Markers and Methods for Assessing and Treating Crohn's Disease and Related Disorders

Abstract

A method for assessment of the suitability of and/or effectiveness of a target therapy for a gastrointestinal-related disorder, such as Crohn's disease, in a subject evaluates the presence, absence, and/or magnitude of expression of one or more genes in a 10-member gene panel in a sample. The method enables identification of the effectiveness of target therapies prior to or after starting a patient on such therapies.

What is claimed: 
     
         1 . A method for evaluating the effectiveness of treatment with an IL-12 antibody therapy for Crohn's disease in a subject, comprising:
 a) preparing a sample of nucleic acids from a specimen obtained from the subject, the subject having received the IL-12 antibody therapy before the specimen is obtained;   b) contacting the sample with a single panel of nucleic acid segments consisting of the nucleotide sequences complementary to or nucleotide sequences hybridizing under stringent conditions to nucleotide sequences of SEQ ID NOS:1-10 to detect the levels of the panel segments;   c) evaluating the sample against a reference standard comprising the nucleotide sequences of SEQ ID NOS:1-10 derived from a Crohn's disease patient and a healthy subject to determine the magnitude of change in the amount of the at least one member present in the sample; and   d) correlating the magnitude of change with the effectiveness of the IL-12 antibody therapy for Crohn's disease.   
     
     
         2 . The method of  claim 1 , wherein the reference standard is a sample selected from the group consisting of an untreated patient with Crohn's disease, a patient with Crohn's disease treated with a therapy other than the IL-12 antibody therapy, and patient with Crohn's disease treated with and non-responsive to the IL-12 antibody therapy. 
     
     
         3 . The method of  claim 2 , wherein the reference standard is from a colon biopsy, serum, or plasma from a Crohn's disease patient or a healthy subject. 
     
     
         4 . The method of  claim 1 , wherein the anti-IL-12 antibody is CNTO1275. 
     
     
         5 . The method of  claim 1 , wherein the panel is an array of nucleic acid segments. 
     
     
         6 . The method of  claim 1 , wherein the evaluating step comprises evaluating the sample against a reference standard and determining whether the average intensity value of each of the members of the panel is equal to or above X or below Y. 
     
     
         7 . The method of  claim 6 , further comprising after the correlating step, stoping treatment of the subject with the IL-12 antibody therapy based on the average intensity value for each of the members of the panel being less than Y. 
     
     
         8 . The method of  claim 1 , wherein the specimen is obtained one week, four weeks, or eight weeks after the start of treatment. 
     
     
         9 . The method of  claim 1 , wherein the IL-12 antibody therapy is administered intravenously and the reference standard is from a subject administered the IL-12 antibody therapy subcutaneously. 
     
     
         10 . The method of  claim 9 , wherein the correlating step comprises evaluating the effectiveness of the IL-12 antibody therapy administered intravenously compared to the IL-12 antibody therapy administered subcutaneously.