Therapeutic Drug Monitoring of Vedolizumab: Should Trough Levels Be Measured…and When?

Kenneth R. McQuaid, MD, FASGE reviewing Singh S, et al. Aliment Pharmacol Ther 2019 Sep 4.

In IBD patients treated with anti-TNF agents, therapeutic drug monitoring (TDM) is commonly used to optimize therapy, reduce risk of antibody formation, and determine mechanisms for primary or secondary nonresponse. The utility of TDM for vedolizumab has not been established. The authors performed a systematic review of cohort studies that reported associations between vedolizumab troughs and clinical outcomes during induction or maintenance therapy.

Of 32 studies reviewed, 5 were included in a quantitative analysis to determine median differences in vedolizumab trough levels in patients who did or did not achieve clinical or endoscopic remission during maintenance therapy. Data from the 5 studies were reviewed to assess the relationship between vedolizumab levels and favorable clinical outcomes.

  • Ulcerative colitis induction therapy: Week 6 vedolizumab trough levels >20 µg/ml were associated with favorable clinical outcomes.
  • Ulcerative colitis maintenance therapy: Median trough levels were significantly higher in patients achieving clinical remission (median difference: 5.1 µg/ml) and endoscopic remission (median difference: 5.1 µg/ml). Maintenance trough levels >12 µg/ml were associated with favorable clinical outcomes.  
  • Crohn’s disease: Meta-analysis found numerically (but not significantly) higher vedolizumab trough levels in patients achieving clinical or endoscopic remission. 
  • Vedolizumab antibodies were detected in 1.7% to 3.0% of patients.


This analysis suggests a relationship between vedolizumab trough levels and favorable clinical outcomes in ulcerative colitis; however, cause-effect is unproven. Patients with favorable clinical predictors (less inflammation, low C-reactive protein, and high albumin) may have reduced drug clearance/loss that results in higher drug trough levels.  

For patients with primary or secondary loss of response to vedolizumab, the authors suggest TDM, with escalation of drug infusions to every 4 weeks if levels are <20 µg/ml at week 6 or <12 µg/ml during maintenance.

Kenneth R. McQuaid, MD, FASGE
Bio and Disclosures

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Singh S, Dulai PS, Vande Casteele N, et al. Systematic review with meta-analysis: association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases. Aliment Pharmacol Ther 2019 Sep 4. (Epub ahead of print) (