Benefits of Long-Term Fingolimod Use for Multiple Sclerosis Questioned


Fingolimod (Gilenya) has shown inconsistent improvements with disability in multiple sclerosis.

Fingolimod (Gilenya) is an immunosuppressant used to treat multiple sclerosis, but improvements with disability have been unsteady with this drug.

The FREEDOMS trials examined the use of fingolimod in patients with relapsing-remitted multiple sclerosis (RRMS). But after two years, most patients had minimal disability changes or were fluctuating. This warranted a longer study, so researchers conducted an analysis over eight years and presented the findings at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Center (CMSC) in National Harbor, Maryland.

The team’s mission was “to investigate over 96 months how patterns of disability evolved and the impact of fingolimod treatment on long-term disability, in the pooled FREEDOMS RRMS population, based on categorical analysis of change in EDSS [Expanded Disability Status Scale] score.”

In these trials, a total of 783 patients received fingolimod 0.5 mg and 773 received a placebo. It was noted if the participants continued the fingolimod therapy or switched during the trial extensions. EDSS was measured at baseline and 24, 48, and 96 months and were categorized by the following criteria:

  • Minimal: If baseline score was less than or equal to 5.5 — EDSS score increase or decrease by 0.5. If baseline score was more than 5.5 – no change to EDSS score.
  • Improving: Decrease of at least 1.0 from baseline EDSS score — either at just at the six-month mark or at the six-month mark and continued until 24, 48, or 96 months
  • Worsening: Increase of at least 1.0 from baseline EDSS score — either at just the six-month mark or at the six-month mark and continued until 24, 48, or 96 months

Meaningful changes were more supported at 96 months than 24 months, the researchers pointed out, which is in line with the previous FREEDOMS trials that didn’t show much change at that point.

In the 106 patients who continuously took fingolimod 0.5 mg, 22.6% were improving, 22.6% were worsening, and 54.7% had minimal or fluctuating changes at the 96-month mark.

“Overall, the proportions of patients in either the improving or worsening categories were greater at 96 months (26.1% to 34.5%) than at 24 months (6.7% to 18.5%),” the authors specified.

However, the 75 patients in the switch group had worse results at the 96-month mark — 20% were improving, 28% were worsening, and 52% had minimal or fluctuating changes. Therefore, not only does long-term treatment yield better results, but consistent treatment plays into positive outcomes as well.

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