The effectiveness of ustekinumab and vedolizumab as third-line biologic therapy in patients with Crohn's disease.

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The effectiveness of Ustekinumab (UST) and Vedolizumab (VDZ) in patients with Crohn's disease (CD) as third-line biologic therapies is unclear. We performed a multicentre, real-world assessment of the effectiveness of UST and VDZ among highly-refractory patients with CD. Data of consecutive patients with CD treated with UST and VDZ as third-line biologic therapy until December 2021 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). 143 patients (UST: n=113; VDZ: n=30) were included. At the end of induction, the rates of clinical response (CR) were 61.9% for UST and 60.0% for VDZ (p=1.00), with steroid-free clinical remission (SFCR) achieved in 38.1% of patients in the UST group and 43.3% of patients in the VDZ group (p=0.75). After 52 weeks of observation, the rates of CR were 65.9% for UST and 71.4% for VDZ (p=0.77), while the rates of SFCR were 51.8% for UST and 57.1% for VDZ (p=0.78). At multiple Cox proportional hazard regression model, age (HR 0.98; p=0.04) and need for systemic steroids at baseline (HR 3.29; p=0.003) were found to be independent predictors of treatment discontinuation. Both VDZ and UST showed high effectiveness as third-line biologic therapy in CD, without significant differences between them.