Table 3.
Safety Profile of Alemtuzumab
| Phase 2 | Phase 3 | Phase 3 | |
|---|---|---|---|
| CAMMS 223* | CARE-MS I | CARE-MS II* | |
| N = 333 | N = 581 | N = 637 | |
| >3 years | >2 years | >2 years | |
| Deaths | 1 due to ITP 1 due to myocardial infarct | 1 due to motor accident | 1 due to motor accident; 1 due to aspiration pneumonia |
| Infusion-associated symptoms | 98 % | 90 % | 92 % |
| Infections | |||
| All | 66 % Mild-to-moderate (47 % on IFNb) | 67 % Mild-to-moderate (46 % on IFNb) | 79 % Mild-to-moderate (66 % on IFNb) |
| Life-threatening | 0 | 0 | 0 |
| Autoimmunity | |||
| Thyroid | 26 % | 18 % | 17 % |
| ITP | 0.9 % | 0.8 % | 1 % |
| Goodpasture’s syndrome | 0 | 1 case on extended follow-up | 0 |
| Neoplasia (alem vs IFNb) | 2.8 % vs 0.9 % | 0.5 % vs 0 | 0.6 % vs 1.5 % |
| Details | 1 colon cancer after IFNb-1a, 1 cervical cancer, 1 breast cancer, and 1 non–EBV-associated Burkitt’s lymphoma in patients receiving the 24-mg dose of alem | 2 cases of papillary thyroid cancer after alem | 1 basal cell carcinoma on IFNb and 1 on alem, 1 thyroid and 1 parathyroid tumor after alem 1 acute myeloid leukemia on IFNb-1a |
Alem = alemtuzumab; CAMMS = Campath in Multiple Sclerosis; IFNb-1a = interferon beta-1-alpha; ITP = immune thrombocytopenia; MS = Multiple Sclerosis
*Only reporting the results of the 12 mg/kg arm