Methods for prediction of anti-tnf alpha drug levels and autoantibody formation

Abstract

In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNFα drug during the course of anti-TNFα drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNFα drug in a subject during the course of anti-TNFα drug therapy. Systems for predicting anti-TNFα drug levels and the likelihood of autoantibody formation during the course of anti-TNFα 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-TNFα drug therapy.

1 . A method for predicting whether a subject will develop autoantibodies to an anti-TNFα drug at a later time point during a course of therapy with the anti-TNFα drug, the method comprising measuring the level of the anti-TNFα drug in a sample obtained from the subject at an earlier time point during the course of therapy. 
     
     
         2 . A system for predicting whether a subject will develop autoantibodies to an anti-TNFα drug at a later time point during a course of therapy with the anti-TNFα drug, the system comprising:
 (a) a data acquisition module configured to produce a data set comprising one or more predictor variables for the subject determined at an earlier time point during the course of therapy and/or prior to the initiation of the course of therapy; 
 (b) a data processing module configured to process the data set by applying a statistical analysis to the data set to produce a statistically derived decision predicting whether the subject will develop autoantibodies to the anti-TNFα drug based upon the one or more predictor variables; and 
 (c) a display module configured to display the statistically derived decision. 
 
     
     
         3 . A method for predicting the level of an anti-TNFα drug in a subject at a later time point during a course of therapy with the anti-TNFα drug, the method comprising determining one or more predictor variables for the subject at an earlier time point during the course of therapy and/or prior to the initiation of the course of therapy.