Claims for Patent: 9,995,752

Summary for Patent: 9,995,752

Title:	Methods and compositions for determining and treating relapse in inflammatory bowel disease
Abstract:	Described are methods and compositions for evaluating the relapse risk n subjects having an inflammatory bowel disease (IBD). Some embodiments include selecting a treatment for an evaluated IBD relapse risk in a subject.
Inventor(s):	Denson; Lee A. (Wyoming, OH), Trapnell; Bruce C. (Liberty Township, OH), Dabritz; Jan (Berlin, DE)
Assignee:	Children\'s Hospital Medical Center (Cincinnati, OH) Westfaelische Wilhelms-Universitaet Muenster (Muenster, DE)
Application Number:	14/890,257
Patent Claims:	1. A method of determining and treating an increased relapse risk for a subject having inflammatory bowel disease (IBD) in clinical remission, comprising: measuring an increased level of an anti-GM-CSF antibody in a serum sample from said subject compared to the level of the anti-GM-CSF antibody in a serum sample obtained from said subject at a prior time, thereby determining an increased IBD relapse risk within 2 months for said subject; and administering a treatment to the subject for said increased IBD relapse risk, wherein the treatment is selected from a surgery effective to treat the increased IBD relapse risk, and an effective amount of a therapeutic agent to treat the increased IBD relapse risk, the therapeutic agent selected from the group consisting of a corticosteroid, a 5-aminosalicylate, azathioprine, 6-mercaptopurine, a tumor necrosis factor (TNF) inhibitor, and methotrexate, wherein the treatment is modified from an IBD therapy administered to the subject, or alternative to an IBD therapy administered to the subject. 2. The method of claim 1, wherein said measuring comprises contacting the serum sample with an antibody or antigen-binding fragment thereof. 3. The method of claim 1, wherein the treatment comprises inducing remission. 4. The method of claim 1, wherein the IBD is selected from the group consisting CD and UC. 5. The method of claim 4, wherein the CD is selected from the group consisting of illeal CD, colonic CD, illeo-colic CD, and upper gastrointestinal CD. 6. The method of claim 4, wherein the UC is selected from the group consisting of ulcerative proctitis, left-sided colitis, and pancolitis. 7. The method of claim 1, wherein the sample is ex vivo. 8. The method of claim 1, further comprising measuring the level of fecal S100A8/A9 in a fecal sample from said subject. 9. A method of determining and treating a relapse risk for a subject having inflammatory bowel disease (IBD) in clinical remission, comprising: measuring the level of an anti-GM-CSF antibody in a serum sample from said subject; detecting an increased level of an anti-GM-CSF antibody in a second serum sample obtained from the subject compared to the level of the anti-GM-CSF antibody in a first serum sample obtained from said subject at a prior time is indicative of an increased IBD relapse risk within 2 months, thereby determining the IBD relapse risk for said subject; selecting a treatment for said IBD relapse risk; and administering a treatment to the subject for an increased IBD relapse risk, wherein the treatment is selected from a surgery effective to treat the increased IBD relapse risk and an effective amount of a therapeutic agent to treat the increased IBD relapse risk, the therapeutic agent selected from the group consisting of a corticosteroid, a 5-aminosalicylate, azathioprine, 6-mercaptopurine, a tumor necrosis factor (TNF) inhibitor inhibitor, and methotrexate, wherein the treatment is modified from an IBD therapy administered to the subject, or alternative to an IBD therapy administered to the subject. 10. The method of claim 9 comprising: detecting an increased level of fecal S100A8/A9 in a fecal sample obtained from the subject compared to the level of fecal S100A8/A9 in a fecal sample obtained from said subject at a prior time. 11. The method of claim 9, wherein the first serum sample is obtained at least 8 weeks previous to the second serum sample. 12. The method of claim 9, wherein the concentration of anti-GM-CSF antibody in the second serum sample is greater than 1.7 .mu.g/mL. 13. The method of claim 9, wherein the TNF inhibitor is selected from the group consisting of infliximab, adalimumab, and natalizumab. 14. A method of treating a subject having inflammatory bowel disease (IBD) in clinical remission, comprising: measuring a concentration of anti-GM-CSF antibodies in a serum sample from a subject; determining if the measured concentration is greater than 1.7 .mu.g/mL, wherein the subject is predicted to have a risk of IBD relapse within 2 months; and administering a treatment to the subject for increased IBD relapse risk if the measured concentration of anti-GM-CSF antibodies is determined to be greater than 1.7 .mu.g/mL, wherein the treatment is selected from a surgery effective to treat the increased IBD relapse risk and an effective amount of a therapeutic agent to treat the increased IBD relapse risk, the therapeutic agent selected from the group consisting of a corticosteroid, a 5-aminosalicylate, azathioprine, 6-mercaptopurine, a tumor necrosis factor (TNF) inhibitor, methotrexate, wherein the treatment is modified from an IBD therapy administered to the subject, or alternative to an IBD therapy administered to the subject. 15. The method of claim 14 comprising: detecting an increased level of fecal S100A8/A9 in a second fecal sample obtained from the subject compared to the level of fecal S100A8/A9 in a first fecal sample obtained from said subject at a prior time. 16. The method of claim 15, wherein the first fecal sample is obtained at least 8 weeks previous to the second fecal sample. 17. The method of claim 14, wherein the treatment is administration of a tumor necrosis factor (TNF) inhibitor selected from the group consisting of infliximab, adalimumab, and natalizumab. 18. The method of claim 1, wherein the treatment is administration of a tumor necrosis factor (TNF) inhibitor selected from the group consisting of infliximab, adalimumab, and natalizumab.

Details for Patent 9,995,752

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2033-05-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2033-05-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2033-05-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2033-05-14