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Background Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on real world outcomes are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from two US tertiary IBD centers. Methods Patients with moderately to severely active UC treated with ustekinumab at ______________ and ______________ between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of ≤2, with a combined rectal bleeding and stool frequency subscore of ≤1. Results Sixty-six UC patients were included. 92% of patients had prior exposure to biologics or tofacitinib. 43% and 45% of patients achieved clinical remission by 3 and 12 months, respectively. Anti-TNF non-response and endoscopic Mayo score of 3 were negative predictors of clinical remission. 33% of those followed for a year achieved concurrent endoscopic and histologic healing, which was significantly associated with lower partial Mayo score (P<0.01) and lower stool frequency (P=0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis). Conclusion In this cohort of mostly biologic-refractory UC patients, treatment with ustekinumab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials.

IBD patients on low-dose immunosuppressive therapy have a blunted immune response to HZV as compared with nonimmunosuppressed subjects. Despite this, immunosuppressed IBD patients are able to mount a statistically significant immune response. There were no serious adverse events to HZV.

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