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Title

SAFETY AND EFFICACY OF MONOCLONAL ANTIBODY THERAPY USE IN PATIENTS WITH PEDIATRIC-ONSET MULTIPLE SCLEROSIS: A Systematic Review

Abstract

Introduction:Current therapies for pediatric-onset multiple sclerosis (POMS) rely on disease-modifying treatments (DMTs), which include classical injectable therapies with different formulations of interferon beta (IFN beta) and glatiramer acetate (GA), as well as some high-efficacy drugs: monoclonal antibodies, such as Natalizumab, Rituximab, Ocrelizumab, and Alemtuzumab. Most current guidelines, due to the lack of randomized clinical trials, continue to endorse the use of low-efficacy DMTs as the first-line treatment in the pediatric population, with a step-by-step progressive escalation of therapy in case of disease activity or intolerance to first-line drugs.Objectives: Evaluate literary evidence regarding the efficacy and safety of monoclonal antibody use in patients with pediatric-onset multiple sclerosis.Methods: Systematic literature review, developed according to PRISMA recommendations, searching PubMed, BVS, and SCOPUS databases with the following search strategy:
((MULTIPLE SCLEROSIS) AND (TREATMENT) AND (PEDIATRIC)); and ((MULTIPLE
SCLEROSIS) AND (TREATMENT) AND (PEDIATRIC) AND (NATALIZUMAB) OR
(RITUXIMAB) OR (OCRELIZUMAB) OR (INFLIXIMAB) OR (ALEMTUZUMAB)).
Inclusion criteria: patients diagnosed with pediatric-onset multiple sclerosis, studies conducted in humans, undergoing treatment with monoclonal antibodies or high-efficacy drugs.Results: A total of 3,813 articles were identified, with 8 articles selected for the final sample after applying the selection filters. Prospective studies related to the use of natalizumab, rituximab, ocrelizumab, and alemtuzumab were identified.
The drugs natalizumab, ocrelizumab, rituximab and alemtuzumab showed a reduction in relapse rate, reduction of EDSS in periodic assessments, and control in the increase of T2/FLAIR lesions compared to beta-interferon and glatiramer acetate drugs. Rituximab demonstrated statistical robustness regarding the low number of adverse events and posological safety in the age group below 18 years. Conclusion: The drug rituximab appears to have the highest level of evidence regarding safety and efficacy in treating this population.The evidence in this review shows that the other drugs demonstrate similar efficacy to the adult population.