Method for treating rheumatoid arthritis with a human il-6 receptor antibody and methotrexate

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 .- 80 . (canceled) 
     
     
         81 . A method for treating an interleukin-6 (IL-6) related disease in a patient in need thereof, comprising administering to the patient a combination of (i) 8 mg/kg of a humanized anti-interleukin-6 receptor (anti-IL-6R) antibody PM-1 (hPM-1) every four weeks, wherein the anti-IL-6R monoclonal antibody hPM-1 is administered intravenously, and (ii) MTX orally administered once per week at a dose in a range of 10 to 25 mg. 
     
     
         82 . The method of  claim 81 , wherein the IL-6 related disease is rheumatoid arthritis. 
     
     
         83 . The method of  claim 81 , wherein the patient prior to treatment had an inadequate response or disease flare on methotrexate (MTX) treatment alone. 
     
     
         84 . The method of  claim 81 , wherein the patient has no anti-MRA antibodies following administering the combination of anti-IL-6R antibody hPM-1 and MTX. 
     
     
         85 . The method of  claim 81 , wherein the patient does not experience hypersensitivity following administering the combination of anti-IL-6R antibody hPM-1 and MTX. 
     
     
         86 . The method of  claim 81 , wherein the anti-IL-6R antibody hPM-1 is administered four times at four week intervals. 
     
     
         87 . A method for treating rheumatoid arthritis in a patient in need thereof, comprising administering to the patient a combination of (i) 8 mg/kg of a humanized anti-interleukin-6 receptor (anti-IL-6R) antibody PM-1 (hPM-1) every four weeks, wherein the anti-IL-6R monoclonal antibody hPM-1 is administered intravenously, and (ii) MTX orally administered once per week at a dose in a range of 10 to 25 mg. 
     
     
         88 . The method of  claim 87 , wherein the patient prior to treatment had an inadequate response or disease flare on methotrexate (MTX) treatment alone. 
     
     
         89 . The method of  claim 87 , wherein the patient has no anti-MRA antibodies following administering the combination of anti-IL-6R antibody hPM-1 and MTX. 
     
     
         90 . The method of  claim 87 , wherein the patient does not experience hypersensitivity following administering the combination of anti-IL-6R antibody hPM-1 and MTX. 
     
     
         91 . The method of  claim 87 , wherein the anti-IL-6R antibody hPM-1 is administered four times at four week intervals.