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Fecal calprotectin is a reliable marker of endoscopic response to vedolizumab therapy: A simple algorithm for clinical practice.

ABSTRACT: BACKGROUND AND AIM:The association of fecal calprotectin (FC) and endoscopic response in inflammatory bowel disease patients during vedolizumab (VDZ) treatment is largely unknown. The aim of this study is to assess the diagnostic value of FC to predict endoscopic response. METHODS:Patients with active endoscopic disease at baseline were included. Endoscopies and FC tests were performed at baseline and week 16. Patients with a confirmed endoscopic response at week 16 continued VDZ maintenance therapy, and endoscopy and FC tests were performed at week 52. Endoscopic response was defined as endoscopic Mayo score reduction of ? 1, SES-CD of ? 50%, or Rutgeerts' score of ? 1. Correlations were assessed using Spearman and receiver operating characteristic statistics. RESULTS:A total of 114 patients, 46 ulcerative colitis and 68 Crohn's disease patients (44 men, median age 40 years), were included after the start of VDZ; 85% was anti-tumor necrosis factor alpha refractory. Endoscopic response was observed in 60 (53%) patients at week 16; the response sustained in 73% at week 52. FC decreased significantly from 819 at baseline to 154 ?g/g at week 16. FC at weeks 16 and 52 were significantly correlated to (sustained) endoscopic response (r = -0.62 / r = -0.67, P < 0.001). FC < 200 ?g/g indicates endoscopic response (area under the curve = 0.89, positive predictive value = 94%), whereas FC > 450 ?g/g indicates endoscopic non-response after induction (negative predictive value = 83%). An increase in FC level of > 400 ?g/g after induction indicates endoscopic loss of response (area under the curve = 0.97, negative predictive value = 96%). CONCLUSION:This prospective study demonstrates a significant correlation between FC and endoscopic response to VDZ. FC < 200 ?g/g prognosticate endoscopic response, and FC > 450 ?g/g endoscopic non-response. An increase in FC of > 400 ?g/g after induction indicates endoscopic loss of response. This simple FC algorithm may guide clinical decisions on the continuation and optimization of VDZ in inflammatory bowel disease patients.

SUBMITTER: Pauwels RWM

PROVIDER: S-EPMC7687080 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Fecal calprotectin is a reliable marker of endoscopic response to vedolizumab therapy: A simple algorithm for clinical practice.

Pauwels Renske Wilhelmina Maria RWM de Vries Annemarie Charlotte AC van der Woude Christien Janneke CJ

Journal of gastroenterology and hepatology 20200504 11

<h4>Background and aim</h4>The association of fecal calprotectin (FC) and endoscopic response in inflammatory bowel disease patients during vedolizumab (VDZ) treatment is largely unknown. The aim of this study is to assess the diagnostic value of FC to predict endoscopic response.<h4>Methods</h4>Patients with active endoscopic disease at baseline were included. Endoscopies and FC tests were performed at baseline and week 16. Patients with a confirmed endoscopic response at week 16 continued VDZ ...[more]

PMID: 32291796

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Project description:Calprotectin has been well emulated recently in adults as well as in children. The aim of this study was to assess fecal calprotectin concentrations in healthy children aged from 1 to 4 years.Volunteers were enlisted from 3 nurseries. A brief questionnaire was used to ensure these children meet the inclusion criteria, and some clinical and sociodemographic factors were collected. Anthro software (version 3.1) was used to calculated Length-for-age Z-scores (LAZ), weight-for-age Z-scores (WAZ), and weight-for-length Z-scores (WLZ) respectively. Fecal calprotectin was detected by a commercially available ELISA.In total 274 children were recruited, with age ranging from 1 to 4 years old. The median FC concentration was 83.19 ?g/g [range 4.58 to 702.50 ?g/g, interquartile range (IQR) 14.69-419.45 ?g/g] or 1.92 log10 ?g/g (range 0.66 log10 to 2.85 log10 ?g/g, IQR 1.17 log10-2.62 log10 ?g/g). All of the children were divided into three groups, 1-2 years (12-24 months), 2-3 years (24-36 months), 3-4 years (36-48 months), with median FC concentrations 96.14 ?g/g (1.98 log10 ?g/g), 81.48 ?g/g (1.91 log10 ?g/g), 65.36 ?g/g (1.82 log10 ?g/g), respectively. There was similar FC level between boys and girls. FC concentrations showed a downward trend by the growing age groups. A statistic difference was found in FC concentrations among groups 1-2 years, 2-3 years and 3-4 years (P = 0.016). In inter-groups comparison, a significant difference was found between children aged 1-2 years and children aged 3-4 years (P = 0.007). A negative correlation trend was found between age and FC concentration (Spearman's rho = -0.167, P = 0.005) in all the participants. A simple correlation was performed among WLZ, WAZ, birth weight, or birth length with FC, and there was no correlation being observed.Children aged from 1 to 4 years old have lower FC concentrations compared with healthy infants (<1years), and higher FC concentrations when comparing with children older than 4 years and adults.

Project description:BackgroundFecal calprotectin is widely used to monitor disease activity in patients with inflammatory bowel disease. Multiple commercial kits exist, however, since the analyses are not standardized, these kits cannot be used interchangeably. We aimed to perform a technical evaluation of two kits (Calpro from Calprolab, Norway and Calprest from Eurospital, Italy) and perform a tuning for detection of clinically relevant disease states in ulcerative colitis.Materials and methodsFor tuning against different clinical states a total of 116 patients with ulcerative colitis were recruited (67 of which were part of an earlier publication). For the technical evaluation an additional series of 80 random samples from the hospital lab were included. Technical evaluation was done by correlation and limits of agreement analysis; cut-off levels were explored by ROC analysis against clinically relevant actual states.ResultsThe technical evaluation revealed good correlation between assays, however a non-linear difference was found: At values below 200 mg/kg, no significant bias was found; in the interval 200-1000 mg/kg the Calprest assay measured on average 30% lower than Calpro; and at higher values Calprest measured 60% higher values than Calpro. Both assays predicted Mayo endoscopic score (MES) 0 (cutoff 28: sensitivity 0.38; specificity 0.82 for Calprest; cutoff 28: sensitivity 0.50; specificity 0.77 for Calpro), and MES 2-3 (cutoff 148: sensitivity 0.72; specificity 0.80 for Calprest; cutoff 208: sensitivity 0.64; specificity 0.80 for Calpro), but did not predict normalization of mucosal TNF transcript per se. A combination of calprotectin and MES predicted mucosal TNF transcript values reasonably well (Calpro: sensitivity 0.85, specificity 0.58; Calprest: sensitivity 0.85, specificity 0.61).ConclusionThe Calpro and Calprest assays correlated well, but subtle differences were found, underlining the need for kit-specific cut-off values. Both kits were most precise in predicting active inflammation (MES 2-3), but less so for prediction of mucosal healing (MES 0) and normalization of mucosal TNF gene expression.

Dataset Information

Fecal calprotectin is a reliable marker of endoscopic response to vedolizumab therapy: A simple algorithm for clinical practice.

Publications

Fecal calprotectin is a reliable marker of endoscopic response to vedolizumab therapy: A simple algorithm for clinical practice.

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