Diagnosis and treatment of autoimmune diseases

Patent metadata

Field	Value
Publication number	US-12061206-B2
Application number	US-202016849492-A
Country	US
Kind code	B2
Filing date	Apr 15, 2020
Priority date	Oct 21, 2013
Publication date	Aug 13, 2024
Grant date	Aug 13, 2024

Abstract

Methods, kits and compositions for diagnosing and treating autoimmune diseases such as rheumatiodi arthritis. Crohn's disease, and ulcerative colitis.

First claim

What is claimed is:

1. A method of analyzing a biological sample, the method comprising:
(i) providing a biological sample of a human subject suspected of having an autoimmune disease;
(ii) measuring a level of cleaved high molecular weight kininogen (HMWK) in the biological sample,
(iii) identifying the human subject having a level of cleaved HMWK in the biological sample that is elevated compared to a control sample as having the autoimmune disease, and
(iv) administering to the human subject identified in step (iii) a plasma kallikrein (pKal) inhibitor, an anti-inflammatory agent, or a combination thereof;
wherein the biological sample and the control sample are a serum sample, a blood sample, or a plasma sample;
wherein the autoimmune disease is selected from the group consisting of: inflammatory bowel disease, rheumatoid arthritis, Crohn's disease, and ulcerative colitis; and
wherein the level of cleaved HMWK is measured by an assay that involves a binding agent specific to cleaved HMWK.

2. The method of claim 1 , wherein the biological sample comprises one or more protease inhibitors, which are added to the biological sample after its collection.

3. The method of claim 1 , wherein the binding agent is an antibody.

4. The method of claim 1 , wherein the assay is an enzyme-linked immunosorbent assay (ELISA) or an immunoblotting assay.

5. The method of claim 1 , wherein the assay is a Western blotting assay.

6. The method of claim 1 , wherein the autoimmune disease is inflammatory bowel disease.

7. The method of claim 1 , wherein the autoimmune disease is rheumatoid arthritis.

8. The method of claim 1 , wherein the autoimmune disease is Crohn's disease.

9. The method of claim 1 , wherein the autoimmune disease is ulcerative colitis.

10. The method of claim 1 , wherein the pKal inhibitor comprises:
(i) amino acids 3-60 of SEQ ID NO: 2 or amino acids 1-60 of SEQ ID NO: 2; or
(ii) an antibody that binds plasma kallikrein.

11. The method of claim 1 , wherein the anti-inflammatory agent is a steroid or a non-steroidal anti-inflammatory drug (NSAID).

12. The method of claim 11 , wherein the steroid is cortisol, cortisone, fludrocortisone, prednisone, 6[alpha]-methylprednisone, triamcinolone, betamethasone, or dexamethasone.

13. The method of claim 11 , wherein the NSAID is aspirin, acetaminophen, tolmetin, ibuprofen, mefenamic acid, piroxicam, nabumetone, rofecoxib, celecoxib, etodolac, or nimesulide.

Assignees

• Takeda Pharmaceuticals Co

Inventors

• Sexton Daniel J
• Adelman Burt
• Nixon Andrew

Classifications

• G01N2800/56

  Staging of a disease; Further complications associated with the disease · CPC title

• G01N2333/745

  Assays involving non-enzymic blood coagulation factors · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title

• G01N2800/102

  Arthritis; Rheumatoid arthritis, i.e. inflammation of peripheral joints · CPC title

• G01N2800/065

  Bowel diseases, e.g. Crohn, ulcerative colitis, IBS · CPC title