Table 1.
RMS (OPERA I/II) |
PPMS (ORATORIO) |
|||
---|---|---|---|---|
IFNβ1a (n = 829) | Ocrelizumab (n = 827) | Placebo (n = 244) | Ocrelizumab (n = 488) | |
Age, median (range), years | 37 (18–55) | 38 (18–56) | 46 (18–56) | 46 (20–56) |
Female, n (%) | 552 (66.6) | 541 (65.4) | 124 (50.8) | 237 (48.6) |
Time since MS diagnosis, median (range), years | 1.7 (0.1–28.5) | 1.8 (0.0–28.9) | 1.3 (0.1–23.8) | 1.6 (0.1–16.8) |
EDSS score, median (range) | 2.5 (0.0–6.0) | 2.5 (0.0–6.0) | 4.5 (2.5–6.5) | 4.5 (2.5–7.0) |
T2w lesion volume, median (range), mL | 6.2 (0.0–76.1) | 5.4 (0.0–96.0) | 6.2 (0.0–81.1) | 7.3 (0.0–90.3) |
No. of T2w lesions, median (range) | 42.0 (0.0–226.0) | 40.0 (1.0–233.0) | 43.0 (0.0–208.0) | 42.0 (0.0–249.0) |
Patients with T1w Gd-enhancing lesions, no./total no. (%) | 327/822 (39.8) | 333/818 (40.7) | 60/243 (24.7) | 133/484 (27.5) |
Normalized brain volume, median (range), cm3 | 1504.8 (1245.9–1751.9) | 1502.4 (1202.7–1761.3) | 1464.5 (1216.3–1701.7) | 1462.2 (1214.3–1711.1) |
EDSS: Expanded Disability Status Scale; Gd: gadolinium; IFNβ1a: interferon β-1a; ITT: intent-to-treat; PPMS: primary progressive multiple sclerosis; RMS: relapsing multiple sclerosis.