Safe and Effective Method of Treating Ulcerative Colitis with Anti-IL12/IL23 Antibody

A pharmaceutical composition of an anti-IL-12/IL-23p40 antibody for use in treating a subject with moderately to severely active ulcerative colitis (UC), comprising an antibody comprising a heavy chain variable region and a light chain variable region, the 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 the 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 and wherein the subject is a responder to treatment by at least one measure of response to treatment selected from the group consisting of:
• (i) having a clinical remission based on at least one of the global definition of clinical remission with Mayo score ≤2 points with no individual subscore >1 and the US definition of clinical remission with absolute stool number ≤3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1, (ii) having an endoscopic healing with a Mayo endoscopy subscore of 0 or 1, (iii) achieving a clinical response based on the Mayo endoscopy subscore, (iv) having improvements from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score, (v) having a mucosal healing, (vi) having a decrease from baseline in Mayo score, and (vii) in clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1, and had previously failed or was intolerant of at least one therapy selected from the group consisting of:
• an anti-TNF, vedolizumab, corticosteroids, azathioprine (AZA), and 6 mercaptopurine (6 MP), or the subject had demonstrated corticosteroid dependence.