US2018280503A1PendingUtilityA1

Anti-pad2 antibody for treating and evaluating rheumatoid arthritis

Assignee: UNIV JOHNS HOPKINSPriority: Apr 4, 2017Filed: Apr 4, 2018Published: Oct 4, 2018
Est. expiryApr 4, 2037(~10.7 yrs left)· nominal 20-yr term from priority
A61P 19/02A61K 39/39533A61K 39/0008A61P 37/06G01N 33/564A61P 29/00G01N 2800/52G01N 2800/7095G01N 2800/50G01N 2800/24G01N 2333/978C12Y 305/03015C07K 16/40C07K 2317/24C07K 2317/76
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Claims

Abstract

A method for obtaining a prognosis for a subject having rheumatoid arthritis by measuring the levels of anti-PAD2 antibodies is described. Methods of using anti-PAD2 antibodies to treat rheumatoid arthritis are also described.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for obtaining a prognosis for a subject having rheumatoid arthritis (RA) comprising:
 a) obtaining a biological sample from a subject having RA;   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 suffering from RA;   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 having RA 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 lower risk of developing a severe form of RA when the amount of a complex of the capture probe and the autoantibodies formed from the subject having RA 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 method is a chemiluminescent immunoassay (CIA) method. 
     
     
         6 . The method of  claim 1 , wherein the method is a particle based multi-analyte test (PMAT). 
     
     
         7 . The method of  claim 1 , wherein the capture probe is bound to the substrate with a binding reagent. 
     
     
         8 . The method of  claim 1 , wherein the biological sample is a blood, plasma, or serum sample. 
     
     
         9 . The method of  claim 1 , wherein the subject is human 
     
     
         10 . The method of  claim 1 , further comprising providing a less aggressive form of treatment of RA to the subject identified as having a lower risk of developing a severe form of RA. 
     
     
         11 . The method of  claim 1 , wherein the subject identified as having a lower risk of developing a severe form of RA has a decreased risk of developing interstitial lung disease. 
     
     
         12 . A method of treating RA in a subject, comprising administering a therapeutically effective amount of an antibody or fragment thereof that specifically binds to peptidyl arginine deiminase 2 (PAD2) protein to the subject. 
     
     
         13 . The method of  claim 12 , wherein the antibody is a monoclonal antibody. 
     
     
         14 . The method of  claim 12 , wherein the subject is human. 
     
     
         15 . The method of  claim 14 , wherein the antibody is a humanized antibody. 
     
     
         16 . The method of  claim 12 , wherein the antibody is administered together with a pharmaceutically acceptable carrier. 
     
     
         17 . The method of  claim 12 , wherein the RA is severe RA. 
     
     
         18 . A kit comprising a substrate having a capture probe comprising PAD2 protein or a portion or fragment thereof bound thereto, and a package for holding the capture probe and other components for obtaining a prognosis for a subject having RA using the method of  claim 1 . 
     
     
         19 . The kit of  claim 18 , further comprising instructions for using the kit to obtain a prognosis for a subject having RA. 
     
     
         20 . The kit of  claim 19 , where the components and instructions are for an enzyme immunoassay method, a chemiluminescence assay (CIA) method, a fluorescent immunoassay, or a particle based multianalyte test (PMAT). 
     
     
         21 . The kit of  claim 18 , wherein the capture probe is bound to the substrate with a binding reagent.

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