Lemtrada Monitoring and Screening

Five years of monthly blood tests is only one requirement...

Lemtrada (alemtuzumab), one of the newest disease-modifying therapies for multiple sclerosis (MS), is an exciting addition to the arsenal of MS treatment, both for effectiveness and ease of administration. I cover some of the basic facts in my article Is Lemtrada for MS Right for You?

One of the first things that people will learn about Lemtrada is that it comes with a number of potential serious side effects, some which can be fatal.

 Because of this safety profile, Lemtrada is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy). As stated by the manufacturer, Genzyme:

“This program has been developed to ensure that access to Lemtrada in the U.S. is only through certified prescribers, healthcare facilities and specialty pharmacies and to also ensure that patients are enrolled in the REMS program. The program is intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion. The REMS is based on a developmental risk management program that was successfully implemented in the Phase 2 and Phase 3 trials and allowed for early detection and management of some of the serious risks associated with Lemtrada.”

Basically, a REMS program like this is something required by the FDA in order for them to agree to approve a medication that has potentially scary side effects, but also could be very beneficial to patients. This is an example of a term that you may hear in relation to certain drugs: risk stratification.

For a more in-depth discussion of risk stratification, see Learning (and Reducing) Your Risk for Serious Side Effects from MS Medications.

Risk stratification is a process that aims to identify patients at higher risk for bad outcomes to try to prevent those outcomes when selecting a treatment. In addition, intensive monitoring also allows physicians to “catch” problems before they become too serious to treat effectively. An example of another MS drug that requires risk stratification is Tysabri (natalizumab). In order to reduce risk of people developing progressive multifocal leukoencephalopathy (PML), they are tested for JC virus antibodies prior to initiating treatment and during treatment to determine their risk for PML.

All that being said, the procedures to reduce risk of serious side effects from Lemtrada are rather extensive, involving screening and monitoring. In order to be considered for Lemtrada, “patients treated with LEMTRADA must be given the Patient Alert Card, the Patient Guide and the Package Leaflet.

Before treatment, patients must be informed about the risks and benefits and the need to commit to at least 48 months of follow-up after the last infusion of LEMTRADA.”

Necessary Screening Before Starting Lemtrada

  • Tuberculosis: People should be evaluated for active or latent tuberculosis.
  • Hepatitis virus: Tests should be performed for hepatitis B virus (HBV) and hepatitis C virus (HCV).
  • HPV: Sexually active females should be screened for human papilloma virus (HPV).
  • EKG: An electrocardiogram (EKG) should be done and assessed before the first treatment course.
  • Varicella zoster (chicken pox) vaccine: It should be determined whether the individual has been vaccinated for varicella zoster virus, and if not, tested for antibodies and vaccinated if needed 6 weeks prior to beginning treatment with Lemtrada. If a person has had chicken pox in the past, the testing for antibodies should demonstrate a titer (level of antibodies) high enough that a vaccination is not necessary.
  • Thyroid function tests: These tests, such as thyroid stimulating hormone level, should be obtained before treatment.
  • Other blood tests: Full blood count with differential and serum creatinine levels should be obtained prior to treatment.
  • Urine test: Urinalysis with urine cell counts should be obtained prior to treatment.
  • Skin exam: A skin exam should occur at start of treatment to check for melanoma.
  • MRI: To assist in the differential diagnosis for progressive multifocal leukoencephalopathy PML, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain is recommended.
  • If you are sick: People with active infections should consider delaying treatment until the infection is controlled.

Monitoring During and After Treatment with Lemtrada

  • HPV: Sexually active females should be tested annually for human papilloma virus (HPV).
  • Thyroid function tests: These tests, such as thyroid stimulating hormone level, should be performed every 3 months during treatment (after the first infusion) and for 48 months after the last infusion, for a total of five years. This is due to the risk of developing Lemtrada-induced autoimmune thyroid disease.
  • Other blood tests: Full blood count with differential and serum creatinine levels should be obtained monthly during treatment (after the first infusion) and for 48 months after the last infusion, for a total of five years.
  • Urine test: Urinalysis with urine cell counts should be obtained monthly during treatment (after the first infusion) and for 48 months after the last infusion, for a total of five years.
  • Skin exam: A skin exam should occur yearly to check for melanoma (honestly, people should do this anyway, Lemtrada or not).

Other Precautions

  • People should not have live-virus vaccines after a course of Lemtrada.
  • Women should wait at least four months after their last course of Lemtrada before trying to conceive and should use an effective form of birth control during treatment. 
  • Women should not breastfeed during treatment or for four months following their last infusion.

Bottom Line: Before you are seduced by the idea of only two courses of infusions (total), it is important to factor in the burden of the screening and monitoring requirements for this drug, which are considerable, including five years of monthly blood tests. Again, if the drug is right for you and your situation, this should not be an obstacle, just a factor in making your decision.

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