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

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.

1 - 37 . (canceled) 
     
     
         38 . 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. 
     
     
         39 . The method of  claim 38 , wherein the amount of laquinimod is effective to induce clinical remission in the patient. 
     
     
         40 . The method of  claim 38 , wherein the amount of laquinimod is effective to maintain clinical remission in the patient. 
     
     
         41 . The method of  claim 38 , wherein the amount of laquinimod is effective to induce and maintain clinical remission in the patient. 
     
     
         42 . The method of any one of  claim 38 , wherein the amount of laquinimod 0.1-0.45 mg/day. 
     
     
         43 . The method of  claim 42 , wherein the amount of laquinimod is 0.1 mg/day, 0.2 mg/day, 0.25 mg/day, 0.3 mg/day, 0.4 mg/day, or 0.45 mg/day. 
     
     
         44 . (canceled) 
     
     
         45 . (canceled) 
     
     
         46 . The method of  claim 38 , wherein the amount of laquinimod is effective to
 a) induce or maintain steroid-free remission,   b) improve or maintain the patient's quality of life,   c) improve or maintain the patient's Inflammatory Bowel Disease Questionnaire (IBDQ) score,   d) increase the patient's IBDQ score by at least 16 points, and/or   e) increase the patient's IBDQ score by at least 170 points.   
     
     
         47 . The method of  claim 38 , wherein the Crohn's disease is anti-TNFα refractory Crohn's disease. 
     
     
         48 . The method of  claim 38 , wherein the Crohn's disease is non-fibrostenotic Crohn's disease. 
     
     
         49 . The method of  claim 38 , wherein the Crohn's disease is inflammatory Crohn's disease. 
     
     
         50 . The method of  claim 38 , wherein the Crohn's disease is steroid refractory Crohn's disease. 
     
     
         51 . The method of  claim 38 , wherein the Crohn's disease had not been surgically treated. 
     
     
         52 . The method of  claim 38 , wherein the laquinimod is laquinimod sodium. 
     
     
         53 . The method of  claim 38 , wherein the periodic administration is daily administration. 
     
     
         54 . The method of  claim 38 , wherein the periodic administration is oral administration. 
     
     
         55 . The method of  claim 38 , wherein the amount of laquinimod is administered by a unit dose. 
     
     
         56 . The method of  claim 38 , wherein the amount of laquinimod is administered as adjunct therapy with an other Crohn's disease treatment. 
     
     
         57 . The method of  claim 56 , wherein the other Crohn's disease treatment is oral steroid, 6-Mercaptopurine, azathioprine, or methotrexate.