disease (IBD) but results have been inconsistent. The aim of the present study was to investigate the prevalence of alexithymia in a large IBD cohort and to establish the impact of alexithymia on health-related quality of life (HRQOL) in these patients. MATERIAL AND METHODS: A cross-sectional prospective study was undertaken including 534 consecutive IBD patients. Independent variables were measured using one socio-demographic and clinical questionnaire, the hospital anxiety and depression scale (HADS) and the Toronto alexithymia scale (TAS-26). Dependent variables were measured using the short form 36 health survey (SF-36) and the inflammatory bowel disease questionnaire (IBDQ-36). Multiple linear regression and logistic regression were performed to identify factors associated with HRQOL. RESULTS: Participation rate was 91.3%. The overall prevalence of alexithymia was 30.2% (95% CI: 26.0-35.0), with no difference between Crohn's disease and ulcerative colitis. The most affected scales in quality of life were general health (mean = 48.35, 95% CI: 46.43-50.27), vitality (mean = 55.81, 95% CI: 53.59-58.04) and systemic symptoms (mean = 5.19, 95% CI: 5.08-5.29). Alexithymia was significantly associated with an impaired quality of life (OR = 3.34, 95% CI: 1.98-5.65). "Difficulty identifying feelings" and "externally oriented thinking" were the alexithymia factors related to the impaired HRQOL. CONCLUSIONS: Alexithymia is highly prevalent in IBD and represents a significant determinant of HRQOL. Alexithymia and its components need to be taken into consideration in the management of IBD patients.