Claims for Patent: 10,012,654

Summary for Patent: 10,012,654

Title:	Biomarkers in inflammatory bowel disease
Abstract:	The present invention provides a method of determining whether a patient with inflammatory bowel disease (IBD) and who has been treated with anti TNF.alpha. therapy is in immunological remission (IR), said method comprising determining the level of a cytokine selected from TNF.alpha., IL-17 and IFN-y in a Gl mucosal sample from said patient. Also provided are methods of prognosis and treatment using said method of determination, in particular discontinuing treatment if said patient is in IR and continuing treatment if said patient is not in IR.
Inventor(s):	Florholmen; Jon (Tromso, NO), Olsen; Trine (Tromso, NO), Rismo; Renathe (Tromso, NO), Goll; Rasmus (Tromso, NO), Cui; Guanglin (Tromso, NO)
Assignee:	UNIVERSITY OF TROMSO (Tromso, NO)
Application Number:	14/653,750
Patent Claims:	1. A method of assaying whether a patient with inflammatory bowel disease (IBD) and who has been treated with an anti TNF.alpha. antibody is in immunological remission (IR) comprising assaying a GI mucosal sample from said patient for the expression level of TNF.alpha., detecting the expression level of TNF.alpha. in said sample using PCR or an immunological assay, wherein the detected expression level of TNF.alpha. is not normalized relative to a control and thus the patient is not in IR, treating the patient with continued anti-TNF.alpha. antibodies; wherein the detected expression level of TNF.alpha. is normalized relative to a control and thus the patient is in IR, ceasing treatment with TNF.alpha. antibodies. 2. The method of claim 1 wherein the level of at least one further cytokine is determined. 3. The method of claim 1 wherein said patient has ulcerative colitis (UC). 4. The method of claim 3 further comprising detecting the expression level of IFN.gamma.. 5. The method of claim 3 wherein said patient has an Ulcerative Colitis Disease Activity Index (UCDAI) score of 3 points or lower. 6. The method of claim 1 wherein said patient is in endoscopic remission. 7. The method of claim 1 wherein said patient has been treated with certolizumab, golimumab, infliximab, or adalimumab. 8. The method of claim 1 wherein said patient is human. 9. The method of claim 1 wherein the expression level of TNF-.alpha. in the GI mucosal sample of said patient is not normalized and said treatment is continued, said method further comprising repeating the method of claim 1 and discontinuing treatment if the expression level of TNF-.alpha. in the GI mucosal sample of said patient is normalized and continuing treatment if the expression level of TNF-.alpha. in the GI mucosal sample of said patient is not normalized. 10. The method of claim 1 wherein detecting the expression level of TNF-.alpha. is carried out by detecting the level of nucleic acid encoding TNF-.alpha.. 11. The method of claim 10 wherein detecting the expression level of TNF-.alpha. is carried out by PCR. 12. The method of claim 1 wherein detecting the expression level of TNF-.alpha. is carried out by detection of TNF-.alpha. at the protein level. 13. The method of claim 12 wherein detecting the expression level of TNF-.alpha. is carried out by an ELISA or RIA based assay.

Details for Patent 10,012,654

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2032-12-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2032-12-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2032-12-21
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2032-12-21