NATALIZUMAB IN MULTIPLE SCLEROSIS – A REVIEW OF DIFFERENT DOSING REGIMENS, SIDE EFFECTS, COMPARISON WITH OTHER DISEASE-MODIFYING THERAPIES WITH ADDITIONAL ATTENTION TO USE IN PREGNANCY AND THE PEDIATRIC POPULATION

Abstract

Objective: The aim of this review was to evaluate the clinical efficacy, optimization of dosing regimens, safety profile, and socioeconomic aspects of natalizumab (NTZ) use in the treatment of multiple sclerosis (MS), with a additional focus on pregnant and pediatric populations. Methodology: A systematic review of the PubMed database was conducted, identifying 220 records. Thirty-two publications meeting the criteria regarding the mechanism of action, efficacy, adverse event profile, and comparison with other disease-modifying therapies (DMTs) were included in the final analysis. Results: The analysis demonstrated that the extended interval dosing (EID, every 6 weeks) regimen maintains clinical and radiological efficacy comparable to the standard interval dosing (SID, every 4 weeks), while significantly reducing the risk of progressive multifocal leukoencephalopathy (PML) by 88–94%. It was recognized that natalizumab is safer than other DMTs, such as ocrelizumab, without compromising efficacy. In the pediatric population, NTZ showed the highest efficacy in reducing relapse rates compared to fingolimod and injectable therapies. In pregnant women, continuing treatment until the 34th week prevents postpartum rebound relapses and improves EDSS scores, showing no teratogenic effects. Economically, the subcutaneous form of NTZ and the use of EID generate significant direct and societal cost savings. Conclusions: Natalizumab remains a highly effective and cost-efficient therapeutic option for the treatment of relapsing-remitting MS. Personalization of treatment through the EID regimen and the subcutaneous formulation allows for an improved safety profile and patient quality of life, while simultaneously reducing the systemic burden on healthcare.