Combination therapy using a TNF binding protein for treating TNF-mediated diseases

Abstract

The invention relates to methods for treating or preventing acute and/or chronic arthritis. The method comprises administering to patients in need thereof therapeutically effective amounts of a TNF binding protein and methotrexate (N-[4-[[2,4-diamino-6-pteridinyl)methylamino]benzoyl]-L-glutamic acid). In a preferred embodiment, the TNF binding protein is sTNFR-I or sTNFR-II. The invention also relates to pharmaceutical compositions containing a TNF binding protein and methotrexate useful in such methods.

We claim:  
     
         1 . A method for treating an acute or chronic inflammatory disease which comprises administering to a patient in need thereof therapeutically effective amounts of a TNF binding protein and at least one additional anti-inflammatory drug, wherein said TNF binding protein and additional anti-inflammatory drug are administered separately or in combination.  
     
     
         2 . The method of  claim 1  wherein the anti-inflammatory drug is methotrexate (N-[4-[[2,4-diamino-6-pteridinyl)methylamino]benzoyl]-L-glutamic acid).  
     
     
         3 . The method of  claim 1  wherein the anti-inflammatory drug is a fas fusion protein.  
     
     
         4 . The method of  claim 1 , wherein said TNF binding protein is wherein said TNF binding protein is sTNFR-I, sTNFR-II, sTNFR fragments or sTNFR Fc.  
     
     
         5 . The method of any one of claims  1  through  4 , wherein said inflammatory disease is an inflammatory disease of a joint.  
     
     
         6 . The method of  claim 5 , wherein said inflammatory disease of a joint is rheumatoid arthritis.  
     
     
         7 . The method of  claim 3 , wherein said TNF binding protein and said methotrexate are administered in a pharmaceutically acceptable carrier.  
     
     
         8 . The method of  claim 3 , wherein said TNF binding protein and said fas fusion protein are administered in a pharmaceutically acceptable carrier.  
     
     
         9 . A pharmaceutical composition comprising a TNF binding protein and an additional anti-inflammatory drug.  
     
     
         10 . The pharmaceutical composition wherein the anti-inflammatory drug is methotrexate.  
     
     
         11 . The pharmaceutical composition wherein the anti-inflammatory drug is a fas fusion protein.  
     
     
         12 . The pharmaceutical composition of  claim 9 , wherein said TNF binding protein is sTNFR-I, sTNFR-II, sTNFR fragments or sTNFR Fc.  
     
     
         13 . The pharmaceutical composition of  claim 9 , wherein said TNF binding protein is present in an amount of up to about 20 mg.  
     
     
         14 . The pharmaceutical composition of  claim 10 , wherein said methotrexate is present in an amount of up to about 25 mg.  
     
     
         15 . A use of an anti-inflammatory drug, other than a non-TNF binding protein, in the preparation of a medicament for treating an acute or chronic inflammatory disease in a mammal in combination with the administration of a TNF binding protein.  
     
     
         16 . The use of  claim 15 , wherein the anti-inflammatory drug is methotrexate.  
     
     
         17 . The use according to  claim 16  wherein the methotrexate in the medicament is up to about 25 mg.  
     
     
         18 . The use according to claims  15  through  17  wherein said methotrexate is administered orally, intraperitoneally, subcutaneously or intravenously.  
     
     
         19 . The use according to claims  15  through  17  wherein said methotrexate is administered orally.  
     
     
         20 . The use of  claim 15 , wherein the anti-inflammatory drug is a fas fusion protein.  
     
     
         21 . A use of a TNF binding protein in the preparation of a medicament for treating an acute or chronic inflammatory disease in a mammal in combination with the administration of an additional anti-inflammatory drug.  
     
     
         22 . The use of according to  claim 21 , wherein the anti-inflammatory drug is methotrexate.  
     
     
         23 . The use according to claims  20  through  22  wherein said methotrexate is administered orally, intraperitoneally, subcutaneously or intravenously.  
     
     
         24 . The use of according to  claim 21 , wherein the anti-inflammatory drug is a fas fusion protein.  
     
     
         25 . The use according to claims  21  through  24  wherein the TNF binding protein is sTNFR-I, sTNFR-II, sTNFR fragments or sTNFR Fc.  
     
     
         26 . The use according to claims  21  through  25  wherein the TNF binding protein in the medicament is present in an amount of up to about 200 mg.