Ponesimod (Ponvory)

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• Who can take ponesimod (Ponvory)?
• How do you take ponesimod (Ponvory)?
• How does ponesimod (Ponvory) work?
• How well does ponesimod (Ponvory) work?
• Ponesimod (Ponvory) side effects
• What tests do you need with ponesimod (Ponvory)?
• Stopping ponesimod (Ponvory)
• Ponesimod (Ponvory) and pregnancy, breastfeeding and contraception

Who can take ponesimod (Ponvory)?

You can have ponesimod if:

• you have active relapsing MS. ‘Active’ means you’ve had a recent relapse and/or MRI scans show you have new, active or growing lesions.

At the very start of treatment ponesimod can slow down your heartbeat. So people with some heart problems might not be able to take it, or will need extra checks.

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How do you take ponesimod (Ponvory)?

Ponesimod (Ponvory) is a tablet you take once a day.

You begin treatment with a starter pack, with one tablet to take each a day for 14 days. Each tablet has a bit more drug in it than the tablet from the day before. On day 15 you switch to a tablet with the standard dose, which is what you take from then on. This gradual rise in the dose avoids one of the drug’s side effects, a short-lived slowing of your heartbeat.

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How does ponesimod (Ponvory) work?

Ponesimod (Ponvory) works by targeting white blood cells called T and B cells. These are special types of cells in your immune system. It’s thought they cause a lot of the damage in MS.

These cells kill viruses and bacteria. But in MS they also attack and damage myelin. That’s the protective covering around nerves in your brain and spinal cord. They do this by stripping away myelin. Myelin protects nerves from damage and helps messages travel along them.

Ponesimod (Ponvory) is in the group of drugs called ‘sphingosine-1-phosphate (S1P) receptor modulators’. A DMT that ends with ‘mod’ is one of these drugs.

These drugs stick to the surface of B and T cells. This stops them leaving your lymph nodes, where they’re made. Fewer of them can get into your bloodstream, then into your brain and spinal cord. That means they can’t attack myelin around the nerves there and cause lesions and relapses.

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How well does ponesimod (Ponvory) work?

The effectiveness of ponesimod (Ponvory) is classed as 'good'. Each DMT can be rated as ‘moderate’, ‘good’ or ‘high’ based on two things. One is how much it reduces relapses. The other is how much it slows down disability getting worse.

Ponesimod (Ponvory) is classed as ‘good’ because of how much it reduces relapses. It’s less clear how well it slows down how fast people’s disability gets worse.

A two year long trial from 2021 called OPTIMIUM compared ponesimod with teriflunomide (Aubagio), a drug already used to treat MS. It showed that ponesimod was much better than teriflunomide at reducing relapses. These results led to ponesimod (Ponvory) getting the green light for use in the UK.

Relapses dropped by: 30.5% compared to teriflunomide

This means that over the two years of the trial, on average, people saw a 30.5% drop in the number of relapses they had. This was compared to people who took teriflunomide.

Disability getting worse

Ponesimod slowed down disability by about the same amount as teriflunomide did. See how much teriflunomide can slow down disability 

Over the two years of the trial nine in ten people on both drugs saw their disability get no worse. 

Other benefits of ponesimod (Ponvory)

In the OPTIMUM trial people on ponesimod saw their brains shrink less. Everyone’s brain shrinks as they get older, but this happens more with MS. Brain shrinkage is linked to more disability and to poorer memory and thinking.

People on ponesimod also had fewer new lesions on their MRI scans. They were also more likely to have no signs that their MS was still active. That means they had no relapses, no new lesions, no worsening disability, and less brain shrinkage. People on ponesimod also said they had less MS fatigue.

How well does ponesimod (Ponvory) work over many years?

Two studies have followed people on ponesimod for around eight years. These showed that the drug kept working as well as it did in the earlier OPTIMUM trial. There were no new side effects that doctors didn’t already know about. In one of these studies over half of people stayed relapse-free, while in the other study two thirds did.

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Ponesimod (Ponvory) side effects

Side effects of ponesimod (Ponvory) are mostly caused by the drug triggering a fall in levels of white blood cells (T and B cells). These cells fight off viruses and bacteria.

Very common side effects (more than 1 in 10 people get them):

• infections like colds and sore throats. Also, infections in your chest and urinary tract (your bladder, kidney or urethra)
• headache
• higher levels of some enzymes (proteins made by your liver). This often causes no symptoms. But it might lead to tiredness, feeling sick, and pain in the upper part of your belly. Jaundice is another sign. This causes yellow skin or eyes, dark pee, pale poo, and itchy skin
• high blood pressure

Common side effects (between 1 in 100 and 1 in 10 people get them): 

• a change in your heartbeat and blood pressure with your first dose. This happens to about 1 in 50 people. It  soon goes back to normal
• more serious infections like pneumonia or ones caused by herpes viruses. This can include cold sores or more serious infections like shingles. In the early trial 1 in 20 got such infections
• shortness of breath
• macular oedema. This is a build-up of fluid in the back of your eye. If this happens, it’s mostly in the first four months. It causes changes to your vision. This should get better if you stop taking the drug. Around 3 in 100 people got this in a long-term study
• a fit or seizure. This happened to about one in 70 people in the early trial (but most already had things like epilepsy)

Uncommon side effects (between 1 in 100 and 1 in 1,000 people get them): 

• certain types of skin cancer. In the early trial this happened to around one in a hundred people. Some weren’t life-threatening, but others were

Find out more about all the possible side effects of ponesimod (Ponvory)

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What tests do you need with ponesimod (Ponvory)?

Tests before treatment begins

Blood

A blood test will check that your liver is working as it should. It also checks your levels of white blood cells. This will show how well your immune system is working.

Heart

Ponesimod (Ponvory) can slow down your heartbeat when you first take it. If you have a heart problem, you’ll have an electrocardiogram (ECG) test before your first dose. This checks how your heart is working. During this painless test you have pads with electrodes in them stuck on your body.

Eyes

If you’re at higher risk of macular oedema, you’ll have your eyes checked. Your risk is higher if you’re diabetic or ever had the eye inflammation uveitis.

Other tests

If you can get pregnant, you need a negative pregnancy test result before you start ponesimod. This is because the drug might harm an unborn baby.

Vaccination

Like most DMTs, this drug makes infections more likely. Before you start it, your neurologist will check if you have protection against some of the infections it puts you at risk of.

Your neurologist will check you’re up to date on your vaccines. This includes childhood ones like chickenpox (that vaccine protects you against shingles). It also includes the MMR vaccine for measles, mumps and rubella. Some ‘live’ vaccines, like these two, aren’t safe to have once you’ve started many DMTs. Your MS team or GP can tell you whether a vaccine is ‘live’ or not.

You’ll have any vaccines you need a few weeks before you start this drug. It’s safe to have the annual flu jab while taking this DMT.

Read more about vaccines

Tests during treatment

Blood

Regular blood tests will check how your liver is working. They’ll also show how many white blood cells you have (the cells that ponesimod targets). This tells your neurologist how well your immune system is working.

Your blood pressure will be measured from time to time.

Heart

People with certain heart problems (or who take certain blood pressure drugs) have their first dose in hospital. Doctors can then check their heart and blood pressure for a few hours after the first dose. An irregular heartbeat usually goes back to normal with 24 hours. After that you take your doses like everyone else - at home and without monitoring.

Eyes

If you’re at higher risk of macular oedema, your eyes should be checked regularly.

Tell your MS team if you notice any changes to your vision. This can be:

• a blind spot
• things appearing blurred
• colours not looking right
• being sensitive to the light

Skin

There’s a slightly higher risk of skin cancer with ponesimod (Ponvory). Your doctor should check your skin near the start of your treatment, and now and again after that.

If your doctor doesn’t check your skin, you can do this yourself. If you have a lot of moles, take photographs. As treatment goes on, you can compare your skin with how it was before you started.

Let your doctor know if you find anything you think is unusual. As well as checking your skin, avoid sunbeds and sunbathing. Protect yourself from the sun by covering up or using sunscreen.

Other tests

Your neurologist might want you to have an MRI scan once a year to see if the drug is working. But how often you have scans depends on what your neurologist thinks you need. If your MS seems stable, you might have scans less often.

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Stopping ponesimod (Ponvory)

You should never stop taking a DMT without telling your neurologist. With some DMTs there’s a risk of ‘rebound’ if you suddenly stop. This is when your MS gets much worse within a few weeks or months. There’s a chance this might happen with ponesimod (Ponvory), but this seems rare.

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Ponesimod (Ponvory) and pregnancy, breastfeeding and contraception

Pregnancy

We don’t have research on whether ponesimod (Ponvory) can harm unborn babies. But we know it can cause this kind of damage in animals. That’s why, if you can get pregnant, you need a negative pregnancy test result before starting this drug.

If you can get pregnant, you must use reliable contraception while taking ponesimod. If you stop taking it, you must keep using contraception for one week after your final dose. One week is how long the drug takes to leave your body.

If you want to have a child, discuss this with your neurologist. If you think you’ve become pregnant, let your medical team know at once. Never stop your DMT without first getting their advice.

Breastfeeding

Studies in animals show ponesimod (Ponvory) can get into breast milk. So if you want to breastfeed, you shouldn’t feed your baby this way while on this drug.

Contraception

If you can get pregnant, you must avoid this while on ponesimod (Ponvory). Reliable contraception includes the ‘pill’, condoms, injections, an implant or coil. If you stop taking this drug, you should keep using contraception for one week after your final dose.

Read more about pregnancy, breastfeeding and contraception and DMTs

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