IntroductionTocilizumab (TCZ), an anti-interleukin-6 receptor (IL-6R) biologic agent, is commonly used to treat systemic juvenile idiopathic arthritis (sJIA); however, the optimal dosing strategy for susceptible children and the timing of administration for safe attenuated live vaccines remain unclear. This study aimed to determine the optimal dose-escalation regimen for TCZ in children with sJIA, as well as to investigate the recommended live-vaccine schedules for pediatric patients exposed to this drug.MethodsA physiologically-based pharmacokinetic (PBPK) model integrating a target-mediated drug disposition (TMDD) structure was built for adults and extrapolated to pediatric patients.ResultsThe PBPK model successfully predicted and verified the pharmacokinetics (PKs) of TCZ in children aged < 2 years and 2–17 years.
The predicted PK data were within two-fold of the observed data. According to the simulations, dose-escalation strategies were proposed to mitigate early hypersensitivity reactions: a 6-8-12 mg/kg sequence for patients weighing <30 kg, including infants aged <2 years and children aged 2–17 years, and a 4-6-8 mg/kg sequence for children aged 2–17 years weighing ≥30 kg.
Frontiers in Immunology published a clinical update in Infectious Disease on 01 Jun 2026.
The item focuses on Model-informed safety management of tocilizumab for pediatric sJIA: a PBPK approach for dose-escalation and vaccination timing.
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