Claims for Patent: 9,541,560

Summary for Patent: 9,541,560

Title:	Serological markers of inflammatory bowel disease phenotype and disease progression
Abstract:	Disclosed are novel biomarkers and methods related to diagnostic tests for the detection and characterization of inflammatory bowel diseases, such as Crohn\'s disease and ulcerative colitis. In particular, the instant invention relates to novel biomarkers and methods of using such biomarkers to predict disease behavior and severity, to differentiate among disease types, and to optimize selection of treatment options in individuals suspected of having an inflammatory bowel disease.
Inventor(s):	Denson; Lee (Wyoming, OH), Trapnel; Bruce Colston (Hamilton, OH), Uchida; Kanji (Tokyo, JP)
Assignee:	Children\'s Hospital Medical Center (Cincinnati, OH)
Application Number:	14/686,628
Patent Claims:	1. A method for the diagnosis and treatment of an inflammatory bowel disease in a subject comprising: (a) measuring the concentration of anti-GM-CSF antibodies in a serum sample obtained from the subject; (b) diagnosing whether the subject has an inflammatory bowel disease, or the severity of an inflammatory bowel disease, based upon an increased concentration of the anti-GM-CSF antibodies in the sample as compared to the concentration of anti-GM-CSF antibodies in serum from a subject not having an inflammatory bowel disease; and (c) administering a therapy to the diagnosed subject, wherein the therapy is selected from the group consisting of an effective amount of anti-TNF.alpha. antibodies, an effective amount of GM-CSF, and surgery. 2. The method according to claim 1, wherein the inflammatory bowel disease is selected from the group consisting of small bowel Crohn's disease (CD.sub.SB), Colonic Crohn's disease (CD.sub.C), and Ulcerative Colitis (UC). 3. The method according to claim 1, wherein the increased concentration of anti-GM-CSF antibodies is indicative of the severity of the inflammatory bowel disease. 4. The method of claim 1, wherein the concentration of anti-GM-CSF antibodies in the sample is indicative of a stricturing or penetrating disease state. 5. The method of claim 1, wherein the therapy is an effective amount of anti-TNF.alpha. antibodies. 6. The method according to claim 1, further comprising detecting the level of GM-CSF dependent up-regulation of cell surface CD11b in the sample. 7. The method according to claim 1, wherein (a) further comprises: washing the complex to remove non-specifically bound components; and detecting the antigen-antibody complex. 8. The method of claim 1, wherein the GM-CSF comprises sargramostim. 9. A method for the prognosis and treatment of an inflammatory bowel disease in a patient comprising: (a) determining the concentration of anti-GM-CSF antibodies in a serum sample obtained from the patient comprising contacting the sample with an immobilized GM-CSF; and (b) determining whether the patient has an increased risk of the inflammatory bowel disease progressing based upon increased binding of the GM-CSF to the anti-GM-CSF antibodies as compared to the binding of GM-CSF to anti-GM-CSF antibodies in a serum sample from a subject not having an inflammatory bowel disease; and (c) administering an effective amount of anti-TNF.alpha. antibodies to the patient having the increased risk of disease progression. 10. The method of claim 9, wherein the concentration of anti-GM-CSF antibodies in the sample obtained from the patient is greater than or equal to about 1.5 .mu.g/ml is indicative of an increased risk of disease progression. 11. A method for the prognosis and targeted treatment of an inflammatory bowel disease in a patient comprising: (a) measuring an increased concentration of anti-GM-CSF antibodies in a serum sample obtained from the patient compared to the concentration of anti-GM-CSF antibodies in a sample from a subject not having an inflammatory bowel disease (b) determining whether the patient has an increased risk of inflammatory bowel disease progression when the increased concentration of anti-GM-CSF antibodies is measured; and (c) administering an effective amount of anti-TNF.alpha. antibodies to the patient having an increased risk of inflammatory bowel disease progression. 12. The method according to claim 11, wherein the inflammatory bowel disease is selected from the group consisting of small bowel Crohn's disease (CD.sub.SB), Colonic Crohn's disease (CD.sub.C), and Ulcerative Colitis (UC). 13. The method of claim 11, wherein the sample obtained from the patient comprises an antibody selected from the group consisting of anti-saccharomyces cervisiae antibody, anti-neutrophil cytoplasmic antibody with perinuclear staining, anti-CBir1 antibody, anti-I2 antibody, and anti-OmpC antibody. 14. The method according to claim 11, wherein the concentration of anti GM-CSF antibodies is determined by a method comprising: providing an immobilized GM-CSF; contacting the sample with the GM-CSF to form an antigen-antibody complex; washing the complex to remove non-specifically bound components; and detecting the antigen-antibody complex. 15. The method of claim 14, wherein the immobilized GM-CSF is sararamostim. 16. The method of claim 11, wherein the concentration of the anti-GM-CSF antibodies in a serum sample obtained from the patient is greater than 1.5 .mu.g/ml. 17. The method of claim 11, wherein (a) comprises comparing the concentration of anti-GM-CSF antibodies in a serum sample obtained from the patient compared to the concentration of anti-GM-CSF antibodies in a sample from a subject not having an inflammatory bowel disease.

Details for Patent 9,541,560

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	03/05/1991		2027-03-30
Partner Therapeutics, Inc.	LEUKINE	sargramostim	Injection	103362	03/05/1991		2027-03-30