Safety and Efficacy of Fingolimod and Ocrelizumab in Pediatric Patients With Multiple Sclerosis

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.