Administration of a selective il-6-trans-signalling inhibitor

Abstract

A selective IL-6-trans-signalling inhibitor can be used to treat a variety of IL-6-mediated conditions, including inflammatory diseases and cancer. The inhibitor can safely be administered to humans at a variety of doses. Moreover, the inhibitor lessens deleterious effects associated with other IL-6 inhibitors such as lowering neutrophil counts, platelet counts and levels of C-reactive protein.

1 .- 23 . (canceled) 
     
     
         24 . A method for the treatment of an inflammatory disease or an IL-6-mediated condition in a human, said method comprising administering to a human in need thereof an effective amount of a polypeptide dimer that inhibits IL-6 trans-signaling, wherein the polypeptide dimer comprises two monomers, each monomer comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 1, wherein the effective amount is 0.5 mg to 5 g of the polypeptide dimer. 
     
     
         25 . The method of  claim 24 , wherein each monomer comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 1. 
     
     
         26 . The method of  claim 24 , wherein the monomers have SEQ ID NO: 1. 
     
     
         27 . The method of  claim 24 , wherein the effective amount is 7.5 mg to 1 g of the polypeptide dimer. 
     
     
         28 . The method of  claim 24 , wherein the effective amount is 60 mg to 1 g of the polypeptide dimer. 
     
     
         29 . The method of  claim 24 , wherein the polypeptide dimer is administered daily or twice- or thrice-weekly. 
     
     
         30 . The method of  claim 24 , wherein the polypeptide dimer is administered every 7-60 days. 
     
     
         31 . The method of  claim 24 , wherein the polypeptide dimer is administered every 7-30 days. 
     
     
         32 . The method of  claim 24 , wherein the polypeptide dimer is administered every 7-20 days. 
     
     
         33 . The method of  claim 24 , wherein the polypeptide dimer is administered every 7 days. 
     
     
         34 . The method of  claim 31 , wherein the polypeptide dimer is administered every 14 days. 
     
     
         35 . The method of  claim 24 , wherein the polypeptide dimer is administered parenterally, intravenously or subcutaneously. 
     
     
         36 . The method of  claim 24 , wherein the inflammatory disease or IL-6-mediated condition is inflammatory bowel disease. 
     
     
         37 . The method of  claim 36 , wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis. 
     
     
         38 . The method of  claim 36 , wherein the treatment induces or maintains the remission of inflammatory bowel disease. 
     
     
         39 . The method of  claim 24 , wherein the inflammatory disease or IL-6-mediated condition is rheumatoid arthritis, psoriasis, uveitis or atherosclerosis. 
     
     
         40 . The method of  claim 24 , wherein the inflammatory disease or IL-6-mediated condition is colitis not associated with inflammatory bowel disease. 
     
     
         41 . The method of  claim 40 , wherein the colitis is radiation colitis, diverticular colitis, ischemic colitis, infectious colitis, celiac disease, autoimmune colitis, or colitis resulting from allergies affecting the colon. 
     
     
         42 . The method of  claim 24 , wherein neutrophil counts, platelet counts and/or levels of C-reactive protein are maintained within a physiologically normal range after administration of the polypeptide dimer. 
     
     
         43 . The method of  claim 24 , wherein each monomer comprises the gp130 D6 domain corresponding to the amino acids at positions 585-595 of SEQ ID NO: 1, and an Fc domain hinge region comprising the amino acids at positions 609-612 of SEQ ID NO: 1, and each monomer does not comprise a linker between the gp130 D6 domain and the Fc domain hinge region.