Treatment Methods for Rheumatoid Arthritis

Abstract

The present invention provides methods for selecting treatment methods for rheumatoid arthritis based on an objective selection process (algorithm). The present invention also provides methods for treating rheumatoid arthritis with treatment methods selected based on the algorithm disclosed herein. The methods of the present invention provide a more effective means for treating patients with rheumatoid arthritis.

What is claimed is: 
     
         1 . A method for treating a patient with rheumatoid arthritis, wherein the method comprises:
 i. Determining serum levels in the patient of at least two biomarkers selected from the group consisting of Vascular Cell Adhesion Molecule 1, Vascular Endothelial Growth Factor-A, Interleukin-6, Tumor Necrosis Factor Receptor Type 1, Matrix Metalloproteinase-1, Matrix Metalloproteinase-3, YKL-40, Leptin, Resistin, Serum Amyloid A, and C-Reactive Protein;   ii. Identifying at least two biomarkers each one with at least 40% elevated serum level over control serum level;   iii. Selecting at least one treatment method that is known to affect the at least two biomarkers identified in step (ii), wherein the treatment method is selected from the group consisting of Plaquenil (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Arava (or Leflunomide), Tumor Necrosis Factor-α inhibitors, Atabacept (or Orencia), Tocilizumab (or Actemra), Rituxan, and Tofacitinib (or Xeljanz); and   iv. Administering the treatment selected in step (iii) to the patient.   
     
     
         2 . The method of  claim 1  wherein the selecting in (iii) further comprises selecting a treatment method that is known to affect the maximum number of biomarkers identified in step (ii). 
     
     
         3 . The method of  claim 1  wherein the selecting in (iii) further comprises selecting a treatment method that is known to affect the maximum number of the highest elevated biomarkers. 
     
     
         4 . The method of  claim 1  wherein the selecting in (iii) further comprises avoiding a treatment method that is contraindicated or causes an allergic response in the patient. 
     
     
         5 . The method of  claim 1  wherein the selecting further comprises selecting a treatment method that is administered via a route selected from the group consisting of intravenous, intraarterial, enteral (oral or rectal), intramuscular, subcutaneous, transdermal, intradermal, nasal, intramuscular, intraperitoneal, intracardiac, epidural, intrathecal, and transmucosal. 
     
     
         6 . The method of  claim 5  wherein the route is preferred by the patient. 
     
     
         7 . The method of  claim 4  wherein the selecting further comprises selecting a treatment method that is known to affect the maximum number of biomarkers identified in step (ii). 
     
     
         8 . The method of  claim 4  wherein the selecting further comprises selecting a treatment method that is known to affect the maximum number of highest elevated biomarkers. 
     
     
         9 . The method of  claim 1  wherein the selecting in (iii) comprises selecting a treatment method that is required under the patient's medical plan. 
     
     
         10 . The method of  claim 9  wherein the selecting in (iii) further comprises avoiding a treatment method that is contraindicated or causes an allergic response in the patient. 
     
     
         11 . The method of  claim 10  wherein the selecting further comprises selecting a treatment method that is known to affect the maximum number of biomarkers identified in step (ii). 
     
     
         12 . The method of  claim 10  wherein the selecting further comprises selecting a treatment method that is known to affect the maximum number of highest elevated biomarkers. 
     
     
         13 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least three biomarkers each one with at least 40% elevated serum level. 
     
     
         14 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least four biomarkers each one with at least 40% elevated serum level. 
     
     
         15 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least five biomarkers each one with at least 40% elevated serum level. 
     
     
         16 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least six biomarkers each one with at least 40% elevated serum level. 
     
     
         17 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least two biomarkers each one with at least 50% elevated serum level. 
     
     
         18 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least two biomarkers each one with at least 60% elevated serum level. 
     
     
         19 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least two biomarkers each one with at least 70% elevated serum level. 
     
     
         20 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least two biomarkers each one with at least 80% elevated serum level. 
     
     
         21 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least two biomarkers each one with at least 90% elevated serum level. 
     
     
         22 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least three biomarkers each one with at least 60% elevated serum level. 
     
     
         23 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least four biomarkers each one with at least 60% elevated serum level. 
     
     
         24 . The method of  claim 1  wherein the selecting comprises selecting a treatment method that is known to affect at least five biomarkers each one with at least 60% elevated serum level. 
     
     
         25 . A method for treating a patient with rheumatoid arthritis, wherein the method comprises:
 i. Determining serum levels in the patient of at least two biomarkers selected from the group consisting of Vascular Cell Adhesion Molecule 1, Vascular Endothelial Growth Factor-A, Interleukin-6, Tumor Necrosis Factor Receptor Type 1, Matrix Metalloproteinase-1, Matrix Metalloproteinase-3, YKL-40, Leptin, Resistin, Serum Amyloid A, and C-Reactive Protein;   ii. Identifying at least two biomarkers each one with at least 40% elevated serum level over control serum level;   iii. Selecting a first treatment method that is known to affect the at least two biomarkers identified in step (ii), wherein the treatment method is selected from the group consisting of Plaquenil (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Arava (or Leflunomide), Tumor Necrosis Factor-α inhibitors, Atabacept (or Orencia), Tocilizumab (or Actemra), Rituxan, and Tofacitinib (or Xeljanz); and   iv. Administering the first treatment method selected in step (iii) to the patient; and   v. Determining effectiveness or ineffectiveness of the first treatment method administered in step (iv) to the patient.   
     
     
         26 . The method of  claim 25  which further comprises
 vi. Selecting a second treatment method, and 
 vii. Administering the second treatment method selected in step (vi) to the patient. 
 
     
     
         27 . The method of  claim 25  wherein the determining in (v) comprises:
 i. Determining Vectra DA Score, CRP level, and Sedimentation Rate in the patient before and after the first treatment method; and 
 ii. Comparing the Vectra DA Score, CRP level, and Erythrocyte Sedimentation Rate in the patient before and after the first treatment method. 
 
     
     
         28 . The method of  claim 26  wherein the selecting for the second treatment method in (vi) comprises:
 i. Identifying at least two biomarkers selected from the group consisting of Vascular Cell Adhesion Molecule 1, Vascular Endothelial Growth Factor-A, Interleukin-6, Tumor Necrosis Factor Receptor Type 1, Matrix Metalloproteinase-1, Matrix Metalloproteinase-3, YKL-40, Leptin, Resistin, Serum Amyloid A, and C-Reactive Protein, each one with at least 40% elevated serum level over control serum level; and 
 ii. Selecting a second treatment method that is known to affect the at least two biomarkers identified in step (ii), wherein the treatment method is selected from the group consisting of Plaquenil (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Arava (or Leflunomide), Tumor Necrosis Factor-α inhibitors, Atabacept (or Orencia), Tocilizumab (or Actemra), Rituxan, and Tofacitinib (or Xeljanz). 
 
     
     
         29 . The method of  claim 25  wherein the determining in (v) comprises:
 i. Determining one or more selected from the group consisting of Vectra DA Score, CRP level, and Sedimentation Rate in the patient before and after the first treatment method; and 
 ii. Comparing the one or more selected from the group consisting of Vectra DA Score, CRP level, and Erythrocyte Sedimentation Rate in the patient before and after the first treatment method.