Claims for Patent: 9,651,560

Summary for Patent: 9,651,560

Title:	Methods for detecting antibodies
Abstract:	The present invention relates to methods of detecting Anti-Drug Antibodies. The present invention also relates to methods of monitoring patients undergoing therapeutic antibody treatment. The invention further relates to kits suitable for the implementation of the above methods.
Inventor(s):	Parussini; Ermis (Lentilly, FR), Noguier; Guillaume (Bussy Saint George, FR)
Assignee:	THERADIAG SA (Croissy-Beaubourg, FR)
Application Number:	14/745,765
Patent Claims:	1. A method for immunodetecting an Anti-Drug Antibody (ADA) in a sample from a patient treated with a drug, wherein the drug is a therapeutic antibody or etanercept, said therapeutic antibody or etanercept being directed against a target antigen, the method comprising detecting, in a sample from the patient, the presence or amount of: a) therapeutic antibody or etanercept; b) target antigen; and c) ADA. 2. The method of claim 1, wherein said detection is performed by immunoassay. 3. The method of claim 2, wherein the immunoassay is an ELISA, immuno-capture, microarrays, Flow cytometry or multiplex dot. 4. The method of claim 1, wherein said target antigen is TNF.alpha.. 5. The method of claim 4, wherein the therapeutic antibody is an anti-TNF.alpha. antibody selected from infliximab, adalimumab, golimumab and certolizumab pegol. 6. The method of claim 1, wherein the patient has an autoimmune or inflammatory disease. 7. The method of claim 1, further comprising detecting, in a sample from said patient, the presence or amount of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR). 8. The method of claim 1, wherein the patient is treated with anti-TNF.alpha. antibody, the method comprising determining, in a sample from the patient, the presence or amount of: the anti-TNF.alpha. antibody, the TNF.alpha. and Anti-Drug Antibodies directed against said anti-TNF.alpha. antibody. 9. The method of claim 4, further comprising determining, in a sample from said patient, the presence or amount of at least one additional marker selected from cytokines, chemokines, hormones, growth factors, and rheumatoid factors. 10. The method of claim 4, further comprising determining, in a sample from said patient, the presence or amount of at least one additional marker selected from IL1, IL6, IL8, IL10, IL12, IL17, IL23, GM-CSF, IFNgamma, ProMPP1, ProMPP3, Anti-nuclear antibodies, C-reactive protein (CRP), RF rheumatoid factor, Serum amyloid A, IgG, IgA, IgM, hemoglobin, erythrocyte sedimentation rate (ESR), white cell and platelet counts, the number of CD19 B cells, the number of CD3 T cells, the number of CD4 T cells, the number of CD8 T cells, the number of CD25 T cells, and/or the number of HLA-DR T cell. 11. The method of claim 4, wherein the patient suffers from multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis, Crohn's disease or psoriasis.

Details for Patent 9,651,560

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2030-04-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2030-04-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2030-04-29
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2030-04-29
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2030-04-29
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2030-04-29