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Last Updated: March 29, 2024

Claims for Patent: 9,279,015


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Summary for Patent: 9,279,015
Title:Methods for treatment of ankylosing spondylitis using TNF alpha antibodies
Abstract: The invention provides methods, uses and compositions for the treatment of ankylosing spondylitis (AS). The invention describes methods and uses for treating ankylosing spondylitis, wherein a TNF.alpha. inhibitor, such as a human TNF.alpha. antibody, or antigen-binding portion thereof, is used to reduce signs and symptoms of ankylosing spondylitis in a subject. Also described are methods for determining the efficacy of a TNF.alpha. inhibitor for treatment of ankylosing spondylitis in a subject.
Inventor(s): Wong; Robert L. (Basking Ridge, NJ), Kupper; Hartmut (Mutterstadt, DE), Luo; Michelle P. (Libertyville, IL), Sieper; Joachim (Berlin, DE), Davis; John C. (San Francisco, CA), Maksymowych; Walter P. (Edmonton, CA)
Assignee:
Application Number:12/012,787
Patent Claims:1. A method of treating a subject having early axial spondyloarthritis (SpA), comprising administering to the subject an isolated human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, to the subject, such that early axial spondyloarthritis is treated.

2. The method of claim 1, wherein the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1 and comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2.

3. The method of claim 1, wherein a 40 mg dose of the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, is subcutaneously administered biweekly to the subject.

4. The method of claim 1, 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, 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) comprising a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4, 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.

5. The method of claim 1, wherein the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, is adalimumab.

6. The method of claim 5, wherein a 40 mg dose of adalimumab is subcutaneously administered biweekly to the subject.

7. A method of treating a subject having early axial spondyloarthritis (SpA), comprising selecting a subject having early axial SpA and administering to the subject an isolated human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, to the subject, such that early axial spondyloarthritis is treated, 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, 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) comprising a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 4, 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.

8. The method of claim 7, wherein the subject is selected before occurrence of radiographic sacroiliitis.

9. The method of claim 7, 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 comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2.

10. The method of claim 7, wherein the human anti-TNF.alpha. antibody, or an antigen-binding portion thereof, is adalimumab.

Details for Patent 9,279,015

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 12/31/2002 ⤷  Try a Trial 2026-04-10
Abbvie Inc. HUMIRA adalimumab Injection 125057 02/21/2008 ⤷  Try a Trial 2026-04-10
Abbvie Inc. HUMIRA adalimumab Injection 125057 04/24/2013 ⤷  Try a Trial 2026-04-10
Abbvie Inc. HUMIRA adalimumab Injection 125057 09/23/2014 ⤷  Try a Trial 2026-04-10
Abbvie Inc. HUMIRA adalimumab Injection 125057 11/23/2015 ⤷  Try a Trial 2026-04-10
Abbvie Inc. HUMIRA adalimumab Injection 125057 03/09/2016 ⤷  Try a Trial 2026-04-10
Abbvie Inc. HUMIRA adalimumab Injection 125057 10/17/2016 ⤷  Try a Trial 2026-04-10
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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