{"title":"Safety and Efficacy of Fingolimod and Ocrelizumab in Pediatric Patients With Multiple Sclerosis","authors":"Benton Spirek BS , J. Nicholas Brenton MD","doi":"10.1016/j.pediatrneurol.2024.12.015","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Fingolimod and ocrelizumab are approved treatments for adults with multiple sclerosis (MS); however, only fingolimod is approved by the Food and Drug Administration for the treatment of pediatric MS. Currently, there are limited data for the safety and efficacy of ocrelizumab use in children.</div></div><div><h3>Methods</h3><div>This retrospective cohort study included patients with relapsing-remitting MS who started either ocrelizumab or fingolimod before age 18 years. Neuroimaging, electrocardiogram, laboratory evaluation, relapse history, and side effects were recorded at baseline and every six months.</div></div><div><h3>Results</h3><div>Thirty-six pediatric patients were included (fingolimod, n = 14; ocrelizumab, n = 22). Clinical relapses occurred in 14% of patients treated with fingolimod versus in none of the patients treated with ocrelizumab. Seventy-one percent of patients in the fingolimod group switched or discontinued therapy compared with 9% treated with ocrelizumab (<em>P</em> = 0.0001). From patients with greater than six months of treatment on the given therapy (fingolimod n = 10, ocrelizumab n = 17), 60% on fingolimod exhibited new/enlarged T2-hyperintense lesions on brain magnetic resonance imaging compared with 6% on ocrelizumab (<em>P</em> = 0.004). Of those treated with ocrelizumab, 10 of 22 (45%) had infusion reactions during their initial infusion. Reaction rates decreased to 20% with subsequent infusions.</div></div><div><h3>Conclusions</h3><div>Ocrelizumab is associated with fewer brain lesions, lower clinical relapse rates, and reduced discontinuation rates compared with fingolimod. Although both therapies have the potential for adverse effects, these are unlikely to prompt discontinuation of therapy in isolation. These findings highlight the benefits of ocrelizumab as a treatment option for children and youth living with MS.</div></div>","PeriodicalId":19956,"journal":{"name":"Pediatric neurology","volume":"164 ","pages":"Pages 89-96"},"PeriodicalIF":3.2000,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric neurology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0887899424004247","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Fingolimod and ocrelizumab are approved treatments for adults with multiple sclerosis (MS); however, only fingolimod is approved by the Food and Drug Administration for the treatment of pediatric MS. Currently, there are limited data for the safety and efficacy of ocrelizumab use in children.
Methods
This retrospective cohort study included patients with relapsing-remitting MS who started either ocrelizumab or fingolimod before age 18 years. Neuroimaging, electrocardiogram, laboratory evaluation, relapse history, and side effects were recorded at baseline and every six months.
Results
Thirty-six pediatric patients were included (fingolimod, n = 14; ocrelizumab, n = 22). Clinical relapses occurred in 14% of patients treated with fingolimod versus in none of the patients treated with ocrelizumab. Seventy-one percent of patients in the fingolimod group switched or discontinued therapy compared with 9% treated with ocrelizumab (P = 0.0001). From patients with greater than six months of treatment on the given therapy (fingolimod n = 10, ocrelizumab n = 17), 60% on fingolimod exhibited new/enlarged T2-hyperintense lesions on brain magnetic resonance imaging compared with 6% on ocrelizumab (P = 0.004). Of those treated with ocrelizumab, 10 of 22 (45%) had infusion reactions during their initial infusion. Reaction rates decreased to 20% with subsequent infusions.
Conclusions
Ocrelizumab is associated with fewer brain lesions, lower clinical relapse rates, and reduced discontinuation rates compared with fingolimod. Although both therapies have the potential for adverse effects, these are unlikely to prompt discontinuation of therapy in isolation. These findings highlight the benefits of ocrelizumab as a treatment option for children and youth living with MS.
期刊介绍:
Pediatric Neurology publishes timely peer-reviewed clinical and research articles covering all aspects of the developing nervous system.
Pediatric Neurology features up-to-the-minute publication of the latest advances in the diagnosis, management, and treatment of pediatric neurologic disorders. The journal''s editor, E. Steve Roach, in conjunction with the team of Associate Editors, heads an internationally recognized editorial board, ensuring the most authoritative and extensive coverage of the field. Among the topics covered are: epilepsy, mitochondrial diseases, congenital malformations, chromosomopathies, peripheral neuropathies, perinatal and childhood stroke, cerebral palsy, as well as other diseases affecting the developing nervous system.