ORCID: https://orcid.org/0009-0001-4129-1276; Mahdaoui, Sahla El
ORCID: https://orcid.org/0000-0003-2737-8305; Johnson, Poljanka
ORCID: https://orcid.org/0000-0003-4153-428X; Soares, Mafalda Delgado
ORCID: https://orcid.org/0000-0002-7508-0645; Koerbel, Kimberly
ORCID: https://orcid.org/0000-0002-7081-3096; Held, Friederike
ORCID: https://orcid.org/0009-0008-1190-9435; Bajrami, Albulena
ORCID: https://orcid.org/0000-0002-6322-9545; Pozzilli, Valeria
ORCID: https://orcid.org/0000-0002-0556-0176; Lucchini, Matteo
ORCID: https://orcid.org/0000-0002-0447-2297; Barbuti, Elena
ORCID: https://orcid.org/0000-0002-0450-7699; Bartels, Frederik
ORCID: https://orcid.org/0000-0003-3523-4520; Barket, Robert
ORCID: https://orcid.org/0000-0001-6909-6109; Cordano, Christian
ORCID: https://orcid.org/0000-0002-1413-0442; Hemmer, Bernhard
ORCID: https://orcid.org/0000-0001-5985-6784; Cagol, Alessandro
ORCID: https://orcid.org/0000-0002-7703-0553; Schiavetti, Irene
ORCID: https://orcid.org/0000-0002-5460-2977 und Sormani, Maria Pia
ORCID: https://orcid.org/0000-0001-6892-104X
(2026):
Neurofilament light chain as a surrogate candidate for disease activity in multiple sclerosis (LUMINOUS) - A meta-regression of randomized controlled trials.
In: Multiple Sclerosis Journal [Forthcoming]
Abstract
Background/Objectives:
Neurofilament light chain (NfL) is a promising biomarker for monitoring disease activity and treatment response in multiple sclerosis (MS). This meta-regression assesses the relationship between treatment effects on serum/plasma NfL (s/pNfL) and clinical and radiological endpoints in randomized controlled trials (RCTs).
Methods:
A systematic PubMed search identified RCTs in MS (1999–2023) with ⩾24 months’ duration and s/pNfL data. Extracted outcomes included treatment effects on s/pNfL, annualized relapse rate (ARR), confirmed disability worsening (CDW), magnetic resonance imaging (MRI) new/enlarging T2 lesions, and percentage brain volume change (PBVC). We evaluated the association of treatment effect on the selected outcomes at the trial level by a meta-regression, weighted by trial size and duration.
Results:
Fifteen RCTs (n = 6814) were included, nine in relapsing MS (RMS, n = 5221), and six in progressive MS (PMS, n = 1593). Treatment effects on s/pNfL showed a moderate association with treatment effects on MRI new/enlarging T2 lesions (R2 = 0.42, p = 0.01), ARR (R2= 0.33, p = 0.03) and CDW (R2= 0.30, p = 0.04), but not with PBVC. In RMS-only trials, association with ARR (R2= 0.45, p = 0.05) and CDW (R2= 0.50, p = 0.03) was more pronounced.
Conclusion:
In MS, treatment effects on s/pNfL are moderately associated with therapeutic effects on ARR, MRI new/enlarging T2 lesions, and CDW, whereas no consistent association was observed with PBVC.
| Item Type: | Journal article |
|---|---|
| Faculties: | Medicine > Munich Cluster for Systems Neurology (SyNergy) |
| Subjects: | 600 Technology > 610 Medicine and health |
| ISSN: | 1352-4585 |
| Language: | English |
| Item ID: | 132253 |
| Date Deposited: | 25. Feb 2026 07:24 |
| Last Modified: | 08. May 2026 13:03 |
| DFG: | Gefördert durch die Deutsche Forschungsgemeinschaft (DFG) - 390857198 |
