Baseline demographics and disease characteristics of the REFLEXION intent-to-treat population (at the time of randomisation to REFLEX)
| Characteristic | sc IFN β-1a tiw n=127 (74.3% of REFLEX) | sc IFN β-1a qw n=142 (81.1% of REFLEX) | DT n=133 (77.8% of REFLEX) | Overall n=402 (77.8% of REFLEX) |
|---|---|---|---|---|
| Age, years | 31.8 (8.6) | 31.4 (8.2) | 31.0 (8.2) | 31.4 (8.3) |
| Women, n (%) | 78 (61.4) | 88 (62.0) | 82 (61.7) | 248 (61.7) |
| EDSS score | 1.5 (0–4.0)* | 1.5 (0–3.5) | 1.5 (0–3.5) | 1.5 (0–4.0)* |
| Time since FCDE, days | 57.6 (3.83) | 57.7 (3.40) | 57.8 (4.04) | 57.7 (3.75) |
| Classification of FCDE as monofocal,† n (%) | 66 (52.0) | 76 (53.5) | 72 (54.1) | 214 (53.2) |
| Steroid use at FCDE, n (%) | 90 (70.9) | 99 (69.7) | 95 (71.4) | 284 (70.6) |
| Presence of ≥1 T1 Gd+ lesion, n (%) | 48 (37.8) | 62 (43.7) | 52 (39.1) | 162 (40.3) |
| T1 Gd+ lesion number | 1.2 (2.5) | 1.5 (3.4) | 1.0 (1.8) | 1.2 (2.7) |
| T1 Gd+ lesion volume, mm3 | 147.94 (430.64) | 169.20 (384.88) | 142.93 (453.35) | 153.79 (422.07) |
| T1 hypointense lesions | 6.4 (7.3) | 6.1 (7.6) | 5.6 (8.1) | 6.0 (7.7) |
| T1 hypointense lesion volume, mm3 | 787.05 (1163.61) | 806.48 (1344.18) | 705.40 (1115.41) | 766.90 (1213.36) |
| T2 lesion number | 22.6 (17.4) | 24.3 (21.8) | 20.7 (19.7) | 22.6 (19.8) |
| ≥9 T2 lesions, n (%) | 100 (78.7) | 104 (73.2) | 95 (71.4) | 299 (74.4) |
| T2 lesion volume, mm3 | 3312.00 (3370.44) | 3798.88 (4490.66) | 3296.99 (3937.93) | 3479.02 (3977.55) |
| Normalised brain volume, cm3 | 1533.12 (76.83) | 1532.72 (65.95) | 1541.25 (64.95) | 1535.65 (69.21) |
Data are presented as mean (SD) or median (range), unless indicated otherwise.
*Data missing for one patient.
†As classified by the adjudication committee.
DT, delayed treatment; EDSS, Expanded Disability Status Scale; FCDE, first clinical demyelinating event; Gd+, gadolinium-enhancing; IFN, interferon; MS, multiple sclerosis; qw, once weekly; REFLEX, REbif FLEXible dosing in early MS; REFLEXION, REbif FLEXible dosing in early MS extensION; sc, subcutaneously; tiw, three times weekly.