Methods of treating ulcerative colitis with anti-il23 specific antibody
AssigneeJanssen Biotech, Inc.
InventorsMatthew Germinaro, Thomas Baker
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 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.
Claims19
A method of treating ulcerative colitis in a patient, comprising administering to the patient an initial subcutaneous dose of 400 mg of an antibody specific to IL23, a 400 mg subcutaneous dose about 4 weeks after the initial dose and a 400 mg subcutaneous dose about 8 weeks after the initial dose, wherein the patient is a responder to the antibody and is identified as meeting a clinical endpoint and wherein the clinical endpoint is selected from the group consisting of:
- (i) clinical remission at Week 12;
- (ii) symptomatic remission at Week 12;
- (iii) endoscopic improvement at Week 12;
- (iv) clinical response at Week 12;
- (v) clinical remission at Week 24;
- (vi) symptomatic remission at Week 24;
- (vii) endoscopic improvement at Week 24;
- and/or (viii) clinical response at Week 24;
- and (ix) histologic-endoscopic mucosal improvement at Week 12.
A method of treating moderately to severely active ulcerative colitis in a patient, comprising (i) administering to the patient an initial subcutaneous dose of 400 mg of an antibody specific to IL23, a 400 mg subcutaneous dose about 4 weeks after the initial dose and a 400 mg subcutaneous dose about 8 weeks after the initial dose, and (ii) further administering a dose of 200 mg of antibody about every 4 weeks after the dose at about 8 weeks or a dose of 100 mg of antibody about every 8 weeks after the dose at about 8 weeks, 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 remission at Week 12.
Dependencies are inferred from the claim text.