Table 4.
IARs by course in pooled CARE-MS I and II patients.
| Incidence, n (%) | ||||||
|---|---|---|---|---|---|---|
| Course 1 | Course 2 | Course 3 | Course 4 | Course 5 | Course 6 | |
| Alemtuzumab-only group | n = 811a | n = 791 | n = 302 | n = 105 | n = 26 | n = 5 |
| Any IAR eventsb | 687 (84.7) | 544 (68.8) | 188 (62.3) | 66 (62.9) | 11 (42.3) | 2 (40.0) |
| Any serious IAR eventsb | 16 (2.0) | 8 (1.0) | 2 (0.7) | 0 | 0 | 0 |
| IFN–alemtuzumab group | n = 282 | n = 266 | n = 70 | n = 12 | – | – |
| Any IAR eventsb | 232 (82.3) | 174 (65.4) | 45 (64.3) | 5 (41.7) | − | − |
| Any serious IAR eventsb | 1 (0.4) | 2 (0.8) | 1 (1.4) | 0 | − | − |
a
Safety analysis included nine patients who received alemtuzumab 12 mg/day in the CARE-MS II core study, despite randomization to the alemtuzumab 24 mg/day core study arm.
b
IARs were any adverse event that occurred during or within 24 h after the end of the infusion.
CARE-MS, Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis; IAR, infusion-associated reaction; IFN, interferon.