Oral treatment with Gilenya (fingolimod) is more effective than Avonex (interferon beta-1a) for controlling brain lesion activity and brain volume loss in children with pediatric-onset multiple sclerosis (POMS), two-year results of the PARADIGMS study show.
That means Gilenya provides an effective treatment option for children and adolescents with relapsing MS, researchers said.
The study “Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIGMS study” was published in the Journal of Neurology, Neurosurgery & Psychiatry.
Gilenya, manufactured by Novartis, is a treatment approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for patients with relapsing-remitting multiple sclerosis (RRMS).
In May 2018, the U.S. Food and Drug Administration (FDA) approved an extension of Gilenya’s label to include the treatment of children and adolescents age 10 and older with relapsing forms of MS. Soon after, in November 2018, the European Commission approved the same additional indication.
Both approvals were based on results from the Phase 3 clinical trial PARADIGMS (NCT01892722). The study enrolled 215 children and adolescents, ages 10 to 17, with relapsing MS.
Patients were assigned randomly to receive either 0.25 or 0.5 mg Gilenya capsules once daily (depending on the child’s weight, 107 patients), or once weekly intramuscular injections of Avonex (marketed by Biogen, 108 patients) for up to two years.
At the end of the study, patients could continue to a five-year open-label extension, to evaluate the long-term use of Gilenya. This phase is currently ongoing.
The primary trial results demonstrated superior effectiveness of Gilenya versus Avonex. By the end of the study (up to two years), treatment with Gilenya had lowered the rate of annual relapses to 0.12; this rate was 0.67 in patients taking Avonex — an 82% difference between the two therapies.
Patients on Gilenya also developed fewer additional or larger T2 brain lesions detected by magnetic resonance imaging (MRI) — which are regions with loss of myelin, the protective sheath covering nerve fibers.
In the present study, researchers specifically analyzed the brain MRI results of the trial, including the rate of new or enlarging T2 brain lesions (regions of myelin loss, or demyelination), the number of gadolinium-enhancing (Gd+) T1 lesions (which represent lesions with active inflammation), the rate of new T1 hypointense lesions (areas of relatively severe damage), and the combined number of unique active lesions. Changes in lesion volume and annual rate of brain atrophy (brain volume loss) also were measured.
For the assessments, patients received MRI scans at the study start (baseline) and every six months for up to two years or until the end of the study, in case they stopped the treatment or left the study earlier.
Results showed that compared to Avonex, treatment with Gilenya resulted in a 52.6% reduction in the accumulation of demyelinated lesions (T2 lesions), a decrease of 66% in the number of inflammatory active lesions (Gd+ T1 lesions), and a reduction by 62.8% in the yearly rate of new lesions with brain tissue damage (T1 hypointense lesions).
At the last assessment, the number of all active lesions combined was 60.7% lower in patients treated with Gilenya, compared to those given Avonex.
Lesions with myelin damage grew less in those treated with Gilenya compared with the Avonex group — 18.4% vs. 32.4%. Also, lesions with active inflammation significantly shrank in those taking Gilenya (72.3% decrease in volume), in contrast to lesions in patients using Avonex, which became larger (4.9% increase in volume).
Gilenya also mitigated overall brain volume loss (atrophy), partially because such loss was more accelerated in patients given Avonex. The annual rate of brain atrophy was 0.48% in patients using Gilenya, compared to 0.80% in the Avonex group.
Additionally, 51% of patients on Gilenya and 19.4% of patients on Avonex were free of lesions with active inflammation or new or larger areas of myelin damage.
Formation of new or larger lesions with myelin loss were consistently lower in the Gilenya group, regardless of patients’ sex, age, body weight, or prior treatment experience with other disease-modifying therapies (DMTs).
“We conclude that treatment with fingolimod showed better efficacy compared with IFN β-1a [Avonex] in reducing MRI activity, relapses and brain volume loss, supporting the overall beneficial effect of fingolimod in pediatric patients with MS,” researchers wrote.
“Fingolimod provides an effective treatment option for children and adolescents with MS,” the team concluded.
Notably, the study was supported by Novartis, and three of its 18 authors are Novartis employees.
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