Phase 3 Trial Update of Lemtrada for Multiple Sclerosis
Genzyme, a Sanofi company, reported additional data from the Phase 3 CARE-MS II trial, a randomized clinical trial comparing treatment with Lemtrada (alemtuzumab) to treatment with Rebif (subcutaneous interferon beta-1a 44mcg; EMD Serono, Inc.) in 840 patients who relapsed while receiving prior multiple sclerosis (MS) treatment. Patients enrolled in the trial had to have active MS, with at least one relapse occurring while on MS therapy, including standard injectable disease modifying therapies.
The mean Expanded Disability Status Scale (EDSS) score for patients treated with alemtuzumab decreased over a two-year period, indicating an improvement in their physical disability, while the mean score for patients given Rebif increased, indicating a worsening of disability (-0.17 vs. 0.24; P<0.0001). At two years, 29% of patients treated with alemtuzumab had experienced a six-month sustained reduction in disability, meaning their level of disability improved, as compared to only 13% with Rebif (P=0.0002). Sixty-five percent of patients treated with alemtuzumab were relapse-free at two years, meaning they did not experience any relapses in the trial, compared to 47% with Rebif (47% risk reduction; P<0.0001).
Alemtuzumab, a humanized monoclonal antibody, targets the cell-surface glycoprotein CD52, which is highly expressed on T- and B-lymphocytes. Preliminary research suggests that alemtuzumab initially depletes the T- and B-cells that may be responsible for the cellular damage in MS. This depletion of T- and B-cells is followed by a distinctive pattern of lymphocyte repopulation.
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