Patent ID: 11884731
Assignee: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Field: Pharmaceuticals (Chemistry)
Classification: CPC C  A  G | IPC A  C  G

Claim 0:
1. A method for treating a human patient suffering from perianal fistulizing Crohn's disease, the method comprising
identifying a human patient having fistulizing moderately to severely active Crohn's disease and who had a lack of an adequate response with, loss response to, or was intolerant to treatment with a tumor necrosis factor-alpha antagonist and has at least one perianal draining fistula(e),
administering a humanized antibody having binding specificity for human α4β7 integrin to the human patient,
wherein the humanized antibody is administered to the human patient according to the following dosing regimen:
a. an initial dose of 300 mg of the humanized antibody as an intravenous infusion;
b. followed by a second subsequent dose of 300 mg of the humanized antibody as an intravenous infusion at about two weeks after the initial dose;
c. followed by a third subsequent dose of 300 mg of the humanized antibody as an intravenous infusion at about six weeks after the initial dose;
d. followed by a fourth and subsequent doses of 300 mg of the humanized antibody as an intravenous infusion every eight weeks after the third subsequent dose of the humanized antibody as needed; and
e. administering antibiotics during weeks 0 to 6 of treatment with the humanized antibody;
wherein at least 50% of the perianal draining fistulae are closed 30 weeks after the initial dose;
wherein the Perianal Disease Activity Index (PDAI) score of the patient is reduced by at least 3 points from baseline; and
wherein the humanized antibody comprises an antigen binding region of nonhuman origin and at least a portion of an antibody of human origin, wherein the humanized antibody has binding specificity for the α4β7 complex, wherein the antigen-binding region comprises the CDRs:
Light chain: CDR1 SEQ ID NO:7
CDR2 SEQ ID NO:8 and
CDR3 SEQ ID NO:9; and

Heavy chain: CDR1 SEQ ID NO:4
CDR2 SEQ ID NO:5 and
CDR3 SEQ ID NO:6.