Table 3.
AE incidence over years 0–9 in the HAD alemtuzumab-treated populations from CARE-MS I and II (primary definition)
| AEs, n (%) | Alemtuzumab-treated HAD patients over years 0–9 | |
|---|---|---|
| CARE-MS I (N = 105) | CARE-MS II (N = 103) | |
| Any AE | 104 (99.0) | 103 (100.0) |
| Serious AEs | 40 (38.1) | 41 (39.8) |
| Infections | 89 (84.8) | 93 (90.3) |
| Serious infections | 7 (6.7) | 9 (8.7) |
| Autoimmune AEsa | ||
| Thyroid AEs | 51 (48.6) | 45 (43.7) |
| Serious thyroid AEs | 5 (4.8) | 7 (6.8) |
| ITP | 3 (2.9) | 0 |
| Nephropathies | 1 (1.0) | 1 (1.0) |
| Malignancies | 3 (2.9) | 0 |
| Deaths | 1 (1.0) | 2 (1.9) |
Primary HAD definition: ≥ 2 relapses in the year prior to baseline and ≥ 1 Gd-enhancing lesion at baseline
AE adverse event, CARE-MS Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Gd gadolinium, HAD highly active disease, ITP immune thrombocytopenia
aFirst occurrence of AE within the time period