Treatment for rheumatoid arthritis

Patent metadata

Field	Value
Publication number	US-2024417455-A1
Application number	US-202418817360-A
Country	US
Kind code	A1
Filing date	Aug 28, 2024
Priority date	Sep 20, 2012
Publication date	Dec 19, 2024
Grant date	—

Abstract

The present invention provides anti-GM-CSF antibodies for use in the treatment of rheumatoid arthritis. Anti-GM-CSF antibodies, in particular MOR103, are administered to patients suffering from rheumatoid arthritis at dosages that are beneficial in a clinical setting.

First claim

1 . An anti-GM-CSF antibody for use in the treatment of a patient suffering from rheumatoid arthritis, wherein said antibody is administered to said patient in a manner to achieve a therapeutically effective antibody level in the blood of said patient equal or higher compared to the intravenous administration of said antibody at a dose of at least 1.0 mg/kg when administered weekly over at least four weeks.

2 . The anti-GM-CSF antibody of claim 1 , wherein said antibody is administered subcutaneously.

3 . The anti-GM-CSF antibody of claim 2 , wherein said antibody is administered at a dose of at least 2.0 mg/kg.

4 . The anti-GM-CSF antibody of claim 3 , wherein said antibody is administered at a dose of about 2.0 mg/kg, about 3.0 mg/kg or about 4.0 mg/kg.

5 . The anti-GM-CSF antibody of any one of claims 1 to 4 , wherein said antibody is administered biweekly, monthly or bimonthly.

6 . The anti-GM-CSF antibody of claim 2 , wherein said antibody is administered at a fixed dose of about 75 mg, of about 100 mg, of about 150 mg, of about 200 mg, of about 300 mg or of about 400 mg.

7 . The anti-GM-CSF antibody of claim 1 , wherein said antibody is administered intravenously.

8 . The anti-GM-CSF antibody of claim 7 , wherein said antibody is administered at a dose of at least 1.0 mg/kg.

9 . The anti-GM-CSF antibody of claim 8 , wherein said antibody is administered at a dose of about 1.0 mg/kg or at a dose of about 1.5 mg/kg.

10 . The anti-GM-CSF antibody of any one of claims 7 to 9 , wherein said antibody in administered weekly over at least four weeks.

11 . The anti-GM-CSF antibody of any one of the preceding claims , wherein said anti-GM-CSF antibody is an antibody comprising an HCDR1 region of sequence GFTFSSYWMN (SEQ ID NO.: 2), an HCDR2 region of sequence GIENKYAGGATYYAASVKG (SEQ ID NO.: 3, an HCDR3 region of sequence GFGTDF (SEQ ID NO.: 4), an LCDR1 region of sequence SGDSIGKKYAY (SEQ ID NO.: 5), an LCDR2 region of sequence KKRPS (SEQ ID NO.: 6), and an LCDR3 region of sequence SAWGDKGM (SEQ ID NO.: 7).

12 . The anti-GM-CSF antibody of any one of the preceding claims , wherein said anti-GM-CSF antibody is administered in combination with a DMARD, such as methotrexate.

13 . A method of treating a patient suffering from rheumatoid arthritis, said method comprising administering to said patient an anti-GM-CSF antibody subcutaneously at
(i) a dose of at least 1.0 mg/kg, or (ii) a fixed dose of between 40 mg and 400 mg.

14 . A method according to claim 13 , wherein said anti-GM-CSF antibody is administered to said patient in a manner to achieve to a serum concentration of said antibody at at least 2 μg/ml in said patient over the duration of said treatment.

15 . A method according to claim 13 or 14 , wherein said antibody is administered to said patient in a manner to achieve a therapeutically effective antibody level in the blood of said patient equal or higher compared to the intravenous administration of said antibody at a dose of at least 1.0 mg/kg when administered weekly over at least four weeks.

16 . A method according to any one of claims 13 to 15 , wherein said antibody is administered subcutaneously at a dose at least 1.0, at least 1.5, at least 2.0, at least 2.5, at least 3.0, at least 3.5 or at least 4.0 mg/kg.

17 . A method according to claim 16 , wherein said antibody is administered biweekly, monthly or bimonthly.

18 . A method according to any one of claims 13 to 15 , wherein said antibody is administered at a fixed dose of 40 mg, at a fixed dose of 75 mg, at a fixed dose of 100 mg, at a fixed dose of 140 mg, at a fixed dose of 150 mg, at a fixed dose of 180 mg, at a fixed dose of 200 mg, at a fixed dose of 280 mg, at a fixed dose of 300 mg or at a fixed dose of 400 mg.

19 . A method according to claim 18 , wherein said antibody is administered every week, every second week, every third week, every fourth week or every sixth week.

20 . A method according to cliam 18 , wherein said antibody is administered weekly.

Assignees

• Morphosys Ag

Inventors

• Hartle Stefan
• Leclair Stephane
• Shebl Amgad
• Steidl Stefan
• Brocks Bodo
• Ducata Daniela Della
• Rosport Kai

Classifications

• C07K2317/76

  Antagonist effect on antigen, e.g. neutralization or inhibition of binding · CPC title

• A61K39/3955 Primary

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• A61K31/519

  ortho- or peri-condensed with heterocyclic rings · CPC title

• C07K16/2866

  against receptors for cytokines, lymphokines, interferons · CPC title

• C07K2317/21

  from primates, e.g. man · CPC title