# US 2011/0218203 A1 · Treatment of rheumatoid arthritis with a combination of laquinimod and methotrexate > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2011/0218203 A1 - Document ID: US20110218203A1 - Status: Published application - Kind: A1 - Application number: 13/039,188 - Filed: 2011-03-02 - Published: 2011-09-08 - Earliest claimed: 2010-03-03 - Assignees: Teva Pharmaceutical Industries Ltd. - Inventors: Joel Kaye; Eran Blaugrund; Nora Tarcic - Web page: https://patentgrep.com/patent/US20110218203A1 ## CPC - A61K 31/4704: 2-Quinolinones, e.g. carbostyril - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61P 19/00: Drugs for skeletal disorders - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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 ### Claim 1 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. ### Claim 2 (depends on 1) The method of claim 1, wherein the amount of laquinimod or pharmaceutically acceptable salt thereof and the amount of methotrexate when taken together is more effective to treat the subject than when each agent is administered alone. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) The method of claim 1, wherein the pharmaceutically acceptable salt of laquinimod is laquinimod sodium. ### Claim 5 (depends on 1) The method of claim 1, wherein the periodic administration of laquinimod or pharmaceutically acceptable salt thereof is effected orally. ### Claim 6 (depends on 1) The method of claim 1, wherein the amount of laquinimod administered is 0.0005-10 mg/kg/day. ### Claim 7 (depends on 1) The method of claim 1, wherein the amount of laquinimod administered is 0.1-2.0 mg/day. ### Claim 8 (depends on 1) The method of claim 1, wherein the periodic administration of methotrexate is effected orally. ### Claim 9 (depends on 1) The method of claim 1, wherein the amount of methotrexate administered is 0.02-1.0 mg/kg/day. ### Claim 10 (depends on 1) The method of claim 1, wherein the amount of methotrexate administered is 1-3 mg/day. ### Claim 11 (depends on 1) The method of claim 1, further comprising administration of nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, slow-acting drugs, gold compounds, hydroxychloroquine, sulfasalazine, combinations of slow-acting drugs, corticosteroids, cytotoxic drugs, immunosuppressive drugs and/or antibodies. ### Claim 12 (depends on 1) The method of claim 1, wherein the periodic administration of laquinimod or pharmaceutically acceptable salt thereof and methotrexate substantially eliminates a symptom associated with rheumatoid arthritis. ### Claim 13 (depends on 1) The method of claim 1, wherein the periodic administration of laquinimod or pharmaceutically acceptable salt thereof and methotrexate reduces the severity of a symptom associated with rheumatoid arthritis. ### Claim 14 (depends on 1) The method of claim 1, wherein the periodic administration of laquinimod or pharmaceutically acceptable salt thereof and methotrexate reduces the number of joints affected by a symptom associated with rheumatoid arthritis. ### Claim at position 15 15-18. (canceled) ### Claim 19 (depends on 1) The method of claim 1, wherein the periodic administration of laquinimod or pharmaceutically acceptable salt thereof and methotrexate reduces proteinuria in the subject. ### Claim 20 (depends on 19) The method of claim 19, wherein proteinuria reduction is measured by 24 hour urine protein, 24 hour protein to creatinine ratio, spot protein to creatinine ratio, 24 hour urine albumin, 24 hour albumin to creatinine ratio, spot albumin to creatinine ratio, or by a urinary dipstick. ### Claim at position 18 21-22. (canceled) ### Claim 23 (depends on 1) The method of claim 1, wherein either the amount of laquinimod or pharmaceutically acceptable salt thereof when taken alone, the amount of methotrexate when taken alone, or each such amount when taken alone is not effective to treat the subject. ### Claim 24 (depends on 1) The method of claim 1, wherein subject is receiving methotrexate therapy prior to initiating laquinimod therapy. ### Claim 25 (depends on 1) The method of claim 1, wherein the subject is a mammal. ### Claim 26 (depends on 25) The method of claim 25, wherein the mammal is human. ### Claim at position 23 27-28. (canceled)