US2016263219A1PendingUtilityA1
Treatment Methods for Rheumatoid Arthritis

Assignee: GRAHAM L DOUGLASPriority: Sep 3, 2013Filed: May 18, 2016Published: Sep 15, 2016
Est. expirySep 3, 2033(~7.1 yrs left)· nominal 20-yr term from priority
A61K 31/519A61K 38/1774A61K 31/42A61K 31/573A61K 39/3955A61K 31/4706G01N 2800/102C07K 14/70521G01N 2800/52C07K 2317/55G01N 33/564A61K 31/343C07K 2319/30A61K 31/5377A61K 31/52C07K 2317/24A61K 38/191C07K 16/248C07K 16/241C07K 16/2866C07K 16/2827C07K 2319/00C07K 2317/21
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Claims
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.
Claims

exact text as granted — not AI-modified
1 - 29 . (canceled) 
     
     
         30 . A method for treating a patient with rheumatoid arthritis, with one or more treatments 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 (or Rituximab), and Tofacitinib (or XELJANZ), which comprises: administering to a patient, assessed to have at least 40% elevated serum levels over control serum levels 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, Resistin, Serum Amyloid A, and C-Reactive Protein, a treatment method, wherein if the at least two biomarkers with at least 40% elevated levels are:
 1) Vascular Cell Adhesion Molecule 1 and Vascular Endothelial Growth Factor-A, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 2) Vascular Cell Adhesion Molecule 1 and Interleukin-6, selecting treatment with one or more of ARAVA (Leflunomide) and Atabacept (ORENCIA); 
 3) Vascular Cell Adhesion Molecule 1 and Tumor Necrosis Factor Receptor Type 1, selecting treatment with one or more of ARAVA (Leflunomide) and Tumor Necrosis Factor-α inhibitors; 
 4) Vascular Cell Adhesion Molecule 1 and Matrix Metalloproteinase-1, selecting treatment with one or more of ARAVA (Leflunomide) and Tumor Necrosis Factor-α inhibitors; 
 5) Vascular Cell Adhesion Molecule 1 and Matrix Metalloproteinase-3, selecting treatment with one or more of ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors and Atabacept (or ORENCIA); 
 6) Vascular Cell Adhesion Molecule 1 and YKL-40, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 7) Vascular Cell Adhesion Molecule 1 and Resistin, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 8) Vascular Cell Adhesion Molecule 1 and Serum Amyloid A, selecting treatment with one or more of ARAVA (or Leflunomide) and Tumor Necrosis Factor-α; 
 9) Vascular Cell Adhesion Molecule 1 and C-Reactive Protein, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Atabacept (or ORENCIA); 
 10) Vascular Endothelial Growth Factor-A and Interleukin-6, selecting treatment with one or more of Sulfasalazine, Methotrexate and Tocilizumab (or ACTEMRA); 
 11) Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Receptor Type 1, selecting treatment with one or more of Sulfasalazine and Tumor Necrosis Factor-α inhibitors; 
 12) Vascular Endothelial Growth Factor-A and Matrix Metalloproteinase-1, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 13) Vascular Endothelial Growth Factor-A and Matrix Metalloproteinase-3, selecting treatment with one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 14) Vascular Endothelial Growth Factor-A and YKL-40, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 15) Vascular Endothelial Growth Factor-A and Resistin, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 16) Vascular Endothelial Growth Factor-A and Serum Amyloid A, selecting treatment with one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 17) Vascular Endothelial Growth Factor-A and C-Reactive Protein, selecting treatment with one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 18) Interleukin-6 and Tumor Necrosis Factor Receptor Type 1, selecting treatment with one or more of Sulfasalazine and ARAVA (or Leflunomide); 
 19) Interleukin-6 and Matrix Metalloproteinase-1, selecting treatment with one or more of ARAVA (or Leflunomide), Tocilizumab (or ACTEMRA) and Tofacitinib (or XELJANZ); 
 20) Interleukin-6 and Matrix Metalloproteinase-3, selecting treatment with one or more of Sulfasalazine, Methotrexate, ARAVA (or Leflunomide), Atabacept (or ORENCIA), Tocilizumab (or ACTEMRA) and Tofacitinib (or XELJANZ); 
 21) Interleukin-6 and YKL-40, selecting treatment with one or more of Tocilizumab (or ACTEMRA); 
 22) Interleukin-6 and Serum Amyloid A, selecting treatment with one or more of PLAQUENIL (or Hydroxychloroquine), Sulfasalazine, Methotrexate, ARAVA (or Leflunomide) and Tocilizumab (or ACTEMRA). 
 
     
     
         31 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Vascular Endothelial Growth Factor-A and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         32 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Interleukin-6 and the selected treatment is one or more of ARAVA (Leflunomide) and Atabacept (ORENCIA). 
     
     
         33 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Tumor Necrosis Factor Receptor Type 1 and the selected treatment is one or more of ARAVA (Leflunomide) and Tumor Necrosis Factor-α inhibitors. 
     
     
         34 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Matrix Metalloproteinase-1 and the selected treatment is one or more of ARAVA (Leflunomide) and Tumor Necrosis Factor-α inhibitors. 
     
     
         35 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Matrix Metalloproteinase-3 and the selected treatment is one or more of ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors and Atabacept (or ORENCIA). 
     
     
         36 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and YKL-40 and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         37 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Resistin and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         38 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and Serum Amyloid A and the selected treatment is one or more of ARAVA (or Leflunomide) and Tumor Necrosis Factor-α. 
     
     
         39 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Cell Adhesion Molecule 1 and C-Reactive Protein and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Atabacept (or ORENCIA). 
     
     
         40 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and Interleukin-6 and the selected treatment is one or more of Sulfasalazine, Methotrexate and Tocilizumab (or ACTEMRA). 
     
     
         41 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Receptor Type 1 and the selected treatment is one or more of Sulfasalazine and Tumor Necrosis Factor-α inhibitors. 
     
     
         42 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and Matrix Metalloproteinase-1 and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         43 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and Matrix Metalloproteinase-3 and the selected treatment is one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         44 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and YKL-40 and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         45 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and Resistin and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         46 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and Serum Amyloid A and the selected treatment is one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         47 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Vascular Endothelial Growth Factor-A and C-Reactive Protein and the selected treatment is one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         48 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Interleukin-6 and Tumor Necrosis Factor Receptor Type 1 and the selected treatment is one or more of Sulfasalazine and ARAVA (or Leflunomide). 
     
     
         49 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Interleukin-6 and Matrix Metalloproteinase-1 and the selected treatment is one or more of ARAVA (or Leflunomide), Tocilizumab (or ACTEMRA) and Tofacitinib (or XELJANZ). 
     
     
         50 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Interleukin-6 and Matrix Metalloproteinase-3 and the selected treatment is one or more of Sulfasalazine, Methotrexate, ARAVA (or Leflunomide), Atabacept (or ORENCIA), Tocilizumab (or ACTEMRA) and Tofacitinib (or XELJANZ). 
     
     
         51 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Interleukin-6 and YKL-40 and the selected treatment is one or more of Tocilizumab (or ACTEMRA). 
     
     
         52 . The method of  claim 30  wherein the at least two biomarkers with at least 40% elevated levels are Interleukin-6 and Serum Amyloid A and the selected treatment is one or more of PLAQUENIL (or Hydroxychloroquine), Sulfasalazine, Methotrexate, ARAVA (or Leflunomide) and Tocilizumab (or ACTEMRA). 
     
     
         53 . A method for treating a patient with rheumatoid arthritis, with one or more treatments 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 (or Rituximab), and Tofacitinib (or XELJANZ), which comprises: administering to a patient, assessed to have at least 40% elevated serum levels over control serum levels 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, Resistin, Serum Amyloid A, and C-Reactive Protein, a treatment method, wherein if the at least two biomarkers with at least 40% elevated levels are:
 1) Interleukin-6 and C-Reactive Protein, selecting treatment with one or more of PLAQUENIL (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Atabacept (or ORENCIA), Tocilizumab (or ACTEMRA) and RITUXAN (or Rituximab); 
 2) Tumor Necrosis Factor Receptor Type 1 and Matrix Metalloproteinase-1, selecting treatment with one or more of ARAVA (or Leflunomide) and Tumor Necrosis Factor-α, inhibitors; 
 3) Tumor Necrosis Factor Receptor Type 1 and Matrix Metalloproteinase-3, selecting treatment with one or more of Sulfasalazine, ARAVA (or Leflunomide) and Tumor Necrosis Factor-α inhibitors; 
 4) Tumor Necrosis Factor Receptor Type 1 and YKL-40, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 5) Tumor Necrosis Factor Receptor Type 1 and Resistin, selecting treatment with Tumor Necrosis Factor-α, inhibitors; 
 6) Tumor Necrosis Factor Receptor Type 1 and Serum Amyloid A, selecting treatment with one or more of Sulfasalazine, ARAVA (or Leflunomide) and Tumor Necrosis Factor-α inhibitors; 
 7) Tumor Necrosis Factor Receptor Type 1 and C-Reactive Protein, selecting treatment with one or more of Sulfasalazine and Tumor Necrosis Factor-α inhibitors; 
 8) Matrix Metalloproteinase-1 and Matrix Metalloproteinase-3, selecting treatment with one or more of ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors, Tocilizumab (or ACTEMRA) and Tofacitinib (or XELJANZ); 
 9) Matrix Metalloproteinase-1 and YKL-40, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 10) Matrix Metalloproteinase-1 and Resistin, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 11) Matrix Metalloproteinase-1 and Serum Amyloid A, selecting treatment with one or more of ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 12) Matrix Metalloproteinase-1 and C-Reactive Protein, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 13) Matrix Metalloproteinase-3 and YKL-40, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 14) Matrix Metalloproteinase-3 and Resistin, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 15) Matrix Metalloproteinase-3 and Serum Amyloid A, selecting treatment with one or more of Sulfasalazine, Methotrexate, ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 16) Matrix Metalloproteinase-3 and C-Reactive Protein, selecting treatment with one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors, Atabacept (or ORENCIA) and Tocilizumab (or ACTEMRA); 
 17) YKL-40 and Resistin, selecting treatment with Tumor Necrosis Factor-α inhibitors; 
 18) YKL-40 and Serum Amyloid A, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 19) YKL-40 and C-Reactive Protein, selecting treatment with one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA); 
 20) Resistin and Serum Amyloid A, selecting treatment with Tumor Necrosis Factor-a inhibitors; 
 21) Resistin and C-Reactive Protein, selecting treatment with Tumor Necrosis Factor-α inhibitors; and 
 22) Serum Amyloid A and C-Reactive Protein, selecting treatment with one or more of PLAQUENIL (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
 
     
     
         54 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Interleukin-6 and C-Reactive Protein and the selected treatment is one or more of PLAQUENIL (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Atabacept (or ORENCIA), Tocilizumab (or ACTEMRA) and RITUXAN (or Rituximab). 
     
     
         55 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Tumor Necrosis Factor Receptor Type 1 and Matrix Metalloproteinase-1 and the selected treatment is one or more of ARAVA (or Leflunomide) and Tumor Necrosis Factor-a inhibitors. 
     
     
         56 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Tumor Necrosis Factor Receptor Type 1 and Matrix Metalloproteinase-3 and the selected treatment is one or more of Sulfasalazine, ARAVA (or Leflunomide) and Tumor Necrosis Factor-α inhibitors. 
     
     
         57 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Tumor Necrosis Factor Receptor Type 1 and YKL-40 and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         58 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Tumor Necrosis Factor Receptor Type 1 and Resistin and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         59 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Tumor Necrosis Factor Receptor Type 1 and Serum Amyloid A and the selected treatment is one or more of Sulfasalazine, ARAVA (or Leflunomide) and Tumor Necrosis Factor-α inhibitors. 
     
     
         60 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Tumor Necrosis Factor Receptor Type 1 and C-Reactive Protein and the selected treatment is one or more of Sulfasalazine and Tumor Necrosis Factor-α inhibitors. 
     
     
         61 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-1 and Matrix Metalloproteinase-3 and the selected treatment is one or more of ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors, Tocilizumab (or ACTEMRA) and Tofacitinib (or XELJANZ). 
     
     
         62 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-1 and YKL-40 and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         63 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-1 and Resistin and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         64 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-1 and Serum Amyloid A and the selected treatment is one or more of ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         65 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-1 and C-Reactive Protein and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         66 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-3 and YKL-40 and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         67 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-3 and Resistin and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         68 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-3 and Serum Amyloid A and the selected treatment is one or more of Sulfasalazine, Methotrexate, ARAVA (or Leflunomide), Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         69 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Matrix Metalloproteinase-3 and C-Reactive Protein and the selected treatment is one or more of Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors, Atabacept (or ORENCIA) and Tocilizumab (or ACTEMRA). 
     
     
         70 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are YKL-40 and Resistin and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         71 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are YKL-40 and Serum Amyloid A and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         72 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are YKL-40 and C-Reactive Protein and the selected treatment is one or more of Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA). 
     
     
         73 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Resistin and Serum Amyloid A and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         74 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Resistin and C-Reactive Protein and the selected treatment is Tumor Necrosis Factor-α inhibitors. 
     
     
         75 . The method of  claim 53  wherein the at least two biomarkers with at least 40% elevated levels are Serum Amyloid A and C-Reactive Protein and the selected treatment is one or more of PLAQUENIL (or Hydroxychloroquine), Sulfasalazine, Methotrexate, Tumor Necrosis Factor-α inhibitors and Tocilizumab (or ACTEMRA).
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