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 . A method for treating TNFα-mediated inflammation of the joints in a human subject, comprising:
 administering subcutaneously to a human subject having TNFα-mediated inflammation of the joints a total body dose of 40 mg of a human anti-TNFα antibody once every 13-15 days for a time period sufficient to treat the TNFα-mediated inflammation of the joints, 
 wherein the anti-TNFα antibody comprises 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. 
 
     
     
         2 . The method of  claim 1 , wherein the dosage is administered from a 40 mg dosage unit form. 
     
     
         3 . The method of  claim 2 , wherein the dosage unit form is a preloaded syringe. 
     
     
         4 . The method of  claim 3 , wherein the human anti-TNFα antibody is administered in combination with methotrexate. 
     
     
         5 . The method of  claim 2 , wherein the human anti-TNFα antibody is administered in combination with methotrexate. 
     
     
         6 . The method of  claim 1 , wherein the human anti-TNFα antibody is administered in combination with methotrexate. 
     
     
         7 . The method of  claim 1 , 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 human anti-TNFα antibody has the amino acid sequence of SEQ ID NO:2. 
     
     
         8 . The method of  claim 7 , wherein the dosage is administered from a 40 mg dosage unit form. 
     
     
         9 . The method of  claim 8 , wherein the dosage unit form is a preloaded syringe. 
     
     
         10 . The method of  claim 9 , wherein the human anti-TNFα antibody is administered in combination with methotrexate. 
     
     
         11 . The method of  claim 8 , wherein the human anti-TNFα antibody is administered in combination with methotrexate. 
     
     
         12 . The method of  claim 7 , wherein the human anti-TNFα antibody is administered in combination with methotrexate.