| 摘要 |
<p>Provided is the use of an isolated human anti-TNFá antibody, or an antigen-binding portion thereof, in the manufacture of a medicament for treating a human subject having an autoimmune disease in which TNFá activity is detrimental, wherein the medicament is adapted for biweekly administration as a total body dose, and wherein the human anti-TNFá antibody, or antigen-binding portion thereof, has the following characteristics: a) dissociates from human TNFá with a koff rate constant of 1 x 10-3 s-1 or less, as determined by surface plasmon resonance; b) has light chain variable region (LCVR) comprising a CDR3 domain comprising a specified amino acid sequence, or modified from it by a single alanine substitution at position 1, 4, 5, 7, or 8, or by one to five conservative amino acid substitutions at positions 1, 3, 4, 6, 7, 8, and/or 9; and, c) has heavy chain variable region (HCVR) comprising a CDR3 domain comprising a specified amino acid sequence, or modified from it by a single alanine substitution at position 2, 3, 4, 5, 6, 8, 9, 10, or 11, or by one to five conservative amino acid substitutions at positions 2, 3, 4, 5, 6, 8, 9, 10, 11, and/or 12.</p> |
