Treatments for MS: Immunotherapy. Gilenya (fingolimod) Glatiramer acetate (Copaxone )

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1 Treatments for MS: Immunotherapy There are currently several disease-modifying therapies approved for people with MS in Australia. These therapies, called immunotherapies, work to reduce disease activity in the central nervous system and reduce the frequency and severity of relapses in people with MS. Gilenya (fingolimod) Gilenya belongs to a class of medications call sphingosine 1-phosphate (s1p) receptor modulator. The active ingredient in Gilenya is fingolimod. Gilenya acts on certain types of white blood cells called lymphocytes. In multiple sclerosis, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds the nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Gilenya helps prevent lymphocytes leaving the lymph nodes. This lowers the number of Lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord. Gilenya has been shown in clinical trials to: Reduce the frequency of relapses 1,2 Delay progression of physical disability 1,2 There is also evidence it may have a direct effect in enhancing re-myelination of damaged nerve cells. Glatiramer acetate (Copaxone ) Copaxone is a synthetic protein made up of a combination of four amino acids, which are the natural building blocks of protein in the body. It is thought to work by connecting cells to stop them attacking the myelin. It is administered by a daily injection given under the skin. In Australia, glatiramer acetate is sold under the brand name Copaxone. My Support Team is a telephone helpline (call ) run by CSL Biotherapies for people using this treatment. In clinical trials Copaxone has been shown to: delay the onset of definite MS after a first time experience of symptoms that suggests MS 4 Glatiramer acetate is not an interferon so it does not have any flu-like side effects. Some discomfort at the injection site may be experienced and this can usually be managed by the use of heat or cold packs prior to injecting and carefully rotating injection sites. On rare occasions, a post-injection reaction has been experienced by some people, where they experience a sense of panic shortly after injecting. This passes quickly reduce the frequency of relapses 3. delay progression of physical disability 3. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia

2 Interferon beta (Avonex, Betaferon, Rebif ) Interferons are proteins that occur naturally in the body. They help fight viral infections and regulate the immune system. It is thought interferon beta may reduce immune responses directed at myelin. These medications are given as an injection either just under the skin or into the muscle. In Australia, there are three different types of interferon beta available. Each type is sold under a different brand name: Avonex (interferon beta-1a): An injection into the muscle once per week. The Avonex Alliance is a telephone helpline (call ) run by Biogen Idec Australia. Betaferon (interferon beta-1b): An injection given under the skin every second day. Betaplus is a telephone helpline (call ) run by Bayer Australia. Rebif (interferon beta-1a): Injected under the skin three times per week. Rebif Extracare is a telephone helpline (call ) run by Merck Serono Australia. In clinical trials interferon beta has been shown to: reduce the frequency and severity of relapses 5,6,7. slow the rate of disease progression and physical disability 6,7. delay the onset of definite MS after a first time experience of symptoms that suggests MS 8,9. All the interferons may give you mild flu-like symptoms (e.g. chills, fever, head/muscle aches and sweating) when you don t actually have the flu. These side effects are usually easily managed by taking paracetamol or ibuprofen pain relief prior to injecting and they generally settle after a period of time. On rare occasions, some people may develop liver, blood or thyroid problems, allergic reactions or depression. Some irritation and discomfort may be experienced at the injection site. This can be managed by using a heat or cold pack prior to injecting and by applying a soothing cream or lotion after the injection if required. Tecfidera (dimethyl fumarate) Tecfidera (dimethyl fumarate) - previously known as BG-12 - is an oral treatment for Australian patients with relapsing-remitting multiple sclerosis (MS). The recommended starting dose of Tecfidera is 120mg, twice daily. After 7 days the dose may be increased to the recommended dose of 240mg twice daily. Tecfidera has been shown to have antiinflammatory and neuro-protective properties. It is thought that Tecfidera works in MS by inhibiting immune cells and molecules, and may have antioxidant properties that protect the brain and spinal cord from damage. Clinical trials have shown it can reduce relapse rates and delay the progression of disability in people with relapsing remitting MS. In clinical trials of Tecfidera, the most common side-effects experienced were flushing, diarrhea, nausea and abdominal pain. Less common but more serious side-effects include more severe gastrointestinal side-effects, effects on the kidneys and liver, and reduced white blood cell counts. While increased frequencies of infection were not seen in clinical trials, it is recommended that patients on Tecfidera have their white blood cell counts monitored at least annually. Tecfidera has not been tested in people under the age of 18 or in women who are pregnant or breastfeeding. Women who are pregnant, planning pregnancy or breastfeeding should seek advice from their doctor. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 2

3 Natalizumab (Tysabri ) Natalizumab belongs to a class of medications called monoclonal antibodies (MABs) which are a type of protein. Natalizumab works by attaching to the surface of specific immune cells. It then indicates to the body that these cells should not cross from the blood stream into the central nervous system (the brain and spinal cord), where they could attack the myelin sheath. This treatment is administered through the veins (intravenous infusion) once a month. In Australia, natalizumab is sold under the brand name Tysabri. Tysabri Linked Care is a patient support program (call ) run by Biogen Idec Australia. In clinical trials, natalizumab has been shown to: The most common possible side effects are joint pain, fever, blocked or runny nose, tiredness, nausea, headache and dizziness. A rare but serious brain infection, progressive multifocal leucoencephalopathy (PML), has occurred in a very small percentage of people taking natalizumab. There are tests to help determine your individual risk of developing PML. Your neurologist can provide you with more information about these tests. To reduce the risk of people developing PML, and to make sure that PML is picked up as quickly as possible in people who develop the condition, there are strict safety protocols in place which include an observation period after your infusion.neurologist. reduce the frequency of relapses 10. slow the rate of disease progression and physical disability 10. Teriflunomide (Aubagio ) Teriflunomide belongs to a class of medications called pyrimidine synthesis inhibitors. It is a film coated tablet taken daily by mouth. Teriflunomide acts by interrupting the lifecycle of certain types of white blood cells, called lymphocytes. In MS, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Teriflunomide works by reducing the production of an enzyme (a type of protein) which lymphocytes, need to divide and mature. This lowers the number of lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord. In Australia, teriflunomide is sold under the brand name Aubagio. In clinical trials teriflunomide has been shown to: reduce the frequency of relapses11,12. delay progression of physical disability11,12. Side effects include Nausea, abnormal liver tests, diarrhoea and hair thinning or loss. On rare occasions, some people may develop liver skin or blood problems, increased blood pressure or pain. Teriflunomide interacts with ingredients in some oral contraceptive pills so it is important to discuss with your doctor the type of contraceptive pill you are taking if you are. INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 3

4 Lemtrada (alemtuzumab) Lemtrada is in a class of medications called monoclonal antibodies, which means it can bind specifically to molecules present on the surface of cells. Lemtrada works by binding to CD52 molecules which are present on the surface of B and T cells of the immune system and once it is bound, the body s own immune system destroys those cells. Since B and T cells are known to play a role in the disease process of MS, depleting B and T cells in the circulation may slow the disease process in some individuals. Lemtrada is used to treat relapsing forms of MS in adults with active disease. Lemtrada is not recommended for patients with inactive disease or those who are stable on their current therapy. Lemtrada is a liquid preparation which is given by intravenous infusion in two treatment courses one year apart. The first course consists of infusions given over five consecutive days, the second course consists of infusions given over three days. Due to potential side effects, once you have received Lemtrada you will need to undergo regular monitoring so that any side effects can be detected and treated promptly. Monitoring must continue for four years after the last infusion. In clinical trials, Lemtrada has been shown to: Reduce the frequency of relapses when compared with interferon beta treatment Delay the progression of disability in some people when compared to interferon beta treatment. 13,14 The treatment does have side effects including infusion-associated reactions (such as headache, rash and nausea), lowered blood cell counts and infections. Serious autoimmune side effects include: An overactive or underactive thyroid gland, leading to thyroid-related side effects. These side effects are treatable but can require careful monitoring and lifelong thyroid medication. A blood clotting disorder known as immune thrombocytopenic purpura (ITP), which is caused by low numbers of platelets in the blood. This can lead to internal bleeding. ITP can be fatal, but monitoring strategies enable ITP to be detected early and treated appropriately.13, 14 There is an increase in the risk of infection with Lemtrada treatment, though the incidence of serious infections in clinical trials was low. Lemtrada has not been tested in women who are pregnant. Women of childbearing age should use effective birth control measures when receiving a course of treatment with Lemtrada and for 4 months following that course of treatment. For more information on these treatments or other treatments in MS Speak to your neurologist about what treatment best suits your individual circumstances. MS Nurses also provide information, training and ongoing support in managing your immunotherapy. Contact your state office on or visit for more information. MS Research Australia (MSRA) provides information on the latest research and clinical trials in MS. Visit for more information. Making Sense of MS Research provides plain language summaries of independent, high-quality research about MS treatments. Visit INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 4

5 For information about MS and MS Australia services: Freecall: Web: Disclaimer: Information contained in this fact sheet is intended to provide useful and accurate information of a general nature for the reader but is not intended to be a substitute for legal or medical advice. MS Australia is not recommending medical or legal advice and readers must seek their own medical or legal advice as may be appropriate. Printing and photocopying this publication in its original form is permitted for educational purposes only. Reproduction in any other form without written permission is prohibited. References 1) Kappos L, Raude EW, O Connor P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. NEJM 2010;362: ) Cohen JA, Barkhof F, Comi G et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. NEJM 2010;362: ) Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis. Neurol 1995;45: ) Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome. Lancet 2009;374: ) Jacobs LD, Cookfair DL, Rudick R A et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39: ) INFB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Neurol 1993;43: ) PRISMS Study Group. Randomised double-blind placebo controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352: ) Jacobs LD, Beck RW, Simon JH et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. NEJM 2000;343: ) Kappos L, Polman CH, Freedman MS et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurol 2006;67: ) Polman CH, O Connor PW, Havrdova E et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. NEJM 2006;354: ) O Connor PW, Li D, Freedman MS et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurol 2006:66: ) 12. O Connor P, Wolinsky JS, Confavreux C et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis NEJM 2011; 365: ) Cohen JA, Coles AJ, Arnold DL et al., Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012;380(9856): ) Coles AJ, Twyman CL, Arnold DL et al., Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380(9856): INFORMATION FOR PEOPLE LIVING WITH MS September 2014 MS Australia 5

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