Methods for diagnosis and treatment of chronic immune diseases

Abstract

Methods are provided for diagnosing and/or characterizing chronic immune disease activity in a subject. In the subject methods, a sample is obtained from a subject suspected of having or known to have a chronic immune disease. The sample is then assayed for the presence of native Stat-1 protein and/or any lower molecular weight fragments of Stat-1 protein present. The assay results are used to diagnose the presence of chronic immune disease activity and/or characterize chronic immune disease activity in the subject, e.g., to confirm an initial chronic immune disease diagnosis, to determine the stage of the disease, to monitor disease progression, to predict disease attacks, and the like. In certain embodiments, the assay results are also used to predict the effectiveness of a particularly treatment protocol, e.g., to determine whether an interferon based treatment protocol will be effective. In addition, methods of Stat-1 based methods of treating chronic immune disease conditions are provided. Also provided by the subject invention are kits for practicing the methods.

1 . A method for diagnosing whether a host suffers from a chronic immune disease, said method comprising:
 (a) assaying a sample from said host for the presence of at least one low molecular weight Stat-1 fragment to obtain assay results; and   (b) determining whether said host suffers from a chronic immune disease using said assay results;   whereby said host is diagnosed for said chronic immune disease.   
   
   
       2 . The method according to  claim 1 , wherein said chronic immune disease is selected from the group consisting of CFS and MS. 
   
   
       3 . The method according to  claim 1 , wherein said sample is a blood cell derived sample. 
   
   
       4 . The method according to  claim 1 , wherein said sample is a PBMC derived sample. 
   
   
       5 . The method according to  claim 1 , wherein said host is a human. 
   
   
       6 . A method of characterizing chronic immune disease activity in a human subject, said method comprising:
 (a) obtaining a sample from said subject;   (b) determining the relative amounts of native Stat-1 protein to one or more low molecular weight Stat-1 protein fragments in said sample; and   (c) using said relative amounts to characterize the chronic immune disease activity in said subject.   
   
   
       7 . The method according to  claim 6 , wherein said chronic immune disease is selected from the group consisting of CFS and MS. 
   
   
       8 . The method according to  claim 6 , wherein said low molecular weight Stat-1 fragment(s) has a molecular weight of approximately 50 kDa under SDS-PAGE reducing conditions. 
   
   
       9 . The method according to  claim 6 , wherein said sample is a blood derived sample. 
   
   
       10 . The method according to  claim 6 , wherein said blood derived sample is derived from PBMCs. 
   
   
       11 . The method according to  claim 6 , wherein said method is a method of confirming whether said subject suffers from said chronic immune disease. 
   
   
       12 . A method of characterizing a chronic immune disease activity in a human subject, said method comprising:
 (a) obtaining a sample from said subject;   (b) identifying a pattern of low molecular weight Stat-1 fragments in said sample; and   (c) using said pattern to characterize said chronic immune disease activity in said subject.   
   
   
       13 . The method according to  claim 12 , wherein said chronic immune disease is selected from the group consisting of CFS and MS. 
   
   
       14 . The method according to  claim 12 , wherein said sample is a blood derived sample. 
   
   
       15 . The method according to  claim 12 , wherein said blood derived sample is derived from PBMCs. 
   
   
       16 - 39 . (canceled) 
   
   
       40 . A method of predicting the effectiveness of a treatment protocol for a host suffering from a chronic immune disease, said method comprising:
 (a) obtaining a sample from said subject;   (b) assaying said sample for the presence of full-length Stat-1; and   (c) predicting the effectiveness of a treatment protocol based upon said assay result.   
   
   
       41 . The method according to  claim 40 , wherein said treatment protocol is an Interferon (IFN)-based therapy. 
   
   
       42 . The method according to  claim 41 , wherein the presence of full-length indicates that said IFN-based therapy will be effective.