Mobility shift assays for detecting anti-tnf alpha drugs and autoantibodies
OwnerSharat Singh, Scott Hauenstein +1inventors
InventorsSharat Singh, Scott Hauenstein, Linda Ohrmund
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Abstract
The present invention provides assays for detecting and measuring the presence or level of anti-TNFα drugs and/or the autoantibodies to anti-TNFα drugs in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNFα drug therapeutics to detect the presence or level of autoantibodies against the drug. The present invention also provides methods for selecting therapy, optimizing therapy, and/or reducing toxicity in subjects receiving anti-TNFα drugs for the treatment of TNFα-mediated disease or disorders.
Claims27
A method for determining the presence or level of an anti-TNFα drug in a sample, the method comprising:
- (a) contacting a labeled TNFα with a sample having an anti-TNFα drug to form a labeled complex with the anti-TNFα drug;
- (b) subjecting the labeled complex to size exclusion chromatography to separate the labeled complex from free labeled TNFα and to measure the amount of the labeled complex and the amount of the free labeled TNFα;
- (c) calculating a ratio of the amount of the labeled complex to the sum of the labeled complex plus free labeled TNFα;
- and
- (d) comparing the ratio calculated in step (c) to a standard curve of known amounts of the anti-TNFα drug, thereby determining the presence or level of the anti-TNFα drug.
A method for determining the presence or level of an autoantibody to an anti-TNFα drug in a sample, the method comprising:
- (a) contacting a labeled anti-TNFα drug with the sample to form a labeled complex with the autoantibody;
- (b) subjecting the labeled complex to size exclusion chromatography to separate the labeled complex from free labeled anti-TNFα drug and to measure the amount of the labeled complex and the amount of the free labeled anti-TNFα drug;
- (c) calculating a ratio of the amount of the labeled complex to the sum of the amount of the labeled complex plus free labeled anti-TNFα drug;
- and
- (d) comparing the ratio calculated in step (c) to a standard curve of known amounts of the autoantibody, to thereby determine the presence or level of the autoantibody.
A method for determining the total amount of autoantibody in a sample, the method comprising:
- (a) determining the level of autoantibody by:
- (i) contacting a labeled anti-TNFα drug with the sample to form a labeled complex with the autoantibody;
- (ii) subjecting the labeled complex to size exclusion chromatography to separate the labeled complex from free labeled anti-TNFα drug and to measure the amount of the labeled complex and the amount of the free labeled anti-TNFα drug;
- (iii) calculating a ratio of the amount of the labeled complex to the sum of the amount of the labeled complex plus free labeled anti-TNFα drug;
- (iv) comparing the ratio calculated in step (c) to a standard curve of known amounts of the autoantibody, to thereby determine the presence or level of the autoantibody, bound to a labeled anti-TNFα drug;
- and
- (b) adding the amount of autoantibody bound to unlabeled anti-TNFα drug to the level determined in step (a) to produce the total amount of autoantibody in the sample.
Dependencies are inferred from the claim text.