Mayzent and Mavenclad for Treating MS

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In March 2019, the U.S Food and Drug Administration (FDA) approved two new multiple sclerosis (MS) drugs: Mayzent (siponimod) and Mavenclad (cladribine). As disease-modifying therapies, these drugs are meant to reduce relapses and/or slow the progression of the disease.

Mayzent and Mavenclad are both approved to treat relapsing-remitting multiple sclerosis (RRMS), as well as active secondary progressive multiple sclerosis (SPMS). Active SPMS is a type of MS in which a person still experiences relapses, while also experiencing a steady progression of MS-related disability. 

Mayzent (but not Mavenclad) is also approved to treat clinically isolated syndrome (CIS).

Overview of Mayzent

Mayzent is a sphingosine 1-phosphate receptor modulator, similar to Gilyena (fingolimod), and is believed to work by sequestering certain white blood cells (your infection-fighting cells) within a person's lymph nodes. Mayzent may also have direct anti-inflammatory effects in the brain and spinal cord. 

Dosing

Mayzent is an oral medication (taken by mouth). The drug is initially started at a low dose and then titrated up over a period of five days. Unlike with Gilyena, only certain people need first-dose monitoring, mostly those with certain preexisting heart conditions, such as a history of:

  • Low heart rate (called sinus bradycardia)
  • Heart attack
  • Heart failure
  • Heart block

Effectiveness

In a phase III trial in Lancet, over 1,600 patients with secondary progressive MS were randomly assigned to take either Mayzent or a placebo drug. Researchers found that the number of patients with confirmed progression of disability (three months after taking the assigned drug) was significantly lower in the Mayzent group than the placebo group.

In addition, Mayzent decreased the annualized relapse rate (ARR) by 55 percent.

Warnings and Side Effects

Within the above-mentioned study, the most common side effects of Mayzent were:

Furthermore, Mayzent may increase a person's risk of infection by lowering the white blood cell count. Mayzent may also cause macular edema, and a decrease in heart rate and lung function.

When Mayzent is stopped, a person's MS symptoms may return and even get worse. This is why, as with all drugs, it's important to only stop a medication under the guidance of your doctor.

Finally, it's worthy to note that with drugs in the same class as Mayzent, a condition called Posterior Reversible Encephalopathy Syndrome (PRES) has been reported.

If you develop a sudden, severe headache or change in vision, contact your doctor immediately as this may be a sign of PRES.

While PRES usually improves after stopping the drug, it can lead to stroke, if not treated.

The manufacturers of Mayzent advise that women of childbearing years taking the medication use contraception during and for 10 days after stopping it.

Overview of Mavenclad

Mavenclad is a drug that lowers the number of white blood cells involved in the myelin-destroying attack in MS. Myelin is the protective covering of nerve fibers that helps nerve signals be efficiently transmitted; when damaged or destroyed various MS symptoms manifest.

Due to Mavenclad's safety profile, this drug is recommended for people with MS who cannot tolerate or respond well enough to another MS medicine. In other words, it is not considered a first-line treatment option like Mayzent is.

Dosing

Mavenclad is an oral medication with a unique treatment regimen—it is given as two yearly treatment courses.

Effectiveness

In a phase III trial in the New England Journal of Medicine, over 1,300 patients with relapsing MS were randomly assigned to either Mavenclad or a placebo drug.

Investigators found that those who took Mavenclad had a lower number of annual relapses (over 50 percent) compared to those who took a placebo. Moreover, compared to placebo, Mavenclad reduced the risk of disability progression and magnetic resonance imaging (MRI) measures of disease activity at 96 weeks.

Warnings and Contraindications

There are two black box (serious) warnings for Mavenclad:

  • Mavenclad may increase the risk of malignancy (cancer) so it's contraindicated in people with current malignancies.
  • Mavenclad may cause birth defects so it's contraindicated in pregnant women. In fact, women in childbearing years and men are therefore advised to use contraception while taking Mavenclad and for at least six months after the last dose.

In addition to those with cancer or who are pregnant, Mavenclad is not recommended for people who have active infections, or who are human immunodeficiency virus (HIV) positive, breastfeeding, or allergic to cladribine.

Potential Side Effects

The most common side effects of Mavenclad include:

  • Upper respiratory tract infections
  • Headache
  • Decreased white blood cell count

By lowering the white blood cell count, Mavenclad may increase a person's risk for infection, including very serious infections like tuberculosis (TB), hepatitis B and C, and herpes zoster (shingles).

This drug is also associated with liver injury, among other health risks.

A Word From Verywell

Both Mayzent and Mavenclad offer hope for those living with MS, especially those with active secondary progressive MS.

Perhaps more soul-stirring is that these two drugs are baby steps towards eventually finding a cure. Imagine a world without multiple sclerosis—a beautiful thought that may one day be within our grasp.

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Article Sources

  • Giovannoni G, Comi G, Cook S, et. al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):416-26. DOI: 10.1056/NEJMoa0902533.

  • Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 31;391(10127). 1263-73. DOI: 10.1016/S0140-6736(18)30475-6.

  • Medication Guide. (March 2019). Mavenclad (cladiribine). https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/mavenclad-mg.pdf

  • Medication Guide. (March 2019). Mayzent (siponimod). Page 22. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/mayzent.pdf

  • National MS Society. (n.d.). Clinically Isolated Syndrome. https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Clinically-Isolated-Syndrome-(CIS)