US2002010180A1PendingUtilityA1

TNFalpha antagonists and methotrexate in the treatment of TNF-mediated disease

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Assignee: KENNEDY INST OF RHEUMATOLOGYPriority: Oct 8, 1992Filed: Jan 3, 2001Published: Jan 24, 2002
Est. expiryOct 8, 2012(expired)· nominal 20-yr term from priority
Inventors:Marc FeldmannRavinder N. Maini
A61P 37/06A61P 37/00A61P 29/00C07K 2317/24C07K 16/241A61K 45/06C07K 2319/00A61K 31/519A61P 1/00A61K 39/395A61K 38/1793A61K 39/39541A61K 2039/545A61K 2039/505A61K 31/505A61K 39/3955A61P 19/02
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Claims

Abstract

Methods for treating and/or preventing a TNF-mediated disease in an individual are disclosed. Also disclosed is a composition comprising methotrexate and an anti-tumor necrosis factor antibody. TNF-mediated diseases include rheumatoid arthritis, Crohn's disease, and acute and chronic immune diseases associated with transplantation.

Claims

exact text as granted — not AI-modified
What is claimed:  
     
         1 . A method for treating or preventing a tumor necrosis factor-mediated disease in an individual in need thereof comprising co-administering methotrexate and a TNFα antagonist to said individual, in therapeutically effective amounts.  
     
     
         2 . A method of  claim 1  wherein said TNFα antagonist and methotrexate are administered simultaneously.  
     
     
         3 . A method of  claim 1  wherein said TNFα antagonist and methotrexate are administered sequentially.  
     
     
         4 . A method of  claim 1  wherein the tumor necrosis factor-mediated disease is selected from the group consisting of: autoimmune disease, acute or chronic immune disease, inflammatory disease and neurodegenerative disease.  
     
     
         5 . A method of  claim 4  wherein said TNFα antagonist is administered in multiple doses.  
     
     
         6 . A method of  claim 1  wherein said TNFα antagonist prevents or inhibits TNFα synthesis or TNFα release.  
     
     
         7 . A method of  claim 6  wherein said TNFα antagonist is a phosphodiesterase inhibitor.  
     
     
         8 . A method of  claim 7  wherein said phosphodiesterase inhibitor is selected from the group consisting of: pentoxifylline and rolipram.  
     
     
         9 . A method of  claim 6  wherein said TNFα antagonist is selected from the group consisting of: thalidomide and tenidap.  
     
     
         10 . A method of  claim 6  wherein said TNFα antagonist is selected from the group consisting of: a A2b adenosine receptor agonist and a A2b adenosine receptor enhancer.  
     
     
         11 . A method of  claim 5  wherein said TNFα antagonist is an anti-TNFα antibody or antigen-binding fragment thereof.  
     
     
         12 . A method of  claim 11  wherein said anti-TNFα antibody or antigen-binding fragment is a chimeric antibody or chimeric fragment, wherein said chimeric antibody or chimeric fragment comprises a non-human variable region specific for TNFα or an antigen-binding portion thereof and a human constant region.  
     
     
         13 . A method of  claim 12  wherein said chimeric antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:1 or SEQ ID NO:2.  
     
     
         14 . A method of  claim 13  wherein said chimeric antibody competitively inhibits binding of TNFα to monoclonal antibody cA2.  
     
     
         15 . A method of  claim 13  wherein said chimeric antibody is monoclonal antibody cA2.  
     
     
         16 . A method of  claim 11  wherein said anti-TNFα antibody is a humanized antibody or antigen-binding fragment thereof.  
     
     
         17 . A method of  claim 16  wherein said humanized antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:1 or SEQ ID NO:2.  
     
     
         18 . A method of  claim 11  wherein said anti-TNFα antibody is a resurfaced antibody or antigen-binding fragment thereof.  
     
     
         19 . A method of  claim 18  wherein said resurfaced antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:1 or SEQ ID NO:2.  
     
     
         20 . A method of  claim 5  wherein said TNFα antagonist is a soluble TNFα receptor or functional portion thereof.  
     
     
         21 . A method of  claim 20  wherein said soluble TNFα receptor is selected from the group consisting of: p55 TNFα receptor and p75 TNFα receptor.  
     
     
         22 . A method of  claim 20  wherein said soluble TNFα receptor is a TNFα receptor multimeric molecule.  
     
     
         23 . A method of  claim 20  wherein said soluble TNFα receptor is a TNFα receptor immunoreceptor fusion molecule.  
     
     
         24 . A method for treating or preventing arthritis in an individual in need thereof comprising co-administering methotrexate and a TNFα antagonist to said individual, in therapeutically effective amounts.  
     
     
         25 . A method of  claim 24  wherein said TNFα antagonist and methotrexate are administered simultaneously.  
     
     
         26 . A method of  claim 24  wherein said TNFα antagonist and methotrexate are administered sequentially.  
     
     
         27 . A method of  claim 24  wherein said TNFα antagonist is administered in multiple doses.  
     
     
         28 . A method of  claim 24  wherein said TNFα antagonist prevents or inhibits TNFα synthesis or TNFα release.  
     
     
         29 . A method for treating or preventing rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and a TNFα antagonist to said individual, in therapeutically effective amounts.  
     
     
         30 . A method of  claim 29  wherein said TNFα antagonist and methotrexate are administered simultaneously.  
     
     
         31 . A method of  claim 29  wherein said TNFα antagonist and methotrexate are administered sequentially.  
     
     
         32 . A method of  claim 29  wherein said TNFα antagonist is administered in multiple doses.  
     
     
         33 . A method of  claim 29  wherein said TNFα antagonist prevents or inhibits TNFα synthesis or TNFα release.  
     
     
         34 . A method for treating or preventing Crohn's disease in an individual in need thereof comprising co-administering methotrexate a TNFα antagonist to said individual, in therapeutically effective amounts.  
     
     
         35 . A method of  claim 34  wherein said TNFα antagonist and methotrexate are administered simultaneously.  
     
     
         36 . A method of  claim 34  wherein said TNFα antagonist and methotrexate are administered sequentially.  
     
     
         37 . A method of  claim 34  wherein said TNFα antagonist is administered in multiple doses.  
     
     
         38 . A method of  claim 34  wherein said TNFα antagonist prevents or inhibits TNFα synthesis or TNFα release.

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