Observational studyClinical pharmacology and therapeutics2021
Real-World Infliximab Pharmacokinetic Study Informs an Electronic Health Record-Embedded Dashboard to Guide Precision Dosing in Children with Crohn's Disease.
Observational study in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.
- 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
- Infliximab Pharmacokinetics, Dosing, and Response in Hospitalized Patients with COVID-19 Pneumonia: A Secondary Analysis of a Multinational Randomized Clinical Trial (ACTIV-1 IM).Journal of clinical pharmacology · 2025Trial
- Pharmacometric Targets During Anti-TNF Induction and Their Association with Deep Remission in Pediatric Crohn's Disease.Clinical pharmacokinetics · 2026Article
- Evaluation of pharmacokinetic metrics and pharmacodynamic biomarkers associated with endoscopic healing in pediatric Crohn's disease patients treated with anti-tumor necrosis factor biologics.Crohn's & colitis 360 · 2026Article
- Clinical Model-Informed Precision Dosing Consult Service for Accelerating Personalized Medication in Pediatric Patients.Clinical pharmacology and therapeutics · 2026Review
- Article
- Model-Informed Deep Q-Networks to Guide Infliximab Dosing in Pediatric Crohn's Disease.Clinical pharmacology and therapeutics · 2026Article
- Rising Role of Artificial Intelligence in Clinical Pharmacometrics and Model-Informed Precision Dosing in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Machine Learning Modeling for Predicting Infliximab Pharmacokinetics in Pediatric and Young Adult Patients With Crohn Disease: Leveraging Ensemble Modeling With Synthetic and Real-World Data.Therapeutic drug monitoring · 2026Article
- Early Prediction of Primary Non-Response to Infliximab in Crohn's Disease Using Routinely Available Clinical and Week 2 Laboratory Indicators: A Two-Center Real-World Cohort Study.Journal of inflammation research · 2026Article
- Impact of Proactive Therapeutic Drug Monitoring on Infliximab Maintenance Therapy and Clinical Outcomes in Pediatric Inflammatory Bowel Disease: A Randomized Controlled Trial and Review of Literature.Gastro hep advances · 2026Article
- Population Pharmacokinetics Analysis of Infliximab in up to 10-Year-Old Patients with Paediatric Inflammatory Bowel Disease: Label-Recommended Dose Fails to Achieve Therapeutic Target Concentration.Clinical pharmacokinetics · 2026Article
- Building a Beta-Lactam Model-Informed Precision Dosing Service in a Quaternary Care Children's Hospital.Clinical and translational science · 2025Review
- Exploring Health Care Professionals' Engagement With a Precision Dosing Calculator and Supporting Clinical Information: Insights From an Eye-Tracking and Usability Study.Therapeutic drug monitoring · 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
- Pharmacokinetics and Exposure-Response During Infliximab Induction Therapy in Pediatric IBD Using Point-of-Care Assay.Journal of clinical medicine · 2025Article
- A significant number of pediatric inflammatory bowel disease patients are exposed to a medication not approved by the Food and Drug Administration for pediatric use.Journal of pediatric gastroenterology and nutrition · 2025Article
- Hybrid Population Pharmacokinetic-Machine Learning Modeling to Predict Infliximab Pharmacokinetics in Pediatric and Young Adult Patients with Crohn's Disease.Clinical pharmacokinetics · 2025Article
- Model-Informed Precision Dosing of Infliximab in Korean Inflammatory Bowel Disease Patients: External Validation of Population Pharmacokinetic Models.CPT: pharmacometrics & systems pharmacology · 2025Article
- Secondary loss of response to infliximab in pediatric Crohn's disease: real-world experience in China.Translational pediatrics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 1 country.
Funding
Abstract
Standard-of-care infliximab dosing regimens were developed prior to the routine use of therapeutic drug monitoring and identification of target concentrations. Not surprisingly, subtherapeutic infliximab concentrations in pediatric Crohn's disease (CD) are common. The primary aim was to conduct a real-world pharmacokinetic (PK) evaluation to discover blood biomarkers of rapid clearance, identify exposure targets, and a secondary aim to translate PK modeling to the clinic. In a multicenter observational study, 671 peak and trough infliximab concentrations from 78 patients with CD were analyzed with a drug-tolerant assay (Esoterix; LabCorp, Calabasas, CA). Individual area under the curve (AUC) estimates were generated as a measure of drug exposure over time. Population PK modeling (nonlinear mixed-effect modeling) identified serum albumin, antibody to infliximab, erythrocyte sedimentation rate (ESR), and neutrophil CD64 as biomarkers for drug clearance. Week 14 and week 52 biochemical remitters (fecal calprotectin < 250 µg/g) had higher infliximab exposure (AUC) throughout induction. The optimal infliximab AUC target during induction for week 14 biochemical remission was 79,348 µg*h/mL (area under the receiver operating characteristic curve (AUROC) 0.77, [0.63-0.90], 85.7% sensitive, and 64.3% specific) with those exceeding the AUC target more likely to achieve a surgery-free week 52 biochemical remission (OR 4.3, [1.2-14.6]). Pretreatment predictors for subtherapeutic week 14 AUC included neutrophil CD64 > 6 (OR 4.5, [1.4-17.8]), ESR > 30 mm/h (OR 3.8, [1.4-11]), age < 10 years old (OR 4.2, [1.2-20]), and weight < 30 kg (OR 6.6, [2.1-25]). We created a decision-support PK dashboard with an iterative process and embedded the modeling program within the electronic health record. Model-informed precision dosing guided by real-world PKs is now available at the bedside in real-time.
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.