P631 Development and validation of a clinical scoring tool for predicting treatment outcomes with vedolizumab in patients with ulcerative colitis. (25th January 2019)

• Record Type: Journal Article
• Authors: Dulai, P S; Singh, S; Vande Casteele, N; Meserve, J; Winters, A; Chablaney, S; Aniwan, S; Shashi, P; Kochhar, G; Weiss, A; Koliani-Pace, J L; Gao, Y; Boland, B S; Chang, J T; Faleck, D; Hirten, R; Ungaro, R; Lukin, D; Sultan, K; Hudesman, D; Chang, S; Bohm, M; Varma, S; Fischer, M; Shmidt, E; Swaminath, A; Gupta, N; Rosario, M; Jairath, V; Guizzetti, L; Feagan, B G; Siegel, C A; Shen, B; Kane, S; Loftus Jr, E V; Sandborn, W J; Sands, B E; Colombel, J-F; Lasch, K; Cao, C;
• Is Part Of: Journal of Crohn's and colitis. Volume 13(2019)Supplement 1
• Page Start: S433
• Page End: S433
• Publication Date: 2019-01-25
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjy222.755
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: 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). Conclusions: 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).