Mayzent (siponimod)


Mayzent (siponimod) is a disease modifying drug (DMD) for people with active secondary progressive MS who continue to have relapses or show signs of MS activity on MRI scans.

You take Mayzent as a pill once a day, to slow down progression of disability.

Very common side effects include headache, high blood pressure and increased levels of liver enzymes which can be a sign of damage to the liver.


What is Mayzent used for in MS?

Mayzent is a disease modifying drug (DMD) for active secondary progressive MS (SPMS).

Mayzent slows down the increase in disability in SPMS. In clinical trials, people with active SPMS taking Mayzent were 37% less likely to have an increase in their disability which lasted 6 months, compared to people taking placebo. In clinical studies, an increase in disability which has persisted for 6 months is considered to be a reliable indicator of permanent, or long-term, disability.

Analysis of the data for all people, with both active and inactive SPMS, showed that someone taking Mayzent could continue for an extra 4.3 years before they needed to use a wheelchair most of the time, compared to those taking placebo.

Who can take Mayzent?

Mayzent has been approved for people with active secondary progressive MS.

Mayzent has been approved for use on the NHS since 2020. It can only be prescribed by a neurologist.

What is active secondary progressive MS?

Many people initially diagnosed with relapsing remitting MS notice that, over time, they have fewer relapses and increasing disability, such as walking difficulties, poor balance and coordination, bladder, bowel and thinking and memory problems. This is called secondary progressive MS (SPMS).

The change from relapsing remitting to secondary progressive MS is gradual and people may continue having relapses or show signs of new and active lesions on MRI scans while at the same time their disability increases. This is described as active secondary progressive MS.

Who shouldn't take Mayzent?

It’s important that you tell your MS team if you have any health problems or are taking other medicines.

Mayzent may not be appropriate if you have existing medical conditions including active cancer or severe problems with your heart, liver or immune system. If you are hypersensitive to peanut or soya, Mayzent may not be suitable.

If you have certain conditions, including heart problems, liver disease or a condition affecting your eyes, you may need additional medical assessment before Mayzent is prescribed and may need additional monitoring during treatment.

Conception and pregnancy

You must not become pregnant while taking Mayzent. There is an increased risk of harm to the unborn baby if Mayzent is taken during pregnancy.

Women of childbearing age must use an effective method of contraception during treatment and for at least 10 days after stopping Mayzent.

Mayzent should not be started by women who are pregnant.

Women who wish to become pregnant should stop taking the drug but continue to use effective contraception for at least 10 days to ensure that blood levels of Mayzent are low enough for it to be safe to become pregnant.

If you do become pregnant while taking Mayzent you should contact your MS team straight away.

How do I take Mayzent?

You take Mayzent as a pill, once daily.

To give your body time to get used to the drug and reduce the impact of side effects, you start on a low dose for the first few days, gradually increasing to the full dose on day 6.

You should not stop taking Mayzent without discussing your ongoing treatment with your neurologist, as your MS may become more active after stopping Mayzent.

What side effects could I get with Mayzent?

Overview

Very common side effects include headache, high blood pressure and increased levels of liver enzymes which can be a sign of damage to the liver.

Cases of basal cell carcinoma, a kind of skin cancer, have been reported in people taking Mayzent. Basal cell carcinoma is a slow-growing skin cancer that almost never spreads to other parts of the body or becomes life-threatening but can be disfiguring if not treated promptly. You should ensure that you use sun protection when in the sunlight and report any suspicious skin lesions to your doctor.

Mayzent may also cause macular oedema, a condition which causes swelling in the back of the eye which can affect vision.

Common side effects (affecting more than 1 person in 100)

  • headache
  • high blood pressure
  • increased levels of liver enzymes
  • low levels of white blood cells (lymphopenia), which may make you more vulnerable to infections
  • slow heart rate
  • herpes zoster (shingles)
  • basal cell carcinoma, a kind of skin cancer
  • swelling in the back of the eye (macular oedema)

A full list of side effects is included in the manufacturer's Patient Information Leaflet.

Assessment before treatment

Before starting Mayzent, your doctor will carry out a blood or saliva test to find out how well Mayzent will be broken down in your body and decide the best dose for you. In a small number of cases, the test will show that Mayzent is not right for you.

If you have never had chickenpox and have not been vaccinated against it, you should have a blood test to check for immunity against the virus that causes chickenpox. If you are not protected, you will need a vaccination before you start treatment with Mayzent. You will also have blood tests to measure blood cell counts and check how well your liver is working.

As Mayzent must not be taken during pregnancy, women of child-bearing age should be offered a pregnancy test.

If you have a history of heart problems, your heart will be checked with an electrocardiogram (ECG) and you may be monitored for the 6 hours after taking your first dose.

If you have a pre-existing health condition which affects the eye, such as diabetes, you may also have an eye examination.

Assessment during treatment

Once you’ve started treatment, you’ll have regular blood tests to monitor your liver function and measure blood cell counts. Your blood pressure should be checked regularly and you should have regular skin examinations.

About 3-4 months after starting Mayzent you should have an eye test to check for macular oedema. If you have a pre-existing health condition which affects the eye, such as diabetes, you may have more frequent eye examinations during treatment.

During the coronavirus outbreak, you may find that your regular blood tests happen less frequently, may take place in a different location, or may temporarily stop.

How does Mayzent work?

Mayzent binds to the surface of white blood cells (lymphocytes). These cells are then trapped in the lymph glands, which prevents the lymphocytes from crossing into the central nervous system and causing inflammation and damage.

Mayzent belongs to the same class of drugs as Gilenya.

Mayzent (siponimod) is a disease modifying drug (DMD) for people with active secondary progressive MS who continue to have relapses or show signs of MS activity on MRI scans.

Mayzent research

Evidence for the effectiveness of Mayzent came from one large study published in 2018.

EXPAND – Mayzent compared to placebo

The EXPAND trial recruited 1651 people with secondary progressive MS. On average, participants had been diagnosed with MS for approximately 17 years and had had SPMS for about 4 years. Just over half needed walking assistance. Participants took either Mayzent (1105) or placebo (546) daily for up to 3 years.

Disability level (EDSS score) was assessed every three months. Disability progression was confirmed if an increase in EDSS lasted for 3 months and for 6 months.  An increase in disability which has persisted for 6 months (6 month confirmed disabilty progression) is considered to be a reliable indicator of permanent, or long-term, disability.

Mayzent delayed 6-month confirmed disability progression by 26% compared to placebo. Further analysis focussed on a subset with active SPMS – people who had had a relapse in the two years before starting the trial or showed MS activity on MRI scans. For the active SPMS subgroup, Mayzent delayed 6-month confirmed disability progression by 37% compared to placebo. Compared to placebo, Mayzent reduced the number of relapses by 46%.

Mayzent was also more effective than placebo on other measures used in the study:

  • reduced loss of brain volume
  • reduced MRI-detected brain lesion volume

There was no significant difference between the two groups in the time taken to walk 25 feet.

In addition to its effect on disability progression, Mayzent can improve aspects of memory and thinking (cognition) through an improvement in the speed at which the brain processes information.

Find out more

References
National Institute for Health and Care Excellence (NICE)
Siponimod for treating secondary progressive multiple sclerosis.
NICE technology appraisal guidance TA656
Full guideline (link is external)
Scottish Medicines Consortium (SMC)
Advice: siponimod (Mayzent)
12 October 2020
Full guideline (link is external)
Kappos L, et al.
Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study
Lancet. 2018 Mar 31;391(10127):1263-1273.
Summary (link is external)
Gold R, et al.
Efficacy of siponimod in secondary progressive multiple sclerosis patients with active disease: the EXPAND study subgroup analysis
Mult. Scler. 2019, 25:2_suppl, 357-580, P750.
Conference poster (link is external)
Benedict RHB, et al.
Siponimod and cognition in secondary progressive multiple sclerosis: EXPAND secondary analyses
Neurology. 2021 Jan 19;96(3):e376-e386
Full paper (link is external)
Vermersch P, et al.
Siponimod delays the time to wheelchair in patients with SPMS: results from the EXPAND study
Multiple Sclerosis Journal 2019;25(2_suppl):3-130.
Conference abstract (link is external)
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