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Serum NfL projects development of definite MS

AAN 2021
Phase 3, REFLEX
In patients who experienced a first clinical demyelinating event, baseline levels of serum neurofilament light chain (NfL) were associated with conversion to McDonald 2005 MS. This was found in a post-hoc analysis of the phase 3 REFLEX trial.

Serum NfL is a known biomarker for disease activity and treatment efficacy in multiple sclerosis (MS) patients. The phase 3 REFLEX trial (NCT00404352) demonstrated that treatment with subcutaneous interferon-beta-1a (scIFNβ-1a) delayed the onset of MS (as defined by the 2005 McDonald criteria) in patients with a first clinical demyelinating event [1]. This treatment also reduced serum NfL levels from 6 months post-baseline.

A post-hoc analysis of the REFLEX trial showed that baseline levels of serum NfL predicted the conversion to McDonald 2005 MS after 2 years of follow-up in all 3 groups: scIFNβ-1a thrice-weekly (n=171), once-weekly (n=175), and placebo (n=171) [2]. Prof. Jens Kuhle (University of Basel, Switzerland) explained that patients with high serum NfL levels at baseline (>26.1 μg/mL) had an increased risk of developing clinically definite MS within 2 years. Serum NfL subgroup analyses demonstrated that treatment with scIFNβ-1a delayed MS onset in both patients with low and high baseline levels of serum NfL. Younger age, multifocal first clinical demyelinating event, and the number of T1 and T2 lesions predicted the onset of definite MS in all groups of the REFLEX trial.

  1. Comi G, et al. Lancet Neurol. 2012;11(1):33-41.
  2. Kuhle J, et al. Baseline Serum Neurofilament Light Chain Levels Predict Conversion to McDonald 2005 Multiple Sclerosis (MS) Within 2 Years of a First Clinical Demyelinating Event in Patients with MS. P5.080, AAN 2021 Virtual Congress, 17-22 April.

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