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  • Updated 05.28.2021
  • Released 06.03.2019
  • Expires For CME 05.28.2024




Historical note and terminology

Several monoclonal antibodies have been investigated for use in the treatment of multiple sclerosis, and some of these have already been approved. One of these is the humanized monoclonal antibody alemtuzumab, which was first approved in 2001 for the treatment of chronic lymphocytic leukemia and T-cell lymphoma under the trade name Campath, and later approved for the treatment of multiple sclerosis as Lemtrada. It was the first monoclonal antibody to be proven efficient in comparative phase 3 clinical trials against interferon beta-1a as first-line treatment for patients with relapsing-remitting multiple sclerosis (06). It was approved for multiple sclerosis by the U.S. Food and Drug Administration in 2014. There has been some concern about adverse effects, and the use of some monoclonal antibodies has been discontinued. Studies on well-established, effective monoclonal antibodies such as natalizumab and alemtuzumab focus more on long-term efficacy and safety, risk management, and treatment of complications (08). In April 2019, its use was restricted in Europe pending a safety review by the European Medicines Agency because of reports of intracerebral hemorrhage in patients treated with alemtuzumab for multiple sclerosis (14).

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