Novartis’ Gilenya Found to Have Long-Term Positive Effects on Patients with Relapsing-Remitting Multiple Sclerosis

A new study recently published in the Journal of Neurology, Neurosurgery and Psychiatry revealed that long-term fingolimod therapy (marketed as Gilenya by Novartis) can maintain a low disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The study was conducted by an international team of researchers and is entitled “Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomized TRANSFORMS study.”

Multiple sclerosis is a chronic, progressive neurodegenerative disorder that results from an attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, causing inflammation and damage to the myelin layer that covers and protects neurons resulting in motor function impairment (coordination, balance, speech and vision), irreversible neurological disability and paralysis. It is estimated that more than 2.3 million people in the world suffer from MS, and 400,000 in the U.S. alone have the disease. The most frequent form of the disease is RRMS, which is clinically characterized by recurring episodes of neurological symptoms.

Fingolimod is an immunomodulating drug and an effective therapy for RRMS. The safety, tolerability and efficacy of two oral doses of fingolimod (0.5 or 1.25 mg once daily) were assessed in the 12-month, randomized, double-blind phase 3 clinical trial called TRANSFORMS (NCT00340834) in RRMS patients in comparison to treatment with interferon (IFN) beta-1a. The study revealed that fingolimod therapy at both doses significantly improved clinical and magnetic resonance imaging (MRI) outcomes with patients experiencing a reduction in the frequency of relapses in comparison to IFN beta-1a treatment.

Researchers conducted an extension study (up to 4.5 years) of the TRANSFORMS trial in which RRMS patients previously receiving fingolimod continued the same treatment and those under IFN beta-1a therapy received either 0.5 or 1.25 mg of fingolimod. The team analyzed the patient’s annualized relapse rate, disability progression and MRI measures. In total, 1027 RRMS patients entered this extension study and only 772 completed it.

Researchers found that the annualized relapse rate was significantly lower in patients under continuous fingolimod treatment than in patients who switched from IFN beta-1a to fingolimod. Nevertheless, patients who switched from IFN to fingolimod exhibited a 50% reduction in annualized relapse rate and a reduced MRI disease activity. Among the patients who switched therapies, there was an increase of around 50% in the proportion of patients with no evidence of disease activity in the first year after fingolimod treatment. After 4.5 years of fingolimod therapy, both disability progression and MRI outcomes were not significantly different between the groups.

The research team concluded that switching from IFN beta-1a to fingolimod improved treatment efficacy, and that fingolimod therapy has a continuous long-term effect in maintaining a low disease activity in RRMS patients.