Methods for the diagnostic of an autoimmune disease

Abstract

An in vitro method for determining whether a patient has, or is at risk of having or developing an autoimmune disease or for assessing the severity or predicting the outcome of an autoimmune disease, comprising a step of detecting or quantifying in a biological sample obtained from said patient an immune anti-IL2 response, peptides specifically recognised by anti-1L2 antibodies or IL-2-specific T cells of T1D, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome and autoimmune polymyositis patients, and pharmaceutical compositions.

1 - 15 . (canceled) 
     
     
         16 . An in vitro method for determining whether a patient has, or is at risk, of having or developing an autoimmune disease or for assessing the severity or predicting the outcome of an autoimmune disease, wherein said in vitro method comprises a step of detecting or quantifying, in a biological sample obtained from said patient, an immune anti-IL-2 response. 
     
     
         17 . The in vitro method according to  claim 16 , wherein immune anti-IL2 response is evidenced by the detection or quantification of one or more of:
 B cells producing anti-IL-2 AutoAbs;   anti-IL-2 antibodies; and   IL-2-specific T-cells.   
     
     
         18 . The in vitro method according to  claim 17 , wherein immune anti-IL2 response is evidenced by the detection or quantification of B cells producing anti-IL-2 AutoAbs or anti-IL-2 antibodies, wherein the AutoAbs are neutralizing anti-IL-2 AutoAbs. 
     
     
         19 . The in vitro method according to  claim 17 , wherein the detection or quantification of one or more of B cells producing anti-IL-2 AutoAbs, anti-IL-2 antibodies; and IL-2-specific T-cells comprises a step of using a peptide consisting of amino acid sequence: 
       
         
           
                 
                 
               
                     
                   (SEQ ID No 1) 
                 
                     
                   LTRMLTFKFYMPKKA, 
                 
                     
                   or 
                 
                     
                     
                 
                     
                   (SEQ ID No 2) 
                 
                     
                   EFLNRWITFSQSIIS. 
                 
             
                
                
                
                
                
                
               
            
           
         
       
     
     
         20 . The in vitro method according to  claim 16 , wherein the autoimmune disease is selected from the group consisting of type 1 diabetes (T1D), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), Sjögren's syndrome (SJO) and autoimmune polymyositis (JO1). 
     
     
         21 . The in vitro method according to  claim 16 , wherein the method is a method for determining whether a patient has, or is at risk of having or developing, an autoimmune disease. 
     
     
         22 . The in vitro method according to  claim 16 , wherein the method is a method for assessing the severity of an autoimmune disease. 
     
     
         23 . The in vitro method according to  claim 16 , wherein the method is a method for predicting the outcome of an autoimmune disease. 
     
     
         24 . The in vitro method according to  claim 16 , wherein the method is a method for predicting/adjusting the response to exogenously administered IL-2 for therapeutic purposes.