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US 11,884,731 B2Granted
Vedolizumab for the treatment of fistulizing Crohn's disease
AssigneeTakeda Pharmaceutical Company Limited
InventorKaren L. Lasch
Life of this patent
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Abstract
A method for treating a human patient suffering from fistulizing Crohn's disease, comprising administering to a patient suffering from fistulizing Crohn's disease, a humanized antibody having binding specificity for human α4β7 integrin, wherein the human patient has a seton that was surgically placed prior to administration of the antibody, and wherein the dosing regimen induces fistula(e) healing.
Claims20
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.
19 more elements
A method for treating a human patient suffering from perianal fistulizing Crohn's disease, wherein the method comprises
- identifying a human patient having fistulizing moderately to severely active Crohn's disease 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 fistula(e) closure is measured by magnetic resonance imaging (MRI) assessment;
- wherein the human patient had a lack of an adequate response with, loss response to, or was intolerant to treatment with a tumor necrosis factor-alpha antagonist;
- 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.
18 more elements
A method for treating a human patient suffering from perianal fistulizing Crohn's disease, wherein the method comprises
- 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 to the human patient a humanized antibody having binding specificity for human α4β7,
- 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 subsequent dose of 300 mg of the humanized antibody as an intravenous infusion at about 14 weeks after the initial dose;
- e. followed by a fifth subsequent dose and subsequent doses of 300 mg of the humanized antibody as an intravenous infusion every eight weeks after the fourth subsequent dose of the humanized antibody as needed;
- and
- f. administering antibiotics during weeks 0 to 6 of treatment with the humanized antibody;
- wherein the human patient has a seton that was surgically placed prior to administration of the antibody,
- wherein at least 50% of the perianal draining fistulae are closed 30 weeks after the initial dose;
- and
- further 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.
20 more elements
Dependencies are inferred from the claim text.