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Transcript
Choices Disease modifying treatments Read me… Disease modifying treatments Disease modifying treatments (DMTs) are medications which modify the disease course. They target inflammation and are designed to reduce the damage caused by relapses. By doing this, the number and severity of relapses decreases. Some of these drugs have been found to delay the long-term progression of MS and reduce the number of new lesions forming. Not everyone with MS will benefit from DMTs in the same way. New guidance was issued in 2015 by the Association of British Neurologists (ABN) setting out the eligibility criteria for the prescribing of these drugs. The ABN also states that treatment should start as early as possible in eligible patients, before the person with MS shows any disability or sustains damage to their nerve cells. Some treatments are licensed for use in Clinically Isolated Syndrome (CIS) and these are sometimes given before MS has been made as a definitive diagnosis. The guidelines also state that ‘people with MS will face complex choices and must play an active role in treatment decisions’. There are currently a number of disease modifying treatments available Beta Interferon 1a (avonex, rebif and plegridy) Beta Interferon 1b (betaferon and extavia) Copaxone (glatiramer acetate) Gilenya (fingolimod) Tecfidera (dimethyl fumerate or BG-12) Aubagio (teriflunomide) Lemtrada (alemtuzumab, campath) Tysabri (natalizumab) An MS specialist neurologist should assess your eligibility and suitability for DMTs. Once treatment has started, patients should remain under the supervision of a specialist MS neurologists and nurses. The recommendations for starting disease modifying treatment as stated in the ABN guidance are as follows: Eligible patients will normally be ambulant (maximum EDSS 6.5). There are no treatments licensed for use during pregnancy. The currently list of licensed disease modifying drugs are divided broadly into two classes: Drugs of moderate efficacy (‘category 1') Beta Interferons Copaxone Aubagio Tecfidera (more effective) Gilenya (more effective) Drugs of high efficacy (‘category 2’) Lemtrada Tysabri Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets Relapsing remitting multiple sclerosis (RRMS) More active relapsing remitting MS Patients with relapsing remitting MS who have had two or more clinical relapses in the previous two years are considered to have ‘active’ disease that warrants consideration of disease modifying treatments. Increasingly, clinicians are starting treatments in people whose disease is judged ‘active’ because of a single recent relapse and/or on radiological grounds, including both patients newly diagnosed according to the 2010 ‘MacDonald criteria’, and those with longer established disease who develop new MRI lesions without clinical relapse. Patients may be classified as having more active MS by frequent clinical relapses and/or MRI activity either when untreated or whilst on a Category 1 drug. The formal criteria for high-disease activity despite beta interferon or Copaxone requires one relapse in the previous year on beta interferon and either a) gadolinium enhancing MRI lesions or b) at least nice T2-hyperintensive lesions on a cranial MRI. It is recommended that patients with more active disease use on of the Category 2 drugs, either Tysabri or Lemtrada. Both have similar efficacy. The European Medicines Agency has explicitly recognised that disease activity may be established on radiological or clinical grounds (in its licensing of Alemtuzumab). More information can be found in the full ABN guidance, see link above. All people with active relapsing remitting MS should be considered for treatment and most are likely to start treatment with a Category 1 drug. To read more about when each drug is likely to be used over another see the full ABN guidance here: http://www.theabn.org/resources/abnpublications/m/ms-guidelines2015.html Secondary & Primary progressive multiple sclerosis (SPMS & PPMS) None of the current disease modifying treatments are recommended in ‘nonrelapsing’ secondary progressive MS or in primary progressive MS. Some people with relapsing secondary progressive MS, whereby relapses are their main cause of increasing disability, may benefit from a disease modifying treatment. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets Clinically Isolated Syndrome (CIS) Clinically Isolated Syndrome is used to describe a first neurologic episode that lasts at least 24 hours, and is caused by inflammation/demyelination in one or more sites in the central nervous system. This is sometimes diagnosed before a formal diagnosis of MS can be made. Those with CIS who show abnormalities on MRI scans within one year, may be offered treatment with a DMT. Currently only the Beta interferons and Copaxone are licensed for clinically isolated syndrome. People aged under 18 years The ABN guidance states that minors aged between 16-18 years should be treated according to the above guidelines. Children with MS aged under 16 should be treated in specialist clinics, preferably under a combined team including adult and paediatric neurologists with a particular interest in MS. For further information on stopping disease modifying treatments see the full ABN guidance here: http://www.theabn.org/resources/abnpublications/m/ms-guidelines2015.html What is a relapse? The National Institution for Care Excellence (NICE) published guidelines in October 2014 for the management of multiple sclerosis. In these guidelines a relapse can be diagnosed by a GP or neurologist if: ‘The person with MS has developed new symptoms or has a worsening of existing symptoms, and these symptoms have lasted for more than 24 hours in the absence of infection or any other cause after a stable period of a least one month.’ What are the disease modifying treatments? Interferon Beta-1a (Avonex, Rebif & Plegridy) How does it work? Interferons are proteins, produced naturally by the body that help us to fight infection. There are currently three interferon beta-1a DMTs available – avonex, rebif and plegridy. Interferon beta-1a blocks the action of one type of protein called gamma interferon. It reduces the autoimmune reaction that causes inflammation and destruction of myelin. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets How can it help? It has been shown to reduce the rate of relapse by about one-third in people with relapsing remitting MS. It also reduces the severity of relapses that occur. Other less common side effects can be mood swings (mainly from avonex), fever and blood abnormalities. Most people find these effects reduce over a three month period of taking the drug. If they persist, a conversation with an MS nurse or neurologist would be recommended. How is it administered? Avonex must be injected into the muscle once a week and should be stored in the fridge. Rebif must be injected under the skin three times per week and should be stored in the fridge. Rebif comes in two dosages – 22mcg and 44mcg. Plegridy must be injected under the skin every 2 weeks and should be stored in the fridge. Who manufactures it? Avonex – Biogen. Rebif – EMD Serono. Plegridy – Biogen. What type of MS is it prescribed for? All types of interferon beta-1a are classed as ‘Category 1’ drugs therefore they are used in those diagnosed with relapsing remitting MS. Interferon Beta-1b (Betaferon and Extavia) How does it work? Both Betaferon and Extavia are thought to block the action of one type of immune cell, called a T-cell and reduce the autoimmune reaction that causes inflammation and destruction of myelin. How can it help? Both have been shown to reduce the rate of relapse by about one-third in people with relapsing remitting MS and also reduce the severity of relapses that occur. How is it administered? Betaferon and Extavia must be injected subcutaneously (under the skin, into body fat) every other day. They do not need to be stored in the fridge, but must be mixed before use. Who manufactures it? What are the side effects? The most common side effect experienced when taking interferon beta1a is flu-like symptoms after injecting. Injection site irritations may also occur, such as redness, swelling, itching. Betaferon – Schering. Extavia – Novaratis. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets What type of MS is it prescribed for? Who manufactures it? Both types of interferon beta-1b are classed as ‘Category 1’ drugs therefore they are used in those diagnosed with relapsing remitting MS. Teva. What are the side effects? The most common side effects experienced with Betaferon and Extavia are flu-like symptoms after injecting and injection site reactions. They can also cause changes in menstruation, blood abnormalities and mood swings; however, again these symptoms are less common. Copaxone (glatiramer acetate) What type of MS is it prescribed for? It is classed as a ‘Category 1’ drug and therefore licensed for relapsing remitting multiple sclerosis and some people with clinically isolated syndrome. What are the side effects? Common side effects are injection-site reactions and lipotrophy (indentations under the skin). Less commonly, it can also cause chest tightness, breathlessness, anxiety, flushing and palpitations after injection. How does it work? Gilenya (fingolimod) Copaxone acetate works differently from the interferons in that it is a synthetic combination of four amino acids which resemble the myelin protein. It is thought to work by preventing the production of immune cells that attack myelin. How can it help? The rate of relapse in people taking Copaxone is generally reduced by onethird. How does it work? Gilenya is an immuno-modulating drug, which attaches to the surface of certain white blood cells (known as lymphocytes), causing a number of them to retained within the body’s immune system. As a result less lymphocytes get into the blood stream and fewer reach the central nervous system. The potential for immune attack on the cells of the brain and spinal cord is reduced. How is it administered? How can it help? It needs to be injected subcutaneously (under the skin). There are two doses, one for daily injections and another for three time a week injections (only approved in 2015). It needs to be stored in the fridge. Gilenya was shown to reduce the risk of relapses by 67% compared to a placebo in trials. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets How is it administered? It is taken in the form of a capsule, orally, once a day. Who manufactures it? Novartis. What type of MS is it prescribed for? Gilenya is classed a ‘Category 1’ drug although listed as ‘more effective’ rather than moderately effective. It is licensed for adults with highly active relapsingremitting MS. Such people have a high disease activity as characterised as one relapse in the previous year despite being on another disease modifying therapy, such as interferon for at least 12 months. In June 2014, NHS England published new guidelines to allow a switch to fingolimod for those patients with highly active RRMS, if they met the following criteria: with RES RRMS without them having to have taken any previous medication. Gilenya is also undergoing trials for potential use in people with primary progressive MS. Some research evidence points to the drug being neuroprotective and also repairing myelin. The INFORMS study is looking into whether the drug can reduce progression in people with PPMS. What are the side effects? Possible side effects include changes to liver function, macular edema (an accumulation of fluid in the macular area of the eye -- the central area of vision – that sometimes causes blurred vision), headache, respiratory tract infection, shortness of breath, diarrhoea and nausea. Gilenya can cause a decrease in heart rate so the first dose will be monitored in hospital for six hours Tecfidera (Dimethyl fumerate or BG-12) How does it work? Patients whose relapse rate is unchanged, or has increased compared to the previous year, while on any of the beta interferons or glatiramer acetate (Copaxone) Patients who are receiving natalizumab (Tysabri) and are at a high risk of developing PML Additionally in October 2014 the Scottish Medicines Consortium (SMC) licensed fingolimod as a first-line treatment for people with rapidly evolving severe relapsing remitting MS (RES RRMS). This means Gilenya can be offered to people Tecfidera may have an anti-inflammatory effect on the immune system. How can it help? Studies have shown that Tecfidera reduces the annual MS relapse rate by around one-half. During trials, MRI scans showed fewer, smaller or no new active lesions. Some studies also showed a significant reduction in the progression of the disease. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets How is it administered? progression (sustained for 12 weeks) by 30%. Tecfidera is taken as a tablet, twice a day. How is it administered? Who manufactures it? Aubagio is taken as a tablet, once a day. Biogen. Who manufactures it? What type of MS is it prescribed for? Genzyme. Tecfidera is a ‘Category 1’ drug and therefore it is prescribed for people with relapsing remitting MS. It is listed as ‘more effective’ rather than ‘moderately effective’. What type of MS is it prescribed for? Aubagio is a ‘Category 1’ DMT, licensed for relapsing remitting MS. What are the side effects? What are the side effects? Common side effects reported are flushing and feeling hot, gastrointestinal upset and headaches. Common side effects are gastrointestinal upset, hair thinning and changes in liver function. Aubagio should not be taken by women considering pregnancy because of potential risks to the unborn baby. A woman of child-bearing age considering Aubagio must take a pregnancy test and ensure adequate contraception is in place before starting the drug. Aubagio (teriflunomide) How does it work? Aubagio inhibits the function of specific immune cells that have been implicated in MS. It can inhibit a key enzyme required by white blood cells (lymphocytes) – which in turn reduces the T and B immune cells that are active in MS, from multiplying. As well as this, it has shown to have other anti-inflammatory and immune-modulating actions. The drug stays in the body for a long time and if a woman taking Aubagio suspects pregnancy, she must immediately contact her GP and, if a pregnancy is confirmed, Aubagio can be ‘flushed out’ of the body by taking activated charcoal or cholestyramine over several days. Lemtrada (alemtuzumab, campath) How can it help? How does it work? Studies showed that Aubagio reduced relapses by one-third. In trials the higher dose reduced the risk of disability Lemtrada was originally licensed for the treatment of leukemia. It is an anti-CD52 monoclonal antibody which kills T-cells, a Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets type of lymphocyte involved in the MS immune response. Once the T-cells are killed, the immune system repopulates, leading to a modified immune response that no longer regards myelin and nerves as foreign, and therefore stops attacking them. Lemtrada was also shown to have a positive effect on MS progression, with 8 percent of people taking Lemtrada reporting a worsening of their EDSS scale, compared to 11 percent of people on interferon during the two-year trial. How is it administered? How can it help? Two two-year trials looked at the effect of Lemtrada: one trial enrolled people recently diagnosed with relapsing remitting MS, who had not taken any other disease modifying drugs, and another trial looked at people with relapsing remitting MS, who still had relapses despite being on an interferon. Lemtrada is delivered by two infusions, twelve months apart. The first infusion is delivered over five days, and the second over three days. Infusions take place in a hospital or infusion clinic. Who manufactures it? Genzyme. In the first trial of people recently diagnosed with RRMS, Lemtrada reduced relapses by 55 percent compared to people taking interferon beta 1a. In the group of people taking Lemtrada, 78 percent did not experience a relapse during the two years of the trial. What type of MS is it prescribed for? The people in the Lemtrada group also demonstrated that the drug had a greater effect on reducing the progression of MS, compared to the interferon group. Side effects reported for Lemtrada include one-third of people reporting changes to their thyroid function, which while treatable, can mean lifelong medication was necessary. One percent of people reported a blood clotting disorder called Immune Thrombocytopenic Purpura (ITP). While serious, ITP can be treated effectively. Other adverse effects reported related to kidney function, reactions at the infusion site and respiratory infections. In the second trial of people who had been on interferons previously, Lemtrada reduced relapses by 49 percent compared to interferon beta-1a (Rebif). In one of the trials, 65 percent of people taking Lemtrada did not have relapse in the two years of the trial, compared to 49 percent of people taking interferon. Lemtrada is listed as a ‘Category 2’ drug and therefore is licensed for more active forms of relapsing remitting MS. What are the side effects? More common side effects reported were flu-like symptoms after the infusion was given. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets Tysabri (Natalizumab) What type of MS is it prescribed for? How does it work? Tysabri is listed as a ‘Category 2’ drug and therefore is effective when treating highly active forms of relapsing remitting MS. A monoclonal antibody that works in a different way to injectable therapies, Tysabri binds to specific adhesion molecules within the immune cells. This stops the cells from crossing the blood brain barrier and entering the central nervous system, thereby reducing inflammation and damage. How can it help? Studies have shown that people with rapidly evolving severe relapsing remitting MS (RES) showed a decrease of 81% in relapses when taking Tysabri. In addition, the rate of their disease progression was slowed by approximately two thirds and the accumulation of new lesions that could be detected by MRI was reduced. People with relapsing remitting MS also showed a reduction of around two thirds in the number of relapses, fewer MS lesions detected during MRI scans and a significantly reduced rate of disease progression. How is it administered? Tysabri has to be given by intravenous infusion every 4 weeks at either an infusion centre or a hospital. What are the side effects? Side effects can include dizziness, nausea, joint pain, shivering and sometimes inflammation of the nose and throat. Tysabri increases the risk of developing a serious infection called Progressive Multifocal Leukoencephalopathy (PML), which is a rare but sometimes fatal brain infection that affects the central nervous system. The manufacturers of Tysabri state that the risk is less than three cases in a thousand, although there is a slightly increased risk for patients who remain on the therapy for more than two years. PML is caused by a virus called the JC virus (JCV). A blood test is now available to check whether you are positive for JCV and this can help to establish the risk of developing PML. Patients who have been on immune suppressants prior to treatment also have an increased risk factor. Despite these factors, the benefits of the drug continue to outweigh the risks for many people with highly active relapsing remitting MS. Who manufactures it? Biogen. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets Choosing a disease modifying drug Alternatively, it is recommended that you take paracetamol or ibuprofen two hours before the injection to ease the symptoms. Once diagnosed with MS, your neurologist will talk to you about any medication you may require and be eligible for. They will discuss with you all your possible options. One thing to consider when looking at these medications is your lifestyle and how the administration of these drugs will fit into your day-to-day living. If you suffer from injection-site reactions, you could try using Emla cream which numbs the area prior to the injection. Always rotate the injection site – avoid injecting the same area each time. It may also help to ensure the drug is at room temperature and also warming the skin before injecting may also help make your injection more comfortable. There are a number of factors you may want to consider, and discuss with your family and neurologist. For example, what are the benefits of a DMT in the short-, mid- and long-term? What are some of the common side effects? How is the therapy administered – tablet, injection or infusion? Is this right for my lifestyle? Openly discuss all the options with your MS nurse and/or neurologist to come to a decision as to what is the best course of treatment for you. Coping with side effects The side effects of these drugs are different per therapy. It is important to talk to your MS nurse or neurologist about what side effects the drug may cause. Side effects are generally not severe and there are various ways to manage them. If you are on any of the oral therapies, ask your MS nurse how to manage any side effects you are experiencing. If the side effects become severe or you feel unable to cope with them, contact your MS nurse or neurologist who will be able to advise you further. Contact our helpline on 0800 783 0518 to find your nearest MS nurse. Drugs in development All drugs need to be licensed and go through regulatory procedures before they are made available. Many drugs are currently being developed to treat multiple sclerosis. The list below contains drugs that are either currently in trials or have completed their trials, but are not yet licensed. Some have been put forward for European licensing. If you suffer from flu-like symptoms after injecting, try changing the time of day you take your injection; possibly to just before bedtime so you can sleep through the side-effects. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets ATX-MS-1467 Who manufactures it? How does it work? Apitope and Merck Serono. ATX-MS-1467 is a peptide-based drug consisting of four amino acids obtained from myelin basic protein (MBP). What type of MS is it under trial for? It is believed to protect myelin by reducing the immune system’s harmful response to the nerve’s coating. It does this through the inhibition of the T-cell’s response to myelin basic protein (MBP). A T-cell is type of white blood cell or lymphocyte. The drug is currently in early stages of testing for RRMS and SPMS. It is currently in Phase II testing. The drug is currently in trial for relapsing remitting MS and secondary progressive MS. What are the side effects? Currently there have been no side effects reported from trials. Biotin (MS1003) How does it work? How can it help? In the phase I trials, a small number of people with secondary progressive multiple sclerosis were injected with increasing doses of the drug every one to two weeks. This group showed a reduction in the response of the T-cells to MBP. In the phase II trials, people with relapsing-remitting multiple sclerosis were given increasing doses of the drug 2 weeks’ apart. In this group, there was a significant reduction in the number of lesions seen on the MRI. How is it administered? It is given by injection under the skin every 2 weeks. Biotin is one of the B-group vitamins (vitamin B7), also known as vitamin H or coenzyme R. It is an important component of enzymes in the body that help to break down certain substances like fats, carbohydrates and others. It is necessary for cell growth and is involved in the production and synthesis of myelin. Very high doses of biotin may be effective in MS by promoting myelin repair. How can it help? MD1003 is a highly concentrated form of biotin and in trials the intake of biotin was 10,000 times the recommended amount. Therefore classing it as a pharmaceutical preparation rather than a food supplement. An improvement in disability was seen in some small scale trials. Further trials Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets looking into the effect MD1003 may have on optic neuritis are under way. How is it administered? How is it administered? Daclizumab is administered via injection under the skin every four weeks. A capsule is taken three times a day. Who manufactures it? What type of MS in it under trial for? Biogen. So far it has been trailed in secondary and primary progressive MS. What type of MS is it under trial for? What are the side effects? No side effects have been currently reported. Daclizumab How does it work? Daclizumab is a monoclonal antibody that blocks the activity of the chemical messenger interleukin 2, in the immune system. It also helps prevent the growth of lymphocytes. The drug helps to prevent the activation and growth of lymphocytes that is involved in the immune attack that takes place in MS. Studies have shown that the activity of natural killer cells is increased by this drug, strengthening the body’s immune system. It is currently in trial for relapsing remitting MS. What are the side effects? In trials the common side effects were infections, serious skin infections and changes in liver function. Laquinimod How does it work? Laquinimod affects the level of certain cytokines (substances released by immune cells) and reduces the passage of immune cells into the brain and spinal cord. Studies have also suggested that this drug may have a protective effect on the nervous system and anti-inflammatory actions. How can it help? How can it help? In trials, Daclizumab reduced the annualised relapse rate by 54 percent when given as 150mg, and 50 percent when given as 300mg injections, compared to a placebo. In studies Laquinimod was shown to reduce relapses by 23% as well as a reduction in disability progression and brain volume loss. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets How is it administered? How is it administered? By tablets, once a day. It is taken by tablet twice daily. Who manufactures it? Who manufactures it? Teva and Active Biotech. AB Science. What type of MS is it under trial for? What type of MS is it under trial for? It is in trial for primary progressive MS and relapsing remitting MS. Secondary and primary progressive MS. What are the side effects? What are the side effects? The studies show that some people experience an increase in liver enzyme levels, and suffer from back pain and headache. Masitinib seems to be well tolerated according to trials. Most common side effects rash, nausea, oedema, diarrhoea and asthenia (loss of strength and/or energy). Masitinib Ocrelizumab How does it work? How does it work? Masitinib blocks some of the biochemical processes involved in the body’s inflammation and immune responses, leading to a reduction in these processes. The drug targets mast cells – a type of cell involved in allergy and inflammation. Ocrelizumab is a monoclonal antibody that attacks specific target markers on the surface of B cells, which are thought to influence the abnormal immune response that causes the immune system to attack myelin. How can it help? How can it help? In trials, those taking the drug had an improvement in their MS Functional Composite (MSFC) score after a 3-month period. The score assesses walking ability, hand and arm coordination and cognitive function. Early results from trials indicate that ocrelizumab is twice as effective as current disease modifying treatments for relapsing remitting MS, with reductions in lesions seen on an MRI being 85 – 96 percent compared to the placebo. It is given as an infusion every six months. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets How is it administered? How can it help? It is administered by intravenous infusion every 6 months. The phase II trials were conducted on participants with relapsing remitting multiple sclerosis. The trial focused on different delivery mechanisms of Ofatumumab: intravenous infusion and subcutaneous injection. Phase II participants, who received the drug by infusion at different doses, showed a reduction in B-cell activity and a total suppression of new lesions. Who manufactures it? Genentech. What type of MS is it under trial for? Relapsing remitting and primary progressive MS. What are the side effects? In the Phase II trial one patient in the high dose group died due to brain oedema (swelling) after developing systemic inflammatory response syndrome. However, the connection between Ocrelizumab and this particular death is unclear. The trials also showed that people taking Ocrelizumab had more infusion-related adverse events than those in the placebo group. Phase II participants who received the drug as an injection at different doses, showed a 65% reduction in new active lesions on an MRI after 12 weeks for all doses. How is it administered? The trial is moving forward with Ofatumumab being administered as a subcutaneous injection, or via intravenous infusion. Ofatumumab (Arzerra) Who manufactures it? How does it work? GlaxoSmithKline and Genmab. Ofatumumab is currently used to treat leukaemia. It is an immune-suppressing, monoclonal antibody that reduces the number of B-cell lymphocytes, a type of white blood cell. B-cells are believed to be part of the body’s abnormal immune response to myelin. Ofatumumab targets these B-cells and destroys them. What type of MS is it under trial for? Relapsing remitting MS. What are the side effects? Side effects in the phase II trials were linked to injection sites. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets Simvastatin How does it work? Simvastatin comes from the class of drugs used to treat high cholesterol. The drug is said to have anti-inflammatory and neuroprotective properties which led it to being studied as a potential treatment for MS. How can it help? The MS-STAT trial results were published in The Lancet in 2014; 140 people with secondary progressive MS took a high dose (80mg/day) of simvastatin for two years, or placebo. Out of the two groups, those taking the simvastatin were found to have significantly less reduction in brain volume, significantly slower change in EDSS, and significantly improved scores on the MSIS-29 (a measure of the extent to which MS affects daily life). More studies are needed. should pregnant or breastfeeding women. Grapefruit juice should be avoided as it can increase the risk of side effects. Siponimod How does it work? Siponimod belongs to the same class of drugs as Gilenya (fingolimod). The drug is designed to work on certain types of white blood cells (lymphocytes). These are cells that are involved in the attack on myelin. The drug causes the lymphocytes to be retained in the lymph glands, resulting in a reduced immune attack on nerve cells in the brain and spinal cord. How can it help? In phase 2 trials for relapsing remitting MS, sipinimod was demonstrated to reduce the relapse rate by 58 percent, compared to the placebo. How is it administered? Phase 3 trials for secondary progressive MS are currently underway. Statins are taken in tablet form. How is it administered? What type of MS is it under trial for? A tablet taken once daily. Secondary progressive MS. Who manufactures it? What are the side effects? Novartis. Common side effects of statins can include nausea, digestive problems, nosebleeds or a runny/blocked nose, headache. Some statins can interact with other medications. Those with liver problems should not take statins, neither What type of MS is it under trial for? Secondary progressive multiple sclerosis. Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets What are the side effects? In trials, the reported side effects were dizziness, throat infections and slowing of the heart rate. Further reading Drug therapies www.ms-uk.org/choicestreatments Tysabri www.ms-uk.org/choicestreatments Helpline: 0800 783 0518 www.ms-uk.org/choicesleaflets How we create our Choices leaflets MS-UK believes we must listen to the voices of people affected by multiple sclerosis to shape the information and support we provide. It is these people that bring us perspectives that no one else can give. For every Choices leaflet we produce, MS-UK consults the wider MS community to gather feedback, and uses this to inform content. All of our Choices leaflets are then reviewed by the MS-UK Virtual Insight Panel before they are published. Thank you to everyone affected by MS who made this leaflet possible. Sources • None cited Keep in Touch MS-UK Unsworth House | Hythe Quay | Colchester | Essex | CO2 8JF Tel: 01206 226500 MS-UK Helpline: 0800 783 0518 [email protected] @MSUK6 Helpline: 0800 783 0518 MultipleSclerosisUK www.ms-uk.org/choicesleaflets Date: December 2015 Registered Charity Number: 1033731 www.ms-uk.org/choicesleaflets