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OP026 Comparative effectiveness of vedolizumab and TNF-antagonist therapy in ulcerative colitis: a multicentre consortium propensity score-matched analysis

D. Faleck1, P. Shashi2, J. Meserve3, M. Rahal4, S. Kadire4, G. Tran4, A. Weiss5, A. Winters1, S. Chablaney1, S. Aniwan6, J.L. Koliani-Pace7, G. Kochhar2, B. Boland3, S. Singh3, R. Hirten1, E. Shmidt1, K. Lasch8, M. Luo8, M. Bohm4, S. V Sagi4, M. Fischer4, D. Hudesman9, S. Chang9, D. Lukin5, K. Sultan10, A. Swaminath11, N. Gupta12, C.A. Siegel7, B. Shen2, W.J. Sandborn3, B.E. Sands1, J.-F. Colombel1, S. Kane6, E.V. Loftus6, P.S. Dulai3*

1Icahn School of Medicine at Mount Sinai, New York, USA, 2Cleveland Clinic Foundation, Cleveland, USA, 3University of California – San Diego, La Jolla, USA, 4Indiana University, Indianapolis, USA, 5Montefiore Medical Center, New York, USA, 6Mayo Clinic, Rochester, 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 ulcerative colitis (UC).

Methods

Using a multicentre, US-based consortium of UC patients treated with VDZ or TNF-antagonist therapy, we performed propensity score matching (1:1) accounting for age, sex, prior UC-related hospitalisation within the previous year, disease extent, 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 UC-related symptoms), steroid-free remission (on steroids at baseline, tapered off, no repeat steroid prescription for 4 weeks), and endoscopic healing (Mayo endoscopic subscore of 0 or 1). Hazard ratios (HRs) and 95% confidence intervals (CIs) are reported for VDZ compared with TNF-antagonist therapy.

Results

The propensity score model accurately predicted treatment status (area under curve 0.73). Of 646 UC patients, 334 were included after matching (n = 167 VDZ,; 49% male; median age 36 years). After adjusting for concomitant steroid use, concomitant immunomodulator (azathioprine, 6-mercaptopurine, methotrexate) use, and number of prior TNF-antagonists used, VDZ-treated patients had statistically significant higher 12-month cumulative rates of clinical remission (54% vs. 37%; HR 1.54, 95% CI 1.08–2.18) and endoscopic healing (50% vs. 42%, HR 1.73, 95% CI 1.10–2.73). Cumulative 12-month rates for steroid-free remission were numerically higher for VDZ-treated patients, but not statistically significant (49% vs. 38%; HR 1.43, 95% CI 0.79–2.60), These findings were consistent when stratified by disease extent and prior TNF-antagonist exposure.

Conclusion

After accounting for measurable disease and patient-specific characteristics that may impact biologic effectiveness, we observed that VDZ-treated UC patients had significantly higher 12-month cumulative rates of clinical remission and endoscopic healing, and numerically higher steroid-free remission rates, when compared with TNF-antagonist–treated patients. 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 U.S.A., Inc.