Abstract


Background:
There have been no clinical trials for approval of medications for treating multiple sclerosis in patients under the age of 18 years. All treatments are based on personal experience and data from open observational studies. Fingolimod is an oral drug for treating multiple sclerosis that has proven to be efficient and safe in adults. The aim of the present study was to report on patients with multiple sclerosis who started treatment with fingolimod before the age of 18 years.

Participants:
and methods: Seventeen patients treated with fingolimod were identified in the Brazilian database of children and adolescents with multiple sclerosis. The average time of use of the drug was 8.6 months.

Results:
Fingolimod showed a good safety and efficacy profile in these patients, all of whom had very active multiple sclerosis. After starting treatment with fingolimod, only one patient had a relapse and a new lesion on MRI. The patients’ degree of disability did not progress. No major adverse events were reported in relation to the first dose of the drug, nor in the short and medium-term treatment. No patient has been followed for longer than 18 months, thus limiting long-term conclusions.

Conclusions:
Off-label use of fingolimod in patients before the age of 18 years was shown to be a good therapeutic option for multiple sclerosis control.

Labels: pediatric MS, Study