Chitnis T, et al. - In this phase 3 trial, researchers compared fingolimod with interferon beta-1a in patients younger than 18 years of age with multiple sclerosis. Compared to interferon beta-1a, fingolimod had a lower rate of relapse and less accumulation of lesions on magnetic resonance imaging (MRI) over a 2-year period but was related to a higher rate of serious adverse events (infection, leukopenia) among pediatric patients with relapsing multiple sclerosis.

Methods

• For this investigation, researchers randomly assigned subjects 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of ≤40 kg) or intramuscular interferon beta-1a at a dose of 30 μg per week for up to 2 years.
• The annualized relapse rate was the primary end point.

Results

• According to the findings obtained, out of 215 patients, 107 were assigned to fingolimod and 108 to interferon beta-1a; 15.3 years was the mean age of the patients.
• It was observed that there was a mean of 2.4 relapses during the preceding 2 years among all patients.
• Findings revealed that the adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P < 0.001).
• Researchers found that the key secondary end point of the annualized rate of new or newly enlarged lesions on T2-weighted magnetic resonance imaging (MRI) was 4.39 with fingolimod and 9.27 with interferon beta-1a (absolute difference, 4.88 lesions; relative difference, 53%; P < 0.001).
• Excluding relapses of multiple sclerosis, adverse events occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a.
• They observed that serious adverse events occurred in 18 subjects (16.8%) in the fingolimod group and included infection (in 4 patients) and leukopenia (in 2 patients); convulsions were noted in six patients.
• They discovered that serious adverse events occurred in 7 subjects (6.5%) in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient).