Presentation data from US VICTORY Consortium US VICTORY Consortium: Real World Comparative Effectiveness of Vedolizumab and Anti-TNF: Ulcerative Colitis Presentation data from US VICTORY Consortium D. Faleck et al. ECCO 2018: OP026 ECCO 2018

Comparing Vedolizumab and Anti-TNF Effectiveness in Real World (Ulcerative Colitis) Indirect comparisons of RCTs have suggested that anti-TNF therapy and VDZ may be equally efficacious in UC Real-world comparative effectiveness data is lacking AIM: Compare the effectiveness of VDZ to anti-TNF therapy for UC in clinical practice COHORT: Multicenter, US-based consortium (VICTORY) DESIGN: Propensity score matching (1:1) Patient characteristics: Age, sex Disease characteristics: Prior hospitalization, disease extent, disease severity Treatment history: steroid refractoriness/dependence, prior anti-TNF therapy failure D. Faleck et al. ECCO 2018: OP026

Method OUTCOMES: Clinical response and remission: Physician global assessment Steroid-free response and remission: Achieving response/remission, tapering off steroids, and requiring no repeat steroid prescription for 4 weeks Endoscopic healing: Mayo endoscopic sub-score of 0 or 1 ANALYSIS: Cumulative rates of outcomes at 12 months Cox proportional hazard models for comparative effectiveness Adjusted for: concomitant steroid or IMM use and number of prior anti-TNF agents used D. Faleck et al. ECCO 2018: OP026

VDZ and Anti-TNF Data for UC 646 UC patients identified, 334 included after matching Propensity model AUC 0.73 for predicting VDZ vs. anti-TNF therapy VDZ Anti-TNF VDZ Anti-TNF D. Faleck et al. ECCO 2018: OP026

Steroid-free remission Comparative effectiveness of VDZ and TNF-antagonist therapy in UC: A multicentre consortium propensity score–matched analysis Aim: To compare the effectiveness of VDZ to TNF-antagonist therapy for UC (data from the VICTORY consortium) using clinical and steroid-free remission and endoscopic healing at 12 months Results: Propensity score matching accounted for age, sex, prior UC-related hospitalisation within the previous year, disease extent, disease severity, steroid refractoriness or dependence, and prior TNF-antagonist failure Cumulative rates of clinical and steroid-free remission and endoscopic healing at month 12 HR 1.54, 95% CI 1.08-2.18 HR 1.73, 95% CI 1.10-2.73 HR 1.43, 95% CI 0.79-2.60 VDZ (n=167) TNF-antagonist (n=167) Clinical remission Steroid-free remission Endoscopic healing Conclusions: UC patients treated with VDZ had significantly higher 12-month cumulative rates of clinical remission and endoscopic healing, and numerically higher steroid-free remission rates, when compared with patients treated with TNF-antagonist Clinical remission=complete resolution of UC-related symptoms; steroid-free=on steroids at baseline, tapered off, no repeat steroid prescription for 4 weeks; endoscopic healing=Mayo endoscopic subscore of 0 or 1. IM included azathioprine, 6-mercaptopurine, and methotrexate. CI, confidence interval; HR, hazard ratio; IM, immunomodulator; TNF, tumour necrosis factor; UC, ulcerative colitis; VDZ, vedolizumab. Bold and red text indicates significance. Faleck D, et al. ECCO 2018; Abstract OP026.

Conclusions VDZ Anti-TNF aHR 95% CI Clinical remission 54% 37% 1.54 Cumulative rates for clinical remission and endoscopic healing were statistically significantly higher in VDZ treated UC patients as compared to anti-TNF treated UC patients. Cumulative rates for steroid-free remission were numerically higher, but not statistically significant, for VDZ versus anti-TNF therapy Randomized controlled trial data are needed to confirm these findings and determine the optimal position of VDZ in current algorithms VDZ Anti-TNF aHR 95% CI Clinical remission 54% 37% 1.54 1.08 – 2.18 Steroid-free remission 49% 38% 1.43 0.79 – 2.60 Endoscopic healing 50% 42% 1.73 1.10 – 2.73 D. Faleck et al. ECCO 2018: OP026