Method of Treating Ulcerative Colitis with Anti-IL23 Specific Antibody
AssigneeJanssen Biotech, Inc.
InventorsMatthew Germinaro, Kuan-hsiang Gary Huang, Hongyan Zhang
Life of this patent
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Abstract
A method of treating ulcerative colitis in a patient administers an IL-23 specific antibody, e.g., guselkumab, at an initial dose and subsequent doses in order for the patient to respond to the antibody and meet one or more of the clinical endpoints.
Claims39
A method of treating ulcerative colitis in a patient, comprising administering to the patient an antibody specific to IL23, wherein the antibody comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising:
- a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4;
- a CDRL2 amino acid sequence of SEQ ID NO:5;
- and
- a CDRL3 amino acid sequence of SEQ ID NO:6,
- said heavy chain variable region comprising:
- a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1;
- a CDRH2 amino acid sequence of SEQ ID NO:2;
- and
- a CDRH3 amino acid sequence of SEQ ID NO:3, and wherein the patient is deemed a responder to the antibody.
A method of treating moderately to severely active ulcerative colitis in a patient, comprising administering to the patient (i) an initial intravenous dose of 200 mg or 400 mg of an antibody specific to IL23, (ii) a 200 mg or 400 mg intravenous dose of the antibody about 4 weeks after the initial dose, and (iii) a 200 mg or 400 mg intravenous dose of the antibody about 8 weeks after the initial dose, wherein the antibody comprises a light chain variable region amino acid sequence of SEQ ID NO:
- 8 and a heavy chain variable region amino acid sequence of SEQ ID NO:
- 7 and the patient is a responder to the antibody by being identified as meeting a clinical endpoint about 12 weeks after the initial dose, wherein the clinical endpoint is clinical response defined as a decrease from induction baseline in the modified Mayo score by ≥30% and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
A method of treating moderately to severely active ulcerative colitis in a patient, comprising administering to the patient (i) an initial intravenous dose of 200 mg or 400 mg of an antibody specific to IL23, (ii) a 200 mg or 400 mg intravenous dose of the antibody about 4 weeks after the initial dose, (iii) a 200 mg or 400 mg intravenous dose of the antibody about 8 weeks after the initial dose, and (iv) a maintenance dose of the antibody specific to IL23 at a dose of 100 ng or 200 mg about every 4 weeks or 8 weeks after administering the dose about 8 weeks after the initial dose, wherein the antibody comprises a light chain variable region amino acid sequence of SEQ ID NO:
- 8 and a heavy chain variable region amino acid sequence of SEQ ID NO:
- 7 and the patient is a responder to the antibody by being identified as meeting a clinical endpoint about 12, 24, and/or 44 weeks after the initial dose, wherein the clinical endpoint is clinical response defined as a decrease from induction baseline in the modified Mayo score by ≥30% and ≥2 points, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Dependencies are inferred from the claim text.