Bullseye study

See hypothesis.

Crohn's disease is an immune-mediated disease that results in chronic inflammation in genetically predisposed individuals exposed to an appropriate environment. The introduction of monoclonal antibodies has revolutionized the treatment of Crohn’s disease (CD). Unfortunately, the efficacy of these agents is hampered by loss of response in a significant proportion of patients. Recently, vedolizumab, an integrin á4â7 antagonist, has been licensed for the treatment of CD and UC. Response rates vary between 31% for CD and 47% for UC at week 6 (1;2). In biological-naive patients, response rates may be up to 40% at week 6 and 47% at week 10 (unpublished results from Gemini 2 en 3 studies). However, a considerable proportion of patients does not respond to vedolizumab. Since the use of vedolizumab is associated with substantial financial expenditures, tools to identify patients in whom the drug will be effective are warranted.



Hypothesis:

Response and non-response to vedolizumab can be predicted using biomarkers, identified through a System Medicine approach.

Prior to starting therapy; week 2, week 6, week 22, week 52

Vedolizumab therapy