Method of treating crohn's disease with a combination of antibodies to il-23 and tnf alpha

A kit comprising (1) an IL-23 inhibitor and a TNF-α inhibitor, and (2) instructions for treating CD in a patient, wherein the instructions comprise subcutaneously administering to the patient (i) about 320 mg of the IL-23 inhibitor and about 160 mg of the TNF-α inhibitor at weeks 0, 4, and 8;

• (ii) about 160 mg of the IL-23 inhibitor and about 80 mg of the TNF-α inhibitor at weeks 0, 4, and 8;
• (iii) about 160 mg of the IL-23 inhibitor and about 80 mg of the TNF-α inhibitor every 4 weeks;
• (iv) about 40 mg of the IL-23 inhibitor and about 40 mg of the TNF-α inhibitor every 4 weeks;
• or (v) about 20 mg of the IL-23 inhibitor and about 20 mg of the TNF-α inhibitor every 4 weeks.

A method of treating CD in a patent, the method comprising administering a combination of an anti-IL-23p19 antibody and an anti-TNF-α antibody, wherein,

• a) the anti-IL-23p19 antibody comprises (i) the heavy chain CDR amino acid sequences of SEQ ID NOs:
• 1-3 and the light chain CDR amino acid sequences of SEQ ID NOs:
• 4-6, (ii) the heavy chain variable region amino acid sequence of SEQ ID NO:
• 7 and the light chain variable region amino acid sequence of SEQ ID NO:
• 8, or (iii) the heavy chain amino acid sequence of SEQ ID NO:
• 9 and the light chain amino acid sequence of SEQ ID NO:
• 10;
• b) the anti-TNF-α antibody comprises (i) the heavy chain CDR amino acid sequences of SEQ ID NOs:
• 11-13 and the light chain CDR amino acid sequences of SEQ ID NOs:
• 14-16, (ii) the heavy chain variable region amino acid sequence of SEQ ID NO:
• 17 and the light chain variable region amino acid sequence of SEQ ID NO:
• 18, or (iii) the heavy chain amino acid sequence of SEQ ID NO:
• 19 and the light chain amino acid sequence of SEQ ID NO:20;
• and
• c) the method results in a clinical response in the patient and the clinical response is based on a clinical endpoint selected from the group consisting of:
• (i) achievement of Crohn's Disease Activity Index (CDAI) score <150, (ii) achievement of a ≥50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score, (iii) achievement of an abdominal pain (AP) mean daily score ≤1 and stool frequency (SF) mean daily score ≤3, and no worsening of the AP or SF from baseline, and (iv) achievement of SES-CD≤2 or SES-CD score ≤4 with at least 2 points reduction from baseline and no subscore >1 in any individual component.