Early vedolizumab trough levels predict mucosal healing in inflammatory bowel disease: a multicentre prospective observational study

Aliment Pharmacol Ther. 2018 Apr;47(7):906-912. doi: 10.1111/apt.14548. Epub 2018 Jan 31.


Background: The correlation between vedolizumab trough levels during induction therapy and mucosal healing remains unknown.

Aim: To compare early vedolizumab trough levels in patients with and without mucosal healing within the first year after treatment initiation.

Methods: We prospectively collected vedolizumab trough levels in all inflammatory bowel disease patients at weeks 2, 6 and 14 of vedolizumab treatment in three French referral centres between 1 June 2014 and 31 March 2017. Results of every patient that underwent mucosal assessment by magnetic resonance imaging and/or endoscopy in the first year after treatment initiation were analysed.

Results: Median vedolizumab trough levels in the overall population (n = 82) were 27 μg/mL (interquartile range, IQR 21.2-33.8 μg/mL) at week 2, 23 μg/mL (IQR 15-34.5 μg/mL) at week 6 and 10.7 μg/mL (IQR 4.6-20.4 μg/mL) at week 14. Only median vedolizumab trough levels at week 6 differed between patients with and without mucosal healing within the first year after treatment initiation (26.8 vs 15.1 μg/mL, P = 0.035). A cut-off trough level of 18 μg/mL at week 6 predicted mucosal healing within the first year after the start of vedolizumab with an area under the receiver operating curve of 0.735 (95% confidence interval 0.531-0.939). A vedolizumab trough level above 18 μg/mL at week 6 was the only independent variable associated with mucosal healing within the first year of treatment (odds ratio 15.7, 95% confidence interval 2.4-173.0, P = 0.01).

Conclusion: Early therapeutic drug monitoring might improve timely detection of vedolizumab-treated patients in need for an intensified dosing regimen.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / blood*
  • Antibodies, Monoclonal, Humanized / pharmacokinetics
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Drug Monitoring / methods
  • Endoscopy
  • Female
  • Humans
  • Inflammatory Bowel Diseases / blood
  • Inflammatory Bowel Diseases / diagnosis
  • Inflammatory Bowel Diseases / drug therapy*
  • Intestinal Mucosa / drug effects
  • Intestinal Mucosa / physiology
  • Male
  • Middle Aged
  • Mucous Membrane / drug effects
  • Mucous Membrane / physiology
  • Prognosis
  • Prospective Studies
  • Treatment Outcome
  • Wound Healing* / drug effects


  • Antibodies, Monoclonal, Humanized
  • vedolizumab