Methods for treating interleukin-6 related diseases

Abstract

A pharmaceutical composition for the treatment of interleukin-6 (IL-6) related diseases, comprising an interleukin-6 antagonist (IL-6 antagonist) and immunosuppressants. The IL-6 antagonist is preferably an antibody to an interleukin-6 receptor (IL-6R).

1 . A method for treating rheumatoid arthritis in a patient, comprising administering an effective amount of an anti-human interleukin-6 receptor (anti-IL-6R) antibody and an effective amount of methotrexate (MTX) to the patient. 
     
     
         2 . The method of  claim 1 , wherein the anti-IL-6R monoclonal antibody is administered at a dose in a range of 2 to 8 mg/kg once every two weeks. 
     
     
         3 . The method of  claim 1 , wherein the MTX is administered at a dose in a range of 10 to 25 mg once per week. 
     
     
         4 . The method of  claim 1 , wherein the anti-IL-6R monoclonal antibody is administered orally, systemically, or topically. 
     
     
         5 . The method of  claim 4 , wherein the anti-IL-6R monoclonal antibody is administered subcutaneously. 
     
     
         6 . The method of  claim 4 , wherein the anti-IL-6R monoclonal antibody is administered intravenously. 
     
     
         7 . The method of  claim 4 , wherein the anti-IL-6R monoclonal antibody is administered orally. 
     
     
         8 . The method of  claim 1 , wherein the anti-IL-6R monoclonal antibody and MTX are administered simultaneously or with a time interval between administration of the anti-IL-6R monoclonal antibody and administration of MTX. 
     
     
         9 . The method of  claim 8 , wherein the anti-IL-6R monoclonal antibody and MTX are administered twice per week, once per week, once every two weeks, once every 4 weeks, once every 6 weeks, or once every 8 weeks. 
     
     
         10 . The method of  claim 9 , wherein the anti-IL-6R monoclonal antibody and MTX are administered once every two weeks. 
     
     
         11 . The method of  claim 1 , wherein the anti-IL-6R monoclonal antibody and MTX improve the American College of Rheumatology (ACR) response in the patient, wherein the ACR response is selected from the group consisting of ACR20, ACR50, and ACR70. 
     
     
         12 . The method of  claim 11 , wherein the ACR response is ACR20. 
     
     
         13 . The method of  claim 11 , wherein the ACR response is ACR50. 
     
     
         14 . The method of  claim 11 , wherein the ACR response is ACR70. 
     
     
         15 . The method of  claim 1 , wherein the patient was prior treated with MTX. 
     
     
         16 . The method of  claim 1 , wherein the patient previously had an inadequate response to MTX. 
     
     
         17 . The method of  claim 1 , wherein the antibody is a human or humanized anti-human interleukin-6 receptor (anti-IL-6R) monoclonal antibody. 
     
     
         18 . A pharmaceutical composition comprising a human anti-human interleukin-6 receptor (anti-IL-6R) monoclonal antibody and methotrexate (MTX). 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein the anti-IL-6R monoclonal antibody is present in a dose in a range of 2 to 8 mg/kg. 
     
     
         20 . The pharmaceutical composition of  claim 18 , wherein the MTX is present in a dose in a range of 10 to 25 mg. 
     
     
         21 . The pharmaceutical composition of  claim 18 , wherein the pharmaceutical composition is capable of being administered subcutaneously, intravenously, or orally. 
     
     
         22 . The pharmaceutical composition of  claim 21 , wherein the pharmaceutical composition is capable of being administered subcutaneously. 
     
     
         23 . The pharmaceutical composition of  claim 21 , wherein the pharmaceutical composition is capable of being administered intravenously. 
     
     
         24 . The pharmaceutical composition of  claim 21 , wherein the pharmaceutical composition is capable of being administered orally.