ArticleInflammatory bowel diseases2022
Pharmacokinetic-Pharmacodynamic Model of Vedolizumab for Targeting Endoscopic Remission in Patients With Crohn Disease: Posthoc Analysis of the LOVE-CD Study.
Article in Inflammatory bowel diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02646683 (An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Crohn's Disease), which is not on this map. Cited by 14 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.
An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study (LOw Countries VEdolizumab in CD Study)
Who cites it
14 citing papers in PubMed, 24 citations in OpenAlex.
- Population Pharmacokinetics and Exposure-Response Relationships of Etrolizumab in Patients with Moderately-to-Severely Active Crohn's Disease.Journal of clinical pharmacology · 2025Trial
- Physiologically Motivated Sequential Population Modeling of Albumin Trends and Vedolizumab Pharmacokinetics for Pregnancy Dosing Regimen Optimization.Clinical pharmacology and therapeutics · 2026Article
- Post-induction serum vedolizumab levels are not associated with better maintenance outcomes in patients with Crohn's disease.Zeitschrift fur Gastroenterologie · 2026Article
- Dose Exploration Based on Quantitative Pharmacokinetic Analysis of Monoclonal Antibodies for Pediatric Immune-Mediated Diseases: Current Evidence and Future Directions.Drug design, development and therapy · 2026Review
- Vedolizumab in inflammatory bowel disease: pharmacokinetics and the role of immunomodulator co-therapy.Therapeutic advances in gastroenterology · 2026Review
- Article
- Risk factor analysis and nomogram for predicting massive postoperative gastrointestinal bleeding in patients with Crohn's disease: a multicenter retrospective study.Frontiers in medicine · 2025Article
- Article
- Vedolizumab Clearance as a Surrogate Marker for Remission in Inflammatory Bowel Disease Patients: Insights from Real-World Pharmacokinetics.Pharmaceutics · 2024Article
- Vedolizumab Efficacy Is Associated With Decreased Intracolonic Dendritic Cells, Not Memory T Cells.Inflammatory bowel diseases · 2024Article
- Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023Review
- Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics.Journal of clinical medicine · 2023Review
- The Role of Therapeutic Drug Monitoring in Children.Gastroenterology clinics of North America · 2023Review
- Real world population pharmacokinetic study in children and young adults with inflammatory bowel disease discovers novel blood and stool microbial predictors of vedolizumab clearance.Alimentary pharmacology & therapeutics · 2023Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHigher serum concentrations of vedolizumab have been associated with improved outcomes in inflammatory bowel disease. It is unclear how vedolizumab exposure is linked to endoscopic remission in Crohn disease (CD). We aimed to develop a pharmacokinetic-pharmacodynamic model linking vedolizumab exposure to endoscopic remission in CD.
methodsData were obtained from the first 110 patients participating in a phase 4 prospective multicenter trial (LOVE-CD; ClinicalTrials.gov identifier: NCT02646683), where vedolizumab was dosed at 300 mg every 8 weeks and serum concentrations and antibodies to vedolizumab were measured before each infusion. Concentration-time profiles were described by a 2-compartment model with parallel linear and nonlinear elimination. A first-order discrete-time Markov model was used to describe the relationship between pharmacokinetic exposure metrics and the probability of endoscopic remission (Simple Endoscopic Score for CD < 4).
resultsLinear clearance was 0.215 L/d, and the volume of distribution of the central compartment was 4.92 L. Linear clearance was higher and vedolizumab exposure was lower in patients with lower serum albumin concentrations, in the presence of antibodies to vedolizumab, and in patients with previous exposure to other biologic therapy. A week 22 vedolizumab concentration of 20.0 mg/L was predicted to yield a 35% probability of achieving endoscopic remission at week 26. Model-based simulations suggested that endoscopic remission rates of 46.5% or 40.0% could be reached with every-4-weeks dosing in patients who were naïve or previously exposed to biologic therapy, respectively.
conclusionsModel-informed dosing of vedolizumab in CD provides a foundation for future research aiming to maximize endoscopic remission rates.
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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.