Concomitant treatment of rheumatoid arthritis with anti-TNF-α antibodies and methotrexate

DC CAFC

US 8,298,537 B2
Filed: 01/13/2012
Issued: 10/30/2012
Est. Priority Date: 08/01/1996
Status: Expired due to Fees

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1. A method of treating an individual suffering from rheumatoid arthritis who still has active disease despite prior therapy with methotrexate comprising concomitantly administering with methotrexate therapy a different composition comprising an anti-tumor necrosis factor-α

antibody or a tumor necrosis factor-α

binding fragment thereof to the individual, wherein the anti-tumor necrosis factor-α

antibody or fragment thereof (a) binds to tumor necrosis factor-α and

(b) inhibits binding of tumor necrosis factor-α

to tumor necrosis factor-α

cell surface receptors, wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.

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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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1. A method of treating an individual suffering from rheumatoid arthritis who still has active disease despite prior therapy with methotrexate comprising concomitantly administering with methotrexate therapy a different composition comprising an anti-tumor necrosis factor-α
- antibody or a tumor necrosis factor-α
  
  binding fragment thereof to the individual, wherein the anti-tumor necrosis factor-α
  
  antibody or fragment thereof (a) binds to tumor necrosis factor-α and
  
  (b) inhibits binding of tumor necrosis factor-α
  
  to tumor necrosis factor-α
  
  cell surface receptors, wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.
- View Dependent Claims (2, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 28, 30)
- - 2. The method of claim 1, wherein (a) methotrexate is administered at an interval of a week or weeks, and (b) the anti-tumor necrosis factor-α
    - antibody or fragment thereof is administered multiple times, each such administration being separated by an interval of a week or weeks from the prior administration.
  - 5. The method of claim 1, wherein each administration of methotrexate delivers from 0.01-100 mg/kg body weight of the individual.
  - 7. The method of claim 1, wherein each administration of the anti-tumor necrosis factor-α
    - antibody or fragment thereof is separated by an interval of one day to thirty weeks from the prior administration.
  - 9. The method of claim 1, wherein the anti-tumor necrosis factor-α
    - antibody or fragment thereof is an antibody.
  - 11. The method of claim 9, wherein the antibody is a monoclonal antibody.
  - 13. The method of claim 11, wherein the monoclonal antibody is a chimeric antibody.
  - 15. The method of claim 13, wherein the chimeric antibody binds to one or more amino acids of tumor necrosis factor-α
    - selected from the group of consecutive amino acids at positions 87-108 (SEQ ID NO;
      
      2) or at positions 59- 80 (SEQ ID NO;
      
      1).
  - 17. The method of claim 13, wherein the chimeric antibody binds to the epitope recognized by cA2.
  - 19. The method of claim 17, wherein the chimeric antibody is cA2.
  - 21. The method of claim 9, wherein the monoclonal antibody is a recombinant antibody.
  - 23. The method of claim 1, wherein the anti-tumor necrosis factor-α
    - antibody or fragment is administered via infusion.
  - 28. The method of claim 1, wherein 7.5 mg of methotrexate is administered at an interval of a week or weeks, and the anti-tumor necrosis factor-α
    - antibody is cA2 and is administered by infusion at a dosage of one of 1, 3 or 10 mg/kg body weight of the individual.
  - 30. The method of claim 28, wherein the dosage is 3 mg/kg.

3. A method for concomitant treatment of an individual suffering from rheumatoid arthritis who still has active disease despite prior therapy with methotrexate and who is already being treated with methotrexate comprising administering a different composition comprising an anti-tumor necrosis factor-α
- antibody or a tumor necrosis factor-α
  
  binding fragment thereof to the individual, wherein the anti-tumor necrosis factor-α
  
  antibody or fragment thereof is administered to the individual multiple times, each such administration being separated by an interval of a week or weeks from the prior administration, wherein such administration reduces or eliminates signs and symptoms associated with the rheumatoid arthritis.
- View Dependent Claims (4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29)
- - 4. The method of claim 3, wherein the anti-tumor necrosis factor-α
    - antibody or fragment thereof (a) binds to tumor necrosis factor-α and
      
      (b) inhibits binding of tumor necrosis factor-α
      
      to tumor necrosis factor-α
      
      cell surface receptors.
  - 6. The method of claim 3, wherein each administration of methotrexate delivers from 0.01-100 mg/kg body weight of the individual.
  - 8. The method of claim 3, wherein each administration of the anti-tumor necrosis factor-α
    - antibody or fragment thereof is separated by an interval of one day to thirty weeks from the prior administration.
  - 10. The method of claim 3, wherein the anti-tumor necrosis factor-α
    - antibody or fragment thereof is an antibody.
  - 12. The method of claim 10, wherein the antibody is a monoclonal antibody.
  - 14. The method of claim 12, wherein the monoclonal antibody is a chimeric antibody.
  - 16. The method of claim 14, wherein the chimeric antibody binds to one or more amino acids of tumor necrosis factor-α
    - selected from the group of consecutive amino acids at positions 87-108 (SEQ ID NO;
      
      2) or at positions 59-80 (SEQ ID NO;
      
      1).
  - 18. The method of claim 14, wherein the chimeric antibody binds to the epitope recognized by cA2.
  - 20. The method of claim 18, wherein the chimeric antibody is cA2.
  - 22. The method of claim 10, wherein the monoclonal antibody is a recombinant antibody.
  - 24. The method of claim 3, wherein the anti-tumor necrosis factor-α
    - antibody or fragment is administered via infusion.
  - 29. The method of claim 3, wherein 7.5 mg of methotrexate is administered at an interval of a week or weeks, and the anti-tumor necrosis factor-α
    - antibody is cA2 and is administered by infusion at a dosage of one of 1, 3 or 10 mg/kg body weight of the individual.

25. A method of treating an individual suffering from rheumatoid arthritis who still has active disease despite prior therapy with metotrexate comprising administering to the individual a different composition comprising an anti-human tumor necrosis factor antibody, wherein the anti-human tumor necrosis factor-α
- antibody is cA2 and is administered repeatedly as concomitant therapy to methotrexate therapy and wherein such administration reduces or eliminates signs and symptoms associated with the rheumatoid arthritis.
- View Dependent Claims (26)
- - 26. The method of claim 25, wherein the anti-tumor necrosis factor antibody is administered as a repeated infusion of 10 mg/kg body weight of the individual, and the methotrexate is administered at a dose of 10 mg/week.

27. A method of treating an individual suffering from active rheumatoid arthritis despite already receiving methotrexate comprising administering an anti-tumor necrosis factor-α
- antibody to the individual, wherein the anti-tumor necrosis factor-α
  
  antibody binds specifically to tumor necrosis factor-α
  
  , and is administered in a different composition, in single or multiple doses, as concomitant therapy to methotrexate therapy, wherein the methotrexate is administered in multiple doses and wherein such administration reduces or eliminates signs and symptoms associated with the arthritis.

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Litigation Data

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

Application Number

US13/350,262
Publication Number

US 20120141475A1
Time in Patent Office

291 Days
Field of Search

None
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

Concomitant treatment of rheumatoid arthritis with anti-TNF-α antibodies and methotrexate

First Claim

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Abstract

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30 Claims

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Concomitant treatment of rheumatoid arthritis with anti-TNF-α antibodies and methotrexate

First Claim

4 Assignments

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Abstract

39 Citations

30 Claims

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