NZ729780A - Human antibodies to pcsk9 for use in methods of treating particular groups of subjects - Google Patents

Abstract

Disclosed is a method for treating a disease or condition in which PCSK9 expression or activity causes an impact comprising administering a therapeutic amount of an antibody or an antigen-binding fragment thereof which specifically binds hPCSK9 (human proprotein convertase subtilisin/kexin type 9) to a subject in need thereof, wherein the subject in need thereof falls into one or more of the following groups of subjects: (i) subjects having a serum LDL cholesterol (LDL-C) level of at least 100 mg/dL, [at least 130 mg/dL, at least 160 mg/dL / at least 200 mg/dL]; (ii) subjects having a serum HDL-C level of less than 40 mg/dL; (iii) subjects having a serum cholesterol level of at least 200 mg/dL [240 mg/dL]; (iv) subjects having a serum triacylglycerollevel of at least 150 mg/dL [at least 200 mg/dL; at least 500 mg/dL], wherein the triacylglycerollevel is determined after fasting for at least 8 hours; (v) subjects being at least 35 years old [at least 40 /50/55/60/65/70 years old]; (vi) subjects younger than 75 years [65/60/55/50/45/40 years]; (vii) subjects having a BMI of25 [26/27/28/29/30/31/32/33/34/35/36/37/38/39] or more; (viii) male subjects; (ix) female subjects; (x) subjects in which the administration of the antibody or antigen-binding fragment thereof leads to a reduction in the serum LDL-C level by at least 30 mg/dL [40 mg/dL; 50 mg/dL; 60 mg/dL; 70 mg/dL] relative to predose level; or (xi) subjects in which the administration of the antibody or antigen-binding fragment thereof leads to a reduction in the serum LDL-C level by at least 20% [30%; 40%; 50%; 60%] relative to predose level.