Table 1.
Demographic and baseline clinical characteristics
| Less active RRMS | Highly active RRMS | |||
|---|---|---|---|---|
| Placebo (n = 173) | DAC HYP (n = 351) | Placebo (n = 30) | DAC HYP (n = 61) | |
| Demographics | ||||
| Age, years, mean (SD) | 36.5 (9.2) | 35.6 (8.7) | 37.0 (8.4) | 33.0 (9.0) |
| Sex, female (%) | 62 | 67 | 67 | 62 |
| Race, white (%) | 97 | 96 | 93 | 98 |
| MS disease characteristics | ||||
| No prior approved RRMS therapy (%)a | 88 | 84 | 80 | 74 |
| Years since MS diagnosis, mean (median) | 4.2 (5.3) | 4.1 (4.4) | 3.7 (5.2) | 4.1 (5.5) |
| Number of relapses in past year, mean (SD) | 1.2 (0.5) | 1.2 (0.6) | 2.2 (0.5) | 2.3 (0.7) |
| Baseline EDSS score, mean (SD) | 2.8 (1.2) | 2.7 (1.2) | 2.5 (1.1) | 3.0 (1.3) |
| MRI brain lesions | ||||
| ≥1 Gd+ lesion (%) | 35 | 34 | 100 | 100 |
| Number of Gd+ lesions, mean (SD) | 1.5 (4.4) | 1.3 (2.9) | 4.4 (4.4) | 4.3 (4.6) |
| Number of T2-hyperintense lesions, mean (SD) | 36.9 (29.9) | 37.0 (31.3) | 54.2 (40.5) | 58.6 (36.8) |
| Volume of T2-hyperintense lesions, mean (SD) | 7,245.7 (8,623.0) | 7,656.0 (9,299.8) | 12,893.3 (12,214.1) | 12,987.1 (11,360.9) |
RRMS relapsing-remitting multiple sclerosis, DAC HYP daclizumab high-yield process, SD standard deviation, MS multiple sclerosis, EDSS Expanded Disability Status Scale, MRI magnetic resonance imaging, Gd + gadolinium-enhancing
aPatients who had no prior use of approved RRMS treatments (interferon beta-1a, interferon beta-1b, natalizumab, glatiramer acetate or mitoxantrone)