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The PARADIGMS study is the first international, randomized, clinical trial to explore the safety and efficacy of fingolimod in pediatric patients with multiple sclerosis (MS).
The onset of MS symptoms commonly starts in adulthood, but a small percentage of cases (3%-5%) may present before age 18 years. Pediatric patients have a 2- to 3-fold higher rate of relapse than those with adult-onset MS because pediatric patients are likely to be diagnosed with a relapsing-remitting form of MS (RRMS).
The PARADIGMS study was designed to assess the safety and efficacy of fingolimod up to 0.5 mg daily vs intramuscular interferon β-1a (IFN β-1a) 30 μg in pediatric/adolescent patients with RRMS. The trial included patients with MS age 10 to <18 years at time of randomization. Study duration was up to 2 years, with a 5-year open-label extension period. Included patients had an Expanded Disability Status Scale score of 0 to 5.5 and had at least 1 relapse in the previous year, 2 relapses in the past 2 years, or evidence of at least 1 gadolinium-enhancing lesion on magnetic resonance imaging (MRI) in the 6 months prior to randomization.
Included patients (N=215) were randomly assigned to either oral fingolimod up to 0.5 mg daily (adjusted for body weight) or IFN β-1a 30 μg once weekly. The primary end point was annualized relapse rate; major secondary end points included MRI- and relapse-related outcomes.
At baseline, mean disease duration since first symptom was 1.9 years in the fingolimod group and 2.4 years in the IFN β-1a group. The mean number of relapses in the past year was the same for both treatment arms (1.5), as was the median Expanded Disability Status Scale score (1.5).
The full findings, including the primary efficacy data, MRI outcomes, and safety and tolerability data will be presented at the ACTRIMS meeting in San Diego. The authors added that the study’s findings “will determine whether fingolimod is beneficial in this young patient population that has active disease, typically of a shorter clinical duration than patients with adult-onset MS.”
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Chitnis T, Arnold DL, Banwell B, Bruck W, Ghezzi A, Giovannoni G. The PARADIGMS study: a randomized double-blind trial of fingolimod versus interferon β-1a in patients with multiple sclerosis aged 10 to < 18 years. Presented at: ACTRIMS Forum 2018; February 1-3, 2018; San Diego, CA. Abstract P025