Efficacy and safety of ustekinumab treatment in patients with ulcerative colitis. Efficacy and safety of ustekinumab treatment in patients with ulcerative colitis

UNIFI was a randomized placebo-controlled phase 3 clinical trial evaluating the efficacy and safety of ustekinumab (ClinicalTrials.gov Identifier: NCT02407236). Gene expression profiling by microarrays was carried out at baseline on biopsies from the sigmoid colon (15-20cm from anal verge) of patients (n=550) with moderate-to-severe ulcerative colitis and of healthy subjects (n=18). Ulcerative colitis patients received placebo (n=186) or ustekinumab (n=364). The effects of two different dosages were investigated: 130mg (n=180) and 6mg/kg (n=184). Overall design: Patients with moderate-to-severe ulcerative colitis were treated with ustekinumab (n=364) or placebo (n=186) at week 0. Biopsy samples were collected from 550 patients and 18 healthy subjects at baseline for RNA extraction and microarray profiling.