Methods for establishing a vedolizumab dosing regimen to treat patients with irritable bowel disease

A method for predicting whether a subject having inflammatory bowel disease (IBD) is likely to develop autoantibodies to an anti-α4β7 integrin drug, the method comprising:

• (a) detecting the presence or level of at least one predictive marker selected from the group consisting of TNFα, human serum albumin (HSA), VEGF, angiopoietin-1 (ANG-1), angiopoietin-2 (ANG-2), adenosine deaminase (ADA), serum α4β7 integrin, IL-12p40, C-reactive protein (CRP), matrix metalloproteinase 9 (MMP9), MAdCAM-1, VCAM-1, ICAM-1, and a combination thereof in a sample from the subject;
• and
• (b) applying a statistical analysis to the presence or level of the at least one predictive marker of step (a) to generate a predictive marker profile to determine whether the subject is likely to develop or not to develop the autoantibodies.

19-37. (canceled)

A method for inducing clinical remission in a subject having inflammatory bowel disease (IBD) and after receiving an induction therapy of an anti-α4β7 integrin drug, comprising administering a maintenance therapy of an anti-α4β7 integrin drug to a subject with IBD and having a higher level of serum α4β7 integrin and/or a lower level of MadCAM-1 compared to corresponding levels at baseline.

39-43. (canceled)

A therapy regimen for an anti-α4β7 integrin drug, said therapy regimen comprising:

• measuring the presence or level of at least one predictive marker selected from the group consisting of TNFα, human serum albumin (HSA), VEGF, angiopoietin-1 (ANG-1), angiopoietin-2 (ANG-2), adenosine deaminase (ADA), serum α4β7 integrin, IL-12p40, C-reactive protein (CRP), MMP9, MAdCAM-1, VCAM-1, ICAM-1, and a combination thereof in a sample from the subject;
• and
• administering the therapy regimen of the anti-α4β7 integrin drug according to a predictive marker profile based on a higher or lower level of the at least one predictive marker compared to a corresponding reference value.

45-50. (canceled)