Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
Publication/Presentation Date
10-23-2008
Abstract
BACKGROUND: Alemtuzumab, a humanized monoclonal antibody that targets CD52 on lymphocytes and monocytes, may be an effective treatment for early multiple sclerosis.
METHODS: In this phase 2, randomized, blinded trial involving previously untreated, early, relapsing-remitting multiple sclerosis, we assigned 334 patients with scores of 3.0 or less on the Expanded Disability Status Scale and a disease duration of 3 years or less to receive either subcutaneous interferon beta-1a (at a dose of 44 microg) three times per week or annual intravenous cycles of alemtuzumab (at a dose of either 12 mg or 24 mg per day) for 36 months. In September 2005, alemtuzumab therapy was suspended after immune thrombocytopenic purpura developed in three patients, one of whom died. Treatment with interferon beta-1a continued throughout the study.
RESULTS: Alemtuzumab significantly reduced the rate of sustained accumulation of disability, as compared with interferon beta-1a (9.0% vs. 26.2%; hazard ratio, 0.29; 95% confidence interval [CI], 0.16 to 0.54; P
CONCLUSIONS: In patients with early, relapsing-remitting multiple sclerosis, alemtuzumab was more effective than interferon beta-1a but was associated with autoimmunity, most seriously manifesting as immune thrombocytopenic purpura. The study was not powered to identify uncommon adverse events. (ClinicalTrials.gov number, NCT00050778.)
Volume
359
Issue
17
First Page
1786
Last Page
1801
ISSN
1533-4406
Published In/Presented At
CAMMS223 Trial Investigators, Coles, A. J., Compston, D. A., Selmaj, K. W., Lake, S. L., Moran, S., Margolin, D. H., Norris, K., & Tandon, P. K. (2008). Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. The New England journal of medicine, 359(17), 1786–1801. https://doi.org/10.1056/NEJMoa0802670
Disciplines
Medicine and Health Sciences
PubMedID
18946064
Department(s)
Department of Medicine
Document Type
Article