Table 2.
Scores obtained in the clinical/neuropsychological assessment and radiological features at therapy start (Tst), after 6 months (T6m), and after 12 months (T12m) of DMF treatment and statistical comparison results (Wilcoxon signed-rank test with threshold of p < 0.05)
| MS patients | Tst (N = 30) | T6m (N = 30) | T12m (N = 27) | p* | p** |
|---|---|---|---|---|---|
| Clinical/neuropsychological scores | |||||
| EDSS score [median (range)] | 1.5 [0.0–4.0] | 1.5 [0.0–5.5] | 1.5 [0.0–5.5] | ns | ns |
| Pts. with relapse under DMF, n (%)† | – | 1 (3) | 1 (4) | – | – |
| 9-HPT dominant hand, s | 20.0 ± 3.4 | 20.0 ± 3.0 | 19.5 ± 2.9 | ns | ns |
| 9-HPT non-dominant hand, s | 21.4 ± 4.8 | 21.6 ± 4.0 | 21.0 ± 3.6 | ns | ns |
| 25-FWT, s | 6.4 ± 1.4 | 6.5 ± 1.7 | 6.0 ± 1.4 | ns | 0.005 |
| PASAT 3, s | 39.8 ± 15.2 | 42.0 ± 13.4 | 43.5 ± 12.0 | ns | 0.022 |
| PASAT 2, s | 32.5 ± 13.1 | 33.4 ± 10.7 | 33.4 ± 12.8 | ns | ns |
| SDMT | 44.2 ± 12.3 | 44.1 ± 13.1 | 43.0 ± 13.6 | ns | ns |
| Radiological features | |||||
| Brain volume (cm3) | 1,407 ± 259 | – | – | – | – |
| Gray matter volume (cm3) | 743 ± 59 | – | – | – | – |
| T2-lesion volume (cm3) | 8.997 ± 10.700 | 9.215 ± 10.948 | 9.770 ± 11.332 | ns | ns |
| Percentage brain volume change (%)† | – | − 0.12 [− 1.83–1.88] | − 0.24 [− 2.72–1.77] | – | – |
| Pts with new/enlarging lesions under DMF, n (%)† | – | 6 (20) | 6 (22) | – | – |
| Pts with gadolinium-positive lesion, n (%) | 3 (10) | 1 (3)† | 1 (4)† | – | – |
Values are reported as the mean ± standard deviation or median [min–max]
s seconds, ns not statistically significant
9HPT 9-Hole Peg Test, 25FWT, 25-Feet Walk Test, PASAT Paced Auditory Serial Addition Test 3 and 2 s, SDMT Symbol Digit Modalities Test
*Differences between Tst and T6m
**Differences between Tst and T12m
†Respect to baseline