Gilenya Started Earlier in RRMS Disease Course in Recent Years

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.

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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 Avonex, Betaseron, Extavia, Plegridy, and Rebif). By contrast, only about half of participants in PANGAEA had been on these medications before starting in the trial.

Over a quarter of participants in PANGAEA 2.0 had been treated with Tecfidera (dimethyl fumarate), Aubagio (teriflunomide), Lemtrada (alemtuzumab), or Zinbryta (daclizumab) before enrolling. None of these medications were available when PANGAEA enrolled its participants.

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Relative to participants in the earlier study, those in PANGAEA 2.0 had been living with MS for a shorter length of time (7.1 vs. 8.2 years), and had experienced fewer relapses in the year before enrolling in the study (1.2 vs. 1.6). Also, more participants had experienced one or fewer relapses in the year before entering the study (69.5% vs. 51.9%), whereas more participants in PANGAEA had experienced two or more relapses the year before enrolling (48.1% vs. 30.4%).

“Disease severity at baseline [enrollment in the study] was lower in PANGAEA 2.0 patients in comparison to PANGAEA,” the researchers reported.

For example, the mean score on the Expanded Disability Status Scale (EDSS) was lower in PANGAEA 2.0 (2.1 vs. 3.1), indicating less disability. The same trend was evident in other assessments of disease severity, namely the clinical global impression (CGI) and the multiple sclerosis severity score (MSSS), and in cognitive function, assessed by the symbol digit modalities test.

“The analysis suggests that patients included into PANGAEA 2.0 (2015–2018) switched to fingolimod at an earlier stage of disease with respect to disease characteristics and impairment status in comparison to PANGAEA (2011–2013),” the researchers concluded. “In detail, patients had a shorter disease duration, fewer relapses in the past year, and a lower disease severity according to EDSS, CGI severity and MSSS.”

The team noted that starting treatment earlier on in the disease is generally associated with better outcomes (i.e., less disability) in the long-term. While patients in both groups started Gilenya at about the same age, the lower disease activity suggests that efforts to find a more adequate therapy are underway sooner, before irreversible disability progression takes place.

“The trend for lower disease severity in patients with more recent fingolimod initiation suggests that disease management has already improved to some extent and that treatments are switched earlier in an endeavor of finding the patient individual adequate treatment to improve long-term outcomes,” the researchers wrote.