Abstract
Sands et al. expand the therapeutic potential of anti-IL-12/IL-23 blockade in IBD, by demonstrating a clear clinical benefit of ustekinumab as induction and maintenance therapy for ulcerative colitis (UC). The UNIFI trial had a double-blind, placebo-control design and consisted of an 8-week induction and a 44-week randomized-withdrawal maintenance trial. Patients with active, moderate-to-severe UC (total Mayo score of 6-12 with endoscopic subscore of ≥2 via central reading) were recruited from 244 centers worldwide. Patient characteristics were similar across groups in the induction and maintenance arms. Half of the patients who were randomized for the induction trial reported a history of treatment failure with biologics, among whom, 98.8% had failed at least one TNF antagonist, 32.6% both a TNF antagonist and vedolizumab, and 1.2% vedolizumab only.
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