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Last Updated: January 17, 2020

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Claims for Patent: 9,086,418

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Summary for Patent: 9,086,418
Title:Methods and compositions for diagnosing ankylosing spondylitis using biomarkers
Abstract: The invention provides a method for determining the efficacy of a TNF.alpha. inhibitor, such as a TNF.alpha. antibody, or an antigen-binding portion thereof, for treating ankylosing spondylitis (AS), using a collagen degradation biomarker and/or a synovitis biomarker.
Inventor(s): Maksymowych; Walter P. (Edmonton, CA), Wong; Robert L. (Basking Ridge, NJ)
Assignee: ABBVIE BIOTECHNOLOGY LTD. (Hamilton, BM)
Application Number:13/034,809
Patent Claims:1. A method for treating a subject having active ankylosing spondylitis (AS), said method comprising (a) identifying a subject having active AS; (b) administering 40 mg of adalimumab to the subject; (c) determining a post-treatment level of type II collagen C-telopeptide (CTX-II) in a urine sample(s) obtained from the subject following administration of adalimumab to the subject, wherein the post-treatment level of CTX-II is determined using an antibody that specifically binds to CTX-II in an immunoassay; and (d) administering at least one additional dose of 40 mg of adalimumab to the subject provided that the post-treatment level of CTX-II in the sample(s) obtained from the subject is lower than a known standard level of CTX-II, thereby treating the subject having active AS.

2. A method for treating a subject having active ankylosing spondylitis (AS), said method comprising (a) identifying a subject having active AS; (b) administering 40 mg of adalimumab to the subject; (c) determining a post-treatment level of type II collagen C-telopeptide (CTX-II) in a urine sample(s) obtained from the subject following administration of adalimumab to the subject, wherein the post-treatment level of CTX-II is determined using an antibody that specifically binds to CTX-II in an immunoassay; and (d) administering at least one additional dose of 40 mg of adalimumab to the subject provided that the post-treatment level of CTX-II in the sample(s) obtained from the subject is lower than a baseline level of CTX-II in a sample(s) obtained from the subject, thereby treating the subject having active AS.

3. A method for decreasing structural damage associated with ankylosing spondylitis (AS) in a subject having AS, said method comprising (a) identifying a subject having AS; (b) administering 40 mg of adalimumab to the subject; (c) determining a post-treatment level of type II collagen C-telopeptide (CTX-II) in a urine sample(s) obtained from the subject following administration of adalimumab to the subject, wherein the post-treatment level of CTX-II is determined using an antibody that specifically binds to CTX-II in an immunoassay; and (d) administering at least one additional 40 mg dose of adalimumab to the subject, provided that the post-treatment level of CTX-II in the sample(s) obtained from the subject is lower than a known standard level of CTX-II, thereby decreasing structural damage associated with AS in a subject having AS.

4. A method for decreasing structural damage associated with ankylosing spondylitis (AS) in a subject having AS, said method comprising (a) identifying a subject having AS; (b) administering 40 mg of adalimumab to the subject; (c) determining a post-treatment level of type II collagen C-telopeptide (CTX-II) in a urine sample(s) obtained from the subject following administration of adalimumab to the subject, wherein the post-treatment level of CTX-II is determined using an antibody that specifically binds to CTX-II in an immunoassay; and (d) administering at least one additional 40 mg dose of adalimumab to the subject, provided that the post-treatment level of CTX-II in the sample(s) obtained from the subject is lower than a baseline level of CTX-II in a sample(s) obtained from the subject, thereby decreasing structural damage associated with AS in a subject having AS.

5. The method of any one of claims 1-4, further comprising determining a level of C-reactive protein (CRP) in a sample(s) obtained from the subject following administration of adalimumab.

6. The method of any one of claims 1-4, wherein the level of the CTX-II is determined using ELISA.

7. The method of claim 2 or 4, wherein the post-treatment CTX-II level is at least about a 9% decrease relative to the baseline CTX-II level.

8. The method of any one of claims 1-4, further comprising determining a post-treatment level of a synovitis biomarker in a sample(s) obtained from the subject following administration of adalimumab.

9. The method of claim 8, wherein the synovitis biomarker is serum MMP3.

10. The method of claim 9, wherein the level of the serum MMP3 is determined using ELISA.

Details for Patent 9,086,418

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial ABBVIE BIOTECHNOLOGY LTD. (Hamilton, BM) 2021-03-07 RX Orphan search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial ABBVIE BIOTECHNOLOGY LTD. (Hamilton, BM) 2021-03-07 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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