Real-world Spanish Study Confirms Gilenya’s Ability to Reduce Multiple Sclerosis Relapses

Real-world Spanish Study Confirms Gilenya’s Ability to Reduce Multiple Sclerosis Relapses

A real-world medical-facilities setting has confirmed clinical trial findings that Gilenya (fingolimod) can reduce multiple sclerosis relapses, according to a Spanish study published in Plos One.

Gilenya, developed by Novartis Pharmaceuticals, was the first oral disease-modifying therapy to obtain U.S. and European approval. The Food and Drug Administration and European Medicines Agency authorized it for reducing the frequency of relapses and delaying progression of relapsing-remitting multiple sclerosis (RRMS).

Their decisions were supported by the results of three Phase 3 clinical trials: FREEDOMS (NCT00289978), FREEDOMS II (NCT00355134), and TRANSFORMS (NCT00340834). The trials explored the effectiveness and safety of Gilenya in comparison with Avonex (interferon beta-1a) and a placebo.

Researchers from Spain have confirmed the trial results in a study titled “The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study.” It covered 249 MS patients treated for a mean of 33.1 months.

The patients were divided into three groups, according to their previous MS treatment: treatment with Copaxone/interferon beta-1 (immunomodulator), treatment with Tysabri (natalizumab), or no previous treatment.

Gilenya reduced patients’ annual relapse rate in the first 24 months by 75 percent. The figures were 67 percent of patients previously treated with immunomodulators, such as Avonex, Copaxone or Tysabri, and 85 percent in patients who had never been treated.

The results were independent of patients’ age when they began receiving Gilenya, the number of their previous treatments, their gender, the number of their brain lesions, and their basal disability score. The basal ganglia is an area of the brain that controls movement. Scientists use the Expanded Disability Status Scale (EDSS) to assess damage to the ganglia.

“Although fingolimod [Gilenya] benefits MS patients regardless of the EDSS score at the treatment initiation, our data suggest that patients with basal EDSS score of <3 might have better outcomes,” the researchers wrote. The scale runs from 0 to 10, with 0 meaning no disability.

One hundred nineteen patients, or 48 percent, of those who received Gilenya reported at least one adverse event, but most were mild. The most common event was lymphopenia — abnormally low levels of lymphocytes, or white blood cells.

About 18.5 percent of the patients discontinued Gilenya during the study. About 3.2 percent did so because it wasn’t effective, and another 3.2 percent because of adverse events.

“To our knowledge this is the largest observational study carried out in Europe,” the team wrote. “Overall, the real-world benefits observed in this study seem to be similar than those observed in previous clinical trials.”

The U.S.-based Phase 4 MS-MRIUS clinical trail had also demonstrated Gilenya’s long-term effectiveness against RRMS in a real-world setting.

One comment

  1. Ann says:

    I would appreciate reading some studies on the use of Gilenya on people with RRMS who are aged 60+.
    I was first diagnosed with
    RR in 2014 at aged 61 and have been consuming Gilenya since 2015.
    I say first diagnosed in 2014; I experienced an episode of optic neuritis approx 20 years before that date; MRI showed nil. In 1969 at aged 16 I experienced an unexplained loss of vision in one eye, together with a spell of chicken pox. On both occasions vision improved.
    But it seems something odd has been with me most of my life.
    MRI taken 2x-yearly since 2014 show demyelination in both brain and spine. I notice cognitive deficits, short term memory loss, short temper, panic at stressful events such as moving house, poorer planning skills and mobility (I waddle when walking) and cannot stand to gaze at the sky or trees without losing balance. I experience data overload when thinking seems so fatiguing I go to bed for a couple of hours sleep, although I note this has become less frequent since re-joining a gym for swimming (250 – 500 metres 4 times a week) and body strengthening in the gym.
    My neurologist has some concerns about my LFTs, particularly over the past year (LFTs every 2 months) and I guess we both have a little uncertainty about continuing on this medication regime.
    So some data on long term (2yrs+) use of Gilenya in 60+ women would be helpful.
    Thank you.

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