Claims for Patent: 10,168,326

Summary for Patent: 10,168,326

Title:	Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples
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 .mu.g/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.
Inventor(s):	Stubenrauch; Kay-Gunnar (Penzberg, DE), Vogel; Rudolf (Weilheim, DE)
Assignee:	F. HOFFMANN-LA ROCHE INC. (Nutley, NJ)
Application Number:	15/078,140
Patent Claims:	1. An interference-suppressed immunoassay for the detection of anti-drug antibodies against a drug antibody for the treatment of rheumatoid arthritis, juvenile arthritis, or osteoarthritis, said method comprising: (a) incubating a sample from a rheumatoid arthritis, juvenile arthritis, or osteoarthritis patient treated with said drug antibody simultaneously with a mixture comprising 0.5 .mu.g/ml to 10 .mu.g/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 .mu.g/ml to 10 .mu.g/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 .mu.g/ml to 1000 .mu.g/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 an anti-inflammatory antibody. 2. The method of claim 1, wherein the patient is a rheumatoid arthritis patient. 3. The method of claim 1, wherein the first member of a binding pair in said capture antibody is biotin, and the detectable label in said tracer antibody is digoxygenin. 4. The method of claim 3, wherein in step (b) the second member of a binding pair is streptavidin. 5. The method of claim 1 or 2, wherein the sample comprises anti-drug antibodies and rheumatoid factors. 6. The method of any one of claims 1 to 4, wherein the drug antibody is an anti-IL6R antibody. 7. The method of claim 6, wherein the anti-IL6R antibody is tocilizumab.

Details for Patent 10,168,326

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125276	01/08/2010		2033-07-04
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	10/21/2013		2033-07-04
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	11/19/2018		2033-07-04