| CPC C07K 16/249 (2013.01) [A61K 47/12 (2013.01); A61K 47/26 (2013.01); A61P 37/02 (2018.01); A61K 9/0019 (2013.01); A61K 31/4706 (2013.01); A61K 31/519 (2013.01); A61K 31/573 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01)] | 19 Claims |
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1. A method of treating Systemic Lupus Erythematosus (SLE) in a human subject in need thereof comprising subcutaneously or intravenously administering an anti-IFN-α/-ω antibody to the subject as a pharmaceutical composition comprising a formulation selected form the group consisting of:
a.) about 30 mg/mL of the anti-IFN-α/-ω antibody, about 5 mM lactate, about 5% (w/v) lactose, and about 0.02% (w/v) polysorbate 80 (PS80), at pH 5.5;
b.) about 40 mg/mL of the anti-IFN-α/-ω antibody, about 8 mM acetate, about 8% (w/v) maltose, and about 0.06% (w/v) polysorbate 20 (PS20), at pH 5.0;
c.) about 50 mg/mL of the anti-IFN-α/-ω antibody, about 13 mM acetate, about 8.0% (w/v) sucrose, and about 0.04% (w/v) polysorbate 20 (PS20), at pH 5.2;
d.) about 60 mg/mL of the anti-IFN-α/-ω antibody, about 10 mM acetate, about 8% (w/v) lactose, and about 0.06% (w/v) polysorbate 20 (PS20), at pH 5.4; and
e.) about 70 mg/mL of the anti-IFN-α/-ω antibody, about 15 mM lactate, about 10% (w/v) maltose, and about 0.06% (w/v) polysorbate 80 (PS80), at pH 5.0;
wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising heavy chain complementarity determining regions (HCDRs) HCDR1, HCDR2 and HCDR3 amino acid sequences of SEQ ID NOs: 33, 34, and 35, respectively, and the light chain variable region comprising light chain complementarity determining regions (LCDRs) LCDR1, LCDR2 and LCDR3 amino acid sequences of SEQ ID NOs: 30, 31, and 32, respectively, and
wherein a total dosage of the antibody administered is about 0.1 mg/kg, about 0.3 mg/kg, about 1 mg/kg, about 3 mg/kg, about 10 mg/kg, about 15 mg/kg or about 20 mg/kg body weight of the subject per administration.
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