Vedolizumab (Entyvio¬ģ) - Therapeutic Drug Monitoring (TDM)

Vedolizumab (Entyvio) is a humanized monoclonal antibody against alpha 4 beta 7 integrin and used for the treatment of inflammatory bowel diseases such as ulcerative colitis (UC) and Crohn¬īs disease (CD). Therapeutic cut-off (minimum serum concentration of Vedolizumab that gives a positive response to treatment) is still not known.

Alpha 4 beta 7 integrin is a glycoprotein on the surface of T- and B- cells and plays an important role for the cells passage from the blood across the endothelium to the intestinal mucosa. Treatment with Vedolizumab blocks cell passage and thereby down-regulate inflammation in the intestinal mucosa. During treatment, some patients may develop antibodies to Vedolizumab (anti-drug antibodies or ADA). Data and interpretation of Vedolizumab ADA and its serum levels are still very limited.

Testing Vedolizumab concentration:

The assay is performed using an ELISA assay. The lowest detectable concentration of Vedolizumab in serum is 2 ¬Ķg/mL.

Testing Vedolizumab anti-drug antibodies (ADA):

The assay is performed using ELISA.  ADA can only be detected if the Vedolizumab concentration in serum is < 2 ¬Ķg/mL. The lowest detectable concentration of these ADA is 35 ng/mL.

Suggested literature

 

  1. Cherry LN and al., Vedolizumab: an alpha 4 beta 7 integrin antagonist for ulcerative colitis and Crohn’s disease, Therapeutic Advances in Chronic Disease, Vol.6(5), 224233, 2015.
  2. Feagan BG and al., Induction and Maintenance Therapy with Vedolizumab, a novel biologic therapy for ulcerative colitis, Gastroenterology & Hepatology, 10, Issue 1, 2014.
  3. Rosario M. and al., Population pharmacokinetics pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn’s disease, Alimentary Pharmacology and Therapeutics, 2015.
  4. Yu Jin and al., Meta-analysis of the effectiveness and safety of vedolizumab for ulcerative colitis, World Journal of Gastroenterology, 21, issue 20, 2015.
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