Drug safety evaluation of alemtuzumab for multiple sclerosis

Alemtuzumab is a humanised anti-CD52 mAb which has recently been licensed for the treatment of relapsing multiple sclerosis in Europe.

The efficacy and safety of alemtuzumab from open label, Phase II and Phase III trials is reported.

Alemtuzumab causes rapid and profound complement mediated lysis of circulating lymphocytes and allows beneficial modulation of the immune system during a subsequent reconstitution phase. Clinical trials have demonstrated superior efficacy against an active comparator, with reduction in annualised relapse rates and sustained accumulation of disability at 3 years and sustained efficacy at 5 years. The main adverse effects are mild to moderate infusion reactions, an increased incidence of mild to moderate infections and autoimmune adverse events. Thyroid disorders are the most common form of autoimmune adverse events, occurring in approximately one third of patients. Overt Graves' hyperthyroidism represents approximately half of these cases. Careful patient selection and structured monitoring programs allow for effective patient management resulting in a favourable risk benefit profile.