Methods of treating crohn's disease with anti-IL23 specific antibody
AssigneeJanssen Biotech, Inc.
InventorsMatthew Germinaro, Mobolaji Olurinde, Aparna Sahoo, Jacqueline Yee, Omoniyi Adedokun
Life of this patent
Estimating the term…
Abstract
A method of treating Crohn's disease in a patient by administering an IL-23 specific antibody, e.g., guselkumab, at an initial subcutaneous dose and subsequent subcutaneous doses in order for the patient to respond to the antibody and meet one or more of the clinical endpoints.
Claims29
A method of treating Crohn's disease in a patient, comprising administering to the patient an initial subcutaneous induction dose of 400 mg of an antibody specific to IL23, a 400 mg subcutaneous dose about 4 weeks after the initial subcutaneous induction dose, and a 400 mg subcutaneous dose about 8 weeks after the initial subcutaneous induction dose, 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.
A method of treating moderately to severely active Crohn's disease in a patient, comprising (i) administering to the patient an initial subcutaneous induction dose of 400 mg of an antibody specific to IL23, a 400 mg subcutaneous dose about 4 weeks after the initial subcutaneous induction dose and a 400 mg subcutaneous dose about 8 weeks after the initial subcutaneous induction dose, and (ii) further administering a dose of 200 mg of antibody about every 4 weeks after the subcutaneous dose at about 8 weeks after the initial subcutaneous induction dose or a dose of 100 mg of antibody about every 8 weeks after the subcutaneous dose at about 8 weeks after the initial subcutaneous induction 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 subcutaneous dose, wherein the clinical endpoint is clinical remission at Week 12, defined as CDAI less than (<) 150 points or endoscopic response measured by at least a 50% improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
A method of treating Crohn's disease in a patient, comprising administering to the patient an initial subcutaneous induction dose of 400 mg of an antibody specific to IL23, a 400 mg subcutaneous dose about 4 weeks after the initial subcutaneous induction dose, and a 400 mg subcutaneous dose about 8 weeks after the initial subcutaneous induction dose, wherein the initial subcutaneous induction dose of 400 mg, the 400 mg subcutaneous dose about 4 weeks after the initial subcutaneous induction dose, and the 400 mg subcutaneous dose about 8 weeks after the initial subcutaneous induction dose are administered in two consecutive 2 mL injections, wherein each of the 2 mL injections comprises a 200 mg 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.
Dependencies are inferred from the claim text.