IP Library Granted Patent US 8,889,135
Granted Patent B2
US 8,889,135 · App. 10/163,657 · Granted Nov 18, 2014

Methods of administering anti-TNFα antibodies

Inventors: Steven A. Fischkoff (Short Hills, NJ); Joachim Kempeni (Neustadt, DE); Roberta Weiss (Wynnewood, PA)
Assignee: AbbVie Biotechnology Ltd.
C07K16/241A61K39/3955C07K2317/76A61K2300/00A61K2039/505A61K2039/545A61K2039/54C07K2317/21
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Quick Facts
Patent No.
US 8,889,135
App. No.
10/163,657
Granted
Nov 18, 2014
Kind
B2
Abstract

Methods of treating disorders in which TFNα 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.

Claims (5)

1. A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having rheumatoid arthritis 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 rheumatoid arthritis, 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 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 method of claim 2 , wherein the anti-TNFα antibody is administered for a period of at least 24 weeks.

4. The method of claim 1 , wherein the anti-TNFα antibody is administered for a period of at least 24 weeks.

5. A method for treating rheumatoid arthritis in a human subject, consisting of administering subcutaneously to a human subject having rheumatoid arthritis a composition comprising 40 mg of a human anti-TNFα antibody once every 13 -15 days for a time period sufficient to treat the rheumatoid arthritis, 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 CDR3having the amino acid sequence of SEQ ID NO:4, and wherein the human anti-TNFα antibody is administered in the form of a pharmaceutically acceptable composition.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE DATE OF ASSIGNMENT EFFECTIVE NUNC PRO TUNC TO OCTOBER 31, 2001 PREVIOUSLY RECORDED AT REEL: 013997 FRAME: 0780. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Feb 18, 2015
From: FISCHKOFF, STEVEN A.; WEISS, ROBERTA; KEMPENI, JOACHIM
To: ABBOTT BIOTECHNOLOGY LTD.
Reel/Frame 035033/0062 →
CHANGE OF NAME Recorded Nov 8, 2013
From: ABBOTT BIOTECHNOLOGY LTD.
To: ABBVIE BIOTECHNOLOGY LTD
Reel/Frame 031567/0459 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2003
From: FISCHKOFF, STEVEN A.; KEMPENI, JOACHIM; WEISS, ROBERTA
To: ABBOTT BIOTECHNOLOGY LTD.
Reel/Frame 013997/0780 →
Continuity (2)
Provisional Application 60296961 · Jun 8, 2001
Related Publication 20030235585A1 · Dec 25, 2003