Results from a phase III clinical trial have revealed two years of treatment with oral Gilenya (fingolimod) significantly reduced the rate of relapses when compared to Avonex (interferon beta-1a) intermuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS).
The trial consisted of 215 patients, between the ages of 10-17 years, with RMS. 107 patients were assigned to fingolimod, receiving the drug orally at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of ≤40 kg) and 108 were assigned to intramuscular interferon beta-1a at a dose of 30 μg per week. All patients in both groups were treated for up to two years.
Among all patients there was a mean of 2.4 relapses during the preceding two years. The adjusted annualised relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a.
In addition, Gilenya decreased the number of central nervous system lesions as observed with magnetic resonance imaging (MRI) over the same period.
Adverse events, excluding relapses of multiple sclerosis, occurred in 88.8% of patients who received fingolimod and 95.3% of those who received interferon beta-1a. Serious adverse events occurred in 18 patients in the fingolimod group and included infection (in 4 patients) and leukopenia (in 2 patients). Six patients had convulsions. Serious adverse events occurred in 7 patients in the interferon beta-1a group and included infection (in 2 patients) and supraventricular tachycardia (in 1 patient).
The researchers concluded that among paediatric patients with RMS, fingolimod was associated with a lower rate of relapse and less accumulation of lesions on MRI over a two-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 paediatric multiple sclerosis.
Source: MS-UK 18/19/18