Prometheus Laboratories Inc.

Cedars-sinai Medical Center

Mary J Barry

Stephan R Targan

Scott E Plevy

Eric A Vasiliauskas

Kent Taylor

The present invention provides methods based on serological and genetic markers for diagnosing clinical subtypes of Crohn's disease (CD) having characteristic responsiveness to anti-Th1 cytokine therapy. In the methods of the inventions the presence of perinuclear anti-neutrophil antibody (pANCA), the presence of the TNFa10b4c1d3e3 haplotype or the presence TNFa11b4c1d3e3 haplotype each are independently diagnostic of a clinical subtype of CD having an inferior clinical response to anti-Th1 cytokine therapy. In addition, the presence of the homozygous TNF-&bgr; 1111 haplotype involving the TNFc, aa13L, aa26 and NcoI loci is independently diagnostic of a clinical subtype of CD having an inferior clinical response to anti-Th1 cytokine therapy. The presence of speckling anti-pan polymorphonuclear antibody (SAPPA) is diagnostic of a clinical subtype of CD having a superior clinical response to anti-Th1 cytokine therapy.

Methods of diagnosing clinical subtypes of crohn's disease with characteristic responsiveness to anti-Th1 cytokine therapy

Provided herein is a method of diagnosing a clinical subtype of Crohn's disease (CD) by determining whether perinuclear anti-neutrophil antibody (pANCA) is present in a patient with CD, where the presence of pANCA indicates a clinical subtype of CD with features of ulcerative colitis (UC). Also provided is a method of diagnosing a clinical subtype of Crohn's disease in a patient with CD by determining whether pANCA or speckling anti-pan polymorphonuclear antibody (SAPPA) is present in the patient with CD, where the presence of pANCA indicates a clinical subtype of CD with features of ulcerative colitis and where the presence of SAPPA indicates a clinical subtype of CD having perforating, fistulizing or small bowel obstructive disease. The invention further provides a method of diagnosing a clinical subtype of Crohn's disease in a patient with CD by determining the presence or absence of ANCA, pANCA, SAPPA and anti-Saccharomyces cerevisiae antibodies (ASCA) in the patient with CD, where the presence of pANCA combined with the absence of ASCA indicate a clinical subtype of CD with features of UC, the presence of SAPPA indicates a clinical subtype of CD having perforating or fistulizing disease or small bowel obstructive disease, and the presence of ASCA combined with the absence of ANCA indicates a clinical subtype of CD lacking features of ulcerative colitis and having perforating or fistulizing disease or small bowel obstructive disease. Kits for diagnosing a clinical subtype of Crohn's disease, which contain neutrophil and antigen specific for ASCA, also are provided.

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Ramona, CA, United States of America

Mary J Barry