Lemtrada, manufactured by Genzyme (a Sanofi company), is a disease modifying therapy for people with relapsing-remitting forms of multiple sclerosis (RRMS). Biologically, it is a humanized monoclonal antibody aimed at specific receptors on the surface of immune cells to modulate immune responses. Although approved by the U.S. Food and Drug Administration (FDA), the agency recommends its use be restricted to RRMS patients who have had an inadequate response to two or more MS therapies.
How Lemtrada Works
Lemtrada, chemically known as alemtuzumab, is a humanized monoclonal antibody directed at the CD52 protein (also known as CAMPATH-1 antigen) on the surface of immune cells (lymphocytes, monocytes and dendritic cells), and results in the depletion of lymphocytes (white blood cells). Its exact mode of action in vivo is not clear, but studies have shown that when administered in transgenic mice engineered to express human CD52 proteins on the surface of immune cells, alemtuzumab replicated the transient increase in serum cytokines and depletion of peripheral blood lymphocytes observed in humans. Lymphocyte depletion, further, was not as profound in the lymphoid organs.
History of Lemtrada
Successful preclinical studies and safety profiles in people led to further clinical tests, including pivotal Phase 3 studies in RRMS patients, comparing treatment with Lemtrada to high dose subcutaneous interferon beta-1a. Participants in these trials were either new to treatment or had relapsed while on prior therapies. Results showed significant improvements in terms of reduced relapse rates and delayed disease progression, leading to the drug’s approval by the FDA in November 2014 as a treatment option for RRMS patients.
Other Lemtrada Information
A small proportion of patients did have serious, even fatal, side effects while using Lemtrada, including viral infections and infusion reactions, and the drug may cause malignancies such as thyroid cancer, melanoma, and lymphoproliferative disorders. As a result, it is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy), to ensure that patients prescribed Lemtrada are enrolled in the program and undergo periodic monitoring to detect potential health risks. The normal intravenous dosage of the drug is twice annually, with the first intravenous infusion course given over five consecutive days, and the second, 12 months later, administered for three consecutive days. Common side effects include rashes, joint pain, fungal and minor viral infections, fatigue, urinary and upper respiratory tract infections, and nausea. Patients are advised to undergo a thorough medical examination, especially urinalysis, skin tests, and vaccination histories, before using of the drug.
Lemtrada was approved for use in European Union in September 2013.
In addition, Genzyme’s MS One to One program provides Lemtrada-specific information for MS patients, including its potential benefits and risks. The program lets these patients, and their healthcare providers, consult with MS specialist nurses and other qualified disease experts and professionals. Visit www.MSOnetoOne.com, or call 1-855-MSOne2One (855-676-6326) weekdays from 8:30 a.m. to 8:00 p.m. ET.
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