Table 2.
Secondary end points after 9 months of treatment.
| Outcomes | FR (n = 29) | CW (n = 27) | P-value |
|---|---|---|---|
| CUMULATIVE NUMBER OF GD-ENHANCING LESIONS AT MRI | |||
| Mean ± SD | 9.52 ± 17.01 | 5.85 ± 9.42 | 0.496c |
| Median (IQR) | 3 (0–10) | 1 (0–9) | |
| CUMULATIVE NUMBER OF NEW AND ENLARGING T2-WEIGHTED LESIONS AT MRI | |||
| Mean ± SD | 3.86 ± 6.76 | 3.48 ± 5.34 | 0.820c |
| Median (IQR) | 1 (0–2) | 2 (0–4) | |
| NUMBER OF PATIENTS WITH AT LEAST AN ACTIVE SCAN | |||
| N | 22 | 21 | 0.865b |
| RR (95%CI)a | |||
| RELAPSES | |||
| Mean ± SD | 0.34 ± 0.66 | 0.52 ± 0.89 | 2.15 (0.64; 7.18) |
| Median (IQR) | 0 (0–0) | 0 (0–1) | |
| Range | 0–2 | 0–3 | |
| P-valueb | |||
| EDSS SCORE | |||
| Mean ± SD | 1.76 ± 1.33 | 1.33 ± 0.72 | 0.201 |
| Median (IQR) | 1.5 (1–1.78) | 1 (1–1.56) | |
| Range | 0–6.5 | 0–3 | |
| (n = 24)c | (n = 25)c | ||
| BLACK HOLES–NUMBERd | |||
| Mean ± SD | 2.71 ± 4.56 | 1.24 ± 1.61 | 0.666 |
| Median (IQR) | 0 (0–4) | 1 (0–2) | |
| Range | 0–18 | 0–5 | |
| Black HOLES–OVERALL VOLUME (cm3)d | |||
| Mean ± SD | 204.48 ± 396.98 | 489.11 ± 1488.12 | 0.626 |
| Median (IQR) | 0 (0–199.08) | 0 (0–441.07) | |
| Range | 0–1380.44 | 0–7357.59 | |
a
Relapse risk Ratio (RR) were obtained from Poisson model adjusting for the baseline variables (gender, age, disease duration, number of relapses before study entry, EDSS score, MRI metrics). After adjusting for covariates we analyzed 49 subjects with complete information.
b
Non-parametric Wilcoxon rank-sum test (for variables with non-normal distribution).
c
The baseline demographic and clinical characteristics of this subgroup were not different from those of the 7 patients lost for this analysis.
d
At month 12 of the study.