The results of a new study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of multiple sclerosis showed Gilenya (fingolimod) was linked to significantly lower rates of relapse and accumulation of fewer MRI lesions vs. interferon beta-1a over two years. However, Gilenya, was also linked with more serious adverse events.

The PARADIGMS study results show that, compared to interferon beta-1a, Gilenya:

• Significantly reduced annualized relapse rates by 82 percent over a period of up to two years compared to interferon beta-1a 
• Significantly reduced the number of new or newly enlarged T2 lesions up to 24 months by 53 percent. Also, it significantly reduced the average number of gadolinium enhancing T1 lesions per scan at 24 months by 66 percent.
• The safety profile of Gilenya in this study was overall consistent with that seen in previous adult patients
• While more adverse events were reported in the interferon beta-1a group, severe effects were reported at a higher frequency in Gilenya-treated patients
• Cases of seizures were reported in 5.6 percent of Gilenya-treated patients and 0.9 percent of interferon beta-1a-treated patients

Children and adolescents with MS experience more frequent and often more severe relapses than those seen in adults with MS. There is a strong unmet need for younger RMS patients, who often experience more frequent relapses than adults. The researchers said the data will go a long way in helping to advance knowledge and understanding amongst the MS community of how to evaluate and treat pediatric patients with MS.

The full results from study were published in the New England Journal of Medicine.