Treatment of rheumatoid arthritis with a combination of laquinimod and methotrexate

• US 8,501,766 B2
• Filed: 03/02/2011
• Issued: 08/06/2013
• Est. Priority Date: 03/03/2010
• Status: Expired due to Fees

• Current Assignee: Teva Pharmaceutical Industries Limited
• Original Assignee: Teva Pharmaceutical Industries Limited
• Inventors: Kaye, Joel, Blaugrund, Eran, Tarcic, Nora
• Primary Examiner(s): Carter, Kendra D
• Application Number:
  US13/039,188
• Publication Number:
  US 20110218203A1
• Time in Patent Office: 888 Days
• Field of Search: 514/250, 514/262.1, 514/313, 544/350, 544/255, 546/134
• US Class Current: 514/299
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4704 2-Quinolinones, e.g. carbostyril
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• 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 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

Abstract

This invention provides a method of treating a subject afflicted with rheumatoid arthritis comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof and an amount of methotrexate, wherein the amounts when taken together are effective to treat the subject. This invention also provides laquinimod or pharmaceutically acceptable salt thereof for use in combination with methotrexate in treating a subject afflicted with rheumatoid arthritis. This invention also provides a pharmaceutical composition comprising an amount of laquinimod or pharmaceutically acceptable salt thereof and an amount of methotrexate for use in treating a subject afflicted with rheumatoid arthritis.

Claims

1. A method of treating a subject afflicted with rheumatoid arthritis comprising administering to the subject daily, 0.2-2.0 mg of laquinimod or pharmaceutically acceptable salt thereof and 1-3 mg of methotrexate, wherein the amounts when taken together are more effective to treat the subject than when each agent is administered alone.

2. The method of claim 1, wherein the amount of laquinimod or pharmaceutically acceptable salt thereof and the amount of methotrexate when taken together is effective to reduce a clinical symptom of rheumatoid arthritis in the subject.

3. The method of claim 1, wherein the pharmaceutically acceptable salt of laquinimod is laquinimod sodium.

4. The method of claim 1, wherein the administration of laquinimod or pharmaceutically acceptable salt thereof is effected orally.

5. The method of claim 1, wherein the administration of methotrexate is effected orally.

6. The method of claim 1, further comprising administration of nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, hydroxychloroquine, sulfasalazine, corticosteroids, cytotoxic drugs, immunosuppressive drugs and/or antibodies.

7. The method of claim 1, wherein the administration of laquinimod or pharmaceutically acceptable salt thereof and methotrexate reduces the severity of a symptom associated with rheumatoid arthritis.

8. The method of claim 1, wherein the administration of laquinimod or pharmaceutically acceptable salt thereof and methotrexate reduces the number of joints affected by a symptom associated with rheumatoid arthritis.

9. The method of claim 1, wherein the subject is a mammal.

10. The method of claim 9, wherein the mammal is human.