Claims for Patent: 9,395,364

Summary for Patent: 9,395,364

Title:	Biomarkers for inflammatory bowel disease with ankylosing spondylitis
Abstract:	There is provided herein a method for categorizing a patient having inflammatory bowel disease as being at risk for developing ankylosing spondylitis. The method comprises the use of a patient level of auto-antibodies directed against noggin (NOG) and/or sclerostin (SOST) to determine a risk for the patient developing ankylosing spondylitis. There is also provided methods of monitoring ankylosing spondylitis treatment using these auto-antibodies.
Inventor(s):	Tsui; Florence Wing Ling (Oakville, CA), Inman; Robert Davies (Toronto, CA)
Assignee:	UNIVERSITY HEALTH NETWORK (Toronto, CA)
Application Number:	14/764,492
Patent Claims:	1. A method for categorizing a patient having inflammatory bowel disease as being at risk for developing ankylosing spondylitis, the method comprising: a. identifying a patient as having inflammatory bowel disease; b. determining a patient level of auto-antibodies directed against noggin (NOG) and/or sclerostin (SOST) in the patient; c. comparing said level to a control level representing normal individuals; d. determining that the patient is at risk for developing ankylosing spondylitis if the patient level is higher than the control level. 2. The method of claim 1, wherein the auto-antibodies are directed against NOG. 3. The method of claim 2, wherein the auto-antibodies are directed against at least part of a region of NOG comprising amino acids 50-72 thereof (PDPIFDPKEKDLNETLLRSLLGG--SEQ. ID NO. 1). 4. The method of claim 2, wherein the auto-antibodies are directed against at least part of a region of NOG comprising amino acids 73-102 thereof (HYDPGFMATSPPEDRPGGGGGAAGGAEDLA--SEQ. ID NO. 2). 5. The method of claim 1, wherein the auto-antibodies are directed against SOST. 6. The method of claim 5, wherein the auto-antibodies are directed against at least part of a region of SOST comprising amino acids 95-110 thereof (IGRGKWWRPSGPDFRC--SEQ. ID NO. 3). 7. The method of claim 5, wherein the auto-antibodies are directed against at least part of a region of SOST comprising amino acids 146-158 thereof (TRFHNQSELKDFG--SEQ. ID NO. 4). 8. The method of claim 1, wherein the patient has back pain. 9. The method of claim 1, wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis. 10. A method of selecting treatment for a patient having inflammatory bowel disease; the method comprising the method of claim 1, further comprising selecting a treatment consistent with the treatment of both ankylosing spondylitis and inflammatory bowel disease, if the patient level of the auto-antibodies is higher than the control level. 11. The method of claim 10, wherein the treatment is an anti-TNF inhibitor, preferably infliximab, adalimumab, golimumab or certolizumab.

Details for Patent 9,395,364

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2033-01-31
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2033-01-31
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2033-01-31
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2033-01-31
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2033-01-31
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2033-01-31