P583 Efficacy of vedolizumab (VDZ) by disease extension in ulcerative colitis

Abstract

Background: Disease extension in UC is one of the major factors determining long-term prognosis. Results of the pivotal GEMINI 1 trial suggested that VDZ, a humanised monoclonal alpha4beta7 antibody approved for UC, is efficacious regardless of disease extension. Method(s): A post-hoc analysis was conducted on the maintenance phase intent-to-treat population of the GEMINI 1 trial. Efficacy outcomes assessed at week 52 by disease extension (proctosigmoiditis, left-sided colitis, extensive colitis, pancolitis) were: clinical response (reduction in complete Mayo score >=3 points, >=30% reduction from baseline, decrease in rectal bleeding subscore >=1 point or absolute rectal bleeding score of 1); corticosteroid (CS)-free remission in patients receiving CSs at baseline; and mucosal healing (Mayo Endoscopic subscore