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

Paediatric patients ≤ 10 years, demonstrated a higher IFX CL than paediatric patients > 10 to < 17 years and adults, with albumin and CRP explaining the variability of CL. The differences obtained across the IFX assays did not affect overall drug exposure. To maintain trough concentrations above 5 mg/L in paediatric patients ≤ 10 years, a dosing interval of 4 weeks is required.

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Publication Details

Journal
Clinical Pharmacokinetics
Published
2025-10-29
DOI
https://doi.org/10.1007/s40262-025-01565-6
Primary Topic
Inflammatory Bowel Disease
Type
article
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article

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

Qiaolin Zhao, Amit Assa, Tim Preijers, Séamus Hussey et al.
Clinical Pharmacokinetics
Inflammatory Bowel Disease
article

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

Qiaolin Zhao, Amit Assa, Tim Preijers, Séamus Hussey, Kaija‐Leena Kolho, Tim G. J. de Meij, Lorenzo Norsa, Brenda C. M. de Winter, Christine Martinez‐Vinson, S Vuijk, Lissy de Ridder, Raffi Lev‐Tzion, Eytan Wine, Shlomi Cohen, Dror S. Shouval, M Jongsma, Hien Q. Huynh, Victorien M. Wolters
article en

Abstract

Paediatric patients ≤ 10 years, demonstrated a higher IFX CL than paediatric patients > 10 to < 17 years and adults, with albumin and CRP explaining the variability of CL. The differences obtained across the IFX assays did not affect overall drug exposure. To maintain trough concentrations above 5 mg/L in paediatric patients ≤ 10 years, a dosing interval of 4 weeks is required.

Clinical PharmacokineticsVol. 65(1)
University of Helsinki (FI), University of Alberta (CA), Tel Aviv University (IL), Tel Aviv Sourasky Medical Center (IL), Kaplan Medical Center (IL), Helsinki University Hospital (FI), Hospital for Sick Children (CA), Erasmus MC (NL), Shaare Zedek Medical Center (IL), Children's Health Ireland at Crumlin (IE), Emma Kinderziekenhuis (NL), National Children’s Research Centre (IE), Hôpital Robert-Debré (FR), Ospedale dei Bambini Vittore Buzzi (IT), Erasmus MC - Sophia Children’s Hospital (NL), Amsterdam University Medical Centers (NL), Wilhelmina Children's Hospital (NL), Erasmus University Rotterdam (NL)
Openalex Percentile: Top 66%
Inflammatory Bowel Disease
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