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Background Long-term effectiveness of vedolizumab (VDZ) in real-life clinical practice is unknown. We aimed to evaluate clinical efficacy and treatment persistence of VDZ in a real-world cohort of patients with Crohn’s disease (CD). Methods CD patients from a single tertiary IBD referral centre receiving VDZ treatment outside clinical trials between September 2016 and August 2019 were included. Data were collected prospectively at baseline, weeks 22, 54, and 108. Disease activity was assessed using the Harvey Bradshaw index (HBI). The primary endpoint was steroid-free clinical remission, defined as HBI of 4 or lower without the need of corticosteroids. Secondary endpoints were treatment persistence and durability of VDZ response. Results Up to August 2019 114 patients had received at least one VDZ infusion, 79% had prior anti-TNFα drug exposure. Of the 90 patients who reached 54 weeks of follow-up, 68 patients (75,5%) were still under VDZ therapy. 38 of them (55,9%) were in steroid-free clinical remission. We compared the initial response to VDZ at week 22 and at week 54. Among the 29 patients in steroid-free clinical remission at week 22, 25 (86.2%) were still in steroid-free clinical remission at week 54. Three out of 29 patients discontinued VDZ therapy before week 54, for insufficient response and adverse events in two cases and for pregnancy in one. Of the 34 patients who reached 108 weeks of follow-up, 17 (50%) were still under VDZ therapy. 11 of them (64.7%) were in steroid-free clinical remission. We compared the initial response to VDZ at week 22 and at week 108. Among the 11 patients in steroid-free clinical remission at week 22, 6 (54.5%) were still in steroid-free clinical remission at week 108. Two out of 11 patients discontinued VDZ therapy before week 108 for worsening of perianal disease. Conclusion After 1 year, 75.5% of patients were still on treatment, of whom more than 55% achieved remission. 86% of patients maintained a response after the first year of treatment. After 2 years the rate of patients who presented with steroid-free clinical remission and who maintained response tended to decrease, consistent with previously published data. However, half of the patients persisted with VDZ treatment. These data support the long-term effectiveness and favourable safety profile of VDZ.

P367 Real-life long-term effectiveness and treatment persistence of vedolizumab in a single tertiary care cohort of Crohn’s disease patients