Claims for Patent: 8,999,337

Summary for Patent: 8,999,337

Title:	Methods for treating juvenile idiopathic arthritis by inhibition of TNF.alpha.
Abstract:	The invention provides methods and compositions for the treatment of juvenile idiopathic arthritis (JIA) where a TNF.alpha. inhibitor, such as a human TNF.alpha. antibody, or antigen-binding portion thereof, is used to treat JIA. In particular, the invention is directed to methods and compositions relating to a fixed dosing regimen for treating JIA with a TNF.alpha. inhibitor.
Inventor(s):	Medich; John R. (East Hanover, NJ), Paulson; Susan K. (Downers Grove, IL), Noertersheuser; Peter A. (Gro-Karlbach, DE)
Assignee:	AbbVie Biotechnology Ltd. (Hamilton, BM)
Application Number:	12/157,599
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,999,337
Patent Claims:	1. A method for treating juvenile idiopathic arthritis (JIA) in a subject comprising administering an isolated human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, to the subject, wherein 20 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs less than 30 kg, or wherein 40 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs more than or equal to 30 kg. 2. The method of claim 1, wherein the human anti-TNF.alpha. antibody is adalimumab or golimumab, or the antigen-binding portion thereof is a portion of adalimumab or golimumab. 3. A method for treating juvenile idiopathic arthritis (JIA) in a subject comprising subcutaneously administering an isolated human anti-TNF.alpha. antibody, or antigen-binding portion thereof, to the subject, wherein 20 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs less than 30 kg, or wherein 40 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs more than or equal to 30 kg. 4. The method of claim 3, wherein the human anti-TNF.alpha. antibody is adalimumab or golimumab, or the antigen-binding portion thereof is a portion of adalimumab or golimumab. 5. The method of claim 3, wherein the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered every other week. 6. A method for treating juvenile idiopathic arthritis (JIA) in a subject comprising administering an isolated human anti-TNF.alpha. antibody, or an antigen-binding portion thereof to the subject, wherein a mean steady state trough serum concentration of the anti-TNF.alpha. antibody, or antigen-binding portion thereof is about 6 to 7 .mu.g/mL or about 8 to 9 .mu.g/mL, wherein 20 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs less than 30 kg, or wherein 40 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs more than or equal to 30 kg, and wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2. 7. The method of claim 6, wherein the anti-TNF.alpha. antibody, or antigen-binding portion thereof is administered to the subject as a monotherapy. 8. The method of claim 6, wherein the subject weighs more than or equal to 30 kg. 9. The method of claim 6, wherein the subject weighs less than 30 kg. 10. The method of claim 6, wherein the anti-TNF.alpha. antibody, or antigen-binding portion thereof is administered to the subject in combination with methotrexate. 11. A method for treating juvenile idiopathic arthritis (JIA) in a subject comprising administering an isolated human anti-TNF.alpha. antibody, or antigen-binding portion thereof to the subject, wherein a mean steady state trough serum concentration of the human anti-TNF.alpha. antibody, or antigen-binding portion thereof is about 10-11 .mu.g/mL, wherein 20 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs less than 30 kg, or wherein 40 mg of the anti-TNF.alpha. antibody, or antigen-binding portion thereof, is administered to the subject if the subject weighs more than or equal to 30 kg, and wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2. 12. The method of claim 11, wherein the human anti-TNF.alpha. antibody, or antigen-binding portion thereof is administered to the subject in combination with methotrexate. 13. The method of claim 11, wherein the subject weighs less than 30 kg. 14. The method of claim 3, wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, has the following characteristics: a) dissociates from human TNF.alpha. with a K.sub.off rate constant of 1.times.10.sup.-3 s.sup.-1 or less, as determined by surface plasmon resonance; b) has a light chain variable region (LCVR) comprising a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 3; a CDR2 domain comprising the amino acid sequences of SEQ ID NO: 5; and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7; and c) has a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4; a CDR2 domain comprising the amino acid sequences of SEQ ID NO: 6; and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 8. 15. The method of claim 3, wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, comprises a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 3, or modified from SEQ ID NO: 3 by a single alanine substitution at position 1, 4, 5, 7 or 8, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7; and comprises a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4, or modified from SEQ ID NO: 4 by a single alanine substitution at position 2, 3, 4, 5, 6, 8, 9, 10 or 11, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 8. 16. The method of claim 3, wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2. 17. The method of claim 3, wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, comprises a light chain variable region comprising a CDR3 comprising SEQ ID NO: 3, a CDR2 comprising SEQ ID NO: 5, and a CDR1 comprising SEQ ID NO: 7, and a heavy chain variable region comprising a CDR3 comprising SEQ ID NO: 4, a CDR2 comprising SEQ ID NO: 6, and a CDR1 comprising SEQ ID NO: 8. 18. The method of claim 3, wherein said human anti-TNF.alpha. antibody or antigen-binding portion thereof is adalimumab which is administered to the subject with JIA every other week. 19. The method of claim 18, wherein the subject weighs 30 kg.

Details for Patent 8,999,337

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2027-06-11
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2027-06-11