Methods of treating crohn's disease and ulcerative colitis

Abstract

The present disclosure is directed to methods for treating Crohn's disease, and in particular, to methods for inducing clinical remission and/or endoscopic improvement of Crohn's disease, using a JAK1 inhibitor. In certain embodiments, the patient is administered an induction dose of the JAK1 inhibitor to induce clinical remission and/or endoscopic improvement of the Crohn's disease, followed by administration of at least one maintenance dose of the JAK1 inhibitor thereafter. In other embodiments, the present disclosure is directed to methods for treating ulcerative colitis using a JAK1 inhibitor.

1 - 103 . (canceled) 
     
     
         104 . A method of inducing clinical remission of ulcerative colitis in an adult patient having moderately to severely active ulcerative colitis, the method comprising orally administering to the patient a 45 mg dose of upadacitinib once a day for 8 weeks, wherein the patient achieves clinical remission per Adapted Mayo score at 8 weeks after the administration of the initial said 45 mg dose of upadacitinib. 
     
     
         105 . The method of  claim 104 , wherein the patient has had an inadequate response or intolerance to conventional therapy. 
     
     
         106 . The method of  claim 105 , wherein the conventional therapy comprises an aminosalicylate, corticosteroid or immunosuppressant. 
     
     
         107 . The method of  claim 104 , wherein the patient has had an inadequate response or intolerance to biologic therapy. 
     
     
         108 . The method of  claim 107 , wherein the biologic therapy comprises an anti-TNF agent. 
     
     
         109 . A method of inducing endoscopic improvement of ulcerative colitis in an adult patient having moderately to severely active ulcerative colitis, the method comprising orally administering to the patient a 45 mg dose of upadacitinib once a day for 8 weeks, wherein the patient achieves endoscopic improvement at 8 weeks after the administration of the initial said 45 mg dose of upadacitinib. 
     
     
         110 . The method of  claim 109 , wherein the patient has had an inadequate response or intolerance to conventional therapy. 
     
     
         111 . The method of  claim 110 , wherein the conventional therapy comprises an aminosalicylate, corticosteroid or immunosuppressant. 
     
     
         112 . The method of  claim 109 , wherein the patient has had an inadequate response or intolerance to biologic therapy. 
     
     
         113 . The method of  claim 112 , wherein the biologic therapy comprises an anti-TNF agent. 
     
     
         114 . A method of inducing histologic-endoscopic mucosal remission of ulcerative colitis in an adult patient having moderately to severely active ulcerative colitis, the method comprising orally administering to the patient a 45 mg dose of upadacitinib once a day for 8 weeks, wherein the patient achieves histologic-endoscopic mucosal remission at 8 weeks after the administration of the initial said 45 mg dose of upadacitinib. 
     
     
         115 . The method of  claim 114 , wherein the patient has had an inadequate response or intolerance to conventional therapy. 
     
     
         116 . The method of  claim 115 , wherein the conventional therapy comprises an aminosalicylate, corticosteroid or immunosuppressant. 
     
     
         117 . The method of  claim 114 , wherein the patient has had an inadequate response or intolerance to biologic therapy. 
     
     
         118 . The method of  claim 117 , wherein the biologic therapy comprises an anti-TNF agent. 
     
     
         119 . A method of inducing clinical response of ulcerative colitis in an adult patient having moderately to severely active ulcerative colitis, the method comprising orally administering to the patient a 45 mg dose of upadacitinib once a day for 16 weeks, wherein the patient achieves clinical response at 16 weeks after the administration of the initial said 45 mg dose of upadacitinib. 
     
     
         120 . The method of  claim 119 , wherein the patient has had an inadequate response or intolerance to conventional therapy. 
     
     
         121 . The method of  claim 120 , wherein the conventional therapy comprises an aminosalicylate, corticosteroid or immunosuppressant. 
     
     
         122 . The method of  claim 119 , wherein the patient has had an inadequate response or intolerance to biologic therapy. 
     
     
         123 . The method of  claim 122 , wherein the biologic therapy comprises an anti-TNF agent. 
     
     
         124 . A method of inducing clinical response of ulcerative colitis in an adult patient having moderately to severely active ulcerative colitis, the method comprising:
 a) orally administering to the patient a 45 mg dose of upadacitinib once a day for 8 weeks;   b) evaluating the patient for clinical response at 8 weeks after the administration of the initial said 45 mg dose of upadacitinib, and if the patient has not achieved clinical response per Adapted Mayo score at 8 weeks after the administration of the initial said 45 mg dose of upadacitinib;   c) continuing to orally administer to the patient a 45 mg dose of upadacitinib once a day for an additional 8 weeks, wherein the patient achieves clinical response per Adapted Mayo score at 16 weeks after the administration of the initial said 45 mg dose of upadacitinib.   
     
     
         125 . The method of  claim 124 , wherein the patient has had an inadequate response or intolerance to conventional therapy. 
     
     
         126 . The method of  claim 125 , wherein the conventional therapy comprises an aminosalicylate, corticosteroid or immunosuppressant. 
     
     
         127 . The method of  claim 124 , wherein the patient has had an inadequate response or intolerance to biologic therapy. 
     
     
         128 . The method of  claim 127 , wherein the biologic therapy comprises an anti-TNF agent.