EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs

EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs

Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk Assessment Committee (PRAC) that oversees the safety of medicines approved in the European Union has issued final recommendations to minimize the risk of serious side effects linked to its use in relapsing-remitting multiple sclerosis (MS).

Concerns were based on reports of rare but serious complications associated with Lemtrada, including deaths related to immune complications and heart or circulatory disorders.

Specifically, reports of fatalities and severe effects were associated with immune complications that included autoimmune hepatitis (immune-caused liver damage) and hemophagocytic lymphohistiocytosis (a disorder that may affect several organs in the body), and hemolytic anemia (abnormal red cell breakdown). Some immune reactions could happen “many months” after treatment with Lemtrada, PRAC noted.

Reports also surfaced of severe and deadly heart, circulation, and bleeding disorders, including heart attackstroke, bleeding in the lungs, and cervicocephalic arterial dissection (tears in the arteries from the head and neck). These adverse events, PRAC said, could develop within days of Lemtrada’s use.

While PRAC’s review was underway, the committee — an arm of the European Medicines Agency (EMA) — issued preventative measures restricting the use of Lemtrada (marketed by Sanofi Genzyme) to adult RRMS patients who failed prior treatments, or were ineligible for other disease-modifying therapies (DMTs).

The newly published recommendations replace those earlier measures.

PRAC now advises that Lemtrada use be restricted to:

  • adults with RRMS who have “highly active disease despite adequate treatment” with at least one other DMT.
  • adults with RRMS and rapid disease worsening, defined as at least two disabling relapses in a year and new brain lesions seen on MRI (magnetic resonance imaging) scans.
  • Treatment with this vein infusion (drip) medicine take place only in hospitals with “ready access to intensive care facilities (ICUs) and specialists who can manage serious adverse reactions.”

PRAC also recommends that Lemtrada:

  • can no longer be used by patients with certain heart, circulation or bleeding disorders.
  • can no longer be given to RRMS patients with other autoimmune disorders.

The physician’s guide and the patient information that accompanies Lemtrada should also be updated to alert all that serious side effects can occur shortly or many months after a Lemtrada infusion, PRAC said.

These final recommendations will now be reviewed by EMA’s Human Medicines Committee (CHMP), which will issue an opinion. Based on that opinion, the European Commission will make a final decision that will apply to all EU member states.

Lemtrada is a humanized monoclonal antibody used to delay disease progression in adults with RRMS. It works by inhibiting CD52, a protein found on the surface of immune B- and T- cells. By doing so, it inactivates these cells to slow the neuroinflammation associated with MS.

To date, Lemtrada is an approved MS treatment in more than 30 countries; its approval in the European Union came in 2013, and the U.S. in 2014.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
Total Posts: 1,053
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
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7 comments

  1. Dale says:

    This scary news. I’m scheduled to start Lemtrada in January. Considering staying with Ocrevus instead. I know we’re all different but who has some advice?

    • De says:

      I’d stay with Ocrevus. I’ve been on Lemtrada since the drug trials. (starting in ’08) Over the years, I’ve had a host of health issues related to it and some of them are permanent. Each round was worse than the round before. My last round was in 2013, I’ll never take it again.

    • BK says:

      Run Away!
      My wife passed away last month from complications related to the effects of Lemtrada. It was absolutely horrific and excruciatingly painful for her. It was unbearable to witness. In a two month period she went from fully functional to death. The doctors had no idea what was happening to her or how to stop it.
      Seek alternatives unless your a gambling man.

  2. tim says:

    Wow! Doctors are still able to prescribe this stuff. Wow. Boggles the brain. Help the body. Not harm the body. Do no harm. No Harm. Why not try to find out why the bodies’ immune system is attacking itself in the first place? Try healing the immune system from the cellular level? Seems like there are many other ways to slow nueroinflammation. Are there not?

  3. Tom H says:

    Hi Dale – Ed Tobias writes a column for this website called the MS Wire, where he discusses his experiences with Lemtrada. His columns spark some good discussions, that you may find helpful. I was diagnosed in 2018 and started treatment with Ocrevus shortly there after. Good luck, no matter what path you decide to take.

  4. Peter Hardy says:

    I often feel a little embarassed when reading posts about people’s reactions to Lemtrada, as I (and the other 2 people being infused at the same time) had no side effects or reactions from the treatment, other than a small itchy rash that lasted less than an evening. I finished my second treatment in July this year, and although I am conscious that there may be problems at a later stage, it is a case of weighing up the success rates with the problems your MS causes. You will know your body, and how it responds to medicines in general, whether you suffer from allergies and how well you have built yourself up in the run-up to the treatment.

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