Antagonists of IL-6 to raise albumin and/or lower CRIP

Patent metadata

Field	Value
Publication number	US-9241990-B2
Application number	US-201313849597-A
Country	US
Kind code	B2
Filing date	Mar 25, 2013
Priority date	May 21, 2007
Publication date	Jan 26, 2016
Grant date	Jan 26, 2016

Abstract

The present invention is directed to therapeutic methods using IL-6 antagonists such as antibodies and fragments thereof having binding specificity for IL-6 to improve survivability or quality of life of a patient in need thereof. In preferred embodiments these patients will comprise those exhibiting (or at risk of developing) an elevated serum C-reactive protein level or a reduced serum albumin level prior to treatment. In another preferred embodiment, the patient's Glasgow Prognostic Score will be increased and survivability will preferably be improved.

First claim

What is claimed is:

1. A method of improving survivability or quality of life of a patient in need thereof, comprising administering to the patient an anti-interleukin-6 (“IL-6”) antagonist antibody or antibody fragment, whereby the patient's serum C-reactive protein (“CRP”) level is reduced, and monitoring the patient to assess the reduction in the patient's serum CRP level, wherein the anti-IL-6 antibody or antibody fragment either contains the V L CDR polypeptides having the amino acid sequences of SEQ ID NO:87, 88 and 89 and the V H CDR polypeptides having the amino acid sequences of SEQ ID NO:90, 91 and 92; or comprises the V L CDR polypeptides having the amino acid sequences of SEQ ID NO:103, 104 and 105 and the V H CDR polypeptides having the amino acid sequences of SEQ ID NO:106, 107 and 108.

2. The method of claim 1 , wherein the antibody contains V L CDR polypeptides having the amino acid sequences of SEQ ID NO:87, 88 and 89 and V H CDR polypeptides having the amino acid sequences of SEQ ID NO:90, 91 and 92.

3. The method of claim 1 , wherein the antibody contains V L CDR polypeptides having the amino acid sequences of SEQ ID NO:103, 104 and 105 and V H CDR polypeptides having the amino acid sequences of SEQ ID NO:106, 107 and 108.

4. The method of claim 1 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 90% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

5. The method of claim 1 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 95% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or SEQ ID NO:85 and 86.

6. The method of claim 1 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 98% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

7. The method of claim 1 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having the polypeptide sequences of SEQ ID NO: 101 and 102 or of SEQ ID NO:85 and 86.

8. A method of improving survivability or quality of life of a patient in need thereof, comprising administering to the patient an anti-interleukin-6 (“IL-6”) antagonist antibody or antibody fragment, whereby the patient's serum albumin level is increased, and monitoring the patient to assess the increase in the patient's serum albumin level wherein the anti-IL-6 antibody or antibody fragment either contains the V L CDR polypeptides having the amino acid sequences of SEQ ID NO:87, 88 and 89 and the V H CDR polypeptides having the amino acid sequences of SEQ ID NO:90, 91 and 92; or comprises the V L CDR polypeptides having the amino acid sequences of SEQ ID NO:103, 104 and 105 and the V H CDR polypeptides having the amino acid sequences of SEQ ID NO:106, 107 and 108.

9. The method of claim 8 , wherein the antibody contains V L CDR polypeptides having the amino acid sequences of SEQ ID NO:87, 88 and 89 and V H CDR polypeptides having the amino acid sequences of SEQ ID NO:90, 91 and 92.

10. The method of claim 8 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 90% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

11. The method of claim 8 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 95% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

12. The method of claim 8 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 98% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or SEQ ID NO:85 and 86.

13. The method of claim 8 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having the polypeptide sequences of SEQ ID NO: 101 and 102 or of SEQ ID NO:85 and 86.

14. The method of claim 8 , wherein the antibody contains V L CDR polypeptides having the amino acid sequences of SEQ ID NO:103, 104 and 105 and V H CDR polypeptides having the amino acid sequences of SEQ ID NO:106, 107 and 108.

15. A method of improving survivability or quality of life of a patient in need thereof, comprising administering to the patient an anti-interleukin-6 (“IL-6”) antagonist antibody or antibody fragment, whereby the patient's serum CRP level is reduced and the patient's serum albumin level is increased, and monitoring the patient to assess the reduction in the patient's serum CRP level and the increase in the patient's serum albumin level, wherein the anti-IL-6 antibody or antibody fragment either contains the V L CDR polypeptides having the amino acid sequences of SEQ ID NO:87, 88 and 89 and the V H CDR polypeptides having the amino acid sequences of SEQ ID NO:90, 91 and 92; or comprises the V L CDR polypeptides having the amino acid sequences of SEQ ID NO:103, 104 and 105 and the V H CDR polypeptides having the amino acid sequences of SEQ ID NO:106, 107 and 108.

16. The method of claim 15 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 90% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

17. The method of claim 15 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 95% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

18. The method of claim 15 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having at least 98% sequence identity to the polypeptide sequences of SEQ ID NO: 101 and 102 or to SEQ ID NO:85 and 86.

19. The method of claim 15 , wherein the anti-IL-6 antibody or antibody fragment comprises a variable light and heavy polypeptide respectively having the polypeptide sequences-of SEQ ID NO: 101 and 102 or of SEQ ID NO:85 and 86.

20. The method of claim 15 , wherein the antibody contains V L CDR polypeptides having the amino acid sequences of SEQ ID NO:87, 88 and 89 and V H CDR polypeptides having the amino acid sequences of SEQ ID NO:90, 91 and 92.

21. The method of claim 15 , wherein the antibody contains V L CDR polypeptides having the amino acid sequences of SEQ ID NO:103, 104 and 105 and V H CDR polypeptides having the amino acid sequences of SEQ ID NO:106, 107 and 108.

Assignees

• Alderbio Holdings Llc

Inventors

• Smith Jeffrey T L

Classifications

• 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

• C07K16/248 Primary

  IL-6 · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• G01N2333/765

  Serum albumin, e.g. HSA · CPC title

• G01N2333/4737

  C-reactive protein · CPC title