METHODS OF ADMINISTERING ANTI-TNFALPHA ANTIBODIES
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 kit comprising a pharmaceutical composition comprising a human anti-TNFα antibody and a pharmaceutically acceptable carrier, excipient or diluent packaged in association with instructions teaching administering via subcutaneous injection once every 13-15 days 40 mg of a human anti-TNFα antibody, 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 kit 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 anti-TNFα antibody has the amino acid sequence of SEQ ID NO:2.
3 . The kit of claim 2 in which the pharmaceutical composition is provided in unit dosage form.
4 . The kit of claim 3 in which the unit dosage form is a syringe pre-filled with the pharmaceutical composition.
5 . The kit of claim 1 in which the pharmaceutical composition is provided in unit dosage form.
6 . The kit of claim 5 in which the unit dosage form is a syringe pre-filled with the pharmaceutical composition.