Trial reportInflammatory bowel diseases2019
Fecal Calprotectin Responses Following Induction Therapy With Vedolizumab in Moderate to Severe Ulcerative Colitis: A Post Hoc Analysis of GEMINI 1.
Trial report in Inflammatory bowel diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07240168 (Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD), which is not on this map. Cited by 22 papers.
What it found
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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.
Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
Who cites it
22 citing papers in PubMed, 39 citations in OpenAlex.
- Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022Trial
- Fungal abundance across flare and remission in ulcerative colitis patients.Gut pathogens · 2026Article
- Intestinal transcriptomic analysis and prediction of biomarkers associated with mucosal healing following vedolizumab treatment in ulcerative colitis using machine learning.BMC gastroenterology · 2026Article
- Current and novel biomarkers for predicting and assessing therapeutic response in inflammatory bowel disease: a systematic review.Therapeutic advances in gastroenterology · 2026Review
- Comparison of fecal calprotectin levels and endoscopic scores for predicting relapse in patients with ulcerative colitis in remission.World journal of gastroenterology · 2023Article
- Vedolizumab and Adalimumab in Biologic-Naïve Ulcerative Colitis: Comparison of Patient-Level Clinical Trial Data and VARSITY for Week 6 Clinical Remission.Digestive diseases and sciences · 2023Article
- Diagnostic Accuracy of Fecal Calprotectin for Predicting Relapse in Inflammatory Bowel Disease: A Meta-Analysis.Journal of clinical medicine · 2023Review
- iSTART-II: An Update on the i Support Therapy-Access to Rapid Treatment (iSTART) Approach for Patient-Centered Therapy in Mild-to-Moderate Ulcerative Colitis.Journal of clinical medicine · 2023Review
- Early Clinical Remission Is a Predictor of Long-Term Remission with the Use of Vedolizumab for Ulcerative Colitis.Biomedicines · 2022Article
- Prognostic Role of Post-Induction Fecal Calprotectin Levels in Patients with Inflammatory Bowel Disease Treated with Biological Therapies.Biomedicines · 2022Article
- Proposed pathway for therapeutic drug monitoring and dose escalation of vedolizumab.Frontline gastroenterology · 2022Article
- Fecal Calprotectin Is Highly Effective to Detect Endoscopic Ulcerations in Crohn's Disease Regardless of Disease Location.Inflammatory bowel diseases · 2021Article
- Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis.Digestive diseases and sciences · 2021Article
- Small intestinal bacterial overgrowth and evaluation of intestinal barrier function in patients with ulcerative colitis.American journal of translational research · 2021Article
- Prostaglandin E-Major Urinary Metabolite Predicts Relapse in Patients With Ulcerative Colitis in Clinical Remission.Clinical and translational gastroenterology · 2020Observational
- Fecal calprotectin is a reliable marker of endoscopic response to vedolizumab therapy: A simple algorithm for clinical practice.Journal of gastroenterology and hepatology · 2020Article
- Assessment of serum cytokines predicts clinical and endoscopic outcomes to vedolizumab in ulcerative colitis patients.British journal of clinical pharmacology · 2020Article
- Serum Interleukin-6 and -8 as Predictors of Response to Vedolizumab in Inflammatory Bowel Diseases.Journal of clinical medicine · 2020Article
- Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study.Clinical and translational gastroenterology · 2020Observational
- Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid?Current treatment options in gastroenterology · 2020Review
Corrections and comments
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Authors and funding
15 authors at 10 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn patients with ulcerative colitis (UC), fecal calprotectin (FC) concentrations correlate with endoscopic inflammation evidence. This study investigated the effect of vedolizumab induction on FC concentrations and whether FC concentrations could be a reliable surrogate measure of disease status.
methodsData from the placebo-controlled, phase 3 trial GEMINI 1 were used to evaluate week-6 relationships between outcomes (including clinical remission, mucosal healing [MH], and endoscopic remission) and both absolute FC concentration values and relative FC concentration changes from baseline (%FC0-6). Sensitivity and specificity were calculated by cross-tabulation; the value of week-6 FC concentration as surrogate biomarker was measured with Youden J statistic computed for various cut points.
resultsGEMINI 1 induction phase enrolled 895 patients. Fecal calprotectin concentration decreases were deeper in patients with clinical remission, MH, and/or endoscopic remission than in patients without. The best week-6 indicator of clinical or endoscopic remission in this data set was absolute FC concentration ≤150 µg/g. The surrogate biomarker values (based on areas under the curve) for the best-performing cut points (FC0-6 reduction >90%, FC ≤150 µg/g) were fair (range, 0.70-0.77, total population). More patients met the ≤150 µg/g cut point with vedolizumab than with placebo. Baseline FC concentrations were not correlated with clinical outcomes.
conclusionsFecal calprotectin concentration reductions were greater with vedolizumab induction than with placebo. Week-6 FC concentrations had only fair surrogate biomarker value for endoscopic status. Our data suggest that, while FC may reflect inflammatory burden, FC concentration after vedolizumab induction may not be a robust biomarker of mucosal inflammation.
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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.