(HealthDay)—Among pediatric patients with relapsing multiple sclerosis, fingolimod is associated with a lower rate of relapse but a higher rate of serious adverse events than interferon beta-1a, according to a study published in the Sept. 13 issue of the New England Journal of Medicine.
Tanuja Chitnis, M.D., from Massachusetts General Hospital in Boston, and colleagues compared outcomes in patients aged 10 to 17 years with relapsing multiple sclerosis who were randomized to receive fingolimod (107 participants) or interferon beta-1a (108 participants) for up to two years.
The researchers found that 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 percent of patients receiving fingolimod and 95.3 percent receiving interferon beta-1a. Serious adverse events occurred in 18 patients (16.8 and 6.5 percent, respectively). These serious adverse events included seizures (four patients), infection (four patients), and leukopenia (two patients) in the fingolimod group and infection (two patients) and supraventricular tachycardia (one patient) in the interferon beta-1a group.
"Longer studies are required to determine the durability and safety of fingolimod in pediatric multiple sclerosis," the authors write.
Several authors disclosed financial ties to Novartis, which manufactures fingolimod and funded the study.
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