Objectives: To explore the relationship between vedolizumab trough concentrations and clinical and biochemical remission in patients with Crohn's disease (CD) receiving maintenance therapy, analysing intravenous and subcutaneous administration separately in a real-world clinical setting.
Methods: We conducted a retrospective observational study in 69 patients with CD receiving vedolizumab maintenance therapy. Plasma trough concentrations were measured by ELISA. Clinical remission (Harvey-Bradshaw Index <5) and biochemical remission (faecal calprotectin (FCP) <250 µg/g) were evaluated 6 months after trough level measurement. Patients were stratified according to administration route (intravenous and subcutaneous). Statistical analyses included Mann-Whitney tests, receiver operating characteristic (ROC) curves to determine predictive ability, and multiple linear regression to identify factors associated with vedolizumab exposure.
Results: Median vedolizumab trough concentrations were higher in patients achieving clinical remission compared with those without remission in both intravenous (16.4 vs 10.95 µg/mL, p=0.067) and subcutaneous (37.45 vs 23.05 µg/mL, p=0.134) groups, although differences were not statistically significant. ROC analyses revealed modest predictive capacity for the intravenous group (area under the curve (AUC)=0.676, optimal threshold=11.3 µg/mL, sensitivity=85.7%, specificity=58.3%) and strong predictive ability for the subcutaneous group (AUC=0.813, optimal threshold=25.35 µg/mL, sensitivity=83.3%, specificity=75%). Biochemical remission was not significantly associated with trough concentrations. In multivariable regression analysis, subcutaneous administration, higher albumin and lower FCP were significantly associated with increased vedolizumab concentrations, whereas C-reactive protein (CRP) showed a positive association.
Conclusion: Vedolizumab trough concentrations were numerically higher in patients achieving clinical remission, with stronger predictive ability for remission in the subcutaneous group. While isolated trough levels alone may not predict remission, interpretation alongside biomarkers and clinical context can inform therapeutic decisions. Further prospective studies are warranted to validate optimal therapeutic thresholds.
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