Alemtuzumab (Lemtrada)

Jump to:

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

Who can take alemtuzumab (Lemtrada)?

You can take alemtuzumab (Lemtrada) if you have very active relapsing MS. This means:

• despite already taking a DMT, you’ve had a recent relapse and there are new, active or growing lesions on your MRI scans

           or

• whether you’re already on a DMT or not, you’ve had two or more serious relapses in the last year and doctors see significant new lesions on your MRI scans

Because of a risk of serious side effects, fewer people are given this drug. And you’re not likely to get it as your first DMT.

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How does alemtuzumab (Lemtrada) work?

Alemtuzumab (Lemtrada) works by targeting B and T cells. These are special types of white blood cells in your immune system. It’s thought that these cells cause a lot of the damage in MS. They normally kill viruses and bacteria that get into your body. But in MS they attack and damage myelin. That’s the protective covering around nerves in your brain and spinal cord.

Alemtuzumab (Lemtrada) is a monoclonal antibody drug. These artificial antibodies are made in a laboratory. Any DMT that ends with ‘mab’ is one of these drugs. With this drug these antibodies stick to the surface of B and T cells and kills them. So they don't have a chance to get into your brain and spinal cord and damage nerves there. That means you get relapses much less often. Your immune system then makes new cells, which are less likely to attack these nerves. 

Alemtuzumab (Lemtrada) can do what many other DMTs don’t: it makes a permanent change to your immune system. This drug ‘resets’ it for good. That’s why its positive effects can last years after your last dose. And why you don’t need to keep taking it.

You have alemtuzumab as an infusion (or ‘drip’). You have this in a hospital. During an infusion you sit in a chair or lie on a bed. The drug is pumped into your bloodstream through a needle in a vein in your arm or leg. You might go home after each infusion. Or you may stay in hospital for the days when you’re having infusions. Each infusion lasts about four hours. Afterwards you’ll be checked for a further two hours in case you have a bad reaction. 

Most people only ever need two courses of alemtuzumab (Lemtrada). The first course involves an infusion every day for five days. The second course happens twelve months later. That course is only three days of infusions.

Most people don't need treating again after their second dose. But some might need a third, or even fourth course if the drug doesn’t bring their MS under control. Between three and four people out of ten need a third or fourth course.  You can have three courses of infusions on the NHS.

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How well does alemtuzumab (Lemtrada) work?

The effectiveness of alemtuzumab (Lemtrada) is classed as 'high'. 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.

Monoclonal antibody drugs like alemtuzumab (Lemtrada) are some of the DMTs with the best results against MS. 

Most DMTs don’t undo any permanent disability you already have. But with alemtuzumab, if you have it early enough, you might see your disability get better in some ways.

Alemtuzumab (Lemtrada) got the go-ahead in 2014 for use on the NHS based on two trials, CARE MS I and CARE MS II. In both trials they compared alemtuzumab with beta interferon, a standard treatment for MS.

In these trials..

Relapses dropped by:

50-55% compared to beta interferons

This means, on average, people who took alemtuzumab saw a 50-55% drop in the number of relapses they had. This was compared to people who took the beta interferon. 

In the CARE MS I trial almost 8 in 10 people who took alemtuzumab stayed free of relapses over the two years of the trial. They’d never taken a DMT before. Six in ten people who took the beta interferon stayed free of relapses.

In the CARE MS II trial people had taken a DMT before but it hadn’t controlled their relapses. When they were treated with alemtuzumab two thirds of them stayed relapse-free for the two years of the trial. This was compared to people on beta interferon (nearly half of them stayed free of relapses). 

Disability getting worse was slowed down by:

up to 42% compared to beta interferons

This means that in one of the trials (CARE MS II), on average, people who took alemtuzumab saw a drop of up to 42% in the risk of their disability getting worse. This was compared to people who took beta interferons.

In this trial disability didn’t get worse over the two years of the trial for around 9 in 10 people who took alemtuzumab. It didn’t get worse for 8 in 10 people who took beta interferon.

In the CARE MS I trial the drop was 30%. But this wasn't big enough to be 'significant'. In other words, it could've happened by chance and not because of the drug.

How well does alemtuzumab (Lemtrada) work over many years?

The good results seen in these early trials have lasted many years. The chance of a relapse has stayed as low as it was in the early trials. In one study after five years the chance of a relapse was even lower. This risk fell by 69% compared to the people on beta interferon. After five years the risk of disability getting worse dropped by 72% compared to people on beta interferon. 

In both CARE MS trials people treated with alemtuzumab had fewer lesions. This continued in the years that followed. The drug also slowed down how fast people’s brains shrank. Our brains shrink at little as we get older, but this happens faster in MS. It’s linked to problems with memory and thinking.

After six years, very few people who’d taken alemtuzumab in the CARE MS trials saw their relapsing MS turn into secondary progressive MS. This only happened to around 3 in 100 people. Normally over this period you’d expect to see that happen to 18 in a hundred people. 

After 12 years, half of people treated with alemtuzumab saw their level of disability stay the same. For one in five it actually got better. At the end of the 12 years, for 7 out of 10 people there were no signs on their MRI scans that their MS was still active.

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Alemtuzumab (Lemtrada) side effects

Alemtuzumab (Lemtrada) works by causing a drop in how many white blood cells you have. For some time after each infusion, a side effect of this drop is that you’re more likely to get infections. 

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

During an infusion, or within the next 24 hours, most people get one or more of these (but they usually soon go away): 

• headaches
• rash
• a skin rash called hives
• feeling or being sick
• fever
• itching
• going red in the face and neck
• feeling tired 

Other side effects might include sore throat, diarrhoea, pain in your joints, back or stomach, pain or tingling in your arms and legs, dizziness and trouble sleeping.

Before your infusion, and for a month after it, you’ll take medication against herpes virus infections (like ‘cold sores’). You’ll also take antibiotics to prevent infections with a bacteria called listeria. You’ll also be given steroids and anti-histamine medications to make infusion reactions less likely. Around three in 100 people have more serious reactions.

Infections are more common after your first infusion. They get less common over time. 

Mild and easily treated infections are another very common side effect. These can be in your: 

• chest
• throat
• urinary tract (your kidneys, bladder, and the tubes that take your pee out of your body)
• sinuses (the spaces around your nose)
• also herpes infections

Thyroid problems

The most common serious alemtuzumab side effect is damage to your thyroid. This gland in your neck helps control your weight, hormones, temperature, heart rate and blood pressure. This happens to 4 in 10 people, and maybe more in the long run. It can take up to five years to develop. It happens because, as your immune system makes new white blood cells, they can attack your thyroid by mistake. A thyroid problem is treatable but needs lifelong medication. If your thyroid is damaged, you can still have more infusions of alemtuzumab if you need them.

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

• infections caused by the herpes zoster virus (such as shingles)
• pneumonia
• ITP (immune thrombocytopenia). Out of a hundred people, between 1 and 3 get this problem where your blood doesn’t clot like it should. Symptoms include bruising and bleeding too easily. The blood tests you have after alemtuzumab treatment can pick up ITP before any symptoms appear. So it’s important you have these tests regularly and on time.

In trials fewer than 1 in 30 people got a serious infection. These could include things like pneumonia and infection with the HPV virus (which causes genital warts). 

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

• kidney problems. About 1 in 300 people get these. This includes anti-GBM disease. This is when your immune system attacks your kidneys.

Very uncommon but serious side effects:

• a serious allergic reaction. Your mouth or throat becomes swollen, you get heart or breathing problems, or a rash. If this happens, the hospital staff monitoring you will treat this and there won’t be any lasting harm
• Listeria infection. This might happen if you eat food contaminated with the listeria bacteria. You can take an antibiotic to protect against this. Or you can avoid certain risky foods before an infusion and for a month after it
• PML (progressive multifocal leukoencephalopathy). This is a very rare brain infection that only a handful of people taking alemtuzumab have had. Read more about PML.

The 2019 safety review of alemtuzumab (Lemtrada)

After a safety review in 2019 more restrictions were put on who gets alemtuzumab (Lemtrada). This was because of some very rare side effects that are possible in the days or months after an infusion. These affect 1 or 2 people in every 5,000. They can affect your heart, blood vessels and immune system, but also your blood, lungs and liver. Your neurologist will tell you what signs to look out for.

Read more about the 2019 safety review

Read out more about all the possible side effects of alemtuzumab (Lemtrada)

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What tests do you need with alemtuzumab (Lemtrada)?

Tests before treatment begins

Before your first infusion tests on your blood and pee will check if your kidneys, liver and thyroid are working as they should. 

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) and 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. 

You can safely have the annual flu jab while taking this DMT.

Read more about vaccines

Tests during and after treatment

You’ll keep having tests on your blood and pee. These might be each month or every three months. This is to check that your thyroid and kidneys are working as they should. They also monitor how well your immune system is working (by counting your white blood cells). They’ll also check that you’re not developing ITP. You’ll keep having these tests for four years after your last infusion.

A side effect of alemtuzumab (Lemtrada) can be that you pick up human papillomavirus (HPV). This virus is linked to cancer of the cervix in women. But there’s no need for extra screening. Just take up any regular invitation to cervical screening sent to you.  

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Stopping alemtuzumab (Lemtrada)

You only need to take alemtuzumab (Lemtrada) a handful of times. Most people stop this treatment after two or three courses of infusions.

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Alemtuzumab (Lemtrada) and pregnancy, breastfeeding and contraception

Pregnancy

Alemtuzumab (Lemtrada) might harm unborn babies. So you mustn’t get pregnant while being treated with this drug, or for four months after your final infusion. Four months is this drug’s ‘washout period’. That’s how long it takes for it to leave your body. 

Alemtuzumab (Lemtrada) can be a good choice if you want children. Once four months have passed since your final infusion, you can safely get pregnant any time you want to. 

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. Regular blood tests will pick up any drug side effects that might happen during your pregnancy. Never stop your DMT without first getting their advice.

Breastfeeding 

Alemtuzumab (Lemtrada) might get into breast milk. So you can’t feed a baby this way while on this treatment or for four months after an infusion.

Contraception

If you can get pregnant, you’ll need reliable contraception during each course of treatment and for four months afterwards. This can be the ‘pill’, condoms, injections, an implant or coil. 

Read more about pregnancy, breastfeeding and contraception and DMTs

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