Treatment with fingolimod in pediatric patients with relapsing multiple sclerosis is associated with a lower rate of relapse but a higher rate of serious adverse events compared to interferon beta-1a, according to a new study published in the New England Journal of Medicine.
Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. Tanuja Chitnis, Massachusetts General Hospital in Boston, and colleagues conducted the study to compare fingolimod with interferon beta-1a in pediatric patients.
In this phase 3 trial, the patients aged 10 to 17 years with relapsing multiple sclerosis were randomized in a 1:1 ratio to receive fingolimod (107 participants) or interferon beta-1a (108 participants) for up to 2 years. The primary endpoint was the annualized relapse rate.
Of a total of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a. The mean age of the patients was 15.3 years.
- The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a.
- The annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging was 4.39 with fingolimod and 9.27 with interferon beta-1a.
- Adverse events occurred in 88.8% of patients receiving fingolimod and 95.3% receiving interferon beta-1a.
- Serious adverse events occurred in 18 patients (16.8 and 6.5%, respectively).
- These serious adverse events included seizures (4 patients), infection (4 patients), and leukopenia (2 patients) in the fingolimod group and infection (2 patients) and supraventricular tachycardia (1 patient) in the interferon beta-1a group.
Based on the study the authors concluded that among pediatric patients with relapsing multiple sclerosis, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a 2-year period than interferon beta-1a but was associated with a higher rate of serious adverse events.
“Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis,” they write.
For further reference log on to 10.1056/NEJMoa1800149