1. 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

2. 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

3. 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

4. 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

5. 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
HR 1.73, 95% CI
HR 1.43, 95% CI
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.

6. 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