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Paper Provides More Details of Impacts of Gilenya® in Children with MS

March 11, 2020

Additional results have been published from the clinical trial of  Gilenya® (fingolimod, Novartis AG) in children with MS, showing it could slow the rate of brain tissue loss and reduce other signs of disease activity as observed on MRI (magnetic resonance imaging) scans significantly more than interferon beta-1a (Avonex®). Based on this phase 3 trial, Gilenya is approved to treat children and teens with MS who are ten years or older.
  • In the largest clinical trial yet in children and adolescents with MS, also known as the PARADIGMS study, Gilenya reduced the annual number of relapses by 82% over two years, compared to treatment with Avonex. After two years, 86% of those on fingolimod had not experienced a relapse, compared to 39% of the Avonex group. These results were published earlier. Now, the PARADIGMS study team has published details on the MRI results.
  • In the PARADIGMS study, 215 children with MS between ages 10 and 18 were randomly assigned to receive either Gilenya or Avonex for up to 2 years. The MRI results show that Gilenya slowed the rate of brain tissue loss 40% more than Avonex. Gilenya also reduced several imaging factors significantly more than Avonex, including new, active lesions (areas of tissue damage), number of lesions per MRI scan, and
“hypointense” (i.e., relatively severe) lesions.
  • MS is an unpredictable disease, and affects individuals differently. There are many factors to consider when selecting a disease modifying therapy and decisions should be individualized.  
  • Gilenya is the only medication approved for the treatment of pediatric MS, but many of the medications used for adults with MS have been studied in children with MS. Skilled pediatric MS healthcare providers can adapt the treatments with FDA approval in adults for their younger patients. Discover what it’s like to navigate a diagnosis of pediatric MS
“Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIGMS study” is published by Dr Douglas L. Arnold (McGill University, Montreal) and colleagues in the Journal of Neurology, Neurosurgery and Psychiatry.
Gilenya is a registered trademark of Novartis AG
Avonex is a registered trademark of Biogen

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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