Subcutaneously administered anti-il-6 receptor antibody

Abstract

The present application discloses methods for treating an IL-6-mediated disorder such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), systemic JIA (sJIA), polyarticular course JIA (pcJIA), systemic sclerosis, or giant cell arteritis (GCA), with subcutaneously administered antibody that binds interleukin-6 receptor (anti-IL-6R antibody). In particular, it relates to identification of a fixed dose of anti-IL-6R antibody, e.g. tocilizumab, which is safe and effective for subcutaneous administration in patients with IL-6-mediated disorders. In addition, formulations and devices useful for subcutaneous administration of an anti-IL-6R antibody are disclosed.

1 . A method of inhibiting progression of structural joint damage in a rheumatoid arthritis patient comprising subcutaneously administering a fixed dose of 162 mg of an anti-IL-6R antibody to the patient every two weeks, wherein structural joint damage at week 24 or week 48 is found to be inhibited. 
     
     
         2 . The method of  claim 1  wherein the rheumatoid arthritis patient is a disease modifying anti-rheumatic drug (DMARD)-inadequate responder. 
     
     
         3 . The method of  claim 1  wherein the rheumatoid arthritis patient is a tumor necrosis factor (TNF)-inhibitor-inadequate responder. 
     
     
         4 . The method of  claim 1  wherein the rheumatoid arthritis patient is methotrexate naive or has discontinued methotrexate. 
     
     
         5 . The method of  claim 1  which further comprises administering to the patient one or more additional drug which treats the rheumatoid arthritis. 
     
     
         6 . The method of  claim 5  wherein the additional drug is selected from the group consisting of: immunosuppressive agent, non-steroidal anti-inflammatory drug (NSAID), disease modifying anti-rheumatic drug (DMARD), methotrexate (MTX), anti-B-cell surface marker antibody, anti-CD20 antibody, rituximab, tumor necrosis factor (TNF)-inhibitor, corticosteroid, and co-stimulatory modifier. 
     
     
         7 . The method of  claim 6  wherein the additional drug is a non-biological DMARD. 
     
     
         8 . The method of  claim 6  wherein the additional drug is a non-steroidal anti-inflammatory drug (NSAID). 
     
     
         9 . The method of  claim 6  wherein the additional drug is a corticosteroid. 
     
     
         10 . The method of  claim 1  wherein the anti-IL-6R antibody is tocilizumab. 
     
     
         11 . (canceled) 
     
     
         12 . A method of treating rheumatoid arthritis in a patient comprising subcutaneously administering tocilizumab to the patient, wherein the tocilizumab is administered as a fixed dose of 162 mg per dose every week or every two weeks. 
     
     
         13 . A method of treating juvenile idiopathic arthritis (JIA) in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient in an amount effective to treat the JIA. 
     
     
         14 . The method of  claim 13  wherein the JIA is systemic JIA (sJIA) and the effective amount is 162 mg every week if the patient's weight is ≥30 kilograms and 162 mg every 10 days if the patient's weight is <30 kilograms. 
     
     
         15 . The method of  claim 13  wherein the JIA is polyarticular course juvenile idiopathic arthritis (pcJIA) and the effective amount is 162 mg every two weeks. 
     
     
         16 . A method of treating a fibrotic disease in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient in an amount effective to treat the fibrotic disease. 
     
     
         17 . The method of  claim 16  wherein the fibrotic disease is systemic sclerosis. 
     
     
         18 . A method of treating giant cell arteritis (GCA) in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient in an amount effective to treat the GCA. 
     
     
         19 . The method of  claim 18  wherein the antibody is administered as a fixed dose of 162 mg per dose. 
     
     
         20 . The method of  claim 19  wherein the 162 mg fixed dose is administered every week or every two weeks.