Natalizumab Therapy for Multiple Sclerosis: A Pharmacokinetic Modeling Study

Strategic Insights -

A recent study has shed new light on the use of natalizumab in treating multiple sclerosis, particularly during pregnancy and in infants. Researchers from the First Affiliated Hospital of Fujian Medical University employed a physiologically based pharmacokinetic (PBPK) model to investigate the plasma concentrations of natalizumab in pregnant women and infants. The study aimed to provide informed guidelines on the timing of drug cessation and vaccination schedules.

Key Takeaways:

  • The PBPK model developed by the researchers successfully predicted the concentration-time profiles of natalizumab in pregnant women, fetuses, and infants, with most observed values within 0.5 to 2 times the predicted values.
  • Plasma natalizumab concentration in pregnant women was found to be lower than in the general population, with the drug clearance time in infants influenced by age and physiological changes.
  • The simulation suggested extending the dosing interval for pregnant women to eight weeks, and withdrawing the drug within 5.5 weeks before delivery.
  • Live vaccine administration should be delayed for infants up to eight months after birth, according to the model.
  • The study provides a theoretical basis for the safe use of natalizumab during pregnancy and helps establish more rational clinical dosing regimens.
  • Natalizumab is a monoclonal antibody approved by the FDA for treating multiple sclerosis, but the optimal timing of the final dose during pregnancy and the postponement of vaccinations for infants remain open to discussion.
  • The study involved researchers from the First Affiliated Hospital of Fujian Medical University, including Chenming Zhong, Peilin Zhou, Wanhong Wu, Meng Ke, Jianwen Xu, Rongfang Lin, Pinfang Huang, and Cuihong Lin.

Statistics:

  • The study found that plasma natalizumab concentration was lower in pregnant women (0.5-1.5 μM) compared to the general population (1-3 μM).
  • The drug clearance time in infants was influenced by age, with a slower clearance rate observed in younger infants.
  • The simulation suggested that extending the dosing interval for pregnant women to eight weeks would reduce the risk of adverse events.
  • The study recommended delaying live vaccine administration in infants for up to eight months after birth.

Sources:

  • Zhong, C., et al. (2025). Physiologically-based Pharmacokinetic Modeling of Natalizumab for Multiple Sclerosis Patients to Predict the Withdrawal Time in Pregnancy and Vaccine Time in Infants. European Journal of Pharmaceutical Sciences, 107301.
  • Elsevier. (n.d.). European Journal of Pharmaceutical Sciences. Retrieved from
  • First Affiliated Hospital of Fujian Medical University. (n.d.). Department of Pharmacy. Retrieved from