Methods of administering anti-tnfalpha antibodies

Abstract

Methods of treating disorders in which TNFα activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor α (hTNFα) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNFα (e.g., K d =10 −8 M or less), a slow off rate for hTNFα dissociation (e.g., K off =10 −3 sec −1 or less) and neutralize hTNFα activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

1 - 6 . (canceled) 
     
     
         7 . A method for treating rheumatoid arthritis in a human patient with moderately to severely active rheumatoid arthritis, comprising:
 administering to said patient, in combination with methotrexate, a human anti-TNFα antibody comprising an IgG1 heavy chain constant region; a variable light (“V L ”) chain region comprising a CDR1 having the amino acid sequence of SEQ ID NO:7, a CDR2 having the amino acid sequence of SEQ ID NO:5, and a CDR3 having the amino acid sequence of SEQ ID NO:3; and a variable heavy (“V H ”) chain region comprising a CDR1 having the amino acid sequence of SEQ ID NO:8, a CDR2 having the amino acid sequence of SEQ ID NO:6 and a CDR3 having the amino acid sequence of SEQ ID NO:4,   wherein the human anti-TNFα antibody is administered subcutaneously in a total body dose of 40 mg once every 13-15 days, and   wherein the human anti-TNFα antibody is administered to said patient for a time period that would be sufficient for more than 49% of the moderate to severe rheumatoid arthritis population in North America to achieve an ACR20 response if so treated.   
     
     
         8 . The method of  claim 7 , wherein the V L  chain region of the anti-TNFα antibody has the amino acid sequence of SEQ ID NO:1 and the V H  chain region of the anti-TNFα antibody has the amino acid sequence of SEQ ID NO:2. 
     
     
         9 . The method of  claim 8 , wherein the human anti-TNFα antibody is administered for at least 24 weeks. 
     
     
         10 . The method of  claim 7 , wherein the human anti-TNFα antibody is administered for at least 24 weeks. 
     
     
         11 . A method for treating rheumatoid arthritis in a human patient with moderately to severely active rheumatoid arthritis, comprising:
 administering to said patient, in combination with methotrexate, a human anti-TNFα antibody comprising an IgG1 heavy chain constant region; a variable light (“V L ”) chain region comprising a CDR1 having the amino acid sequence of SEQ ID NO:7, a CDR2 having the amino acid sequence of SEQ ID NO:5, and a CDR3 having the amino acid sequence of SEQ ID NO:3; and a variable heavy (“V H ”) chain region comprising a CDR1 having the amino acid sequence of SEQ ID NO:8, a CDR2 having the amino acid sequence of SEQ ID NO:6 and a CDR3 having the amino acid sequence of SEQ ID NO:4,   wherein the human anti-TNFα antibody is administered subcutaneously in a total body dose of 40 mg once every 13-15 days, and   wherein the human anti-TNFα antibody is administered to said patient for a time period that would be sufficient for more than 23% of the moderate to severe rheumatoid arthritis population in North America to achieve an ACR50 response if so treated.   
     
     
         12 . The method of  claim 11 , wherein the V L  chain region of the anti-TNFα antibody has the amino acid sequence of SEQ ID NO:1 and the V H  chain region of the anti-TNFα antibody has the amino acid sequence of SEQ ID NO:2. 
     
     
         13 . The method of  claim 12 , wherein the human anti-TNFα antibody is administered for at least 24 weeks. 
     
     
         14 . The method of  claim 11 , wherein the human anti-TNFα antibody is administered for at least 24 weeks. 
     
     
         15 . The method of  claim 11 , wherein the human anti-TNFα antibody is administered for a time period sufficient for more than 49% of the moderate to severe rheumatoid arthritis population in North America to achieve an ACR20 response if so treated. 
     
     
         16 . The method of  claim 15 , wherein the V L  chain region of the anti-TNFα antibody has the amino acid sequence of SEQ ID NO:1 and the V H  chain region of the anti-TNFα antibody has the amino acid sequence of SEQ ID NO:2. 
     
     
         17 . The method of  claim 16 , wherein the human anti-TNFα antibody is administered for at least 24 weeks. 
     
     
         18 . The method of  claim 15 , wherein the human anti-TNFα antibody is administered for at least 24 weeks.