Gilenya (fingolimod) lowered relapse rates in children and adolescents with relapsing multiple sclerosis at a “magnitude” — almost 82 percent — never before seen in a scientific study and could be “life changing” for these hard-to-treat patients, a top researcher with Novartis, the treatment’s developer, said in an interview.
Danny Bar-Zohar, global development head of neuroscience at Novartis, spoke about Gilenya with Multiple Sclerosis News Today at the four-day 7th Joint ECTRIMS-ACTRIMS Meeting that concluded in Paris on Saturday.
Gilenya is approved for the treatment of relapsing MS in adults, and was tested in pediatric patients (ages 10–17) in the randomized and double-blind PARADIGMS Phase 3 trial (NCT01892722). It is continuing in an extension open-label phase may run through 2023.
No disease-modifying treatment currently exists for children and adolescents with MS, and PARADIGMS was the first rigorous scientific trial to successfully conclude.
“Approximately 3 to 5 percent of the 2.3 million MSers in the world are pediatric MS, ages 10 to 18,” Bar-Zohar said, adding that “in general, pediatric MS is much more active in terms of relapse rate and in terms of accumulation of MRI active lesions as compared to adult MS.”
He also underscored the impact MS has on young people. Teenagers are keenly aware of body image and prone to mood swings, so “when you add to that such severe relapses that are treated by high-doses of corticosteroids, this has a major impact on quality of life.”
PARADIGM outcomes showed an 81.9% reduction in relapses in patients treated with Gilenya compared to Avonex (interferon beta-1a), a standard-of-care therapy in pediatric MS.
“Eighty two percent reduction is something in terms of the magnitude of effect … that we have not seen in other MS studies … it is highly significant in this patient population” Bar-Zohar said.
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