METHODS OF TREATING SYSTEMIC LUPUS ERYTHEMATOSUS

• US 20100143373A1
• Filed: 12/06/2007
• Published: 06/10/2010
• Est. Priority Date: 12/06/2006
• Status: Abandoned Application

• Current Assignee: Medimmune LLC (Astrazeneca PLC)
• Original Assignee: Medimmune LLC (Astrazeneca PLC)
• Inventors: White, Barbara
• Application Number:
  US12/517,334
• Publication Number:
  US 20100143373A1
• Time in Patent Office: Days
• US Class Current: 424/158.100
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: C07K 16/249 Interferons
• CPC Class Codes: C07K 2317/21 from primates, e.g. man
• CPC Class Codes: C07K 2317/565 Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/136 : Screening for pharmacological compounds
• CPC Class Codes: C12Q 2600/158 : Expression markers
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention relates to a method of treating SLE in a human subject comprising administration of an anti-interferon α antibody.

Claims

1. A method of treating moderate, severe, or very severe SLE in a human subject in need thereof, said method comprising administration- of an anti-IFNα

monoclonal antibody.

3. The method of claim 1, wherein said human subject is a member of an indicated population composed predominantly of human subjects with moderate, severe, or very severe SLE.

5. The method of claim 1, wherein said human subject has a pre-treatment SLEDAI score of X, wherein X is equal to between and including 6 to 105, said method comprising administration of an anti-interferon α

monoclonal antibody to said subject, wherein said administration yields a post-treatment SLEDAI score of X minus between and including 1 to 105, wherein the lowest SLEDAI value that X minus between and including 1 to 105 can yield is 0.

6. The method of claim 1, wherein said human subject is a member of a population composed predominantly of human subjects with a first pre-treatment SLEDAI score indicative of moderate, severe, or very severe SLE, and wherein said SLEDAI score improves posttreatment.

8. The method of claim 6, wherein said pretreatment SLEDAI score is at least 5.

9. The method of claim 6, wherein said posttreatment SLEDAI score is equal to the pre-treatment SLEDAI score minus at least 1, with 0 being lowest post-treatment SLEDAI score attainable.

10. The method of claim 6, wherein said reduction in SLEDAI score is evident at least 14 days, at least 28 days, or at least 56 days post antibody administration.

11. The method of claim 1, wherein said anti-interferon α

monoclonal antibody is administered at a dose selected from the group consisting of 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 3.0 mg/kg, 4.0 mg/kg, 5.0 mg/kg, 6.0 mg/kg, 7.0 mg/kg, 8.0 mg/kg, 9.0 mg/kg, 10.0 mg/kg, 11.0 mg/kg, 12.0 mg/kg, 13.0 mg/kg, 14.0 mg/kg, 15.0 mg/kg, 16.0 mg/kg, 17.0 mg/kg, 18.0 mg/kg, 19.0 mg/kg, 20.0 mg/kg, 25 mg/kg, and 30 mg/kg.

12. The method of claim 1, wherein said anti-interferon α

monoclonal antibody selectively binds to at least interferon α

subtypes α

2a and/or α

2b.

13. The method of claim 1, wherein said anti-interferon α

monoclonal antibody selectively binds to at least interferon α

subtypes α

1, α

2, α

4, α

5, α

8, α

10, and α

21.

14. The method of claim 1, wherein said antiinteferon α

monoclonal antibody is not MEDI-545.

15. The method of claim 1, further comprising administration of at least one additional therapeutic as part of the treatment regimen.

16. The method of claim 15, wherein said additional therapeutic is selected from the group consisting of:

corticosteroids, NSAIDS, antimalarials, immunomodulating agents, and anticoagulants.

17. The method of claim 16, wherein said corticosteroid is selected from the group consisting of prednisone, prednisolone, methylprednisolone, betamethasone, dexamethasone, triamcinolone and hydrocortisone.

18. The method of claim 17, wherein said corticosteroid is prednisone.

19. The method of claim 1, wherein said anti-interferon α

monoclonal antibody is administered parenterally.

20. The method of claim 19, wherein said anti-interferon α

monoclonal antibody is administered intravenously.

21. The method of claim 19, wherein said anti-interferon α

monoclonal antibody is administered subcutaneously.

2. (canceled)

4. A method of treating SLE in a human population composed predominantly of human subjects with moderate, severe, or very severe SLE, said method comprising administration of an anti-IFNα

monoclonal antibody.

7. A method of reducing SLEDAI flares in a human subject with moderate, severe, or very severe SLE, said method comprising administering to said subject and anti-IFNα

monoclonal antibody.