Prometheus Laboratories Inc.

Nestec S.a.

Prometheus Biosciences, Inc.

Prometheus Biosiences, Inc.

Venkateswarlu Kondragunta

Anjali Jain

Sharat Singh

Michael Hale

The present disclosure provides methods for assessing mucosal healing in a patient with Crohn's Disease. The methods include detecting expression levels of analytes in a serum sample from a patient, and applying a mathematical algorithm to the expression levels, thereby producing a Mucosal Healing Index score for the patient. The present disclosure also provides kits that include two or more binding partners, each or which is capable of binding a different analyte measured in the disclosed mucosal healing assessment methods.

Methods for assessing mucosal healing in inflammatory bowel disease patients

Methods for assessing mucosal healing in ulcerative colitis disease patients

In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNF&#x3b1; drug during the course of anti-TNF&#x3b1; drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNF&#x3b1; drug in a subject during the course of anti-TNF&#x3b1; drug therapy. Systems for predicting anti-TNF&#x3b1; drug levels and the likelihood of autoantibody formation during the course of anti-TNF&#x3b1; drug therapy are also provided herein. The present invention further provides methods for predicting a clinical outcome (e.g., endoscopic response) of a subject on anti-TNF&#x3b1; drug therapy.

Methods for prediction of anti-TNF &#x3b1; drug levels and autoantibody formation

The present disclosure provides methods for assessing mucosal healing in a patient with Chron's Disease. The methods include detecting expression levels of analytes in a serum sample from a patient, and applying a mathematical algorithm to the expression levels, thereby producing a Mucosal Healing Index score for the patient. The present disclosure also provides kits that include two or more binding partners, each or which is capable of binding a different analyte measured in the disclosed mucosal healing assessment methods.

Methods for assessing mucosal healing in Crohn's disease patients

Methods for prediction of anti-TNF&#x3b1; drug levels and autoantibody formation

The present invention provides methods for predicting whether an individual having inflammatory bowel disease (IBD) is likely to respond to vedolizumab treatment. Also provided are methods for predicting whether an individual with IBD such as Crohn's disease or ulcerative colitis will develop autoantibodies against vedolizumab. The present invention also provides a treatment regimen for an IBD patient which includes measuring the level of one or more predictive markers of response to vedolizumab prior to administering the anti-&#x3b1;4&#x3b2;7 integrin drug.

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San Diego, CA, United States of America

Venkateswarlu Kondragunta