Treatment of crohn's disease with laquinimod

Abstract

This application provides for a method of treating a subject suffering from Crohn's disease, the method comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject. This application provides for use of laquinimod in the manufacture of a medicament for treating a subject suffering from Crohn's disease. This application also provides for a pharmaceutical composition comprising laquinimod for use in treating a subject suffering from Crohn's disease.

What is claimed is: 
     
         1 . A method of treating a subject suffering from Crohn's disease, the method comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject. 
     
     
         2 . 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. 
     
     
         3 . The method of  claim 1 , wherein the amount of laquinimod is effective to reduce the Crohn's Disease Activity Index score of the subject, lower the C-Reactive Protein level of the subject, lower the fecal calprotein level of the subject, or reduce the number of open draining fistulas in the subject. 
     
     
         4 . The method of  claim 3 , wherein the Crohn's Disease Activity Index score of the subject is reduced by at least 100 points. 
     
     
         5 . The method of  claim 3  or  4 , wherein the Crohn's Disease Activity Index score of the subject is reduced to under 150. 
     
     
         6 . The method of any one of  claims 3 - 5 , wherein the number of open draining fistulas in the subject is decreased at least 50% as compared to prior to initiation of the periodic administration. 
     
     
         7 . The method of any one of  claims 1 - 6 , wherein the periodic administration is oral. 
     
     
         8 . The method of any one of  claims 1 - 7 , wherein the amount is administered by a unit dose of 0.5 mg of laquinimod. 
     
     
         9 . The method of any one of  claims 1 - 8 , wherein the periodic administration is daily administration. 
     
     
         10 . The method of  claim 9 , wherein the amount of laquinimod is 0.5-2.0 mg/day. 
     
     
         11 . The method of  claim 10 , wherein the amount of laquinimod is 1.0 mg/day. 
     
     
         12 . The method of  claim 10 , wherein the amount of laquinimod is 1.5 mg/day. 
     
     
         13 . The method of  claim 10 , wherein the amount of laquinimod is 2.0 mg/day. 
     
     
         14 . The method of any one of  claims 1 - 13 , wherein a loading dose of an amount different from the intended dose is administered for a period of time at the start of the periodic administration. 
     
     
         15 . The method of  claim 14 , wherein the loading dose is double the amount of the intended dose. 
     
     
         16 . The method of  claim 14  or  15 , wherein the loading is administered for two days at the start of the periodic administration. 
     
     
         17 . The method of any one of  claims 1 - 16 , wherein the subject had active moderate to severe Crohn's disease prior to the administration of laquinimod. 
     
     
         18 . The method of any one of  claims 1 - 17 , wherein the subject had a Crohn's Disease Activity Index score of 220-450 prior to the administration of laquinimod. 
     
     
         19 . The method of any one of  claims 1 - 18 , wherein the subject had a C-Reactive Protein level of above 5 mg/L prior to the administration of laquinimod. 
     
     
         20 . The method of any one of  claims 17 - 19 , wherein diagnosis of the subject prior to administration excluded Indeterminate Colitis. 
     
     
         21 . The method of any one of  claims 17 - 19 , wherein diagnosis of the subject prior to administration excluded Ulcerative Colitis. 
     
     
         22 . The method of any one of  claims 1 - 21 , wherein the periodic administration continues for 8 weeks or more. 
     
     
         23 . The method of any one of  claims 1 - 22 , wherein the laquinimod is in the form of laquinimod sodium. 
     
     
         24 . The method of any one of  claims 1 - 23 , wherein the subject is a human. 
     
     
         25 . The method of any one of  claims 1 - 24 , further comprising administration of 5-aminosalicylic acid, antibiotics, corticosteroids, immunosuppressors, TNFα agents or anti-integrins. 
     
     
         26 . Use of laquinimod in the manufacture of a medicament for treating a subject suffering from Crohn's disease. 
     
     
         27 . A pharmaceutical composition comprising laquinimod for use in treating a subject suffering from Crohn's disease.