Gilenya Started Earlier in RRMS Disease Course in Recent Years

Stuart SchlossmanMS Drug Therapies

 By Marisa Wexler MS on Jul 26, 2021

People with relapsing-remitting multiple sclerosis (RRMS) have switched to treatment with Gilenya (fingolimod) at an earlier stage in their disease in recent years, compared to individuals who switched to the treatment around the time it became available, a new study indicates.

The findings suggest “an increased experience in using fingolimod [Gilenya] for sub-optimally treated RRMS patients and a change in mindset towards an early treatment optimization to improve long-term outcome,” the researchers wrote.

The study, “The Change of Fingolimod Patient Profiles over Time: A Descriptive Analysis of Two Non-Interventional Studies PANGAEA and PANGAEA 2.0,” was published in the Journal of Personalized Medicine. It was funded by Novartis, which markets Gilenya (though generics have also become available in recent years).

Gilenya became the first oral medication approved to treat RRMS in 2011. In the decade since it became available, the landscape of MS treatment has changed dramatically.

In the new study, researchers in Germany conducted a descriptive analysis of two observational clinical trials, called PANGAEA and PANGAEA 2.0. These trials aimed to assess the real-world usage of Gilenya among MS patients in Germany.

In total, the team assessed data from 3,188 patients who were enrolled in PANGAEA from 2011–2013, and for 2,441 patients enrolled in PANGAEA 2.0 from 2015–2019. All patients had not been treated with Gilenya prior to enrolling.

The mean patient age was similar in both studies: 38.8 for PANGAEA and 39.2 for PANGAEA 2.0. The latter trial had a higher proportion of patients under age 30 (25.2% vs. 23.1% in the earlier trial) and of patients over age 50 (16.9% vs. 12%), whereas PANGAEA enrolled more participants between 30 and 50 years old (64.9% vs. 57.9%).

Prior to enrolling in the trial, over 90% of participants in PANGAEA 2.0 had been previously treated with glatiramer acetate (Copaxone and generics), Tysabri (natalizumab), or beta interferons (which include AvonexBetaseronExtaviaPlegridy, and Rebif). By contrast, only about half of participants in PANGAEA had been on these medications before starting in the trial.

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