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Thursday, September 20, 2018

Trial of fingolimod vs interferon beta-1a in pediatric multiple sclerosis

New England Journal of Medicine — Chitnis T, et al. | September 14, 2018

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).
Read the full article on New England Journal of Medicine





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