Composition and method for treating inflammatory diseases

• US 20020009454A1
• Filed: 02/15/2001
• Published: 01/24/2002
• Est. Priority Date: 02/10/1997
• Status: Active Grant

• Current Assignee: Swedish Orphan Biovitrum AB (publ)
• Original Assignee: Amgen Inc.
• Inventors: Collins, David S., Hershenson, Susan, Boone, Thomas C., Bevilacqua, Michael P.
• Granted Patent: US 6,733,753 B2
• Time in Patent Office: Days
• US Class Current: 424/178.1
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 47/6813 the drug being a peptidic cytokine, e.g. an interleukin or interferon
• CPC Class Codes: A61K 47/6835 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
• CPC Class Codes: C07K 14/54 Interleukins [IL]
• CPC Class Codes: C07K 2319/00 Fusion polypeptide
• CPC Class Codes: C07K 2319/30 Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

A protein which exhibits a therapeutic effect on inflammation and is useful for treating IL-1-mediated inflammatory diseases, particularly diseases of the joint.

Claims

1. A method for treating a patient afflicted with an IL-1-mediated disease, comprising administering to a patient in need thereof a therapeutically effective amount of a fusion protein of IL-1ra with all or part of a constant domain of a heavy or light chain of human immunoglobulin at the amino-terminus, the carboxy-terminus or both.

2. The method of claim 1, wherein said disease is an inflammatory disease of a joint selected from the group consisting of rheumatoid arthritis, osteoarthritis and other inflammatory conditions resulting from strain, sprain, trauma, infection, cartilage damage or orthopedic surgery.

3. The method of claim 1 wherein the composition is administered by intraarticular or subcutaneous administration.

4. A pharmaceutical composition comprising an effective amount of a fusion protein of IL-1ra with all or part of a constant domain of a heavy or light chain of human immunoglobulin at the amino-terminus, the carboxy-terminus or both.

5. The composition of claim 4, wherein the IL-1ra concentration is present in a range of 0.1-200 mg/ml.

6. A method for treating a patient afflicted with an IL-1 mediated disease, comprising administering to a patient in need thereof a therapeutically effective amount of a composition comprising a controlled release polymer and a proteinaceous interleukin-1 inhibitor.

7. The method of claim 6, wherein the controlled release polymer is a hydrogel ester.

8. The method of claim 7, wherein the hydrogel ester is hyaluronan or a salt thereof.

9. The method of claim 8, wherein the hyaluronan is hyaluronic acid.

10. The method of claim 8, wherein the hyaluronan is hylan.

11. The method of claim 8, wherein the hyaluronan is sodium hyaluronate.

12. The method of claim 7, wherein the hydrogel ester is poly(vinylpyrrolidone).

13. The method of claim 7-, wherein the hydrogel ester is cellulose.

14. The method of claim 13, wherein the cellulose is carboxymethylcellulose.

15. The method of claim 6, wherein said proteinaceous interleukin-1 inhibitor is an IL-1 receptor antagonist (IL-1ra).

16. The method of claim 6, wherein said disease is an inflammatory disease of a joint selected from the group consisting of rheumatoid arthritis, osteo arthritis and other inflammatory conditions resulting from strain, sprain, trauma, infection, cartilage damage or orthopedic surgery.

17. A pharmaceutical composition comprising an effective amount of a combination of a controlled release polymer and a proteinaceous interleukin-1 inhibitor.

18. The composition of claim 17, wherein the controlled release polymer is hyaluronan or a salt thereof.

19. The composition of claim 18, wherein the hyaluronan is hyaluronic acid.

20. The composition of claim 17, wherein said proteinaceous interleukin-1 inhibitor is an IL-1 receptor antagonist (IL-1ra).