P0788Ability of clinical decision support tool to predict outcomes of vedolizumab therapy in Crohn’s disease patients in daily practice

Background There is a need to identify Crohn’s Disease (CD) patients who will be most suitable and obtain most clinical benefit from treatment with vedolizumab (VDZ), an anti-α4β7 integrin inhibitor for the treatment of ulcerative colitis and Crohn’s Disease (CD). Previously, a clinical decision support tool (CDST) has been developed and validated to guide treatment decisions in CD patients treated with VDZ.1 In this study, we analyzed the ability of the CDST to predict clinical outcomes in CD patients. Methods Patients with moderate to severe CD receiving maintenance treatment with VDZ in single center were retrospectively analyzed using the CDST. We divided patient by CDST into low (≤13 points), intermediate (>13 and ≤19 points) and high response probability groups (>19 points) based on the previously developed scoring system. Clinical outcomes assessed included persistence on therapy and CD-related hospitalizations and surgery rates. Results We included 197 patients who were treated with VDZ for at least 6 months in our center. Using the CDST, at baseline, 23 patients (12%) had a low, 95 (48%) had an intermediate, and 79 (40%) had a high probability of treatment response with VDZ. There was no statistically significant difference in persistence on therapy between patients with low vs medium/high probability (p = 0.43). However, when patients were analyzed according to disease location by Montreal classification, there was a trend in those with isolated ileal (L1) or colonic (L2) CD. In this subgroup, patients with high response probability demonstrated a tendency to longer treatment persistence (p = 0.065); 83% of these patients remained on therapy after two years compared to 59% in the intermediate group. This trend was not observed in ileocolonic (L3) CD, where persistence rates were similar across groups (82% in high and intermediate groups and 83% in the low probability group; p = 0.56). We tried to assess the ability of CDST in prediction of complications of CD and we observed that number of hospitalization days was significantly lower in the high probability group (median: 0; third quartile: 0 days) compared to the low group (median: 17; third quartiles: 9 and 21 days; p < 0.001), while surgery rates showed no significant differences across groups (p = 0.4). Conclusion The CDST partially identifies CD patients likely to benefit from VDZ. Patients with high CDST scores demonstrate better persistence on therapy, particularly in the subgroup with L1/L2 localization, and a lower risk of hospitalization. These findings further validate the CDST as a valuable tool for guiding treatment decisions in CD. Reference: 1. Dulai PS, Boland BS, Singh S, et al. Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn’s Disease. Gastroenterology. 2018;155(3):687-695.e10. Conflict of interest: Dr. Konecny, Stefan: Grant: Ministry of Health of the Czech Republic Personal Fees: Bristol Myers Squib, Celltrion, Eli Lilly, Johnson & Johnson, MagnaPharm, Pfizer, PRO.MED.CS Praha, Swedish Orphan Biovitrum, Takeda, Tichanek, Filip: No conflict of interest Kavříková, Pavla: No conflict of interest Poredska, Karolina: No conflict of interest Prokopova, Lucie: No conflict of interest Zvarova, Veronika: No conflict of interest Zboril, Vladimir: No conflict of interest