Methods for treatment using anti-alpha4beta7 antibody
AssigneeTakeda Pharmaceutical Company Limited
InventorsIrving H. Fox, Catherine Scholz
Life of this patent
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Abstract
Antibody formulations are described comprising a mixture of a non-reducing sugar, an anti-α4β7 antibody and at least one amino acid. The disclosed formulations have improved stability, reduced aggregate formation, and may retard degradation of the anti-α4β7 antibody therein or exhibit any combinations thereof. The present invention further provides a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-α4β7 antibody in vivo.
Claims16
A method for maintaining a mean steady-state target trough serum concentration of a humanized anti-α4β7 immunoglobulin in a human patient having ulcerative colitis or Crohn's disease, the method comprising:
- an induction phase comprising,
- intravenously administering an initial dose of 300 mg of a humanized anti-α4β7 antibody to the human patient, and
- intravenously administering a second dose of 300 mg of the humanized anti-α4β7 antibody to the human patient 2 weeks after the initial dose, and
- intravenously administering a third dose of 300 mg of the humanized anti-α4β7 antibody to the human patient 6 weeks after the initial dose, and
- a maintenance phase comprising,
- intravenously administering a dose of 300 mg of the humanized anti-α4β7 antibody to the human patient every 8 weeks beginning 8 weeks after the third dose,
- wherein the maintenance phase maintains a mean steady state trough serum concentration of the anti-α4β7 humanized antibody of about 5 μg/mL to 25 μg/mL in the human patient,
- wherein the humanized anti-α4β7 antibody is an IgG1 isotype, and
- wherein the humanized anti-α4β7 antibody comprises a light chain comprising SEQ ID NO:
- 11 (LCDR1), SEQ ID NO:
- 12 (LCDR2), and SEQ ID NO:
- 13 (LCDR3), and a heavy chain comprising SEQ ID NO:
- 8 (HCDR1), SEQ ID NO:
- 9 (HCDR2), and SEQ ID NO:
- 10 (HCDR3).
A method for maintaining a mean steady-state target trough serum concentration of a humanized anti-α4β7 immunoglobulin in a human patient having ulcerative colitis or Crohn's disease, the method comprising:
- an induction phase comprising,
- intravenously administering an initial dose of 300 mg of a humanized anti-α4β7 antibody to the human patient, and
- intravenously administering a second dose of 300 mg of the humanized anti-α4β7 antibody to the human patient 2 weeks after the initial dose, and
- intravenously administering a third dose of 300 mg of the humanized anti-α4β7 antibody to the human patient 6 weeks after the initial dose, and
- a maintenance phase comprising,
- intravenously administering a dose of 300 mg of the humanized anti-α4β7 antibody to the human patient every 8 weeks beginning 8 weeks after the third dose,
- wherein the maintenance phase maintains a mean steady state trough serum concentration of the anti-α4β7 humanized antibody of about 5 μg/mL to 25 μg/mL in the human patient, and
- wherein the humanized anti-α4β7 antibody is vedolizumab.
Dependencies are inferred from the claim text.