Use of laquinimod for treating Crohn's disease patients who failed first-line anti-TNF therapy

• US 9,161,935 B2
• Filed: 02/01/2013
• Issued: 10/20/2015
• Est. Priority Date: 02/03/2012
• Status: Active Grant

• Current Assignee: Active Biotech AB
• Original Assignee: Teva Pharmaceutical Industries Limited
• Inventors: Tarcic, Nora, Haviv, Asi, Blaugrund, Eran, Kaye, Joel
• Primary Examiner(s): Lundgren, Jeffrey S
• Assistant Examiner(s): SCHMITT, MICHAEL J
• Application Number:
  US13/757,004
• Publication Number:
  US 20130203807A1
• Time in Patent Office: 991 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 31/4704 2-Quinolinones, e.g. carbostyril
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/06 Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
• 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: C07D 215/56 with oxygen atoms in position 4

Abstract

This application provides for a method of treating a human patient afflicted with anti-TNFα refractory Crohn'"'"'s disease, of treating a human patient afflicted with non-fibrostenotic Crohn'"'"'s disease, and of treating a human patient whose Crohn'"'"'s disease had not been surgically treated, the method comprising periodically administering to the patient an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the patient. This application also provides for a method of inducing or maintaining clinical remission in a human patient afflicted with Crohn'"'"'s disease comprising periodically administering to the patient an amount of laquinimod effective to induce or maintain clinical remission in the patient, which amount of laquinimod is less than 0.5 mg/day.

Claims

1. A method of treating a human patient afflicted with anti-TNFα

refractory Crohn'"'"'s disease, the method comprising periodically administering to the patient an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the patient.

2. The method of claim 1, wherein the Crohn'"'"'s disease is non-fibrostenotic Crohn'"'"'s disease.

3. The method of claim 2, wherein the Crohn'"'"'s disease is inflammatory Crohn'"'"'s disease.

4. The method of claim 1, wherein the Cretin'"'"'s disease is steroid refractory Crohn'"'"'s disease.

5. The method of claim 1, wherein the patient has been administered oral steroids at baseline.

6. The method of claim 1, wherein the patient'"'"'s Crohn'"'"'s disease had not been surgically treated.

7. The method of claim 1, wherein the Crohn'"'"'s disease is refractory to anti-TNFα

treatment using infliximab, adalimimab, certolizumab or natalizumab.

8. The method of claim 1, wherein the patient is naï

ve to anti-TNFα

treatment.

9. The method of claim 1, wherein the amount of laquinimod is effective to reduce a symptom of Crohn'"'"'s disease in the subject, induce clinical response, induce or maintain clinical remission, inhibit disease progression, or inhibit a disease complication in the subject.

10. The method of claim 9, wherein the amount of liaquinimod is effective to induce clinical remission in the patient.

11. The method of claim 9, wherein the amount of liaquinimod is effective to maintain clinical remission in the patient.

12. The method of claim 9, wherein the amount of laquinimod is effective to induce and maintain clinical remission in the patient.

13. The method of claim 1, wherein the amount is administered by a unit dose of 0.25 mg of laquinimod or a unit dose of 0.5 mg of laquinimod.

14. The method of claim 1, wherein the amount of laquinimod is 0.1-1.0 mg/day.

15. The method of claim 14, wherein the amount of laquinimod is 0.25 mg/day, 0.5 mg/day or 1.0 mg/day.

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

17. The method of claims 1, wherein the periodic administration is oral.

18. The method or claims 1, wherein the periodic administration is daily administration.

19. The method of claim 14 wherein the amount of laquinimod is 0.1-0.75 mg/day.

20. The method of claim 14, wherein the amount of laquinimod is 0.3-0.7 mg/day.

21. The method of claim. 1, wherein the laquinimod is administered as adjunct therapy with an other Crohn'"'"'s disease treatment.