Fifth edition March 2012 Revised March 2013 06 MS Essentials For people living with MS This publication is available in large print (22 point) and audio CD Call 020 8438 0799 or email infoteam@mssociety.org.uk Disease modifying drugs Contents 02 Introduction What disease modifying drugs are currently licensed? Are all these drugs available on the NHS? How do I know which drug is for me? 03 Avonex, Rebif, Betaferon, Extavia and Copaxone Key information Side effects Frequently asked questions 12 Tysabri Key information Side effects Frequently asked questions 16 Gilenya Key information Side effects Frequently asked questions 19 Other treatments available 20 Further information 21 Useful organisations If you have relapses with your MS, disease modifying drugs (DMDs) might be a suitable treatment for you. They re not a cure for MS, but they can reduce the number of relapses you experience. It s not yet known if any of the drugs can slow the rate of disability in the long term. In the first part of this booklet we look at the drugs that are currently licensed for MS in the UK, including the eligibility criteria and whether they are available on the NHS. You might need to choose between several drugs and this booklet may help when you are discussing your options with a neurologist or an MS nurse. The second section (page 19) looks at other drug treatments that might be used to reduce relapses, but which aren t licensed specifically for MS. There are also a number of new DMDs currently in development. For information on any of these potential new drugs, visit the MS Society website or contact the UK Information Team. You can also read more in the MS Society s research magazine Research Matters. For copies contact the UK Information Team. Through the booklet, we refer to a number of organisations that can help with particular issues just look for the i. Their details are listed at the back of the booklet in the Useful organisations section (page 21). Contact details for the UK Information Team are listed under Further Information on page 20.
Introduction What disease modifying drugs (DMDs) are currently licensed? Are all DMDs available on the NHS? There are currently seven DMDs licensed in the UK: Avonex (beta interferon-1a) Rebif (beta interferon-1a) Betaferon (beta interferon-1b) Extavia (beta interferon-1b) Copaxone (glatiramer acetate) Tysabri (natalizumab) Gilenya (fingolimod) There s more information on how the drugs work, how they re taken, possible side effects and other issues in the later sections of this booklet. When a drug is licensed, it does not automatically mean that it will be available on the NHS. Licensing means that it can be used in the UK. For a drug to become widely available on the NHS, it would normally need to have been recommended by the National Institute for Health and Clinical Excellence (NICE) in England, Wales and Northern Ireland, or the Scottish Medicines Consortium (SMC) in Scotland. Their role is to assess a drug on the basis of its effectiveness and cost, and decide whether it represents good value for money. i The NICE/ SMC decisions about each of the licensed drugs are covered in the sections below. How do I know which drug is for me? This is a decision you will need to make in discussion with your neurologist. Each of the drugs has eligibility criteria for it, usually based on the number of relapses you have had. Most neurologists follow guidelines issued by the Association of British Neurologists (ABN) when prescribing DMDs. These guidelines bring together the different recommendations from NICE or the SMC on which drugs should be used, and represent a consensus on the best use of DMDs to treat MS. i There are other things you will need to think about such as how the drug fits in with your lifestyle. For example, most of the drugs need to be injected, although depending on the drug this can vary from once a day to once a week. There s more information on the criteria for each drug, as well as other things you may need to think about before choosing a drug, in later sections of the booklet. If you are online, the MS Decisions website may also help you to choose between the different drugs: www.msdecisions.org.uk 2
Avonex, Rebif, Betaferon, Extavia and Copaxone (beta interferon and glatiramer acetate) Key information Who are these drugs recommended for? Are they available on the NHS? The ABN guidelines recommend that Avonex, Rebif, Betaferon, Extavia and Copaxone be prescribed for: people with relapsing remitting MS who have experienced at least two clinically significant relapses in the last two years people with secondary progressive MS who are still experiencing relapses, and where these relapses are the predominant cause of their increasing disability The guidelines also say they may be recommended for: people with clinically isolated syndrome (a set of symptoms which may well be due to damaged myelin around nerve fibres, but where there have been no other attacks), when MRI scans show a high likelihood that they will go on to develop MS children and young people with relapsing remitting MS There s more information about relapses in the MS Society booklet Managing a relapse. Our booklet What is MS? explains more about the different types of MS. Avonex, Rebif, Betaferon and Copaxone In 2001, NICE decided that these drugs did not provide enough benefit, given their cost, for them to be available on the NHS. However, challenges to this decision led to an agreement between the Government and the drug companies to make the drugs available through what is known as the Risk Sharing Scheme. Why is it called the Risk Sharing Scheme? The risk in the title refers to a shared financial risk if the drugs do not prove to be as effective as was promised, then the drug companies could be required to reduce the price of the drugs to the NHS. The Risk Sharing Scheme uses a version of the ABN guidelines from 2001. Since then, the guidelines have been updated, most recently in 2009, and some of the recommendations have changed. The Department of Health has issued guidance stating that the Risk Sharing Scheme is still current. In addition, the drugs can be prescribed on the NHS to people outside the ABN guidelines where it is judged clinically necessary. So, if your neurologist thinks you are 3
eligible for treatment according to the 2009 ABN guidelines, the drugs should be funded by the NHS. Extavia Extavia was not licensed until 2009, and so does not come within the Risk Sharing Scheme. Although it has not been assessed by NICE or the SMC, it is available as a prescribed drug on the NHS. How are they taken? How effective are they? How do they work? Avonex, Rebif, Betaferon, Extavia and Copaxone are all selfinjected, between one and seven times a week, depending on which drug is used. The table opposite has more information about injection frequency. Several clinical trials have shown that the different drugs are equally effective for those eligible, with around a 33 per cent reduction in the number of relapses experienced over two years (compared to what would be expected if no treatment was taken). They may also reduce the development of disability, although this benefit was found to be modest at best and some trials did not show any benefit. There is no clear research evidence for long-term benefits. Studies have shown that these drugs are safe to use to treat MS in people under the age of 18. Interferons are proteins produced naturally in the human body. There are different types of interferon, including alpha, beta and gamma. In the immune system, they help fight viral infections. It s thought that beta interferon can reduce (and might prevent) inflammation which can damage nerve fibres in MS. The different beta interferon drugs are named 1a and 1b because of differences in how they are manufactured. The branded drugs Avonex and Rebif are beta interferon-1a, and Betaferon and Extavia are beta interferon-1b. Copaxone (glatiramer acetate) acts like a part of the myelin coating around nerve fibres. It seems that it works by attaching itself to the immune cells that target myelin, which stops them from attacking the real myelin and causing damage. How do I know which drug is best for me? Although all of the drugs are equally effective, there are differences in frequency, preparation and storage of Avonex, Rebif, Betaferon, Extavia and Copaxone. These are summarised in the table opposite. You may find it helps to discuss the options with your neurologist and, if you have one, your MS nurse. They will be able to talk about experiences others have had, and about medical considerations over which drug is suitable. But your choice will also depend on your own preference about, for example, how often you want to inject and what will suit you best. 4
Comparing these drugs Drug name How often is it injected? Where is it injected? Is the drug pre-mixed, ready to inject? How should it be stored? Avonex (beta interferon 1a) Once a week Into the muscle It is available in two versions: one is pre-mixed and ready to inject; the other needs to be mixed each time The pre-mixed version generally needs to be kept in the fridge (2 8 C), but can be kept at room temperature for up to a week before use. The unmixed version can be kept at room temperature for up to two years Rebif (beta interferon 1a) Three times a week Under the skin Yes, it is pre-mixed Generally needs to be stored in the fridge (2 8 C), but can be stored at room temperature (15 25 C) for up to 14 days Betaferon (beta interferon 1b) Alternate days Under the skin No, it needs to be mixed each time At room temperature, for up to two years Extavia (beta interferon 1b) Alternate days Under the skin No, it needs to be mixed each time At room temperature, for up to two years Copaxone (glatiramer acetate) Every day Under the skin Yes, it is pre-mixed Generally needs to be stored in the fridge (2 8 C), but can be stored at room temperature (15 25 C) for up to a month before use 5
What am I commiting to? Taking any of these DMDs involves a long-term commitment. They are intended to reduce the number and severity of relapses over several years, so they need to be taken regularly for some time. While taking a disease modifying drug, you will have regular review appointments with your MS nurse, if you have one, and an annual assessment by a neurologist at the prescribing centre. Possible side effects Most people tolerate these drugs well, but, as with any treatment, there can be side effects. If you take any of these drugs, you will be monitored to check for any side effects. Your neurologist or MS nurse can tell you more about the possible side effects covered here, but if you notice unusual or unexpected effects, you should contact them even if you have been taking the drug without problems for some time. Skin reactions Betaferon, Copaxone, Extavia and Rebif are all injected under the skin. DMDs injected under the skin commonly cause reactions at the site of the injection (reddening, hardening, bruising or itching). Your MS nurse, if you have one, can help you develop good injection technique. Avoiding site injection problems Good practice includes washing your hands thoroughly and then cleaning the skin where you will inject though there is no particular cleaning method recommended for this. Applying an ice pack just before cleaning the skin or after injecting can help reduce painful skin reactions. Also, it is advisable to keep the injecting needle dry avoid discharging any liquid medication onto the outside of the needle before you inject. Allowing the medication to warm to room temperature also helps. Rotating injection sites is important, too, as is injecting where there is sufficient body fat. MS nurse support when you start treatment and throughout your treatment should make injecting manageable. 6
Less commonly, some people injecting under the skin experience a condition at injection sites called lipoatrophy, in which the fat is lost in small areas under the skin. This leaves dents in the skin, which, if they occur, are usually permanent. The problem can be kept to a minimum by looking out for early signs of dents and avoiding sites which have been affected, rotating injection sites for every injection. Flu-like symptoms Changes in menstrual periods Mood changes Avonex, Betaferon, Extavia and Rebif may cause periods of flu-like symptoms, such as muscle ache, fever, chills or headache generally for no longer than 48 hours. These are usually worse in the first three months and often (though not always) lessen over time. Ibuprofen or paracetamol can prevent or improve these symptoms. Injecting immediately before going to bed and taking ibuprofen or paracetamol at that time can alleviate the flu-like symptoms you may sleep through the worst of these. Some people find drinking more fluids on the day of the injection can help reduce the headache. Some women taking Avonex, Betaferon, Extavia or Rebif experience irregular, early or late periods. If you are concerned, you should ask for a referral to a gynaecologist. This is not a common side effect of these drugs. It affects only around one per cent of people taking them. Depression is relatively common in people with MS. It has been suggested that Avonex, Rebif, Betaferon or Extavia can make it worse, though it is not certain that this is the case. Before you start on any disease modifying drug, your neurologist or MS nurse will ask if you have been prone to mood changes. If you have been diagnosed with depression in the past, you might not be prescribed Avonex, Rebif, Betaferon or Extavia, though Copaxone may still be a suitable option. This would all be assessed on an individual basis, so having a history of depression does not automatically rule out being prescribed one of these drugs. Neurological symptoms Rarely, people taking beta interferon experience a flare-up of their MS symptoms following injection. This normally lasts no more than 48 hours. Some people notice their muscles get stiff during this time. This flare-up of symptoms could be because the drugs have caused a mild fever many people with MS notice their symptoms get worse when their body temperature rises like this. This side effect, if it occurs at all, usually lessens over the months and years of taking the drug. As with the flu-like symptoms, ibuprofen or paracetamol can help. 7
A few people using Copaxone experience chest pain or tightness immediately following the injection, which can be accompanied by anxiety, flushing, sweating, palpitations or a perceived difficulty in breathing. These side effects do not happen often, but can be unpredictable they might happen the first time you take the drug, or after many doses. They usually only last a short time and although unpleasant, have not been linked to permanent or serious harm. They are not a reason to have to stop taking Copaxone. Liver function and blood count Anyone taking Avonex, Rebif, Betaferon and Extavia will have regular blood tests to check liver function and blood cell count. Occasionally, they can cause problems such as mild anaemia, liver abnormalities or a reduction in white blood cell count. Liver abnormalities are actually quite common in people taking these drugs, but are usually mild, settle down on their own and only very rarely mean the person must stop taking the drug. Frequently asked questions Who prescribes these drugs? A neurologist based at one of the regional prescribing centres. There is one of these centres in most large towns or cities. If your neurologist is not based at a centre which prescribes these drugs, they may refer you to your nearest centre for this. You can still choose to see your existing neurologist for other matters. This is something to discuss with them when they make the referral. Are there any reasons why I might have to stop taking the drugs? As long as the drug seems to be having a positive effect (for example, if your relapses are less severe or less frequent than before) it should continue to be prescribed. However, there might be circumstances in which you decide, together with your neurologist, to stop taking a disease modifying drug, such as: if you or your health care team notice signs of a serious side effect or adverse reaction if you find the side effects intolerable if you are planning to get pregnant if you develop an increased number and severity of relapses if you do not see a reduction in the number of relapses compared to the one to two years before you started taking it if you develop neutralising antibodies (see opposite) if you develop secondary progressive MS and can no longer walk if a more suitable treatment becomes available 8
What are neutralising antibodies? Sometimes, the body s immune system begins to react against beta interferon, by producing antibodies which might prevent the drug from being effective. This can be checked by a blood test. Experts disagree about how much these antibodies can affect the way the drugs work. In some cases, levels of antibodies go down over time. Sustained, high levels of neutralising antibodies might suggest that the drug is no longer effective, and can be a factor in choosing to stop treatment. Guidance issued by the Department of Health stresses that anyone being prescribed these drugs should only come off them for clinical reasons. Treatment on the NHS should not be stopped for financial reasons. If your MS becomes more active and you become eligible for another drug, this might be a reason to discuss changing treatments with your neurologist. None of the drugs are licensed for combination with any of the other DMDs, so you would stop taking one drug before beginning the other. Can I switch drugs? Yes, if you need to, you can switch to another of the drugs that you are eligible for. You would need to discuss any planned change with the prescribing neurologist. People s reactions to drugs vary and if, for example, you get continuing side effects which prove intolerable, you might want to change drugs. Note that if you switch from a beta interferon (Avonex, Rebif, Betaferon or Extavia) because of neutralising antibodies, it only makes sense to switch to Copaxone (glatiramer acetate) because the antibodies will neutralise other forms of interferon as well. Do I have to inject myself? These drugs do need to be injected, but most people, even many who were afraid of needles, find that they soon get used to it. None of the drugs are injected into a vein. Instead, they are injected just under the skin or into the muscle. The drugs are available with autoinject a system which means you don t need to see the needle going in, and where the action of injecting comes down to the click of the pen holding the syringe. One of the drugs, Rebif, is available with an injecting device known as RebiSmart. This device uses pre-filled syringe cartridges which only need loading once a week. It allows for changing needles and injecting without having to see the needle itself, and also keeps a record of when the injections happen. The speed and depth of the injection can also be controlled, so you can set it to your own comfort level. 9
When you are prescribed any of these drugs, a nurse will go through good injection technique with you. Most people find they are able to do the injections themselves, which gives them independence over when and where to do it, but it is possible for a family member or friend to be given this training so they can do it for you. It is also sometimes possible for injections to be given by a practice nurse at a local clinic. How do I store the drugs and syringes? Do these drugs affect pregnancy or breast feeding? What about travelling with the drugs? Different drugs have different storage requirements, as shown in the table on page 5. Most need to be kept in the fridge, and you would also need to have a safe space to store syringes and discarded needles. The drug company will supply a box for these discarded sharps. An MS nurse can help with storage ideas and how to approach family or friends who you might want to explain things to. It is not known whether Avonex, Rebif, Betaferon, Extavia or Copaxone present a risk to a baby or foetus. If you are trying to conceive or are already pregnant, it is important to discuss all your medications with your doctor. Women are advised to stop taking a disease modifying drug if they are trying to conceive, are pregnant or breastfeeding. You should discuss all these matters with your doctor. Taking these drugs should not prevent you from travelling, though you might need to plan well in advance. Keeping the drugs cool When you start treatment, you will be given a travel bag, with ice packs, to make it easier to keep the drugs cool and the syringes safe when you travel. All of the drugs can all be stored at room temperature for a limited amount of time. This ranges from one week to two years. It is recommended that you transfer the drugs to a fridge or equivalent cool place as soon as you reach your destination. In case of delays You may want to take a few more doses than you would normally need when you travel in case of unexpected delays. 10
Air travel For air travel, it s advisable to keep syringes and drugs in the cabin, rather than in your standard luggage. Temperatures can get extremely low in the baggage hold of an aircraft. The Department for Transport says that syringes are prohibited in hand luggage unless required for medical reasons, and that in general, airport managers and aircraft operators have the discretion to refuse any potential weapon. You should contact both the airport and your individual airline to let them know you will be bringing the medication with you in your hand luggage and ask for any special instructions. For security reasons, the crew may lock them in a special locker in the cabin for the duration of the flight. Ensure you have documentation with you to establish why you need to travel with the drug for example, a letter from your neurologist, MS nurse or GP. The makers of each drug may be able to provide paperwork to help with travel. Eurostar and Eurotunnel If you re travelling on Eurostar or through the Eurotunnel, you should carry a letter with you from your neurologist, MS nurse or GP stating that you need to travel with the drug. At the time of writing, you do not need to tell the travel operator in advance that you will be carrying these items, but it s a good idea to always check with them before travelling in case of any changes to the security situation. Are these treatments vegan-friendly or vegetarian-friendly? Avonex and Rebif both contain animal products. Betaferon and Extavia do not contain animal product, but contain human serum albumin, a protein found in our blood and produced by the liver. Copaxone is synthetic and does not contain human or animal material. As with many other licensed drugs, they have all been tested in animals. 11
Tysabri (natalizumab) Key information Who is Tysabri recommended for? Is Tysabri available on the NHS? How is it taken? The ABN guidelines recommend that Tysabri be prescribed for: people with aggressive multiple sclerosis who have had two or more disabling relapses in one year, and an increase in lesions as shown on an MRI scan people who have had an increase in the number or severity of relapses while taking one of the other drugs (Avonex, Rebif, Betaferon, Extavia or Copaxone) Yes. NICE and SMC recommend Tysabri, using the same criteria as the ABN guidelines. If you and your neurologist feel you meet the criteria for Tysabri, it should be available to you on the NHS. At the moment, however, this is not always the case. The MS Society has produced a guide to campaigning for access to MS medicines, which may help if you feel you meet the criteria for Tysabri but you have been denied it. Contact the UK Information Team for a copy or visit the MS Society website: www.mssociety.org.uk Tysabri is given by a health care professional as a monthly infusion into a vein, lasting about an hour. This usually happens at the neurology unit of a hospital. How effective is it? How does it work? A two-year study showed that, on average, people taking Tysabri had a 67 per cent reduction in the number of relapses (compared to what would be expected if no treatment was taken). Tysabri also slowed the accumulation of disability over two years. Only 17 per cent of people taking the drug had worse disability, compared with 29 per cent of people taking a placebo (dummy treatment). We do not yet know if Tysabri can deliver long-term benefits. There have not been studies to show whether Tysabri is safe for people under 18, so it is not normally prescribed for children or young people. Tysabri is an antibody, just like those found naturally in the immune system (where antibodies help fight infection). By attaching itself to receptors on the outside of certain immune cells, Tysabri prevents these cells from leaving the blood stream and entering the brain and spinal cord where, in MS, they can cause inflammation and damage. 12
Possible side effects Most people taking Tysabri tolerate it well, but there can be side effects including a very rare, but potentially fatal infection called PML (see below). Everyone taking Tysabri is monitored closely. Each month, when you visit the clinic for your infusion, the doctor or nurse will ask if you have any lasting medical problems which are getting worse, such as changes to eyesight, your memory or thinking, or balance. They will also ask specific questions about any reactions you might have noticed after the last infusion of Tysabri, or any fever or infection. During or shortly after the infusion Common side effects During the infusion of Tysabri, and up to an hour afterwards, some people shiver, or feel sick or dizzy. These effects are usually mild and normally pass before the end of the infusion. They are not usually a reason for having to stop the treatment. Around one in 25 people who take Tysabri have a more serious allergic reaction to taking it, either during the infusion or in the hour following. These allergic reactions can include an itchy rash, swelling of the face, lips or tongue or difficulty breathing. Other signs of an allergic reaction might be picked up by health care professionals, such as an increased body temperature, decreased blood pressure and a faster pulse. The health care team would give medical attention if this reaction occurs, to manage the symptoms. Treatment with Tysabri has to be stopped for anyone who has an allergic reaction to it. Common side effects include joint pain, fever, tiredness, a runny or blocked nose, sore throat, feeling or being sick, headache or dizziness. Fewer than ten per cent of people taking Tysabri experience these side effects, but these milder side effects are far more common than, for example, liver problems or PML. PML (progressive multifocal leukoencephalopathy) Because of the way that Tysabri works, it can leave the immune system more open to infections. PML is a viral brain infection. It can cause severe neurological symptoms, which may at first be mistaken for MS relapses. But the symptoms rapidly worsen and may lead to death or disability. Several people treated with Tysabri have died because of PML. 13
Analysis of the number of cases of PML suggests that the overall risk is about 1 in every 500 people treated with Tysabri. However, there are factors which appear to affect a person s risk of developing PML: The length of time they ve been taking Tysabri there have not been any recorded cases in a person who s been taking it for less than a year. Previous use of another immunosuppressant drug, such as mitoxantrone (Avonex, Rebif, Betaferon, Extavia and Copaxone are not considered to be immunosuppressants). Testing positive for the JC virus. This is a common virus that affects around 70 to 90 per cent of the general population, usually without any symptoms. However, in people who are taking immunosuppressants or have weakened immune systems it may cause PML. Any hospital prescribing Tysabri must ensure that everyone professionals and patients is aware of the risks, the early signs of PML to look out for and what to do if they notice these signs. Liver problems Long-term side effects Serious liver problems for people taking Tysabri are also very rare and ought to be picked up in routine blood tests. Early signs of liver problems include the skin or whites of the eyes turning slightly yellow, and urine turning unusually dark. It is too soon to know about possible long-term side effects from Tysabri, but people taking the drug are being monitored, which should give a better picture for the future. 14
Frequently asked questions Who prescribes Tysabri? How long will I be prescribed the drug? How will taking Tysabri affect any other treatments? Does Tysabri affect pregnancy or breast feeding? Is Tysabri vegan-friendly or vegetarian-friendly? Tysabri can be prescribed on the NHS by any neurologist, just like any other prescription drug with the same considerations around suitability, potential benefits and possible side effects. A neurologist would be guided in their decision to prescribe by the NICE/ SMC guideline for the drug. Because of rare but potentially very serious side effects (see page 13), anyone taking Tysabri needs to be carefully monitored, with regular check-ups. There are no formal guidelines for stopping treatment with Tysabri. You could expect to take it for as long as you and your neurologist agree it seems to be working. If the side effects become a problem, or blood tests show early signs of health problems, these would be reasons to stop. Occasionally, the immune system begins to act against Tysabri and stop it working. If this occurs at all, it is normally in the first six months of treatment, when it would show up with a blood test. This can sometimes be a reason to stop taking Tysabri. Because of the way it works, Tysabri is not suitable for people with weakened immune systems, so it cannot be combined with treatments which alter the way the immune system works, such as the other DMDs. People taking Tysabri can still receive short courses of steroids to treat relapses. As with the other licensed DMDs, it is not known if Tysabri presents a risk to the foetus and babies. If you are trying to conceive, are pregnant or breastfeeding, you are advised to stop taking Tysabri. Speak to your neurologist for further advice on this. Tysabri is made by combining DNA from mouse and human cells, to create an antibody similar to those in the human immune system. As with other licensed drugs, Tysabri has been tested in animals. 15
Gilenya (fingolimod) Key information Who is Gilenya recommended for? Is Gilenya available on the NHS? Gilenya was licensed in 2011 for treating rapidly evolving relapsing remitting MS. This means that it is suitable for people who still have relapses despite taking Avonex, Rebif, Betaferon or Extavia, or who have had two or more relapses in the past year. Yes. Both NICE and SMC have recommended the use of Gilenya on the NHS for the treatment of adults with highly active relapsing remitting MS. This means that people with MS who have regular relapses or increased relapse rates (compared to the previous year), despite taking beta interferon (Avonex, Rebif, Betaferon or Extavia), will be eligible for the treatment on the NHS. If you have only ever taken Copaxone (glatiramer acetate), and have no evidence of taking any of the beta interferons, then you are not likely to be considered eligible for Gilenya. You need to have taken, and failed to respond to, beta interferon in order to be considered eligible. If you and your neurologist feel you meet the criteria for Gilenya, it should be available to you on the NHS. However, this is not always the case. The MS Society has produced a guide to campaigning for access to MS medicines, which may help if you feel you meet the criteria for Gilenya but have been denied it. Contact the UK Information Team for a copy or visit the MS Society website: www.mssociety.org.uk How is it taken? Gilenya is taken once a day, in tablet form. How effective is it? How does it work? A two-year study comparing Gilenya to a dummy treatment showed that it reduced relapse rates by 54 to 60 per cent, and reduced disability progression by about 30 per cent. A one-year study showed that it reduced relapse rates by 53 per cent compared to beta interferon-1a. A specialised type of immune cell, called a T-cell, is thought to be responsible for much of the damage caused in relapsing remitting MS. Gilenya acts by grabbing these T-cells from the bloodstream and trapping them inside organs in the body called lymph nodes. This prevents these T-cells from getting into the brain and causing damage. 16
Possible side effects Gilenya is generally well-tolerated, although some people may experience side effects, some of them potentially quite serious. Lowered heart rate When you first take Gilenya it can cause your heart rate to slow down or become irregular. This may make you feel dizzy or tired. You will be expected to stay under medical supervision for six hours after taking the first dose, to check for any serious side effects. Irregular heart rate should return to normal within a day, and a slow heart rate can take up to a month to return to normal. If it doesn t, or if you notice a change after you ve been taking Gilenya for a while, then you should speak to your neurologist or MS nurse. Following a safety review in 2012, the European Medicines Agency updated their prescribing guidelines for Gilenya. They now recommend that doctors should not prescribe Gilenya to people with a history of heart disease or problems with blood supply to the brain (such as stroke), or who are taking medication that affects their heart rate. However, even in these circumstances, the guidelines say that if your neurologist considers treatment with Gilenya necessary then they can still prescribe it to you. You would need to stay under medical supervision at least overnight following your first dose of Gilenya, and you may also have ongoing monitoring of your heart. Increased risk of infections Gilenya lowers the numbers of white blood cells in your blood. As white blood cells fight infection, you may find that you pick up illnesses and infections more easily while taking Gilenya. Any infection that you already have may get worse, and could become serious. Speak to your doctor if you have an infection or fever, particularly if it seems to be getting worse. Macular oedema Very rarely, Gilenya can cause a problem with your vision, known as macular oedema. It s caused by leaking blood vessels causing fluid to build up in the macular (part of the retina at the back of your eye). Symptoms of macular oedema can be similar to optic neuritis (inflammation of the optic nerve), and can include blurring or a blind spot in the centre of your vision, or problems seeing colours or fine detail. Sometimes you may not notice any symptoms. Because macular oedema is more likely to develop in the first few months of taking Gilenya, you may need to have an eye examination after about three or four months. Some people who are at a higher risk of developing macular oedema, for example 17
people with diabetes or anyone who s had an eye infection known as uveitis, may need extra monitoring. If you notice any changes in your eyesight at any point, let your neurologist or MS nurse know as it may be a sign of macular oedema. Liver problems Common side effects Long-term side effects Serious liver problems for people taking Gilenya are also very rare and ought to be picked up in routine blood tests. Early signs of liver problems include the skin or whites of the eyes turning slightly yellow, and urine turning unusually dark. Common side effects of Gilenya include headache, diarrhoea, back pain, cough and dizziness. These milder side effects affect around one in ten people taking Gilenya. It is too soon to know about possible long-term side effects from Gilenya, but people taking the drug are being monitored, which should give a better picture for the future. Frequently asked questions Who prescribes Gilenya? How long will I be prescribed the drug? How would taking Gilenya affect any other treatments? Gilenya can be prescribed on the NHS by any neurologist, just like any other prescription drug with the same considerations around suitability, potential benefits and possible side effects. A neurologist would be guided in their decision to prescribe by the NICE/ SMC guideline for the drug. There are no formal guidelines for stopping treatment with Gilenya. You could expect to take it for as long as you and your neurologist agree it seems to be working. If the side effects become a problem, or tests show early signs of health problems, these would be reasons to stop. Because of the way that Gilenya affects the immune system, you would not be able to take it with any of the other DMDs. Similarly, if your immune system is weakened already, Gilenya would not be a suitable drug for you. Does Gilenya affect pregnancy or breast feeding? Is Gilenya vegan-friendly or vegetarian-friendly? As with the other licensed DMDs, it s not known whether Gilenya can cause harm to an unborn baby. If you re trying to conceive, or you are pregnant or breastfeeding, you would be advised to stop taking Gilenya. Speak to your neurologist for further advice on this. The active ingredients in Gilenya are contained within a capsule made from gelatine, which is of animal origin. As with other licensed drugs, Gilenya has been tested in animals. 18
Other treatments available In the first part of this booklet, we looked at drugs licensed specifically for MS. There are also other treatments that NICE or the ABN guidelines mention might be used for treating MS, but which aren t licensed specifically for treating MS. Mitoxantrone Azathioprine The drug mitoxantrone (brand name Novantrone) is approved in the US for treating secondary progressive MS and worsening relapsing remitting MS (when there is not complete remission between relapses). Mitoxantrone is currently licensed in the UK as a cancer-fighting drug. It is not licensed for MS, but it is prescribed for some people with MS (on an individual named patient basis ). It is given by drip, at a hospital. Treatment with mitoxantrone is limited to courses ranging from six months to two years. This is because, above a certain cumulative dose, it can be toxic to the heart. People taking mitoxantrone also have an increased risk of developing a potentially fatal leukaemia. A neurologist can explain more fully the potential benefits and risks. A number of small studies have found that a combination of a short course of mitoxantrone followed by Copaxone can significantly reduce relapse rates and disability progression while also limiting possible side effects from the mitoxantrone. The drug azathioprine (Imuran) is sometimes used to help prevent rejection during transplantation and it is also used in a variety of diseases where the immune system is at fault, like MS. Although not licensed for MS, it has been used in MS since the 1960s although not commonly in the UK. There have not been many trials looking at azathioprine, but a recent review of the available evidence found that it can help to reduce the number of relapses. There are concerns with possible side effects, but these can be reduced by limiting both the overall dose and the number of years that someone takes the drug. IVIg IVIg (intravenous immunoglobulin) is a blood product given by infusion. You would need to go into hospital for the treatment, which can take several hours. It is not a standard treatment for MS. But some neurologists argue that it has a place for reducing a woman s risk of having a relapse in the three months after giving birth a time when, if she breast feeds, she would be advised against taking currently licensed DMDs. These potential benefits remain unproven. 19
Further information UK Information Team 020 8438 0799 infoteam@mssociety.org.uk National offices see back cover www.mssociety.org.uk Read more Our free booklets help explain MS, look at its practical and emotional effects, and help you find your own ways to manage life with MS. Titles are available in large print, audio format and a number of languages. We can help you find and borrow other books, research articles and DVDs about living with MS. Search online or call the UK Information Team. Find out more online Get the latest on research, campaigns and MS news. Chat online with our message boards and Facebook. Follow us on Twitter, see the MS community at Flickr and watch us on YouTube. Children and teenagers can find out more and link up through our YoungMS site: www.youngms.org.uk Join us Receive local and national magazines and newsletters, and get involved locally and nationally. Be as involved as you like. Just by being a member you strengthen the voice of all people with MS, and help us continue our vital work. Join online, or call 020 8438 0759 or your national office. Get in touch The freephone MS Helpline offers confidential emotional support and information for anyone affected by MS, including family, friends and carers. Information is available in over 150 languages through an interpreter service. 0808 800 8000 (weekdays 9am- 9pm) or helpline@mssociety.org.uk Contact the UK Information Team or your national office if you have any questions about MS. Near you Our volunteers run over 300 local branches and support groups. They provide information about MS and local services, and a chance to meet others affected by MS and take part in a range of activities. In many parts of the country, you can pick up our booklets at MS Society Info Points. Larger information centres including ones in our national offices in London, Belfast, Cardiff and Edinburgh (Newbridge) can help you with information about MS and services in your area. Or come along to our local and national events and learn more about MS from expert care professionals, researchers and other people with the condition. Find out more online or call your national office. 20
Useful organisations Association of British Neurologists Ormond House 27 Boswell Street London WC1N 3JZ Telephone 020 7405 4060 www.abn.org.uk National Institute for Health and Clinical Excellence MidCity Place 71 High Holborn London WC1V 6NA Telephone 0845 003 7780 www.nice.org.uk Scottish Medicines Consortium Delta House (8th floor) 50 West Nile Street Glasgow G1 2NP Telephone 0141 225 6989 www.scottishmedicines.org.uk 21
Further reading MS Decisions Funded by the Department of Health, this online decisions tool aims to help people consider whether disease modifying treatment is the right option for them and, if so, which of the available drugs might suit them best. www.msdecisions.org.uk References A list of references is available on request, and all cited articles are available to borrow from the MS Society library (there may be a small charge). Contact the UK Information Team, or visit www.mssociety.org.uk/library 22
Authors and contributors First edition written by Debbie Reeves This edition edited by Jude Burke With thanks to Dr Alasdair Coles, Kerry Mutch, Bernadette Porter and the rest of the MS Nursing Team at the National Hospital for Neurology and Neurosurgery, and all those affected by MS who contributed to this booklet. Disclaimer: We have made every effort to ensure that information in this publication is correct. We do not accept liability for any errors or omissions, and policy and practice may change. Seek advice from the sources listed. Suggestions for improvement in future editions are welcomed. Please send them to infoteam@mssociety.org.uk Multiple Sclerosis Society, 2013 First edition, August 2004 Fifth edition, March 2012 Revised, March 2013 This title will be reviewed within three years. The MS Society provides this information free of charge but if you would like to help cover the cost, which will help towards our essential work, please call 0800 100 133 or visit the fundraising section of our website to make a donation. Anything you can give will be greatly appreciated. 23
MS Society Multiple sclerosis (MS) is the most common disabling neurological disorder affecting young adults and we estimate that around 100,000 people in the UK have MS. MS is the result of damage to myelin the protective sheath surrounding nerve fibres of the central nervous system. This damage interferes with messages between the brain and other parts of the body. For some people, MS is characterised by periods of relapse and remission while, for others, it has a progressive pattern. For everyone, it makes life unpredictable. The MS Society is the UK s largest charity dedicated to supporting everyone whose life is touched by MS. We provide a freephone MS Helpline; grants for home adaptations, respite care and mobility aids; education and training; support for specialist MS nurses; and a wide range of information. Local branches cater for people of all ages and interests and are run by people with direct experience of MS. The MS Society also funds around 80 vital MS research projects in the UK. Membership is open to people with MS, their families, carers, friends and supporters. You can help the work of the MS Society by: becoming a member making a donation offering your time as a volunteer Contact information MS National Centre 372 Edgware Road London NW2 6ND Telephone 020 8438 0700 info@mssociety.org.uk MS Society Scotland National Office, Ratho Park 88 Glasgow Road Ratho Station Newbridge EH28 8PP Telephone 0131 335 4050 msscotland@mssociety.org.uk MS Society Northern Ireland The Resource Centre 34 Annadale Avenue Belfast BT7 3JJ Telephone 028 9080 2802 information@mssociety.org.uk MS Society Cymru Temple Court Cathedral Road Cardiff CF11 9HA Telephone 029 2078 6676 mscymru@mssociety.org.uk National MS Helpline Freephone 0808 800 8000 (weekdays 9am-9pm) www.mssociety.org.uk Multiple Sclerosis Society. Registered charity nos 1139257 / SC041990. Registered as a limited company in England and Wales 07451571. ES06/0313