Abstract Details

Title Long-term Effect of Fingolimod in Reducing Blood Neurofilament Light Levels in Patients with Relapsing-remitting Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-032

Objective

To assess the effect of long-term treatment with fingolimod on blood neurofilament light chain (NfL) levels in patients with relapsing-remitting multiple sclerosis (RRMS).

Background

NfL, a cytoskeleton protein, is elevated in blood upon neuroaxonal damage. Blood NfL is a promising biomarker for monitoring disease activity, treatment response, and prognosis in MS.

Design/Methods

This post hoc analysis was based on data from patients who received fingolimod 0.5 mg once daily or placebo/interferon ß-1a (IFN) 30 μg once weekly in pivotal studies (24-month FREEDOMS/12-month TRANSFORMS), and then fingolimod in the open-label LONGTERMS extension study for up to 10 years. The analysis included a subset of patients who had blood NfL assessments at baseline, end of core (EoC) in pivotal studies, and end of study (EoS) in LONGTERMS. Patients were categorized into two groups: a continuous group (n=37) who received fingolimod throughout the studies and a switched group (n=42) who transitioned from placebo/IFN group to fingolimod in the LONGTERMS. NfL was measured using Single Molecule Array (SIMOA^TM) immunoassay. The geometric mean change in NfL levels from baseline to EoS was analyzed using Wilcoxon signed-rank test.

Results

The mean exposure to fingolimod was 3483 days in the continuous group and 2822 days in the switched group. In the continuous group, baseline NfL levels of 33 pg/mL were significantly reduced by approximately 40% at both EoC and EoS (20 pg/mL; P<0.0001 and P=0.0002, respectively). In the switched group, baseline NfL levels of 29 pg/mL were reduced by 15% at EoC (25 pg/mL, P>0.44) and 41% at EoS (17 pg/mL, P<0.0001).

Conclusions Fingolimod 0.5 mg significantly reduced blood NfL, maintaining its low levels with continuous treatment for up to 10 years. NfL levels were reduced to a lesser extent during treatment with IFN but decreased further with switch to fingolimod, demonstrating the greater impact of highly effective therapy in RRMS.

Authors/Disclosures
Jeffrey A. Cohen, MD (Cleveland Clinic) PRESENTER	Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
Nadia Tenenbaum, MD (EMD Serono Research & Development Institute)	Dr. Tenenbaum has received personal compensation for serving as an employee of EMS Serono. Dr. Tenenbaum has stock in EMS Serono.
	No disclosure on file
Harald Kropshofer	Harald Kropshofer has nothing to disclose.
Davorka Tomic	Davorka Tomic has stock in Meck KGaA.
Jens Kuhle, MD	Dr. Kuhle has nothing to disclose.

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