Table 1.
Baseline and follow-up clinical and radiological characteristics and serum GFAP levels.
| Non-progressor (N = 46) |
Progressor (N = 42) |
Total (N = 88) |
p Value | |
|---|---|---|---|---|
| Female (%) | 76.1 | 73.8 | 75.0 | NS |
| Age (years) | 35.6 ± 8.6 | 38.2 ± 8.4 | 36.9 ± 8.6 | NS |
| Disease duration at baseline (years) | 7.36 (3.83–11.8) | 7.61 (4.17–12.7) | 7.36 (3.83–12.1) | NS |
| Duration of clinical follow-up (years) | 7.08 (4.47–9.69) | 8.34 (5.78–11.2) | 7.15 (4.92–10.3) | .038 |
| Duration of sample follow-up (years) | 4.75 (4.00–6.08) | 5.55 (5.00–7.06) | 5.17 (4.31–6.69) | .0075 |
| Patients with relapses (%) | ||||
| 1 year prior to baseline | 83.7 | 85.7 | 84.7 | NS |
| During first year of NTZ | 10.9 | 19.0 | 14.8 | NS |
| After 1 year of NTZ | 10.9 | 7.14 | 9.1 | NS |
| Baseline MRI | ||||
| With T1 GE (%) | 70.0 | 67.5 | 68.8 | NS |
| T1 GE lesion load (amount of lesions) | 2.50 (0–7.00) | 1.00 (0–3.25) | 2.00 (0–5.25) | NS |
| T2 load ⩽ 38 lesions (%) | 65.1 | 65.9 | 65.5 | NS |
| T2 lesion load if ⩽38 lesions (lesions) | 25.0 (15.0–30.0) | 29.5 (17.3–33.0) | 26.0 (15.0–30.0) | NS |
| Radiological activity a (%) | ||||
| During first year of NTZ | 28.3% | 32.5% | 30.2% | NS |
| After 1 year of NTZ | 6.52% | 9.52% | 7.95% | NS |
| Disability at baseline | ||||
| EDSS | 3.5 (2.5–5.0) | 4.0 (2.5–5.5) | 3.5 (2.5–5.0) | NS |
| 9-HPT (seconds) | 20.7 (18.7–26.4) | 22.7 (20.6–25.2) | 21.6 (19.8–26.2) | NS |
| T25FW (seconds) | 4.8 (3.7–6.1) | 5.50 (4.3–8.28) | 4.90 (3.9–7.3) | NS |
| Disability at 12M | ||||
| EDSS | 3.0 (3.0–4.0) | 4.0 (3.0–6.0) | 4.0 (3.0–5.0) | NS |
| 9-HPT (seconds) | 20.7 (19.4–26.0) | 22.8 (20.2–25.8) | 21.7 (19.7–26.0) | NS |
| T25FW (seconds) | 4.7 (3.5–5.7) | 5.20 (4.3–7.7) | 4.85 (4.0–6.1) | NS |
| Disability at last clinical follow-up | ||||
| EDSS | 3.5 (2.0–4.0) | 5.0 (3.5–6.0) | 4.0 (3.0–5.5) | <0.001 |
| 9-HPT (seconds) | 20.3 (18.6–25.3) | 24.1 (21.2–30.1) | 23.1 (19.9–27.9) | 0.024 |
| T25FW (seconds) | 4.3 (3.8–5.8) | 5.8 (4.8-10.4) | 5.0 (4.1–7.4) | <0.001 |
| Serum GFAP (pg/ml) | ||||
| Baseline | 116.4 (83.8–151.0) | 102.8 (82.3–142.1) | 110.8 (82.3–147.7) | NS |
| 3M | 90.4 (66.9–110.4) | 86.9 (65.6–110.9) | 88.5 (66.6–110.7) | NS |
| 12M | 89.2 (72.7–116.7) | 87.4 (71.8–112.1) | 88.7 (71.8–113.0) | NS |
| 24M | 84.1 (62.5–111.1) | 90.9 (77.7–113.0) | 87.5 (65.0–112.5) | NS |
| Last sample follow-up | 97.0 (74.7–121.5) | 91.9 (77.5–111.7) | 94.0 (74.8–119.8) | NS |
| Serum NfL (pg/ml) | ||||
| Baseline | 16.6 (10.8–29.6) | 14.0 (9.76–20.8) | 15.0 (10.1–26.6) | NS |
| 3M | 11.2 (8.72–15.4) | 11.4 (8.04–16.4) | 11.2 (8.54–15.9) | NS |
| 12M | 7.44 (5.94–10.5) | 8.20 (6.65–11.0) | 8.09 (5.96–11.0) | NS |
| 24M | 8.05 (5.80–10.2) | 7.67 (5.74–11.1) | 7.87 (5.75–10.5) | NS |
| Last sample follow-up | 7.86 (5.45–11.6) | 9.56 (6.47–10.5) | 8.83 (5.59–11.2) | NS |
| Baseline brain fraction b (%) | ||||
| Whole brain | 71.9 (69.5–73.8) | 71.2 (69.6–73.7) | 72 (69.6–73.7) | NS |
| Ventricle | 2.8 (2.2–3.5) | 2.9 (2.2–3.4) | 2.9 (2.2–3.5) | NS |
| Thalamus | 0.8 (0.7–0.9) | 0.8 (0.7–0.8) | 0.8 (0.7–0.8) | NS |
| Lesion | 0.8 (0.3–1.3) | 0.5 (0.1–1.2) | 0.6 (0.2–1.3) | NS |
| Annualized volume change (%) | ||||
| Whole brain, 12M-last clinical follow-up | −0.24 (−0.81 to 0.49) | −0.29 (−0.94 to 0.31) | −0.27 (−0.82 to 0.35) | NS |
| Ventricle, 12M-last clinical follow-up | 0.09 (−1.19 to 1.24) | 0.38 (−0.60 to 1.47) | 0.23 (−0.78 to 1.32) | NS |
| Thalamus, 12M-last clinical follow-up | −0.36 (−0.84 to 0.54) | −0.45 (−1.14 to 0.17) | −0.40 (−1.00 to 0.21) | NS |
| Lesion, 12M-last clinical follow-up | −2.07 (−7.19 to 5.84) | −0.91 (−4.67 to 3.69) | −1.97 (−5.25 to 4.38) | NS |
Mean values are displayed with ± standard deviation. Median values are displayed with (interquartile range). p Values were calculated using chi-square test for categorical variables and t-test and Mann–Whitney U test for normally and non-normally distributed continuous variables, respectively. Progressor status was defined as significant change in EDSS+ status.
NS: non-significant; NTZ: natalizumab; MRI: magnetic resonance imaging; GE: gadolinium-enhancing; FU: follow-up; EDSS: expanded disability status scale; 9-HPT: nine-hole peg test; T25FW: timed 25-foot walk test; EDSS+: EDSS with 9-HPT and T25FW; GFAP: glial fibrillary acidic protein; NfL: neurofilament light; 3M: 3 months after baseline; 12M: 12 months after baseline; 24M: 24 months after baseline.
MRI activity was defined as new/enlarged T2 lesions and/or T1 gadolinium-enhancing lesions.
Volumes were defined as fraction and were calculated as the sum of tissue, divided by intracranial volume.