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

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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.

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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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  1. Martin Matko says:

    Many, many feel and know that Multiple Sclerosis is a mechanical issue that no drug, treatment, or therapy can rectify !

    • flap says:

      I beg your pardon, but mechanical in nature? Despite the science and evidence to support immunomodulation drugs? In what way is MS, in your mind, a mechanical issue? I fail to see any discussion of same in recent research. Please offer some support for your assumption. Thanks

  2. PELUS says:

    Dear FLAP:
    There is a new founding of a “certain mechanical system” involved in MS. A recent research found that there exists a linfatic link which allows inmune cells to reach the CNS. This is so incredible since nobody has noticed this before, in fact there was believe no such thing exists at all. Medical science tought of the CNS as a sealed and independent entity with no physical connection with a linfatic system to irrigate the brain. This discovery admits certain questioning about the “mechanical” issues playing in development of MS as well as the probable mechanism of action of the inmune system over the brain; it is an incredible discover which im sure is going to change medicine books forever.

    Here is the link:

    • George says:

      Pelus, in my opinion the effectiveness of SOP1 receptor treatments such as gilenya in addition to monoclonal antibody therapies including alemtizumab and netalizumab, have shown that the disease progression is highly due to faults in circulatory blood vessels rather than lymph. Additionally the high success rates of stem cell therapies have also indicated this. Stem cells are not the cure but the key to stopping the progress of multiple sclerosis (once again my opinion).

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