A case-control study to evaluate the immunoinflammatory effect of prior exposure to anti-TNF therapy in patients with ulcerative colitis starting vedolizumab therapy
Inflammatory bowel disease (IBD)- ulcerative colitis (UC) and Crohn's disease (CD)- are chronic conditions of the gastrointestinal tract. Treatment generally consists of immunosuppression to modify the dysregulated immune responses. Vedolizumab, an inhibitor of α4β7, is a highly effective therapy for treating IBD, that minimized adverse effects through its gut selective inhibition of lymphocyte trafficking. However, the mechanism of action remains incompletely characterized especially in those previously treated to other biologics and why some patients are either vedolizumab non-responders or fail to respond over time. We would like to address the question whether anti-TNF non-responders as well as those that either do not respond or fail overtime to respond to vedolizumab identifies a specific population with difficult to treat disease that have alternate trafficking patterns and whether prior exposure to anti-TNF alters the mucosal immune responses, and/or trafficking patterns when compared to anti-TNF naive patients that may help explain impaired response to vedolizumab induction therapy.
Study Type
OBSERVATIONAL
Enrollment
1
standard vedolizumab induction (300mg IV at week 0, 2, 6)
Stanford University
Stanford, California, United States
University of Western Ontario
London, Ontario, Canada
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells)
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) in patients with and without prior anti-TNF exposure
Time frame: changes from enrollment to end of treatment (week 14)
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins)
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins) in vedolizumab responders versus non-responders
Time frame: changes from enrollment to end of treatment (week 14)
Analysis of the serum and tissue concentrations of vedolizumab
Analysis of the serum and tissue concentrations of vedolizumab in patients with and without prior anti-TNF exposure
Time frame: changes from enrollment to end of treatment (week 14)
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