Vedolizumab clinical decision support tool predicts clinically relevant targets in patients with Crohn’s disease

Background: The vedolizumab-specific clinical decision support tool (VDZ-CDST) was developed to predict the probability of a response to vedolizumab treatment in patients with Crohn’s disease (CD). Objective: This post hoc analysis aimed to characterize the VDZ-CDST’s ability to predict clinical outcomes and quality of life (QoL) among vedolizumab-treated patients. Design: Post hoc analysis of pooled clinical trial data. Methods: Pooled data from GEMINI 2, VERSIFY, and VISIBLE 2 clinical trials were utilized, and patients with CD were classified using the VDZ-CDST as having a low, intermediate, or high probability of response to vedolizumab. Mean patient-reported outcome 2 score, symptomatic response, symptomatic remission, and QoL (Inflammatory Bowel Disease Questionnaire) were assessed. Data up to 1 year were analyzed. Results: Overall, 1189 patients with CD were included. The VDZ-CDST classified 240, 548, and 401 patients as having a low, intermediate, and high probability of response to vedolizumab, respectively. Mean patient-reported outcome 2 scores decreased from baseline to week 52 in all groups, with fastest and greatest reductions in the high probability group. Symptomatic response at week 6 was achieved by 40.4%, 23.9%, and 9.6% in the high, intermediate, and low probability groups, respectively, and rates in the high probability group were greatest through week 52. Rates of symptomatic remission were highest in the high probability group, followed by intermediate and low at week 6 through week 52. The greatest improvements in QoL were observed in the high probability group. Conclusion: These findings provide confirmatory evidence of the utility of the VDZ-CDST in identifying patients with CD who are most likely to achieve optimal clinical and QoL outcomes with vedolizumab treatment.