METHODS OF TREATING ULCERATIVE COLITIS
Methods for maintaining clinical remission of ulcerative colitis in a human patient are described comprising administration of an antibody that has binding specificity for human alpha4beta7 integrin using a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-alpha4beta7 antibody in vivo.
1 . A method for treating a human patient suffering from ulcerative colitis, wherein the method comprises the steps of:
administering to a patient suffering from ulcerative colitis, an initial 300 mg dose of a humanized antibody having binding specificity for human alpha4beta7 integrin,
administering a second subsequent dose of 300 mg of the humanized antibody two weeks after the initial dose;
administering a third subsequent dose of 300 mg of the humanized antibody six weeks after the initial dose; and
administering subsequent doses of 300 mg of the humanized antibody every four weeks or every eight weeks after the third subsequent dose of the humanized antibody as needed;
wherein the humanized antibody comprises light chain CDRs as set forth in SEQ ID NO: 11 (CDR1), SEQ ID NO: 12 (CDR2), and SEQ ID NO: 13 (CDR3), and comprises heavy chain CDRs as set forth in SEQ ID NO: 8 (CDR1), SEQ ID NO: 9 (CDR2), and SEQ ID NO: 10 (CDR3).
2 . The method of claim 1 , wherein the patient had a lack of an adequate response with, loss response to, or was intolerant to treatment with at least one of an immunomodulator, a tumor necrosis factor-alpha antagonist, or combinations thereof.
3 . The method of claim 1 , which induces a clinical response or clinical remission of ulcerative colitis in the human patient.
4 . The method of claim 1 , where the patient previously received treatment with at least one corticosteroid for ulcerative colitis.
5 . The method of claim 1 , wherein the ulcerative colitis is moderate to severely active ulcerative colitis.
6 . The method of claim 1 , wherein the dosing regimen results in a reduction, elimination or reduction and elimination of corticosteroids use by the patient.
7 . A method for treating a human patient suffering from ulcerative colitis, wherein the method comprises the steps of:
administering to a patient suffering from ulcerative colitis, an initial 300 mg dose of vedolizumab,
administering a second subsequent dose of 300 mg of vedolizumab two weeks after the initial dose;
administering a third subsequent dose of 300 mg of vedolizumab six weeks after the initial dose; and
administering subsequent doses of 300 mg of vedolizumab every four weeks or every eight weeks after the third subsequent dose.
8 . The method of claim 7 , wherein the patient had a lack of an adequate response with, loss response to, or was intolerant to treatment with at least one of an immunomodulator, a tumor necrosis factor-alpha antagonist, or combinations thereof.
9 . The method of claim 7 , which induces a clinical response or clinical remission of ulcerative colitis in the human patient.
10 . The method of claim 7 , where the patient previously received treatment with at least one corticosteroid for ulcerative colitis.
11 . The method of claim 7 , wherein the ulcerative colitis is moderate to severely active ulcerative colitis.
12 . The method of claim 7 , wherein the dosing regimen results in a reduction, elimination or reduction and elimination of corticosteroids use by the patient.