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OP025 Comparative effectiveness of vedolizumab and tumour necrosis factor-antagonist therapy in Crohn’s disease: a multicentre consortium propensity score-matched analysis

M. Bohm1, S.V. Sagi1, M. Fischer1, S. Kadire1, G. Tran1, M. Rahal1, S. Aniwan2, J. Meserve3, A. Weiss4, G. Kochhar5, P. Shashi5, D. Faleck6, A. Winters6, S. Chablaney6, J.L. Koliani-Pace7, B. Boland3, S. Singh3, R. Hirten6, E. Shmidt6, K. Lasch8, M. Luo8, D. Hudesman9, S. Chang9, D. Lukin4, K. Sultan10, A. Swaminath11, N. Gupta12, C.A. Siegel7, S. Kane2, E.V. Loftus2, B.E. Sands6, W.J. Sandborn3, J.-F. Colombel6, B. Shen5, P.S. Dulai3*

1Indiana University, Indianapolis, USA, 2Mayo Clinic, Rochester, USA, 3University of California - San Diego, La Jolla, USA, 4Montefiore Medical Center, New York, USA, 5Cleveland Clinic Foundation, Cleveland, USA, 6Icahn School of Medicine at Mount Sinai, New York, USA, 7Dartmouth-Hitchcock Medical Center, Lebanon, USA, 8Takeda Pharmaceuticals U.S.A., Inc., Deerfield, USA, 9New York University (NYU), New York, USA, 10North Shore University Hospital, Manhasset, USA, 11Lenox Hill Hospital, New York, USA, 12University of Mississippi, Jackson, USA

Background

We aimed to compare the effectiveness of vedolizumab (VDZ) to tumour necrosis factor (TNF)-antagonist therapy for Crohn’s disease (CD).

Methods

Using a multicentre, US-based consortium of CD patients treated with VDZ or TNF-antagonist therapy, we performed propensity score matching (1:1) accounting 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. Treatment response was categorised using the Physician Global Assessment. Using Cox proportional hazard models, we compared cumulative rates of clinical remission (complete resolution of CD-related symptoms), steroid-free remission (on steroids at baseline, tapered off, no repeat steroid prescription for 4 weeks), and endoscopic healing (absence of ulcers or erosions). Hazard ratios (HR) and 95% confidence intervals (CI) are reported for VDZ vs. TNF-antagonist therapy.

Results

The propensity score model accurately predicted treatment status (area under curve 0.80). Of 1122 CD patients, 538 were included after matching (n = 269 VDZ; 44% male; median age 35 years). After adjusting for concomitant steroid or immunomodulator use, disease location (isolated small bowel, ileocolonic, isolated colonic), and number of prior TNF-antagonists used, VDZ-treated patients had numerically, but not statistically significant higher 12-month cumulative rates for clinical remission (38% vs. 34%; HR 1.27, 95% CI 0.91–1.78) and steroid-free remission (26% vs. 18%; HR 1.75, 95% CI 0.90–3.43). VDZ-treated patients had significant higher 12-month cumulative rates for endoscopic healing (50% vs. 41%; HR 1.67, 95% CI 1.13–2.47). Among patients with colonic involvement, VDZ-treated patients had significantly higher rates of clinical remission, steroid-free remission, and endoscopic healing (Table 1).

Table 1. Vedolizumab vs. TNF-antagonist therapy in Crohn’s disease. Adjusted for concomitant steroid use, concomitant immunomodulator use, and number of prior TNF-antagonists used.

LocationClinical remissionSteroid-free remissionEndoscopic healingIsolated small-bowel diseaseHR 0.70; 95% CI 0.32–1.51HR 0.60; 95% CI 0.17–2.05HR 1.45; 95% CI 0.52–4.10Colonic or ileocolonic diseaseHR 1.51; 95% CI 1.04-2.20HR 4.90; 95% CI 2.44–9.83HR 1.70; 95% CI 1.10–2.61

Conclusion

After accounting for measurable disease- and patient-specific characteristics that may affect biological effectiveness, VDZ-treated CD patients had numerically higher 12-month cumulative rates of clinical remission, steroid-free remission, and endoscopic healing than TNF-antagonist-treated patients. CD patients with colonic involvement were significantly more likely to respond to VDZ than to TNF-antagonist therapy. Randomised controlled trial data are needed to confirm these findings. Statistical analyses were conducted at the University of California, San Diego. Research funding was provided in part by Takeda Pharmaceuticals.