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@ARTICLE{Cordts:298921,
author = {I. Cordts and C. Fuetterer and A. Wachinger and R. von
Heynitz and T. Kessler$^*$ and M. Freigang and A. L. Quinten
and B. Bjelica and S. Brakemeier and E. Hobbiebrunken and T.
Hagenacker and S. Petri and J. C. Koch and A. Hahn and P.
Lingor and M. Deschauer and R. Günther and M. Weiler and B.
Haller and E. Feneberg},
title = {{L}ong-{T}erm {D}ynamics of {CSF} and {S}erum
{N}eurofilament {L}ight {C}hain in {A}dult {P}atients {W}ith
5q {S}pinal {M}uscular {A}trophy {T}reated {W}ith
{N}usinersen.},
journal = {Neurology},
volume = {104},
number = {5},
issn = {0028-3878},
address = {Philadelphia, Pa.},
publisher = {Wolters Kluwer},
reportid = {DKFZ-2025-00357},
pages = {e213371},
year = {2025},
abstract = {The availability of disease-modifying therapies for
5q-associated spinal muscular atrophy (SMA) has heightened
the need to identify suitable biomarkers. This study
investigates neurofilament light chain (NfL) concentrations
during long-term nusinersen treatment in adult SMA.In a
retrospective study of prospectively collected data, NfL
concentrations in the CSF (cNfL) and serum (sNfL) were
measured in patients with SMA from 8 German centers and in
neurologic controls using a single-molecule array (Simoa)
assay. NfL concentrations and clinical characteristics,
including the clinical scores Hammersmith Functional Motor
Scale Expanded (HFMSE), Revised Upper Limb Module (RULM),
and Amyotrophic Lateral Sclerosis Functional Rating
Scale-Revised (ALSFRS-R), were analyzed for defined
treatment intervals (T1-T4 [loading phase until 4 months],
T5-T8 [until 23 months], T9-T12 [until 37 months], and
T13-T19 [until 60 months]). Linear mixed models with a
random intercept were used to assess the changes in NfL
levels during treatment, considering time and covariates as
fixed effects.One hundred thirteen adult patients with SMA
(median age 35, $46\%$ female), with a treatment duration of
maximum 60 months, and 52 controls were included. At
baseline, NfL concentrations were significantly higher in
SMA {cNfL median, 585 (interquartile range [IQR] 428-787)
pg/mL; sNfL, 11 (IQR 8-14) pg/mL} than in controls (cNfL,
420 [IQR 323-662] pg/mL; sNfL, 8 [IQR 6-12] pg/mL) (cNfL, p
= 0.021; sNfL, p = 0.030). Median differences for all
clinical scores were the highest for T5-T8 compared with the
loading phase (Δ HFMSE, 0.6 [IQR 0.1-1.4], p = 0.017; Δ
RULM, 0.9 [IQR 0.4-1.3], p < 0.001; Δ ALSFRS-R, 0.7 [IQR
0.4-1.0], p < 0.001), but not for subsequent intervals.
Longitudinal analysis revealed a significant decrease of NfL
concentrations during each treatment interval compared with
the loading phase (p < 0.05, respectively) except for sNfL
in T13-T19. Even among patients with no measurable clinical
improvement (Δ HFMSE ≤ 0), more than $50\%$ showed
declining cNfL and sNfL levels up to T13-T19.NfL decreased
during nusinersen treatment, suggesting its potential as a
pharmacodynamic response marker in adult SMA. However, in
patients without detectable clinical improvement, our study
cannot determine whether they represent a more sensitive
outcome measure or are not clinically meaningful.},
keywords = {Humans / Neurofilament Proteins: blood / Neurofilament
Proteins: cerebrospinal fluid / Male / Female / Adult /
Oligonucleotides: therapeutic use / Retrospective Studies /
Middle Aged / Muscular Atrophy, Spinal: drug therapy /
Muscular Atrophy, Spinal: blood / Muscular Atrophy, Spinal:
cerebrospinal fluid / Biomarkers: blood / Biomarkers:
cerebrospinal fluid / Young Adult / nusinersen (NLM
Chemicals) / Neurofilament Proteins (NLM Chemicals) /
neurofilament protein L (NLM Chemicals) / Oligonucleotides
(NLM Chemicals) / Biomarkers (NLM Chemicals)},
cin = {B320 / HD01},
ddc = {610},
cid = {I:(DE-He78)B320-20160331 / I:(DE-He78)HD01-20160331},
pnm = {312 - Funktionelle und strukturelle Genomforschung
(POF4-312)},
pid = {G:(DE-HGF)POF4-312},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:39946662},
doi = {10.1212/WNL.0000000000213371},
url = {https://inrepo02.dkfz.de/record/298921},
}