Table 4.
Comparison of selected adverse events across randomized studies with alemtuzumab
| CAMMS22315
|
CARE-MS-116
|
CARE-MS-217
|
Total
|
|||||
|---|---|---|---|---|---|---|---|---|
| IFN beta-1a (n=107) | Alemtuzumaba (n=216) | IFN beta-1a (n=187) | Alemtuzumab (n=376) | IFN beta-1a (n=202) | Alemtuzumaba (n=596) | IFN beta-1a (n=496) | Alemtuzumab (n=1,188) | |
| Patients with adverse event | 107 (100%) | 215 (100%) | 172 (92%) | 361 (96%) | 191 (95%) | 587 (99%) | 470 (95%) | 1,163 (98%) |
| Discontinuation due to adverse event | 13 (12%) | 3 (1%) | 11 (6%) | 5 (1%) | 15 (7%) | 20 (3%) | 39 (8%) | 28 (2%) |
| Infusion-associated reactions | NA | 213 (99%) | NA | 338 (90%) | NA | 549 (92%) | NA | 1,100 (93%) |
| Infections | 50 (47%) | 142 (66%) | 85 (45%) | 253 (67%) | 134 (66%) | 468 (79%) | 269 (54%) | 863 (73%) |
| Serious infections | 2 (2%) | 9 (4%) | 2 (1%) | 7 (2%) | 3 (1%) | 22 (4%) | 7 (1%) | 38 (3%) |
| Thyroid disorders | 3 (3%) | 49 (23%) | 12 (6%) | 68 (18%) | 10 (5%) | 100 (17%) | 25 (5%) | 217 (18%) |
| Serious thyroid disorders | 0 | 3 (1%) | 0 | 4 (1%) | 0 | 4 (0.7%) | 0 | 11 (9%) |
| Blood and lymphatic system disorders | Not reported | Not reported | 36 (19%) | 66 (18%) | 28 (14%) | 84 (14%) | 64 (17%)b | 150 (15%)c |
| Serious immune thrombocytopenic purpura | 0 | 5 (2%)d | 0 | 3 (1%) | 0 | 5 (<1%) | 1 (<1%) | 13 (1%) |
| Serious agranulocytosis | 0 | 0 | 0 | 2 (1%) | 0 | 0 | 0 | 2 (<1%) |
| Serious thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (<1%) |
| Serious anemia | 0 | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (<1%) |
| Serious febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (<1%) |
| Malignant disease | 0 | 0 | 0 | 2 (1%) | 2 (1%) | 5 (<1%) | 2 (<1%) | 7 (<1%) |
Notes:
a
12 mg and 24 mg dose arms combined;
b
percentage calculated for n=389;
c
percentage calculated for n=972;
d
one death attributed to serious immune thrombocytopenia. Data from CAMMS223 Trial Investigators et al,15 Cohen et al16 and Coles et al.17
Abbreviations: CAMMS, Campath-1H in Multiple Sclerosis; IFN, interferon; NA, not available; CARE-MS, Comparison of Alemtuzumab and Rebif® efficacy in Multiple Sclerosis.