P130 Efficacy and safety of ustekinumab in Crohn’s disease: a real-world study from the west midlands

Introduction Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, was approved in the United Kingdom for the treatment of moderate to severe Crohn’s disease (CD) in 2017 as it has demonstrated effectiveness in clinical trials. Yet often, large international trial data does not concord with regional or even national experience. This retrospective dual centre study aims to assess the efficacy and safety of UST in a real-world, multi-ethnic and anti-TNF exposed CD cohort. Methods All patients commenced on UST were included in the study from two sites of The University of Birmingham NHS Trust. Detailed data on demographics, previous treatment and disease phenotype were recorded. UST was given as an infusion (6 mg/kg) at week 0 followed by 90 mg subcutaneous injection at week 8 and 90 mg SC every 8 weeks as maintenance. Clinical endpoints were 1) remission (Harvey Bradshaw Index (HBI) ≤ 4) 2) response (reduction in HBI of ≥3 or sustained HBI ≤4 points) at 12, 24 and 52 weeks. Adverse events were recorded. Results 62 patients (table 1) were included of whom 60 (97%) were biologic exposed and 44 (71%) had failed >1 previous biologic. 12-week clinical response was 69%, 24-week and 52-week remission rates were 52% and 69% respectively. 18 (29%) were on concurrent immunomodulation (IM). The 12-week response rate with concurrent IM was 78% versus 65% in non IM group. Clinical remission was higher in those not on IM (56% not on IM versus 42% on IM)) Clinical response rates were not significantly different in those with perianal disease versus without. Adverse events occurred in 8 (13%), 3 (5%) were considered major (suicidal ideation, severe headache, hypotension). Conclusions In this treatment resistant CD group, Ustekinumab is effective with a low side effect profile. Concurrent IM therapy improved clinical response rate, but this was not sustained in longer term remission rates and reflects international trial data. CD phenotype did not affect outcomes.