Compared with interferon beta-1a, treatment with fingolimod (Gilenya; Novartis) resulted in an 82% reduction in annualized relapse rate in children and adolescents with relapsing multiple sclerosis (MS). These findings from the Phase 3 PARADIGMS study were presented at the 7th Joint European and Americas Committee for Treatment and Research in Multiple Sclerosis meeting.
“There are currently no FDA-approved MS therapies for the pediatric population,” said Dr. Tanuja Chitnis, Principal Investigator for PARADIGMS and Director of the Partners Pediatric Multiple Sclerosis Center, Massachusetts General Hospital, Boston, and Scientist, Ann Romney Center, Brigham and Women’s Hospital, Boston. “PARADIGMS was designed specifically for pediatric patients, who oftentimes have more frequent relapses than adults with early MS.”
Children and adolescents (n=215; ages 10 to <18yrs) in PARADIGMS were randomized to receive either oral fingolimod or interferon beta-1a IM over a period of up to two years, followed by a 5-year open label extension phase; the primary endpoint was frequency of relapse in patients treated up to 24 months. Secondary endpoints included the number of new or newly enlarged T2 lesions, Gadolinium enhancing TI lesions, and the safety and pharmacokinetic properties of fingolimod; brain atrophy was an exploratory endpoint.
In addition to the significant reduction in the rate of relapse, fingolimod-treated patients had a significant reduction in the number of new/newly enlarging T2 lesions and Gadolinium-TI lesions in the brain. An exploratory analysis showed that patients treated with fingolimod also had significantly less brain atrophy compared with those treated with interferon beta-1a.
With regard to safety, while more adverse events were reported in the interferon beta-1a group, the number of severe adverse events was greater in the fingolimod group.
Currently, fingolimod, a sphingosine 1-phosphate receptor modulator, is approved to treat relapsing forms of MS in adults. Novartis is in the process of submitting applications to health authorities worldwide for pediatric approval.
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