Fingolimod as an effective therapeutic strategy for pediatric relapsing-remitting multiple sclerosis: two case reports.

Approximately 3-10% of patients with multiple sclerosis (MS) have onset during childhood. Pediatric MS is characterized by a relapsing-remitting course and a high relapse rate. In 2010, fingolimod (Gilenya®) was approved in the USA for the treatment of relapsing-remitting MS in adults. In 2018, both the United States Food and Drug Administration and the European Medicines Agency expanded the approved indications of fingolimod to include its use in children with relapsing MS, and the drug was approved in Italy for this indication in September 2020. We describe two cases of children with relapsing-remitting MS who were treated with fingolimod at IRCCS Ospedale San Raffaele Multiple Sclerosis Center (Milan, Italy) for more than 2 years. Our real-world data confirm that fingolimod is an effective therapeutic strategy for children with relapsing MS, and its use could be considered in pediatric patients with active disease.