October 29, 2008
Omar Khan, M.D.
The article, “Alemtuzumab vs. Interferon Beta-1a in Early Multiple Sclerosis,” was published Oct. 22, and describes the findings of a multi-center study to determine the effectiveness of alemtuzumab in treating MS. Omar Khan, M.D., served as principal investigator on the study for the School of Medicine. Dr. Khan is professor of Neurology and director of the Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory for the Wayne State University School of Medicine. He also serves as director of the MS Clinic for Harper University Hospital.
“This phase II study very convincingly showed that treatment with alemtuzumab, a monoclonal antibody directed against the CD52 molecule expressed on lymphocytes and monocytes, is more effective than high-dose, high-frequency interferon-beta 1a, which is one of the FDA-approved therapies for MS,” Dr. Khan said. “The efficacy data, including clinical and MRI outcomes demonstrated with alemtuzumab treatment, are by far the best with respect to any MS therapy to date. Ongoing phase III trials will confirm these impressive data and perhaps redefine platform first-line therapy for MS in the future.”
Dr. Khan noted that equally important is the question regarding the safety of alemtuzumab. Researchers have to determine the price patients will pay if the drug effectively knocks out CD52 expressing immune system cells and induces long-term immunosuppression. That question, he said, will be better addressed by two large ongoing phase III trials at the School of Medicine’s MS Center and several other sites in the U.S.
“Achieving a therapeutic equipoise by balancing efficacy with safety will be the mainstay of the next generation of highly effective designer drugs for the treatment of MS,” he said.
Despite the initial side effects, “the bar of efficacy has unequivocally been lifted much higher by alemtuzumab,” Dr. Khan said.
The phase 2 study detailed in the New England Journal of Medicine article involved a randomized, blinded trial of 334 patients with previously untreated early relapsing–remitting multiple sclerosis. The patients received either subcutaneous interferon beta-1a three times per week or annual intravenous cycles of alemtuzumab for 36 months. Alemtuzumab, Dr. Khan noted, significantly reduced the rate of sustained accumulation of disability compared to treatment with interferon beta-1a.
The researchers concluded that in patients with early relapsing–remitting multiple sclerosis, alemtuzumab was “more effective than interferon beta-1a, but was associated with autoimmunity” that in its most serious level manifested as immune thrombocytopenic purpura, a bleeding condition in which the blood doesn’t clot as it should.