NfL levels were reduced during treatment with fingolimod, providing further evidence of the long-term benefit of the drug and demonstrating a greater impact of highly effective therapy in relapsing-remitting multiple sclerosis.
Jeffrey Cohen, MD
The results of a recent post hoc analysis that assessed the effect of long-term treatment with fingolimod on blood neurofilament light chain (NfL) levels in patients with relapsing-remitting multiple sclerosis demonstrate that fingolimod 0.5 mg significantly reduced NfL and maintained its low levels with continuous treatment for up to 10 years.
This analysis was based on the data from 2 pivotal studies, 24-month FREEDOMS and 12-month TRANSFORMS in which patients received fingolimod 0.5 mg daily or placebo/interferon β-1a (IFN) 30 μg once weekly, in additional to the open-label LONGTERMS extension study where patients received fingolimod for up to 10 years. The analysis also included a subset of patients who had NfL assessments at baseline, the end of core in pivotal studies, and the end of study in the open-label extension.
“The study provides further evidence of the long-term benefit of fingolimod. It also supports the utility of NfL as a biomarker,” Jeffrey Cohen, MD, neurologist at the Cleveland Clinic Mellen Center, told NeurologyLive in an interview. “In the phase trials fingolimod reduced serum NfL levels compared to placebo (FREEDOMS) and interferon beta-1a (TRANSFORMS) and when patients were treated with fingolimod in the LONGTERMS extension study NfL remained low up to 10 years.”
Investigators categorized patients into 2 groups, a continuous group (n=37) who received fingolimod throughout the studies, and a switched group (n=42) who transitioned from placebo/IFN to fingolimod in the open-label extension study.
In the continuous group, the mean exposure to fingolimod was 3483 days and baseline NfL levels of 33 pg/mL were significantly reduced by about 40% at the end of core and end of study (20 pg/mL; P = .0002, respectively). In the switched group, the mean exposure to the intervention therapy was 2822 days, and baseline NfL levels of 29 pg/mL were reduced by 15% (25 pg/mL; P >.44) at end of core and 41% at end of study (17 pg/mL; P <.0001).1
The study results showed that fingolimod 0.5 mg significantly reduced blood NfL levels and maintained its low levels for up to 10 years. While NfL levels were slightly reduced during treatment with IFN, the levels decreased further when switching to fingolimod, demonstrating its long-term benefit in relapsing-remitting multiple sclerosis.
The study’s findings were presented in a poster session at the 2019 American Academy of Neurology Annual Meeting in Philadelphia, Pennsylvania.
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1. Cohen J, Kappos L, Tenenbaum N, et al. Long-term Effect of Fingolimod in Reducing Blood Neurofilament Light Levels in Patients with Relapsing-remitting Multiple Sclerosis. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA. Poster P3.2-032.