Table 2.
AEs by disease activity and treatment group
| 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) |
AE adverse event, RRMS relapse-remitting multiple sclerosis, DAC HYP daclizumab high-yield process, ALT alanine aminotransferase, AST aspartate aminotransferase, 5× ULN five times the upper limit of normal [12]
aExcluding multiple sclerosis relapse
bAEs that occurred in ≥10 % of patients in any disease activity and treatment group