Compositions comprising il6r antibodies for the treatment of uveitis and macular edema and methods of using same

Abstract

The present invention provides compositions and methods of treating and improving the symptoms of uveitis and/or macular edema using an antibody that specifically binds human interleukin-6 receptor (hIL-6R).

1 . A method for treating macular edema in a subject in need thereof comprising administering to the subject an effective amount of an antibody that specifically binds IL-6 receptor and an effective amount of methotrexate, wherein the antibody comprises three complementarity determining regions (CDRs) from a heavy chain variable region comprising the sequence of SEQ ID NO:2, and three CDRs from a light chain variable region comprising the sequence of SEQ ID NO:3. 
     
     
         2 . The method of  claim 1 , wherein the the heavy chain variable region comprising the sequence of SEQ ID NO:2 and the light chain variable region comprising the sequence of SEQ ID NO:3. 
     
     
         3 . The method of  claim 2 , wherein the antibody is sarilumab. 
     
     
         4 . The method of  claim 1 , wherein the subject is suffering from at least one symptom of macular edema selected from the group consisting of ocular inflammation, impaired vision, impaired color recognition, tissue thickening, and leakage of ocular vessels. 
     
     
         5 - 11 . (canceled) 
     
     
         12 . The method of  claim 1 , wherein the subject has been previously treated for at least three months with a corticosteroid. 
     
     
         13 . The method of  claim 12 , wherein the corticosteroid is prednisone. 
     
     
         14 . The method of  claim 13 , wherein the prednisone is administered from 15 to 80 mg/day. 
     
     
         15 . (canceled) 
     
     
         16 . The method of  claim 1 , wherein the methotrexate is administered from 6 to 25 mg/week. 
     
     
         17 - 21 . (canceled) 
     
     
         22 . The method of  claim 1 , wherein the subject achieves after 16 weeks a reduction in the VH level on the Miami 9 point scale of at least 2 steps or a reduction of corticosteroid dose to less than 10 mg per day. 
     
     
         23 . The method of  claim 1 , wherein the subject achieves after 16 weeks a reduction in the VH level on the Miami 9 point scale of at least 2. 
     
     
         24 . The method of  claim 1 , wherein the subject achieves after 16 weeks a reduction of corticosteroid dose to less than 10 mg per day. 
     
     
         25 . The method of  claim 1 , wherein the subject experiences:
 greater than 20% reduction in CRT,   greater than 10 letters of improvement in BCVA,   a reduction in retinal vessel leakage, and/or   an improvement in uveitis clinical assessment score.   
     
     
         26 . The method of  claim 1 , wherein the subject achieves after 16 weeks an improvement in BCVA. 
     
     
         27 . The method of  claim 1 , wherein the subject achieves after 16 weeks an improvement in CRT. 
     
     
         28 . The method of  claim 1 , wherein the subject achieves after 16 weeks an improvement in retinal vessel leakage. 
     
     
         29 . The method of  claim 1 , wherein the subject achieves after 16 weeks an improvement in a clinical assessment score. 
     
     
         30 . The method of  claim 1 , wherein the antibody is administered subcutaneously. 
     
     
         31 . The method of  claim 1 , wherein the antibody is administered from about 150 to about 200 mg once every two weeks. 
     
     
         32 . The method of  claim 1 , wherein the antibody is administered at about 150 mg once every two weeks. 
     
     
         33 . The method of  claim 1 , wherein the antibody is administered at about 200 mg once every two weeks. 
     
     
         34 - 108 . (canceled)