P1036 The PODIUM Study: A three-arm comparison of target therapies after anti-TNFα in ulcerative colitis – an interim analysis

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Abstract Background Anti-tumor necrosis factor(TNF)α are the first target therapies approved to treat ulcerative colitis(UC). Drugs with different mechanisms of action(MoA) have then entered the market, but data on the optimal management of UC after failure of 1-line anti-TNFα are lacking. Methods The PODIUM study is a retrospective, observational study comparing the real-life effectiveness and safety of 2-line vedolizumab(VDZ), ustekinumab (UST) and JAK inhibitors(JAKi). Consecutive UC patients(pts) failure to 1+ anti-TNFα and never exposed to other MoA were enrolled from 13 European centres. Sociodemographic data, data on clinical activity and adverse events of interest(AEIs) were collected, from the initiation of 2-line therapy until 1 year of observation/drug discontinuation/last follow-up. The primary outcome was steroid-free clinical remission(SFCR); inverse probability of treatment weighting(IPTW) was applied to all outcomes. This interim analysis includes data collected up to August 2024; data collection is still ongoing. Results Data on 352 patients (187VDZ, 76UST, 89JAKi) were included. Baseline characteristics are presented in Table1. After IPTW, the cumulative probability of achieving SFCR during the first year was 52%, 68% and 71% for VDZ, UST and JAKi, respectively; both UST and JAKi were superior to VDZ at Log-rank test(p<0.05), with no differences between the two (Figure1). Stool frequency scores were significantly lower at 12 months in the UST- and JAKi-groups, compared to the VDZ-group(0.5 and 0.5 vs 1.2, p<0.05 for both); rectal bleeding scores were nearly significantly lower at 12 months in the UST- and JAKi-groups, compared to the VDZ-group(0.2 and 0.2 vs 0.6, p<0.05 for both). Recorded AEIs were 10(5.3% of VDZ pts, 4 infections) in the VDZ group, 7(9.2% of UST pts, 1 infection) in the UST group, 17(19.1% of JAKi pts, 10 infections including 1 Zoster reactivation) in the JAKi group. Conclusion This preliminary analysis suggests that both UST and JAKi might have superior effectiveness, compared to VDZ, as second-line agents in patients with UC, after anti-TNF-α. A significantly higher rate of AEIs was observed in the TOF group. Confirmatory analysis with a larger sample size will be performed.