ArticleAlimentary pharmacology & therapeutics2023
Real world population pharmacokinetic study in children and young adults with inflammatory bowel disease discovers novel blood and stool microbial predictors of vedolizumab clearance.
Article in Alimentary pharmacology & therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Reshaping study design for faster extrapolation-based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN-NASPGHAN position paper.Journal of pediatric gastroenterology and nutrition · 2026Pooled it
- North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition position paper on the therapeutic drug monitoring in pediatric inflammatory bowel disease.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Gut microbiome-associated predictors as biomarkers of response to advanced therapies in inflammatory bowel disease: a systematic review.Gut microbes · 2023Pooled it
- Physiologically Based Pharmacokinetic Modeling of Vedolizumab in Healthy Adults and Patients with Inflammatory Bowel Disease.Clinical pharmacokinetics · 2026Article
- Emerging Role of Gut Microbiota in Modulating Response to Therapies in IBD.Microorganisms · 2026Review
- Off-Label Ustekinumab and Vedolizumab in Pediatric Anti-TNFα Refractory IBD: Therapeutic Drug Monitoring Insights from a Case Series.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Gut microbiota as a potential predictor of therapeutic response in adults with Crohn's disease: A systematic review.World journal of gastrointestinal pathophysiology · 2025Article
- The Coming of Age of Model-Informed Precision Therapeutics for Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Association of Serum Levels of Ustekinumab, Vedolizumab, and Faecal Calprotectin in Paediatric Patients with Inflammatory Bowel Diseases: A Prospective Observational Study.Paediatric drugs · 2025Observational
- Role of Gut Microbiota and Metabolomics in Predicting Response to Vedolizumab in Inflammatory Bowel Disease: A Systematic Review.Pharmaceutics · 2025Review
- Gut Microbiota in Different Treatment Response Types of Crohn's Disease Patients Treated with Biologics over a Long Disease Course.Biomedicines · 2025Article
- [Position paper of the Society for Paediatric Gastroenterology and Nutrition (GPGE) on the off-label use of biologics and signal inhibitors in children and adolescents with IBD that have already been approved for adults].Zeitschrift fur Gastroenterologie · 2025Article
- Baseline Drug Clearance Predicts Outcomes in Children With Inflammatory Bowel Disease Treated With Vedolizumab: Results From the VedoKids Prospective Multicentre Study.Alimentary pharmacology & therapeutics · 2025Article
- Vedolizumab Clearance as a Surrogate Marker for Remission in Inflammatory Bowel Disease Patients: Insights from Real-World Pharmacokinetics.Pharmaceutics · 2024Article
- Considerations in Paediatric and Adolescent Inflammatory Bowel Disease.Journal of Crohn's & colitis · 2024Review
- De Novo Crohn's Disease Diagnosed in the Setting of Acute SARS-Cov-2 Infection Requiring Escalation of Infliximab Therapy Guided by Personalized Pharmacokinetics.Journal of pediatrics, perinatology and child health · 2024Article
- 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
- Current Role of Monoclonal Antibody Therapy in Pediatric IBD: A Special Focus on Therapeutic Drug Monitoring and Treat-to-Target Strategies.Children (Basel, Switzerland) · 2023Review
- Editorial: achievements and unresolved questions in improving the pharmacokinetics of vedolizumab in adolescents with inflammatory bowel disease-authors' reply.Alimentary pharmacology & therapeutics · 2023Article
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Authors and funding
15 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundVedolizumab for inflammatory bowel disease (IBD) is often intensified based on distinct pharmacokinetics in children. Prior adult-specific population pharmacokinetic models have identified limited covariates of drug clearance.
aimsTo establish a population pharmacokinetic model for children and young adults to identify novel covariates of drug clearance to better account for paediatric-specific inter-patient variability in vedolizumab pharmacokinetics; a key secondary exploratory aim was to identify microbial signatures of pharmacokinetic outcomes in a subset of patients.
methodsThe study included data from 463 observed vedolizumab concentrations (59 peaks and 404 troughs) from 74 patients with IBD (52 with Crohn's disease and 22 with ulcerative colitis or unclassified IBD, median age 16 years). Pharmacokinetic analysis was conducted with non-linear mixed effects modelling. For the evaluation of the exposure-response relationship, clinical outcomes were evaluated by trough levels, clearance and vedolizumab exposure. Whole-genome metagenomic sequencing was conducted at baseline and week 2.
resultsA two-compartment population pharmacokinetic model was identified with a clear correlation between CL and weight, erythrocyte sedimentation rate, and hypoalbuminemia. Trough concentrations before infusion 3 (37 μg/ml) and before infusion 4 (20 μg/ml) best predicted steroid-free clinical remission at infusion 4. Using faecal metagenomics, we identified an early (baseline and week 2) abundance of butyrate-producing species and pathways that were associated with an infusion 4 trough concentration >20 μg/ml.
conclusionsThis novel paediatric vedolizumab pharmacokinetic model could inform precision dosing. While additional studies are needed, an abundance of faecal butyrate producers is associated with early response to vedolizumab, suggesting that microbial analysis may be beneficial to biological selection.
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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.