831 Serum Biomarkers Are Associated With Endoscopic and Clinical Outcomes in Crohn’s Disease Patients Receiving Vedolizumab Therapy

Abstract

INTRODUCTION: Vedolizumab is a selective monoclonal antibody directed against a4b7 integrin on lymphocytes and is safe and effective for the induction and maintenance of remission in Crohn’s disease. Serum biomarkers are needed to help guide therapy and predict patient outcomes. This study evaluated biomarker concentrations and patient outcomes during vedolizumab treatment. METHODS: Serum was collected from patients with Crohn’s disease receiving vedolizumab infusions at weeks 0, 2, 6, 14 and ≥26. Biomarkers including soluble(s)-a4b7, s-vascular cell adhesion molecule (VCAM)-1, s-intracellular adhesion molecule (ICAM)-1, and s-mucosal addressin cell adhesion molecule (MAdCAM)-1 were measured and evaluated as surrogate markers associated with clinical and endoscopic outcomes. Statistical analysis was performed using the Mann-Whitney U test for continuous data. RESULTS: Twenty-two patients with Crohn’s disease were included (Table 1). In all patients, s-MAdCAM significantly decreased over time as compared to baseline, and s-a4b7 increased compared to baseline (Figure 1). Overall, s-ICAM1 and s-VCAM1 did not change significantly over time in the entire cohort, however, differentially changed in patients with remission. At week 2, median concentrations of s-ICAM1 were higher in patients with compared to those without clinical remission: 675.1 ng/mL vs. 270.1 ng/mL, respectively (P = 0.046). At week 6, median s-ICAM1 concentrations were higher in patients with compared to without endoscopic remission: 545.7 ng/mL vs. 286.2 ng/mL, respectively (P = 0.027) and clinical remission: 669.1 ng/mL vs. 291 ng/mL, respectively (P = 0.034). At week 6, median s-VCAM1 concentrations were higher in patients with compared to without endoscopic remission: 859.6 vs. 460.31, respectively (P = 0.027) and numerically higher in patients with clinical remission: 859.6 ng/mL vs. 460.6 ng/mL, respectively (P = 0.1). At week 26, there was no difference in median s-VCAM1 or s-ICAM1 concentrations between remitters vs. non-remitters (Table 2). CONCLUSION: Higher concentrations of s-ICAM-1 and s-VCAM-1 early in treatment with vedolizumab may be predictive of subsequent remission in patients with Crohn’s disease. During maintenance, there was no association between serum biomarkers and endoscopic or clinical outcomes. These findings may help predict early patient response to treatment with vedolizumab in Crohn’s disease but will require further validation.