IP Library Granted Patent US 9,902,996
Granted Patent B2
US 9,902,996 · App. 13/372,359 · Granted Feb 27, 2018

Methods of predicting the need for surgery in crohn's disease

Inventors: Marla C. Dubinsky (Los Angeles, CA); Dermot P. McGovern (Los Angeles, CA); Jerome I. Rotter (Los Angeles, CA); Stephan R. Targan (Santa Monica, CA)
Assignee: Cedars-Sinai Medical Center
C12Q1/6883C12Q2600/118C12Q2600/156
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Quick Facts
Patent No.
US 9,902,996
App. No.
13/372,359
Granted
Feb 27, 2018
Kind
B2
Abstract

The present invention relates to methods of predicting susceptibility to a severe form of Crohn's disease in an individual by determining the presence or absence of one or more risk variants. In one embodiment, the risk variants comprise a combination of genetic risk variants and clinical risk factors. In another embodiment, the genetic risk variants are at the IL12B genetic locus. In another embodiment, the severe form of Crohn's disease is characterized by a rapid progression to a condition requiring surgery for treatment.

Claims (25)

1. A method, comprising:

providing a sample from a human with Crohn's Disease;

utilizing an allelic discrimination assay or an oligonucleotide hybridization assay to analyze the sample for an “A” allele at position 513 of SEQ ID NO: 1;

detecting the “A” allele at position 513 of SEQ ID NO: 1 in the sample;

determining a need for surgical intervention in the human having the “A” allele at position 513 of SEQ ID NO: 1 in the sample; and

treating the human by performing on the human determined to need surgical intervention a surgical intervention comprising intestinal resection.

2. The method of claim 1 , further comprising determining the presence of two or more factors selected from the group consisting of clinical factors, serologic factors, genetic risk factors and combinations thereof.

3. The method of claim 1 , further comprising determining the presence of anti-ASCA, pANCA, anti-Cbirl, anti-OmpC and/or anti-12.

4. The method of claim 1 , further comprising detecting an “A” allele at position 251 of SEQ ID NO: 7.

5. The method of claim 1 , further comprising detecting the presence of the “A” allele at position 201 of SEQ ID NO: 2, the “G” allele at position 301 of SEQ ID NO: 3, the “G” allele at position 251 of SEQ ID NO: 4, the “G” allele at position 401 of SEQ ID NO: 5, the “A” allele at position 501 of SEQ ID NO: 6, the “A” allele at position 251 of SEQ ID NO: 7, and the “G” allele at position 2156 of SEQ ID NO: 8.

6. The method of claim 1 , further comprising detecting the “A” allele at position 201 of SEQ ID NO: 2.

7. The method of claim 1 , further comprising detecting the “G” allele at position 301 of SEQ ID NO: 3.

8. The method of claim 1 , further comprising detecting the “G” allele at position 251 of SEQ ID NO: 4.

9. The method of claim 1 , further comprising detecting the “G” allele at position 401 of SEQ ID NO: 5.

10. The method of claim 1 , further comprising detecting the “A” allele at position 501 of SEQ ID NO: 6.

11. The method of claim 1 , further comprising detecting the “G” allele at position 2156 of SEQ ID NO: 8.

12. A method, comprising:

utilizing an allelic discrimination assay or an oligonucleotide hybridization assay to detect in a sample from a human with Crohn's disease, an “A” allele at position 513 of SEQ ID NO: 1;

identifying one or more risk factors selected from the group consisting of a diagnosis of Crohn's disease in the small bowel location, age of diagnosis, and risk serological factors;

prognosticating Crohn's disease with requiring surgery for treatment in the human having the “A” allele at position 513 of SEQ ID NO: 1 and the identified one or more risk factors; and

treating the human by performing surgery on the human prognosed with Crohn's disease requiring surgery for treatment, wherein the surgery comprises intestinal resection.

13. The method of claim 12 , further comprising detecting one or more alleles selected from the group consisting of the “A” allele at position 201 of SEQ ID NO: 2, the “G” allele at position 301 of SEQ ID NO: 3, the “G” allele at position 251 of SEQ ID NO: 4, the “G” allele at position 401 of SEQ ID NO: 5, the “A” allele at position 501 of SEQ ID NO: 6, the “A” allele at position 251 of SEQ ID NO: 7, and the “G” allele at position 2156 of SEQ ID NO: 8.

14. The method of claim 12 , wherein the risk serological factors are selected from the group consisting of anti-ASCA, pANCA, anti-Cbirl, anti-OmpC and anti-12.

15. The method of claim 12 , further comprising detecting the presence of the “A” allele at position 201 of SEQ ID NO: 2, the “G” allele at position 301 of SEQ ID NO: 3, the “G” allele at position 251 of SEQ ID NO: 4, the “G” allele at position 401 of SEQ ID NO: 5, the “A” allele at position 501 of SEQ ID NO: 6, the “A” allele at position 251 of SEQ ID NO: 7, and the “G” allele at position 2156 of SEQ ID NO: 8.

16. The method of claim 12 , further comprising detecting the “A” allele at position 251 of SEQ ID NO: 7.

Assignments (2)
CONFIRMATORY LICENSE Recorded Sep 18, 2015
From: CEDARS-SINAI MEDICAL CENTER
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 036640/0651 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2012
From: DUBINSKY, MARLA; MCGOVERN, DERMOT P.; ROTTER, JEROME I.; TARGAN, STEPHAN R.
To: CEDARS-SINAI MEDICAL CENTER
Reel/Frame 027778/0603 →
Continuity (2)
Provisional Application 61442045 · Feb 11, 2011
Related Publication 20120208900A1 · Aug 16, 2012