Introduction
Materials and methods
Study design
Patients
Assessments
Statistical analyses
Results
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) |
Less active RRMS | Highly active RRMS | |||
---|---|---|---|---|
Placebo (n = 173) | DAC HYP (n = 351) | Placebo (n = 30) | DAC HYP (n = 61) | |
Any AE, n (%) | 136 (79) | 258 (74) | 25 (83) | 49 (80) |
Infections | 77 (45) | 183 (52) | 12 (40) | 32 (52) |
Cutaneous events | 25 (14) | 72 (21) | 2 (7) | 11 (18) |
Elevation of ALT/AST >5× ULN | 1 (<1) | 14 (4) | 0 | 3 (5) |
Most common AEs, n (%)a,b
| ||||
Nasopharyngitis | 27 (16) | 50 (14) | 4 (13) | 10 (16) |
Headache | 18 (10) | 33 (9) | 3 (10) | 7 (11) |
Upper respiratory infection | 12 (7) | 32 (9) | 2 (7) | 8 (13) |
Paraesthesia | 7 (4) | 8 (2) | 3 (10) | 1 (2) |