Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in the journal Therapeutic Advances in Neurological Disorders.
MS is an autoimmune disease that affects the central nervous system (consisting of the brain and spinal cord), and given its chronic nature, “patients starting therapy should expect ongoing lifelong treatment to control disease activity and reduce the risk of disability accrual,” the researchers wrote.
“However, data on the safety and efficacy of disease-modifying therapies (DMTs) beyond 5–7 years of therapy are limited, leaving an important knowledge gap in a patient population that may have to undergo several decades or more of therapy,” they added.
Developed by Novartis, Gilenya was the first oral DMT to be approved by the U.S. Food and Drug Administration and the European Commission for the treatment of adults and children with relapsing-remitting multiple sclerosis (RRMS).
The medication works by preventing immune cells from reaching the brain and spinal cord, reducing inflammation, disease progression, and the risk of MS relapses.
LONGTERMS enrolled 4,086 adults with relapsing MS who had previously participated in other clinical trials testing Gilenya — FREEDOMS (NCT00289978), FREEDOMS II (NCT00355134), and TRANSFORMS (NCT00340834) — and who had been exposed to the medication for more than a decade.
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