Table 6 Biomarkers variation during tofersen treatment according to clinical and demographic variables.

From: Neurodegenerative and neuroinflammatory changes in SOD1-ALS patients receiving tofersen

Variable

Time since Tofersen administration, one month

Age at baseline, one year

Gender, female vs male

Time since onset of disease to baseline, one month

DPR at baseline, 1 point/months

CSF NfL

MR (95% CI)

0.97 (0.95–0.99)

1.01 (0.99–1.02)

0.62 (0.38–1.00)

0.99 (0.99–1.00)

1.76 (0.81–3.82)

p-value

0.007

0.59

0.05

0.06

0.15

Serum NfL

MR (95% CI)

0.95 (0.92–0.98)

0.99 (0.96–1.02)

1.79 (0.80–3.99)

0.99 (0.98–0.99)

1013 (0.35–2.89)

p-value

0.001

0.36

0.15

0.010

0.98

CSF NfH

MR (95% CI)

0.97 (0.89–1.06)

1.01 (1.00–1.02)

0.51 (0.11–2.29)

1.00 (0.98–1.01)

2.55 (1.72–3.78)

p-value

0.53

0.26

0.38

0.58

 < 0.001

Serum NfH

MR (95% CI)

0.97 (0.95–1.00)

1015 (0.97–1.06)

2.86 (1.13–7.21)

1.00 (0.99–1.01)

5.90 (1.38–25.25)

p-value

0.042

0.50

0.026

0.77

0.017

CSF SerpinA1

MR (95% CI)

1.13 (1.09–1.17)

0.99 (0.95–1.03)

1.00 (0.44–2.24)

1.00 (0.99–1.01)

1.07 (0.31–3.71)

p-value

 < 0.001

0.54

0.99

0.65

0.92

Serum SerpinA1

MR (95% CI)

1.04 (0.81–1.34)

1.00 (0.98–1.02)

0.70 (0.47–1.03)

1.00 (1.00–1.01)

1.53 (0.85–2.75)

p-value

0.74

0.97

0.07

0.55

0.15

CSF CHI3L1

MR (95% CI)

1.04 (1.01–1.06)

1.02 (1.00–1.04)

0.90 (0.54–1.48)

1.00 (1.00–1.01)

1.76 (0.88–3.52)

p-value

0.002

0.05

0.67

0.52

0.11

Serum CHI3L1

MR (95% CI)

1.02 (1.00–1.03)

1.04 (1.02–1.05)

0.91 (0.60–1.37)

1.01 (1.00–1.01)

2.08 (1.12–3.87)

p-value

0.031

 < 0.001

0.65

0.007

0.021

  1. Mean ratios (MR) with a 95% confidence interval (CI) are reported to explain the average observed variation of neurodegenerative and neuroinflammatory biomarkers, corrected for all covariates. Significance is set with p-values < 0.05, which are reported in bold. The rows of the table display the dependent variables, while the columns show the explanatory variables. An MR of 1 indicates no change in the dependent variable (the biomarker under investigation) per unit change in the explanatory variable after the first Tofersen administration (e.g., baseline age in years). For instance, an MR of 1.01 for age at baseline would suggest a 1% increase in CSF NfH levels for each additional year of age. Conversely, an MR of 0.97 would indicate an average 3% decrease in CSF NfH levels for each additional year of age. CHI3L1, chitinase 3 like-1; CI, confident interval; CSF, cerebrospinal fluid; DPR, disease progression rate; MR, mean ratio; NfH, neurofilament heavy chain; NfL, neurofilament light chain.
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