TABLE 2.
Clinical outcome measures at baseline and follow‐up, and proportion of clinically relevant change
| Clinical outcome | n | Baseline | 3‐month follow‐up | Patients with clinically relevant change (%) |
|---|---|---|---|---|
| Disease activity | 48 a | |||
| Gd+ lesions, n patients (%) | 13 (27.1) b | 5 (10.4) c | 31.3 | |
| New/enlarged T2 lesions without Gd‐enhancement, n patients (%) | n.a. | 1 (2.1) d | n.a. | |
| Relapses, n (%) | n.a. | 4 (8.3) | 8.3 | |
| CIS‐F, mean (SD) | 90 | 34.1 (11.8) | 35.2 (11.6) | 25.6 |
| EDSS, median (IQR) | 93 | 3.5 (2.5–4.0) | 3.5 (2.5–4.5) | 20.4 |
| EDSS Ambulation FS, median (range) | 93 | 1.0 (0–10) | 1.0 (0–11) | 32.3 |
| AMSQ, median (IQR) | 89 | 35.5 (31.0–45.5) | 36.0 (32.0–45.0) | 9.8 |
| SDMT, mean (SD) | 93 | 54.1 (10.4) | 57.1 (10.5) | 51.6 |
Abbreviations: Ambulation FS, Ambulation Functional System; AMSQ, Arm function in MS Questionnaire; CIS‐F, Checklist Individual Strength Fatigue subscale; EDSS, Expanded Disability Status Scale; G+, gadolinium‐enhancing; IQR, interquartile range; SD, standard deviation; SDMT, Symbol Digit Modalities Test.
a
Only patients with relapsing‐remitting multiple sclerosis (RRMS).
b
1 Gd+ lesion, n = 9; 2 Gd+ lesions, n = 2; 6 Gd+ lesions, n = 2.
c
1 Gd+ lesion, n = 2; 2 Gd+ lesions, n = 1; 4 Gd+ lesions, n = 1; 10 Gd+ lesions, n = 1.
d
2 new T2 lesions.