Anti-vla1 (cd49a) antibody pharmaceutical compositions

Abstract

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.