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Updated: Oct 15, 2025

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Model-Informed Precision Dosing during Infliximab Induction Therapy Reduces Variability in Exposure and Endoscopic

Ruben Faelens1, Zhigang Wang1, Thomas Bouillon1

  • 1Department of Pharmaceutical and Pharmacological Sciences, Katholieke Universiteit Leuven, 3000 Leuven, Belgium.

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Summary

Model-informed precision dosing (MIPD) can optimize infliximab treatment for ulcerative colitis (UC) by reducing dose variability. Simulations show MIPD improves the probability of endoscopic improvement (pEI) and reduces patient-to-patient differences.

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endoscopyinflammatory bowel diseaseinfliximabmodel-informed precision dosingmonoclonal antibodypopulation pharmacokinetics-pharmacodynamicssimulationstherapeutic drug monitoringulcerative colitis

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Area of Science:

  • Pharmacology and Gastroenterology
  • Clinical Trial Simulation
  • Drug Efficacy Research

Background:

  • Therapeutic failure of infliximab in ulcerative colitis (UC) is often linked to underexposure.
  • Optimizing infliximab dosing may improve endoscopic outcomes in UC patients.
  • Model-informed precision dosing (MIPD) offers a potential strategy to personalize infliximab therapy.

Purpose of the Study:

  • To investigate the efficacy of MIPD in optimizing infliximab induction dosing for UC patients.
  • To compare standard dosing, higher dose, covariate-based MIPD, and concentration-based MIPD in silico.
  • To evaluate the impact of different dosing strategies on the probability of endoscopic improvement (pEI).

Main Methods:

  • In silico simulation of four infliximab induction dosing regimens.
  • Regimens included label dosing (5 mg/kg), 10 mg/kg, covariate-based MIPD, and concentration-based MIPD.
  • Simulations targeted a specific median area under the concentration-time curve (AUCd84) for MIPD strategies.

Main Results:

  • Increasing infliximab dose from 5 mg/kg to 10 mg/kg improved predicted pEI.
  • Covariate-based and concentration-based MIPD reduced variability in exposure and pEI compared to standard dosing.
  • Concentration-based MIPD achieved further variability reduction but at a higher average dose.

Conclusions:

  • Quantitative simulations suggest MIPD can reduce variability in infliximab exposure and pEI for UC patients.
  • MIPD holds promise for optimizing therapeutic outcomes in infliximab-treated UC.
  • Personalized dosing strategies are crucial for maximizing infliximab efficacy in UC.