Introduction
The predictive value of therapeutic drug monitoring (TDM) of vedolizumab in Crohn’s disease (CD) during the maintenance phase remains uncertain. This study assessed its association with clinical and biochemical remission in routine clinical practice and explored variables influencing trough concentration variability.
Methods
A retrospective observational study was conducted at a tertiary hospital between July 2022 and December 2024. Adult CD patients receiving vedolizumab during maintenance and undergoing routine TDM were included. Clinical variables (age, treatment duration, administration route, perianal disease), laboratory markers (albumin, C-reactive protein [CRP], fecal calprotectin [FCP]), and pharmacokinetic data were collected. Trough concentrations were measured using ELISA. Clinical remission was defined as a Harvey–Bradshaw Index <5 and biochemical remission as FCP < 250 µg/g, both evaluated six months after the trough level. Non-parametric tests, multiple linear regression, ROC analysis, and multiple imputation were used for statistical analysis.
Results
Seventy patients were included. Clinical remission was observed in 76.8%. Median trough levels were higher in patients in clinical remission (17.5 µg/mL [IQR: 12.5–26.2]) than in those without remission (13.4 µg/mL [IQR: 8.8–23.5]; p = 0.07). A total of 65.2% reached ≥14 µg/mL; however, remission rates did not differ significantly between groups with high or low exposure, for either clinical (84.4% vs. 62.5%; p = 0.07) or biochemical remission (73.1% vs. 69.2%; p = 1). ROC analysis identified an optimal threshold of 11.3 µg/mL (AUC = 0.647). Subcutaneous administration was associated with higher concentrations (p = 0.0057), as were higher albumin levels (p = 0.012). Significant correlations were found between vedolizumab levels and CRP (positive, p = 0.0025) and FCP (inverse, p = 0.0186). No anti-drug antibodies were detected.
Conclusions
Vedolizumab trough levels were not significantly associated with clinical or biochemical remission during maintenance. These findings suggest that the isolated use of TDM may have limited predictive value. However, factors such as administration route, albumin, and inflammation levels influence exposure and should be integrated into the interpretation of drug concentrations in clinical practice.
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