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.