Campath® (alemtuzumab)

Parent companies: Genzyme Corporation and Bayer HealthCare Pharmaceuticals.

Administered once yearly by intravenous infusion over three to five consecutive days. The drug is approved for the treatment of B-cell leukemia and targets T cells, B cells, and macrophages. Side effects include a reduction in blood clotting, thyroid disorders, infusion reactions, and infection. Patients need to be monitored closely due to risk of significant toxicities.

The CAMMS223 Phase 2 study compared Campath to high-dose Rebif in an open-label study with RRMS patients. After two years, there was a 73-percent reduction in risk of relapse and a 71-percent reduction in progression to significant disability in those treated with Campath, a significant benefit over treatment with Rebif. Over 50 percent of the Campath-treated patients actually improved, suggesting a possible neuroprotective action.

The CARE-MS Phase III trial is enrolling 525 patients with previously untreated RRMS to further study Campath vs Rebif. They will be treated with 12 mg IV Campath for five days at month zero and three days at month 12, or to high-dose Rebif (44 mcg). Primary outcome measures are time to sustained accumulation of disability and relapse rate; secondary measures include the proportion of patients who remain relapse-free, a change in baseline Expanded Disability Status Scale (EDSS), the development of disability, and the change in lesion volume.