Anti-pad2 antibody for treating and evaluating autoimmune and inflammatory diseases

Abstract

A method for measuring anti-PAD2 antibodies in a subject with an inflammatory or autoimmune disease, and to determine if the subject has a better prognosis for developing a more severe form of inflammation based on anti-PAD2 antibody levels. Methods for the therapeutic use of anti-PAD2 antibodies are also described.

What is claimed is: 
     
         1 . A method for detecting anti-PAD2 antibodies in a subject having an inflammatory or autoimmune disease, including but not limited to RA, Alzheimer's disease, multiple sclerosis, psoriasis, ulcerative colitis, and cancer, comprising:
 a) obtaining a biological sample from a subject;   b) providing a substrate having a first capture probe bound thereto, wherein the capture probe comprises peptidyl arginine deiminase 2 (PAD2) protein or a portion or fragment thereof which comprises an antigen recognized by autoantibodies present in subjects;   c) contacting the substrate having the capture probe bound thereto with the biological sample from the subject;   d) measuring the amount of a complex of the capture probe and the autoantibodies formed by step c);   e) providing a reference level sample;   f) comparing the amount of a complex of the capture probe and the autoantibodies formed from the subject to the amount of a complex of the capture probe and the autoantibodies formed from the reference level sample; and   g) identifying the subject as having a better prognosis for not developing a more severe form of inflammation when the amount of a complex of the capture probe and the autoantibodies formed from the subject is increased compared to the amount of a complex of the capture probe and the autoantibodies formed from the reference level sample.   
     
     
         2 . The method of  claim 1 , wherein the method is an enzyme immunoassay method. 
     
     
         3 . The method of  claim 1 , wherein the method is a radioimmunoassay method. 
     
     
         4 . The method of  claim 1 , wherein the method is an immunoblotting method. 
     
     
         5 . The method of  claim 1 , wherein the capture probe is bound to the substrate with a binding reagent. 
     
     
         6 . The method of  claim 1 , wherein the biological sample is blood, plasma, serum, semen, cell lysates, saliva, tears, urine, fecal material, sweat, buccal, skin, synovial fluid, cerebrospinal fluid, and hair, 
     
     
         7 . The method of  claim 1 , wherein the subject is human. 
     
     
         8 . The method of  claim 1 , further comprising providing a less aggressive form of treatment of inflammation to the subject identified as having a better prognosis for not developing a more severe form of inflammation. 
     
     
         9 . A method comprising administering a therapeutically effective amount of an antibody or fragment thereof that specifically binds to peptidyl arginine deiminase 2 (PAD2) protein to a subject in which anti-PAD2 antibodies may be beneficial. 
     
     
         10 . The method of  claim 9 , wherein the antibody is a monoclonal antibody. 
     
     
         11 . The method of  claim 9 , wherein the subject is human. 
     
     
         12 . The method of  claim 11 , wherein the antibody is a humanized antibody. 
     
     
         13 . The method of  claim 9 , wherein the antibody is administered together with a pharmaceutically acceptable carrier. 
     
     
         14 . The method of  claim 9 , wherein the disease is severe and requires blocking anti-PAD2 function. 
     
     
         15 . A kit comprising a substrate having a capture probe comprising peptidyl arginine deiminase 2 (PAD2) protein or a portion or fragment thereof bound thereto, and a package for holding the capture probe and other components for detecting anti-PAD2 antibodies in a subject having an inflammatory or autoimmune disease using the method of  claim 1 . 
     
     
         16 . The kit of  claim 15 , further comprising instructions for using the kit to obtain a prognosis for a subject having an inflammatory disease. 
     
     
         17 . The kit of  claim 16 , where the components and instructions are for an enzyme immunoassay method, a chemiluminescence assay (CIA) method, a fluorescent immunoassay, or a particle based multi-analyte test (PMAT) 
     
     
         18 . The kit of  claim 15 , wherein the capture probe is bound to the substrate with a binding reagent.