Methods for prediction of anti-TNF α drug levels and autoantibody formation
Inventors
Singh, Sharat • Kondragunta, Venkateswarlu
Assignees
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Publication Number
US-11435347-B2
Publication Date
2022-09-06
Expiration Date
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.
Core Innovation
The invention provides methods for predicting whether a subject having an inflammatory bowel disease will later develop autoantibodies to an anti-TNFα drug during a course of therapy. The method determines one or more predictor variables in one or more samples obtained from the subject at least 24 hours following induction with the anti-TNFα drug, including IL-8 level and an anti-TNFα drug level, IL-8 level and a TNFα/drug ratio, a TNFα/drug ratio, and/or an anti-TNFα drug and a TNFα/drug ratio.
The method compares the one or more predictor variables to a reference level for each predictor variable and, based on the comparison, predicts that the subject will develop autoantibodies to the anti-TNFα drug. The predictive determination is tied to subsequent therapeutic actions during the course of therapy.
After predicting autoantibody development, the method includes administering a modified dose of the anti-TNFα drug, administering a different type of the anti-TNFα drug, or administering an immunosuppressive agent. The related description further includes predicting clinical outcome measures such as endoscopic response, using statistically derived decisions based on analytes and timing relative to induction and therapy.
Claims Coverage
Independent claim coverage centers on predicting later development of autoantibodies to an anti-TNFα drug in an inflammatory bowel disease subject using IL-8-related and TNFα/drug ratio-related predictor variables measured in samples obtained at least 24 hours after induction, followed by prediction based on comparison to reference levels, and selection among subsequent therapeutic adjustments.
Predicting later development of anti-TNFα autoantibodies from IL-8 and TNFα/drug measures
A method for predicting whether a subject having an inflammatory bowel disease will later develop autoantibodies to an anti-TNFα drug during a course of therapy by determining predictor variables comprising IL-8 and anti-TNFα drug level, IL-8 and a TNFα/drug ratio, a TNFα/drug ratio, and/or combinations including IL-8, anti-TNFα drug level, and the TNFα/drug in one or more samples obtained from the subject at least 24 hours following induction with the anti-TNFα drug.
Reference-level comparison and prediction of autoantibody development
Comparing the one or more predictor variables to a reference level for each of the one or more predictor variables and predicting the subject will develop autoantibodies to the anti-TNFα drug based on the one or more predictor variables compared to the reference level for each of the one or more predictor variables.
Therapeutic adjustment after prediction
Administering a modified dose of the anti-TNFα drug to the subject, administering a different type of the anti-TNFα drug to the subject, or administering an immunosuppressive agent to the subject.
The independent claim(s) are directed to autoantibody prediction using IL-8 and anti-TNFα/TNFα-drug-related predictor variables measured at least 24 hours after induction, comparison to reference levels, prediction of later autoantibody development, and post-prediction therapeutic adjustment.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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