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P631 Development and validation of a clinical scoring tool for predicting treatment outcomes with vedolizumab in patients with ulcerative colitis

P. S. Dulai*1, S. Singh1, N. Vande Casteele1, J. Meserve1, A. Winters2, S. Chablaney2, S. Aniwan3, P. Shashi4, G. Kochhar4, A. Weiss5, J. L. Koliani-Pace6, Y. Gao7, B. S. Boland1, J. T. Chang1, D. Faleck2, R. Hirten2, R. Ungaro2, D. Lukin5, K. Sultan7, D. Hudesman8, S. Chang8, M. Bohm9, S. Varma9, M. Fischer9, E. Shmidt10, A. Swaminath11, N. Gupta12, M. Rosario13, V. Jairath14, L. Guizzetti15, B. G. Feagan14, C. A. Siegel6, B. Shen4, S. Kane3, E. V. Loftus Jr3, W. J. Sandborn1, B. E. Sands2, J-F. Colombel2, K. Lasch13, C. Cao13

1University of California San Diego, La Jolla, CA, USA, 2Icahn School of Medicine at Mount Sinai, New York, NY, USA, 3Mayo Clinic, Rochester, MN, USA, 4Cleveland Clinic Foundation, Cleveland, OH, USA, 5Montefiore Medical Center, New York, NY, USA, 6Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA, 7North Shore University Hospital, Manhasset, NY, USA, 8New York University (NYU), New York, NY, USA, 9Indiana University, Indianapolis, IN, United States, 10University of Minnesota, Minneapolis, MN, United States, 11Lenox Hill Hospital, New York, NY, United States, 12University of Mississippi, Jackson, MS, United States, 13Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL, United States, 14University of Western Ontario, London, ON, Canada, 15Robarts Clinical Trials, London, ON, Canada

Background

We created and validated a clinical decision support tool (CDST) for vedolizumab (VDZ) therapy in active ulcerative colitis (UC).

Methods

To identify factors associated with corticosteroid-free remission (CSFREM; full Mayo score ≤2, no sub-score >1), logistic regression analyses were run on data from the GEMINI 1 VDZ trial for UC (derivation set; n = 620) and used to develop a CDST. Correlations between VDZ exposure, onset of action, and efficacy across predicted-probability groups were explored, and the CDST was externally validated in an observational cohort of VDZ-treated UC patients (validation set; n = 199).

Results

Factors independently associated with CSFREM were absence of previous tumour necrosis factor antagonist exposure (+3 points), disease duration ≥2 years (+3 points), baseline endoscopic activity (moderate vs. severe) (+2 points), and baseline albumin concentration (+0.65 points per g/l). Patients were stratified into low (≤26 points), intermediate (>26 to ≤32 points), or high (>32 points) probability of response groups. The higher probability group more rapidly achieved symptom activity reductions and attained higher rates of CSFREM (p < 0.001). In the validation set, a 26-point cut-off value showed high sensitivity (93%) for identifying non-responders. A statistically significant linear relationship was observed between VDZ exposure, probability groups, and efficacy in the derivation set (p < 0.001). In the validation set, only the low–intermediate probability group benefited from VDZ interval shortening for lack of response (p = 0.02).

Conclusion

We developed and externally validated a CDST with good discriminative performance for predicting CSFREM with VDZ in UC patients. Pending further validation, this tool could be a helpful aid in identifying patients who would benefit from VDZ interval shortening due to insufficient response. (GEMINI 1: NCT00783718).