US2013058953A1PendingUtilityA1

Characterization of the cbir1 antigenic response for diagnosis and treatment of crohn's disease

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Assignee: TAYLOR KENT DPriority: May 10, 2007Filed: Mar 2, 2012Published: Mar 7, 2013
Est. expiryMay 10, 2027(~0.8 yrs left)· nominal 20-yr term from priority
Inventors:Kent D. TaylorJerome I. RotterCharles O. ElsonStephan R. Targan
C12Q 2600/112C12Q 1/6883A61P 1/00C12Q 2600/156C12Q 2600/172
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Claims

Abstract

This invention provides methods of diagnosing or predicting susceptibility to Crohn's Disease by determining the presence or absence of genetic variants. In one embodiment, the present invention provides methods to diagnose and/or predict susceptibility to Crohn's Disease in an individual by determining the presence or absence of anti-Cbir1 reactivity and the presence or absence of TLR5 risk variants. In another embodiment, the present invention provides methods to diagnose Crohn's Disease by determining the presence or absence of NFKB1 haplotype H3 and/or ASCA expression. In another embodiment, the present invention provides methods of diagnosing Crohn's Disease by determining the presence or absence of Cbir1 specific peripheral blood T cell proliferation.

Claims

exact text as granted — not AI-modified
1 . A method of diagnosing susceptibility to Crohn's Disease in an individual, comprising:
 determining the presence or absence of one or more risk variants at the NFkB locus; and   diagnosing susceptibility to Crohn's Disease based upon the presence of one or more risk variants at the NFkB locus.   
     
     
         2 . The method of  claim 1 , wherein the individual is human. 
     
     
         3 . The method of  claim 2 , wherein one of the one or more risk variants at the NFkB locus comprises ATA2A03. 
     
     
         4 . The method of  claim 1 , wherein one of the one or more risk variants at the NFkB locus comprises SEQ. ID. NO.: 1. 
     
     
         5 . The method of  claim 1 , wherein one of the one or more risk variants at the NFkB locus comprises SEQ. ID. NO.: 2, SEQ. ID. NO.: 3, SEQ. ID. NO.: 4, SEQ. ID. NO.: 5, SEQ. ID. NO.: 6, SEQ. ID. NO.: 7, SEQ. ID. NO.: 8, SEQ. ID. NO.: 9, SEQ. ID. NO.: 10, SEQ. ID. NO.: 11, SEQ. ID. NO.: 12 and SEQ. ID. NO.: 13. 
     
     
         6 . A method of diagnosing Crohn's Disease in an individual, comprising:
 determining the presence or absence of NFkB haplotype H3;   determining the presence or absence of ASCA reactivity; and   diagnosing Crohn's Disease based upon the presence of NFkB haplotype H3 and the presence of ASCA reactivity.   
     
     
         7 . The method of  claim 6 , wherein the NFkB haplotype H3 comprises SEQ. ID. NO.: 2, SEQ. ID. NO.: 3, SEQ. ID. NO.: 4, SEQ. ID. NO.: 5, SEQ. ID. NO.: 6, SEQ. ID. NO.: 7, SEQ. ID. NO.: 8, SEQ. ID. NO.: 9, SEQ. ID. NO.: 10, SEQ. ID. NO.: 11, SEQ. ID. NO.: 12 and SEQ. ID. NO.: 13. 
     
     
         8 . A method of diagnosing Crohn's Disease in an individual, comprising:
 determining the presence or absence of NFkB haplotype H1;   determining the presence or absence of Cbir1 reactivity; and   diagnosing Crohn's Disease based upon the presence of NFkB haplotype H1 and the presence of Cbir1 reactivity.   
     
     
         9 . The method of  claim 8 , wherein the NFkB haplotype H1 comprises SEQ. ID. NO.: 2, SEQ. ID. NO.: 3, SEQ. ID. NO.: 4, SEQ. ID. NO.: 5, SEQ. ID. NO.: 6, SEQ. ID. NO.: 7, SEQ. ID. NO.: 8, SEQ. ID. NO.: 9, SEQ. ID. NO.: 10, SEQ. ID. NO.: 11, SEQ. ID. NO.: 12 and SEQ. ID. NO.: 13. 
     
     
         10 . A method of treating Crohn's Disease in an individual, comprising:
 determining the presence or absence of NFkB haplotype H3;   determining the presence or absence of ASCA reactivity; and   treating the Crohn's Disease.   
     
     
         11 . A method of treating Crohn's Disease in an individual, comprising:
 determining the presence or absence of NFkB haplotype H1;   determining the presence or absence of Cbir1 reactivity; and   treating the Crohn's Disease.   
     
     
         12 . A method of diagnosing susceptibility to Crohn's Disease in an individual, comprising:
 determining the presence or absence of one or more risk variants at the TLR5 locus; and   diagnosing susceptibility to Crohn's Disease based upon the presence of one or more risk variants at the TLR5 locus.   
     
     
         13 . The method of  claim 12 , wherein one of the one or more risk variants at the TLR5 locus comprises SEQ. ID. NO.: 15, SEQ. ID. NO.: 16 and/or SEQ. ID. NO.: 17. 
     
     
         14 . A method of diagnosing a Crohn's Disease subtype in an individual, comprising:
 determining the presence or absence of an F616L F allele at the TLR5 locus;   determining the presence or absence of an N592S S allele at the TLR5 locus;   determining the presence or absence of OmpC reactivity; and   diagnosing the Crohn's Disease subtype based upon the presence of OmpC reactivity and the presence of the F616L F allele at the TLR5 locus or the N592S S allele at the TLR5 locus.   
     
     
         15 . The method of  claim 14 , wherein the F616L F allele at the TLR5 locus comprises SEQ. ID. NO.: 16. 
     
     
         16 . The method of  claim 14 , wherein the N592S S allele at the TLR5 locus comprises SEQ. ID. NO.: 15. 
     
     
         17 . The method of  claim 14 , wherein the individual is Jewish. 
     
     
         18 . A method of diagnosing a Crohn's Disease subtype in an individual, comprising:
 determining the presence or absence of N592S N allele at the TLR5 locus;   determining the presence or absence of Cbir1 reactivity; and   diagnosing the Crohn's Disease subtype based upon the presence of Cbir1 reactivity and the presence of the N592S N allele at the TLR5 locus.   
     
     
         19 . The method of  claim 18 , wherein the N592S N allele at the TLR5 locus comprises SEQ. ID. NO.: 15. 
     
     
         20 . The method of  claim 18 , wherein the Crohn's Disease subtype comprises internal penetrating phenotype, perianal perforating phenotype and/or severe fibrostenosis phenotype. 
     
     
         21 . A method of treating Crohn's Disease in an individual, comprising:
 determining the presence of a high IL-6 production relative to healthy individuals; and   administering a therapeutically effective amount of anti-Cbir1.   
     
     
         22 . A method of diagnosing Crohn's Disease in an individual, comprising:
 determining the presence or absence of a high amount of Cbir1-specific IFN-gamma producing cells relative to healthy individuals; and   diagnosing Crohn's Disease based upon the presence of a high amount of Cbir1-specific IFN-gamma producing cells relative to healthy individuals.   
     
     
         23 . A method of diagnosing Crohn's Disease in an individual, comprising:
 determining the presence or absence of a high amount of Cbir1-specific peripheral blood T cell proliferation relative to healthy individuals; and   diagnosing Crohn's Disease based upon the presence of a high amount of Cbir1-specific peripheral blood T cell proliferation relative to healthy individuals.

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