METHODS OF TREATING ULCERATIVE COLITIS
Antibody formulations are described comprising a mixture of an anti-4β7 antibody, an antioxidant or chelator, and at least one free amino acid. The disclosed formulations may have improved stability, reduced aggregate formation, or both. 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.
1 .- 12 . (canceled)
13 . A prefilled syringe comprising a liquid pharmaceutical formulation of 108 mg of a humanized anti-α4β7 antibody, wherein the humanized anti-α4β7 antibody comprises a light chain comprising amino acids 20 to 238 of SEQ ID NO: 4 and a heavy chain comprising amino acids 20 to 470 of SEQ ID NO: 2, wherein the humanized anti-α4β7 antibody does not bind to αEβ7, wherein the humanized anti-α4β7 antibody is an IgG1, and wherein the prefilled syringe is for subcutaneous administration, has an injection volume of 1 mL to 3 mL, and comprises a single dose of the humanized anti-α4β7 antibody.
14 . An article of manufacture for treating ulcerative colitis comprising:
a prefilled syringe for subcutaneous administration, containing a liquid pharmaceutical formulation comprising 108 mg of a humanized anti-α4β7 antibody, wherein the prefilled syringe has an injection volume of 1 mL to 3 mL, wherein the humanized anti-α4β7 antibody comprises a light chain comprising amino acids 20 to 238 of SEQ ID NO: 4 and a heavy chain comprising amino acids 20 to 470 of SEQ ID NO: 2, wherein the humanized anti-α4β7 antibody is an IgG1, and wherein the humanized anti-α4β7 antibody does not bind to αEβ7; and
instructions for self-administration of the formulation according to a dosing regimen for treating ulcerative colitis.
15 . An autoinjector comprising a liquid pharmaceutical formulation of 108 mg of a humanized anti-α4β7 antibody, wherein the humanized anti-α4β7 antibody comprises a light chain comprising amino acids 20 to 238 of SEQ ID NO: 4 and a heavy chain comprising amino acids 20 to 470 of SEQ ID NO: 2, wherein the humanized anti-α4β7 antibody is an IgG1, wherein the humanized anti-α4β7 antibody does not bind to αEβ7, and wherein the autoinjector is for subcutaneous administration, has a prefilled syringe with an injection volume of 1 mL to 3 mL, and comprises a single dose of the humanized anti-α4β7 antibody.
16 . An article of manufacture for treating ulcerative colitis comprising:
an autoinjector for subcutaneous administration, containing a liquid pharmaceutical formulation comprising 108 mg of a humanized anti-α4β7 antibody, wherein the autoinjector has prefilled syringe with an injection volume of 1 mL to 3 mL, wherein the humanized anti-α4β7 antibody comprises a light chain comprising amino acids 20 to 238 of SEQ ID NO: 4 and a heavy chain comprising amino acids 20 to 470 of SEQ ID NO: 2, wherein the humanized anti-α4β7 antibody is an IgG1, and wherein the humanized anti-α4β7 antibody does not bind to αEβ7; and
instructions for self-administration of the formulation according to a dosing regimen for treating ulcerative colitis.