Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples
AssigneeHoffmann-La Roche Inc.
InventorsKay-Gunnar Stubenrauch, Rudolf Vogel
Life of this patent
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Abstract
Herein is reported an enzyme linked immunosorbent assay for the detection of anti-drug antibodies against a drug antibody in a sample comprising a capture drug antibody and a tracer drug antibody, wherein the capture drug antibody and the tracer drug antibody are employed in a concentration of 0.5 μg/ml or more, the sample is incubated simultaneously with the capture drug antibody and the tracer drug antibody for 1 to 24 hours, the capture drug antibody and the tracer drug antibody are derivatized via a single lysine residue, the sample comprises 10% serum, and oligomeric human IgG is added to the sample prior to the incubation with the capture drug antibody and the tracer drug antibody.
Claims6
A method of inhibiting IL6 receptor activity in a rheumatoid arthritis, juvenile arthritis, or osteoarthritis patient comprising administering to the patient an effective amount of anti-IL6 receptor antibody (drug antibody) to inhibit IL6 receptor activity and determining the presence of anti-anti-IL6 receptor antibody antibodies (anti-drug antibodies) by carrying out an interference-suppressed immunoassay comprising:
- (a) incubating a sample from the patient treated with said drug antibody simultaneously with a mixture comprising 0.5 μg/ml to 10 μg/ml of a 1:1 conjugate of said drug antibody to a first member of a binding pair via a single lysine residue as a capture drug antibody and 0.5 μg/ml to 10 μg/ml of a 1:1 conjugate of said drug antibody to a detectable label via a single lysine residue as a tracer drug antibody for 0.5 to 24 hours to generate a capture drug antibody/anti-drug antibody/tracer drug antibody complex, wherein the sample comprises 1% to 20% serum and is supplemented with oligomeric human IgG prior to the incubation to a final concentration of 10 μg/ml to 1000 μg/ml,
- (b) immobilizing the capture drug antibody/anti-drug antibody/tracer drug antibody complex formed in step (a) on a solid phase by covalently or non-covalently conjugating said first member of a binding pair to a second member of a binding pair on the solid phase,
- (c) incubating the immobilized complex with an antibody against the detectable label of the tracer drug antibody, conjugated to a second detectable label, and
- (d) detecting the anti-drug antibodies against said drug antibody via a signal of the detectable label of the antibody of step (c), and
- wherein the drug antibody is tocilizumab.
Dependencies are inferred from the claim text.