Pharmaceutical company Novartis has released the full results of a phase III Paradigms study investigating the safety and efficiency of Gilenya (fingolimod) vs. interferon beta-1a in children and adolescents aged 10-17 with MS.
Treatment with Gilenya resulted in an 82% reduction in the rate of relapses over a two year period, compared to interferon beta-1a intramuscular injections. Paradigms is the first ever controlled, randomised trial specifically designed for paediatric MS. The results of this trial were presented at the 7th Joint European and Americans Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS).
'Paediatric MS patients experience more frequent relapses and are more likely to accumulate physical disability at an earlier age than patients diagnosed as adults,' said Dr. Tanuja Chitnis, Principle Investigator for Paradigms and Director of the Partners Paediatric Multiple Sclerosis Centre, Massachusetts General Hospital, Boston, US. 'Yet, current therapies are limited to drugs that have not been tested in a controlled manner in this age group. Paradigms was uniquely designed for this patient population. Its results signify an important step towards a potential new treatment that could improve the lives of these young patients.'
There was a significant reduction in the number of new or newly enlarging T2 and Gd-T1 lesions in the brain of Gilenya treated patients compared to those treated with interferon beta-1a, as measured by MRI. The number and volume of lesions are associated with increased relapses and disability progression.
Individuals treated with Gilenya had significantly less brain shrinkage (measured by MRI as brain volume loss) compared to those treated with interferon beta-1a. Brain shrinkage in adults is associated with the loss of physical and cognitive function.
The safety profile of Gilenya was overall consistent with that seen in previous clinical trials, with more adverse events reported in the interferon group.
In an additional analysis, Gilenya significantly delayed disability progression, defined as Confirmed Disability Progression (CDP), compared to interferon beta-1a.
“There is already substantial evidence that Gilenya is an effective treatment that improves long-term outcomes for adults with relapsing MS. We are delighted that Paradigms has shown such meaningful benefits for children and adolescents with MS,” said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis.
Gilenya is not currently approved for the treatment of paediatric MS. Novartis is working on its submission with health authorities worldwide.