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Last Updated: March 28, 2024

Claims for Patent: 10,386,366


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Summary for Patent: 10,386,366
Title:Assays for the detection of anti-TNF drugs and autoantibodies
Abstract: The present invention provides assays for detecting and measuring the presence or level of anti-TNF.alpha. drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF.alpha. drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.
Inventor(s): Singh; Sharat (Rancho Santa Fe, CA), Wang; Shui-Long (San Diego, CA), Ohrmund; Linda (San Diego, CA)
Assignee: SOCIETE DES PRODUITS NESTLE S.A. (Vevey, CH)
Application Number:15/297,878
Patent Claims:1. A method for optimizing therapy and/or reducing toxicity to an anti-TNF.alpha. drug in a subject receiving therapy with said anti-TNF.alpha. drug, said method comprising: (a) measuring the level of said anti-TNF.alpha. drug in a first sample from said subject, wherein said anti-TNF.alpha. drug is measured with an assay comprising: (i) contacting said first sample with an amount of a labeled TNF.alpha. to form a first complex comprising said labeled TNF.alpha. with said anti-TNF.alpha. drug; and detecting an amount of said first complex by size exclusion chromatography and comparing the amount detected to a standard curve of known amounts of the anti-TNF.alpha. drug, thereby measuring said level of said anti-TNF.alpha. drug; (b) measuring the level of an autoantibody to said anti-TNF.alpha. drug in a second sample from said subject; and (c) determining a subsequent course of therapy for said subject based upon the levels of said anti-TNF.alpha. drug and said autoantibody, thereby optimizing therapy and/or reducing toxicity to said anti-TNF.alpha. drug.

2. The method of claim 1, wherein the subsequent course of therapy comprises co-administering an immunosuppressive drug with said anti-TNF.alpha. drug when said level of said anti-TNF.alpha. drug is a high level and said level of said autoantibody is a low level.

3. The method of claim 1, wherein the subsequent course of therapy comprises increasing the level of said anti-TNF.alpha. drug and co-administering an immunosuppressive drug when said level of said anti-TNF.alpha. drug is a medium level and said level of said autoantibody is a low level.

4. The method of claim 1, wherein the subsequent course of therapy comprises administering a different anti-TNF.alpha. drug when said level of said anti-TNF.alpha. drug is a medium level and said level of said autoantibody is a medium level.

5. The method of claim 1, wherein the subsequent course of therapy comprises administering a different anti-TNF.alpha. drug when said level of said anti-TNF.alpha. drug is a low level and said level of said autoantibody is a high level.

6. The method of claim 4, wherein adalimumab is administered instead of infliximab.

7. The method of claim 1, wherein said autoantibody is measured with an assay comprising: (i) contacting said second sample with an amount of a labeled anti-TNF.alpha. drug to form a second complex comprising said labeled anti-TNF.alpha. drug with said autoantibody; and (ii) detecting said second complex by size exclusion chromatography, thereby measuring said level of said autoantibody.

8. The method claim 1, wherein said anti-TNF.alpha. drug is a member selected from the group consisting of infliximab, etanercept, adalimumab, certolizumab pegol, and combinations thereof.

9. The method of claim 1, wherein said anti-TNF.alpha. drug is infliximab.

10. The method of claim 1, wherein said anti-TNF.alpha. drug is adalimumab.

11. The method of claim 1, wherein said anti-TNF.alpha. drug is etanercept.

12. The method of claim 1, wherein said anti-TNF.alpha. drug is certolizumab pegol.

13. The method of claim 1, wherein said measured anti-TNF.alpha. drug is quantitated.

14. The method of claim 1, wherein said measured autoantibody is quantitated.

15. The method of claim 1, wherein both of said first and second samples are serum samples.

16. The method of claim 1, wherein both of said first and second samples are obtained from said subject during therapy with said anti-TNF.alpha. drug.

17. The method of claim 1, wherein said autoantibody is a member selected from the group consisting of human anti-mouse antibody (HAMA), human anti-chimeric antibody (HACA), human anti-humanized antibody (HAHA), and combinations thereof.

18. The method of claim 2, wherein said immunosuppressive drug is selected from the group consisting of methotrexate, azathioprine, metabolites thereof, and combinations thereof.

19. The method of claim 2, wherein said level of said anti-TNF.alpha. drug is between about 10 to about 50 ng/10 .mu.l and said level of said autoantibody is between about 0.1 to about 2.0 ng/10 .mu.l.

20. The method of claim 3, wherein said level of said anti-TNF.alpha. drug is between about 5.0 to about 20 ng/10 .mu.l and said level of said autoantibody is between about 0.1 to about 2.0 ng/10 .mu.l.

21. The method of claim 4, wherein said level of said anti-TNF.alpha. drug is between about 5.0 to about 20 ng/10 .mu.l and said level of said autoantibody is between about 0.5 to about 10 ng/10 .mu.l.

22. The method of claim 5, wherein said level of said anti-TNF.alpha. drug is between 0 to about 5 ng/10 .mu.l and said level of said autoantibody is between about 3.0 to about 50 ng/10 .mu.l.

Details for Patent 10,386,366

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2029-10-26
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2029-10-26
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2029-10-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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