Methods for treating il-6 mediated inflammation without immunosuppression

Abstract

The disclosure provides methods of treating inflammation without inducing immune suppression. The method comprises administering a therapeutically effective amount of an IL-6 antagonist at a dose sufficient to reduce inflammation without causing immune suppression.

1 . A method for treating IL-6-mediated inflammation in a patient, comprising:
 administering an IL-6 antagonist to a patient with IL-6-mediated inflammation at a dose that is sufficient to reduce inflammation without causing immune suppression.   
     
     
         2 . The method of  claim 1 , wherein the patient has an elevated pre-treatment C-reactive protein (CRP) level. 
     
     
         3 . The method of  claim 2 , wherein the pre-treatment CRP level of the patient is at least 2 mg/L. 
     
     
         4 - 11 . (canceled) 
     
     
         12 . The method of any of the above claims  claim 1 , wherein the inflammation is measured by the level of C-reactive protein (CRP). 
     
     
         13 . The method of  claim 12 , wherein the post-treatment CRP level is no more than 2 mg/L. 
     
     
         14 - 18 . (canceled) 
     
     
         19 . The method of  claim 1 , wherein the immune suppression is measured by absolute neutrophil count (ANC). 
     
     
         20 . The method of  claim 19 , wherein the post-treatment ANC is at least 500 cells/μL. 
     
     
         21 - 33 . (canceled) 
     
     
         34 . The method of  claim 1 , wherein the IL-6 antagonist is administered at a monthly equivalent dose that is no more than 30% of the monthly equivalent dose for treating rheumatoid arthritis with the same IL-6 antagonist. 
     
     
         35 - 41 . (canceled) 
     
     
         42 . The method of  claim 1 , wherein the IL-6 antagonist is an anti-IL-6 antibody. 
     
     
         43 . The method of  claim 42 , wherein the anti-IL-6 antibody is COR-001. 
     
     
         44 . The method of  claim 43 , wherein COR-001 is administered intravenously at a monthly equivalent dose of 2-40 mg. 
     
     
         45 - 50 . (canceled) 
     
     
         51 . The method of  claim 43 , wherein COR-001 is administered subcutaneously at a monthly equivalent dose of 3-70 mg. 
     
     
         52 - 57 . (canceled) 
     
     
         58 . The method of  claim 42 , wherein the anti-IL-6 antibody is siltuximab, gerilimzumab, sirukumab, clazakizumab, olokizumab, VX30 (VOP-R003, Vaccinex), EB-007 (EBI-029, Eleven Bio), or FM101 (Femta Pharmaceuticals, Lonza). 
     
     
         59 - 141 . (canceled) 
     
     
         142 . The method of  claim 1 , wherein the IL-6 antagonist is an anti-IL-6R antibody. 
     
     
         143 . The method of  claim 142 , wherein the anti-IL-6R antibody is tocilizumab, sarilumab, or vobarilizumab. 
     
     
         144 - 187 . (canceled) 
     
     
         188 . The method of  claim 1 , wherein the IL-6 antagonist is a JAK inhibitor. 
     
     
         189 . The method of  claim 1 , wherein the IL-6 antagonist is a STAT3 inhibitor. 
     
     
         190 . (canceled) 
     
     
         191 . The method of  claim 1 , wherein the patient has kidney disease. 
     
     
         192 - 199 . (canceled) 
     
     
         200 . The method of  claim 1 , wherein the patient has cardiovascular disease. 
     
     
         201 - 207 . (canceled) 
     
     
         208 . The method of  claim 1 , wherein the patient has anemia. 
     
     
         209 - 210 . (canceled) 
     
     
         211 . The method of  claim 1 , wherein the patient has diabetes. 
     
     
         212 - 213 . (canceled) 
     
     
         214 . The method of  claim 1 , wherein the patient has liver disease. 
     
     
         215 . (canceled) 
     
     
         216 . The method of  claim 1 , wherein the patient has osteoporosis. 
     
     
         217 . The method of  claim 1 , wherein the patient has depression. 
     
     
         218 . The method of  claim 1 , wherein the patient has asthma. 
     
     
         219 . The method of  claim 1 , wherein the patient has neuroinflammatory disorder. 
     
     
         220 - 223 . (canceled) 
     
     
         224 . The method of  claim 1 , wherein the patient has age-related macular degeneration (AMD). 
     
     
         225 . The method of  claim 1 , wherein the patient has cancer. 
     
     
         226 . (canceled) 
     
     
         227 . The method of  claim 1 , wherein the patient has skin disease. 
     
     
         228 . The method of  claim 1 , wherein the method prevents aging in the patient. 
     
     
         229 . A method for treating inflammation in a patient with cardiovascular disease, comprising:
 administering an IL-6 antagonist to a patient with cardiovascular disease and CRP level greater than 2 mg/L at a dose that is sufficient to reduce CRP levels to 2 mg/L or less without causing neutropenia.   
     
     
         230 - 232 . (canceled) 
     
     
         233 . A method for treating inflammation in a patient with chronic kidney disease (CK D  ), comprising:
 administering an IL-6 antagonist to a patient with CK D  and a CRP level greater than 2 mg/L at a dose that is sufficient to reduce CRP levels to 2 mg/L or less without causing neutropenia.   
     
     
         234 - 236 . (canceled)