ANTI-VLA1 (CD49A) ANTIBODY PHARMACEUTICAL COMPOSITIONS
Formulations of anti-VLA-1 antibodies are described.
1 .- 20 . (canceled)
21 . A method of treating an inflammatory, immune, or autoimmune disorder in a patient comprising administering to the patient an effective amount of an aqueous antibody pharmaceutical composition comprising:
(a) about 150 to about 210 mg/mL of an anti-VLA-1 (anti-Very Late Antigen-1) antibody, said antibody having one or both of: a light chain variable region having the amino acid sequence of SEQ ID NO:4 and a heavy chain variable region having the amino acid sequence of SEQ ID NO:5;
(b) 25 to 35 mM histidine;
(c) 170 to 288 mM sorbitol; and
(d) 0.008 to 0.012% polysorbate; and
wherein the aqueous pharmaceutical composition has a pH of 5 to 7.
22 . A method of treating an inflammatory disorder in a patient, said method comprising administering to said patient an effective amount of the aqueous pharmaceutical composition comprising:
(a) about 150 to about 210 mg/mL of an anti-VLA-1 (anti-Very Late Antigen-1) antibody, said antibody having one or both of: a light chain variable region having the amino acid sequence of SEQ ID NO:4 and a heavy chain variable region having the amino acid sequence of SEQ ID NO:5;
(b) 25 to 35 mM histidine;
(c) 170 to 288 mM sorbitol; and
(d) 0.008 to 0.012% polysorbate; and
wherein the aqueous pharmaceutical composition has a pH of 5 to 7.
23 . The method of claim 22 , wherein said inflammatory disorder is inflammatory bowel disease.
24 . The method of claim 22 , wherein said inflammatory disorder is rheumatoid arthritis and the patient is an adult patient.
25 . The method of claim 23 , wherein said aqueous pharmaceutical composition is administered subcutaneously.
26 . The method of claim 23 , wherein said aqueous pharmaceutical composition is administered weekly.
27 . The method of claim 26 , wherein said aqueous pharmaceutical composition is administered subcutaneously.
28 . The method of claim 23 , wherein said aqueous pharmaceutical composition is administered weekly for at least 6 weeks.
29 . The method of claim 23 , wherein said aqueous pharmaceutical composition is administered to the patient at a dose of 2.0 mg/kg to 6.0 mg/kg.
30 . The method of claim 23 , wherein said patient has demonstrated an inadequate response to a prior alternate treatment for the inflammatory disorder.
31 . The method of claim 21 , wherein said inflammatory disorder is inflammatory bowel disease.
32 . The method of claim 21 , wherein said inflammatory disorder is rheumatoid arthritis and the patient is an adult patient.
33 . The method of claim 32 , wherein said adult patient has demonstrated an inadequate response to a prior alternate treatment for rheumatoid arthritis such that said patient fails to achieve ACR20 after the prior alternate treatment.
34 . The method of claim 32 , wherein said adult patient has demonstrated an inadequate response to a prior alternate treatment for rheumatoid arthritis such that said patient fails to achieve ACR50 after the prior alternate treatment.
35 . The method of claim 32 , wherein said adult patient has demonstrated an inadequate response to a prior alternate treatment for rheumatoid arthritis such that said patient fails to achieve ACR70 after the prior alternate treatment.
36 . The method of claim 32 , wherein said aqueous pharmaceutical composition is administered subcutaneously once weekly to said adult patient.
37 . The method of claim 32 , wherein said prior alternate treatment comprises a biologic agent.
38 . The method of claim 32 , wherein said prior alternate treatment comprises an agent selected from infliximab, adalimumab, certolizumab pegol, golimumab, etanercept abatacept, rituximab, tocilizumab, tofacitinib, methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine.