Development and validation of clinical scoring tool to predict outcomes of treatment with vedolizumab in patients with ulcerative colitis
Clinical Gastroenterology and Hepatology Feb 20, 2020
Dulai PS, Singh S, Casteele NV, et al. - Researchers sought to develop and validate a clinical decision support tool (CDST) that may aid in predicting outcomes of vedolizumab therapy for ulcerative colitis (UC). From the GEMINI 1 trial, data from 620 patients with UC who received vedolizumab induction and maintenance therapy (derivation cohort) were used to perform logistic regression analyses and factors associated with corticosteroid-free remission (full Mayo score of 2 or less, no subscore above 1) were recognized. During vedolizumab therapy, corticosteroid-free remission was observed in independent correlation with absence of exposure to a tumor necrosis factor (TNF) antagonist (+3 points), disease duration of 2 y or more (+3 points), baseline endoscopic activity (moderate vs severe) (+2 points), and baseline albumin concentration (+0.65 points per 1 g/L). The CDST led to the identification of patients most inclined to enter corticosteroid-free remission during vedolizumab therapy, but not anti-TNF therapy. In the derivation and validation cohorts, patients were assigned to groups of low (CDST score, 26 points or less), intermediate (CDST score, 27–32 points), or high (CDST score, 33 points or more) probability of response vedolizumab exposure. In the derivation cohort, a statistically significant linear correlation was observed between probability group and efficacy (area under the receiver operating characteristic curve, 0.65), as well as drug exposure. A cutoff value of 26 points in the validation cohort resulted in the identification of patients who did not respond to vedolizumab with high sensitivity (93%); only the low and intermediate probability groups benefited from reducing intervals of vedolizumab administration due to lack of response.
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