Anti-TNF antibodies and methotrexate in the treatment of arthritis and crohn's disease

US 6,270,766 B1
Filed: 08/01/1996
Issued: 08/07/2001
Est. Priority Date: 10/08/1992
Status: Expired due to Fees

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1. A method of treating arthritis in an individual in need thereof comprising co-administering methotrexate and an anti-tumor necrosis factor alpha antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.

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Abstract

Methods for treating and/or preventing a TNF-mediated disease in an individual are disclosed. Also disclosed is a composition comprising methotrexate and an anti-tumor necrosis factor antibody. TNF-mediated diseases include rheumatoid arthritis, Crohn'"'"'s disease, and acute and chronic immune diseases associated with transplantation.

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30 Claims

1. A method of treating arthritis in an individual in need thereof comprising co-administering methotrexate and an anti-tumor necrosis factor alpha antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.
- View Dependent Claims (2, 3, 4, 5, 6, 7)
- - 2. A method of claim 1 wherein the anti-tumor necrosis factor alpha antibody or antigen binding fragment is administered in a series of doses separated by intervals of days or weeks.
  - 3. A method of claim 1 wherein the anti-tumor necrosis factor alpha antibody or antigen-binding fragment is a chimeric antibody or chimeric fragment, wherein said chimeric antibody or chimeric fragment comprises a non-human variable region specific for tumor necrosis factor alpha or an antigen-binding portion thereof and a human constant region.
  - 4. A method of claim 3 wherein the chimeric antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:
    - 2.
  - 5. A method of claim 3 wherein the chimeric antibody competitively inhibits binding of TNFα
    - to monoclonal antibody cA2.
  - 6. A method of claim 5 wherein the chimeric antibody is monoclonal antibody cA2.
  - 7. A method of claim 1 wherein the anti-TNFα
    - antibody or antigen-binding fragment is a humanized anti-TNFα
      
      antibody or antigen-binding fragment thereof.

8. A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an anti-tumor necrosis factor alpha antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.
- View Dependent Claims (9, 10, 11, 12, 13, 14)
- - 9. A method of claim 8 wherein the anti-tumor necrosis factor alpha antibody or antigen-binding fragment is administered in a series of doses separated by intervals of days or weeks.
  - 10. A method of claim 8 wherein the anti-tumor necrosis factor alpha antibody or antigen-binding fragment is a chimeric antibody or chimeric fragment, wherein said chimeric antibody or chimeric fragment comprises a non-human variable region specific for tumor necrosis factor alpha or an antigen-binding portion thereof and a human constant region.
  - 11. A method of claim 10 wherein the chimeric antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:
    - 1 or SEQ ID NO;
      
      2..
  - 12. A method of claim 10 wherein the chimeric antibody competitively inhibits binding of TNFα
    - to monoclonal antibody cA2.
  - 13. A method of claim 12 wherein the chimeric antibody is monoclonal antibody cA2.
  - 14. A method of claim 8 wherein the anti-TNFα
    - antibody or antigen-binding fragment is a humanized anti-TNFα
      
      antibody or antigen-binding fragment thereof.

15. A method of treating Crohn'"'"'s disease in an individual in need thereof comprising co-administering methotrexate and an anti-tumor necrosis factor alpha antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.
- View Dependent Claims (16, 17, 18, 19, 20, 21)
- - 16. A method of claim 15 wherein the anti-tumor necrosis factor alpha antibody or antigen-binding fragment is administered in a series of doses separated by intervals of days or weeks.
  - 17. A method of claim 15 wherein the anti-tumor necrosis factor alpha antibody or antigen-binding fragment is a chimeric antibody or chimeric fragment, wherein said chimeric antibody or chimeric fragment comprises a non-human variable region specific for tumor necrosis factor alpha or an antigen-binding portion thereof and a human constant region.
  - 18. A method of claim 17 wherein the chimeric antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:
    - 1 or SEQ ID NO;
      
      2.
  - 19. A method of claim 17 wherein the chimeric antibody competitively inhibits binding of TNFα
    - to monoclonal antibody cA2.
  - 20. A method of claim 17 wherein the chimeric antibody is monoclonal antibody cA2.
  - 21. A method of claim 15 wherein the anti-TNFα
    - antibody or antigen-binding fragment is a humanized anti-TNFα
      
      antibody or antigen-binding fragment thereof.

22. A composition comprising methotrexate and an anti-tumor necrosis factor alpha antibody or an antigen-binding fragment thereof.
- View Dependent Claims (23, 24, 25, 26, 27)
- - 23. A composition of claim 22 wherein the anti-tumor necrosis factor alpha antibody or antigen-binding fragment is a chimeric antibody or chimeric fragment, wherein said chimeric antibody or chimeric fragment comprises a non-human variable region specific for tumor necrosis factor alpha or an antigen-binding portion thereof and a human constant region.
  - 24. A composition of claim 23 wherein the chimeric antibody binds to one or more epitopes included in amino acid residues set forth in SEQ ID NO:
    - 1 or SEQ ID NO;
      
      2. .
  - 25. A composition of claim 23 wherein the chimeric antibody competitively inhibits binding of TNFα
    - to monoclonal antibody cA2.
  - 26. A composition of claim 25 wherein the chimeric antibody is monoclonal antibody cA2.
  - 27. A method of claim 22 wherein the anti-TNFα
    - antibody or antigen-binding fragment is a humanized anti-TNFα
      
      antibody or antigen-binding fragment thereof.

28. A method of treating arthritis in an individual in need thereof comprising co-administering to the individual, in therapeutically effective amounts, methotrexate and a soluble TNFα
- receptor or functional portion thereof, wherein said soluble TNFα
  
  receptor is selected from the group consisting of p55 TNFα
  
  receptor and p75 TNFα
  
  receptor.
- View Dependent Claims (29, 30)
- - 29. A method of claim 28 wherein the soluble TNFα
    - receptor is a TNFα
      
      receptor multimeric molecule.
  - 30. A method of claim 28 wherein the soluble TNFα
    - receptor is a TNFα
      
      immunoreceptor fusion molecule.

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Litigation Data

Current Assignee
Mathilda and Terence Kennedy Institute of Rheumatology Trust
Original Assignee
The Kennedy Institute Of Rheumatology (University of Oxford)
Inventors
Feldman, Marc, Maini, Ravinder N.
Primary Examiner(s)
Gambel, Phillip

Application Number

US08/690,775
Time in Patent Office

1,832 Days
Field of Search

424/130.1, 424/133.1, 424/145.1, 424/152.1, 424/158.1, 424/172.1, 424/184.1, 424/192.1, 514/218, 514/885, 514/253, 530/387.1, 530/387.3, 530/388.1, 530/388.2, 530/388.23
US Class Current

424/145.1
CPC Class Codes

A61K 2039/505   comprising antibodies

A61K 2039/545   characterised by the dose, ...

A61K 2300/00   Mixtures or combinations of...

A61K 31/505   Pyrimidines; Hydrogenated p...

A61K 31/519   ortho- or peri-condensed wi...

A61K 38/1793   for cytokines; for lymphoki...

A61K 39/395   Antibodies agglutinins A61K...

A61K 39/39541   against normal tissues, cells

A61K 39/3955   against proteinaceous mater...

A61K 45/06   Mixtures of active ingredie...

A61P 1/00   Drugs for disorders of the ...

A61P 19/02   for joint disorders, e.g. a...

A61P 29/00   Non-central analgesic, anti...

A61P 37/00   Drugs for immunological or ...

A61P 37/06   Immunosuppressants, e.g. dr...

C07K 16/241   Tumor Necrosis Factors

C07K 2317/24   containing regions, domains...

C07K 2319/00   Fusion polypeptide

Anti-TNF antibodies and methotrexate in the treatment of arthritis and crohn's disease

First Claim

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Abstract

200 Citations

30 Claims

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Anti-TNF antibodies and methotrexate in the treatment of arthritis and crohn's disease

First Claim

2 Assignments

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Abstract

200 Citations

30 Claims

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