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Presentation data from US VICTORY Consortium

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1 Presentation data from US VICTORY Consortium
US VICTORY Consortium: Real World Comparative Effectiveness of Vedolizumab and Anti-TNF: Crohn’s disease Presentation data from US VICTORY Consortium M. Bohm et al. ECCO 2018: OP025 ECCO 2018

2 Comparing Vedolizumab and Anti-TNF Effectiveness in Real World (Crohn’s disease)
AIM: Compare the effectiveness of VDZ to anti-TNF therapy for CD in clinical practice COHORT: Multicenter, US-based consortium (VICTORY) DESIGN: Propensity score matching (1:1) Patient characteristics: Age, sex Disease characteristics: Prior hospitalization, stricturing/penetrating disease complication history, prior bowel surgery, disease severity Treatment history: steroid refractoriness/dependence, prior anti-TNF therapy failure M. Bohm et al. ECCO 2018: OP025

3 Methods of Study for Crohn’s disease patients
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: Absence of ulcers or erosions ANALYSIS: Cumulative rates of outcomes at 12 months Cox proportional hazard models for comparative effectiveness Adjusted for: concomitant steroid or IMM use, disease location (ileal vs. colonic), number of prior anti-TNF agents used M. Bohm et al. ECCO 2018: OP025

4 Propensity Matching Results for Crohn’s Disease Vedolizumab vs Anti-TNF
1,122 CD patients identified, 538 included after matching Propensity model AUC 0.80 for predicting VDZ vs. anti-TNF therapy VDZ Anti-TNF VDZ Anti-TNF M. Bohm et al. ECCO 2018: OP025

5 Effectiveness Results for Crohn’s Disease Vedolizumab vs Anti-TNF
VDZ Anti-TNF aHR 95% CI Clinical remission 38% 34% 1.27 0.91 – 1.78 Steroid-free remission 26% 18% 1.75 0.90 – 3.43 Endoscopic healing 50% 41% 1.67 1.13 – 2.47 Vedolizumab vs. Anti-TNF therapy in CD stratified by location Location Clinical Remission aHR, 95% CI Steroid-Free Remission aHR, 95% CI Endoscopic Healing aHR, 95% CI Isolated small bowel disease 0.70 0.32 – 1.51 0.60 0.17 – 2.05 1.45 0.52 – 4.10 Colonic or ileocolonic ds. 1.51 1.04 – 2.20 4.90 2.44 – 9.83 1.70 1.10 – 2.61 M. Bohm et al. ECCO 2018: OP025

6 Steroid-free remission
Comparative effectiveness of VDZ and TNF-antagonist therapy in CD: A multicentre consortium propensity score–matched analysis Aim: To compare the effectiveness of VDZ to TNF-antagonist therapy for CD (data from the VICTORY consortium) Results: Propensity score matching accounted for age, sex, prior CD-related hospitalisation within the previous year, stricturing or penetrating disease complication history, prior bowel surgery, disease severity, steroid refractoriness or dependence, and prior TNF-antagonist failure Cumulative rates of clinical, steroid-free, and endoscopic healing at month 12 VDZ (n=269) TNF-antagonist (n=269) HR 1.67, 95% CI HR 1.27, 95% CI HR 1.75, 95% CI Clinical remission Steroid-free remission Endoscopic healing CD, Crohn’s disease; CI, confidence interval; HR, hazard ratio; TNF, tumour necrosis factor; VDZ, vedolizumab. Clinical remission=complete resolution of CD-related symptoms; steroid-free=on steroids at baseline, tapered off, no repeat steroid prescription for 4 weeks; endoscopic healing=absence of ulcers or erosions. Bold red text indicates significance. Bohm M, et al. ECCO 2018; Abstract OP025.

7 Conclusions Cumulative rates for endoscopic healing were statistical significantly higher in VDZ treated CD patients as compared to anti-TNF treated Cumulative rates for clinical remission and steroid-free remission were numerically higher in VDZ treated CD patients as compared to anti-TNF treated CD patients CD patients with colonic or ileo-colonic involvement were statistical significantly more likely to achieve these outcomes with VDZ as compared to anti-TNF therapy Randomized controlled trial data are needed to confirm these findings and determine the optimal position of VDZ in current algorithms M. Bohm et al. ECCO 2018: OP025


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