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• W3149682716 abstract "Neurofilament (NF) isoforms are major structural proteins of the neuronal cytoskeleton and are released into interstitial fluid in significant quantities following axonal damage or neuronal degeneration. These analyses investigated the change in pNF-H levels in participants treated with nusinersen or sham control in the Phase 3, randomized, double-blind, sham-procedure controlled ENDEAR and CHERISH studies. ENDEAR enrolled symptomatic infants aged ≤7 months at screening with infantile-onset SMA; CHERISH enrolled children aged 2–12 years with later-onset SMA. Blood samples were taken pre-dose at key study visits for pharmacokinetic analysis; pNF-H levels were measured in plasma using a pNF-H ELLA assay from ProteinSimple. pNF-H levels declined over time in the nusinersen and sham-control groups. However, decline was continual in the sham-control group vs a greater initial decline with nusinersen treatment followed by stabilization. In ENDEAR, the greatest difference vs the sham-control group was observed at Day 64: percentage change in pNF-H levels was -71.9 (±SE 2.38) for nusinersen vs -16.2 (±8.73) for sham-control. A similar pattern in pNF-H level decline to Day 85 was observed in CHERISH: percentage change was -48.4 (±SE 3.27) vs 6.2 (±6.82) for the nusinersen and sham-control groups, respectively. Correlations between baseline characteristics and pNF-H levels were also assessed. In ENDEAR, baseline log(pNF-H) correlated with baseline CHOP INTEND (r=-0.30; P=0.001), and age of symptom onset (r=-0.20; P=0.034), at SMA diagnosis (r=-0.25; P=0.006), and at first dose (r=-0.24; P=0.011). In CHERISH, baseline pNF-H correlated with baseline weight (r=-0.44) and disease duration (r=-0.64), age at first dose (r=-0.63; all P<0.0001) and baseline upper limb module test score (r=-0.20; P=0.028). These results suggest pNF-H may be associated with SMA disease characteristics at baseline and declines with nusinersen treatment before stabilization. Further validation and additional analyses, including CSF correlations, will contribute to a fuller understanding of the relationship." @default.
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• W3149682716 date "2018-10-01" @default.
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• W3149682716 title "NEW GENES, FUNCTIONS AND BIOMARKERS" @default.
• W3149682716 doi "https://doi.org/10.1016/j.nmd.2018.06.028" @default.
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