TREATMENT PARADIGM

• US 20190322734A1
• Filed: 10/31/2016
• Published: 10/24/2019
• Est. Priority Date: 11/02/2015
• Status: Abandoned Application

• Current Assignee: GlaxoSmithKline Intellectual Property Development Limited (GSK plc)
• Original Assignee: GlaxoSmithKline Intellectual Property Development Limited (GSK plc)
• Inventors: TAK, Paul-Peter
• Application Number:
  US15/772,664
• Publication Number:
  US 20190322734A1
• Time in Patent Office: Days
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• 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 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/243 Colony Stimulating Factors
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Abstract

An antibody antagonist of GM-CSF for use in the treatment of a patient suffering from rheumatoid arthritis (RA), wherein said antibody is administered to said patient according to the following treatment regimen:

• • i. a first period wherein the antibody is administered once a week; and
  • ii. a second period wherein the antibody is administered every other week and then ceased once said patient has sustained remission for a continuous period of at least two months.

Claims

1. A method for the treatment of RA in a subject comprising administration to the subject an effective amount of an antibody antagonist of GM-CSF, wherein said antibody is administered to said patient according to the following treatment regimen:

i. a first period wherein the antibody is administered once a week; and

ii. a second period wherein the antibody is administered every other week and then ceased once said patient has sustained remission for a continuous period of at least two months.

2. The method for treatment according to claim 1, wherein remission is maintained after the second period for at least six months while treatment with the antibody is ceased.

3. The method for treatment according to claim 1, wherein remission is maintained after the second period for at least one year while treatment with the antibody is ceased.

4. The method for treatment according to claim 1, wherein the first period is five weeks.

5. The method for treatment according to claim 1, wherein the second period is from one to two years.

6. The method for treatment according to claim 1, wherein RA is early RA.

7. The method for treatment according to claim 1, wherein the patient is csDMARD-naï

ve before commencing treatment.

8. The method for treatment according to claim 1, wherein the antibody is specific for GM-CSF.

9. The method for treatment according to claim 8, wherein said antibody specific for GM-CSF is an antibody comprising an HCDR1 region of sequence GFTFSSYWMN (SEQ ID NO.:

1), an HCDR2 region of sequence GIENKYAGGATYYAASVKG (SEQ ID NO.;

     2), an HCDR3 region of sequence GFGTDF (SEQ ID NO.;

     3), an LCDR1 region of sequence SGDSIGKKYAY (SEQ ID NO.;

     4), an LCDR2 region of sequence KKRPS (SEQ ID NO.;

     5), and an LCDR3 region of sequence SAWGDKGM (SEQ ID NO.;

     6).

10. The method for treatment according to claim 8, wherein said antibody specific for GM-CSF is an antibody comprising a heavy chain peptide sequence according to SEQ ID NO:

11 and a light chain peptide sequence according to SEQ ID NO;

12.

11. The method for treatment according to claim 1, wherein the antibody is specific for the GM-CSF receptor.

12. The method for treatment according to claim 11, wherein said antibody specific for the GM-CSF receptor is an antibody comprising a variable heavy chain peptide sequence according to SEQ ID NO:

9 and a variable light chain peptide sequence according to SEQ ID NO;

10.

13. The method for treatment according to claim 1, wherein said antibody is administered at a fixed dose of from 20 mg to 200 mg.

14. The method for treatment according to claim 1, wherein said antibody is administered subcutaneously.

15. The method for treatment according to claim 1, wherein the patient receives csDMARD treatment in combination with the antibody treatment which is continued after the second period.

16. The method for treatment according to claim 1, wherein the csDMARD is administered to said patient once a week.

17. The method for treatment according to claim 16, wherein said csDMARD is methotrexate.

18. The method for treatment according to claim 1, wherein said antibody is administered intravenously.