Trial reportInflammatory bowel diseases2022
Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab.
Trial report in Inflammatory bowel diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02497469 (A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis), which is not on this map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Who cites it
6 citing papers in PubMed, 14 citations in OpenAlex.
- Retrospective Validation of Clinical Decision Support Tools for Predicting Effectiveness Outcomes in Inflammatory Bowel Disease Patients Treated with Vedolizumab.Pharmaceutics · 2025Article
- A Guide to the Patient-Centric Use of Vedolizumab for Crohn's Disease.Inflammatory bowel diseases · 2025Review
- Identifying polyamine related biomarkers in diagnosis and treatment of ulcerative colitis by integrating bulk and single-cell sequencing data.Scientific reports · 2024Article
- Predictive, preventive and personalised approach as a conceptual and technological innovation in primary and secondary care of inflammatory bowel disease benefiting affected individuals and populations.The EPMA journal · 2024Review
- Precision medicine in inflammatory bowel diseases.Intestinal research · 2024Review
- Using a Clinical Decision Support Tool for Inflammatory Bowel Disease.Gastroenterology & hepatology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
Abstract
BACKGROUND &
aimsWe have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with VDZ vs adalimumab (ADA).
methodsIn a post hoc analysis of a clinical trial for VDZ vs ADA in moderate to severe UC (VARSITY trial; NCT02497469), comparative accuracy was evaluated for the VDZ-CDST among an external validation cohort of VDZ- and ADA-treated patients for week 52 HEMI (Mayo endoscopic subscore 0-1 and Geboes score <3.2). Comparative effectiveness of VDZ and ADA was assessed after stratifying the cohort by baseline probability of response to VDZ using the VDZ-CDST.
resultsA total of 419 patients were included. The majority of patients enrolled in the VARSITY trial had a high (61%) or intermediate (29%) baseline predicted probability of response to VDZ. The baseline VDZ-CDST score was significantly more likely to predict week 52 HEMI for VDZ (area under the curve , 0.712; 95% confidence interval, 0.636-0.787) relative to ADA-treated patients (area under the curve, 0.538; 95% confidence interval, 0.377-0.700; P < .001 for AUC comparison). A significant (P < .001) association was observed between the VDZ-CDST and measured VDZ drug exposure over 52 weeks. Superiority of VDZ to ADA was only observed in patients with a high baseline predicted probability of response to VDZ.
conclusionsSuperiority of VDZ to ADA is dependent on baseline probability of response, and a VDZ-CDST is capable of identifying UC patients most appropriate for VDZ vs ADA.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.