ArticleFrontiers in immunology2026
Model-informed safety management of tocilizumab for pediatric sJIA: a PBPK approach for dose-escalation and vaccination timing.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Tocilizumab (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. Methods: A physiologically-based pharmacokinetic (PBPK) model integrating a target-mediated drug disposition (TMDD) structure was built for adults and extrapolated to pediatric patients. Results: The 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. Furthermore, PBPK models indicated that, for pediatric patients of all ages, the advocated timing of live-attenuated vaccination is approximately 55 to 70 days after treatment cessation, provided that the underlying disease activity is closely monitored. Discussion: Our study illustrated that PBPK models can provide a valuable tool to predict the PKs of large macromolecules in children across the age continuum, ultimately informing precision drug-treatment decisions and vaccination regimens for the pediatric sJIA population.
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