Welcome to todays Webinar Your Presenter is: Lyndal Emery Your Facilitator is: Andrea Salmon Acknowledgement We acknowledge and pay respect to the traditional custodians past and present on whose lands we meet today. We acknowledge the deep feelings of attachment and the relationship of Aboriginal people to country and respect the cultural authority of the elders in each community Multiple Sclerosis Limited 1
Informed Choice This presentation has been prepared and is presented by an independent expert. The views presented are not necessarily the views of Multiple Sclerosis Limited. Individuals are encouraged to seek further advice regarding the relevance of the information presented for their situation. Multiple Sclerosis Limited MEDICATIONS IN MS Lyndal Emery Clinical Pharmacist Cabrini Hospital 2
Medicines Information Speak to your doctor or pharmacist Consumer Medicines Information NPS www.nps.org.au MS Society Adverse drug reactions Adverse drug reactions are unintended and sometimes harmful occurrences associated with the use of a medicine Clinical trials provide information about many of the possible adverse events, but do not detect all Important to report Reports by consumers and health professionals provide important information for the TGA's safety monitoring program TGA Online: www.tga.gov.au NPS Adverse Medicine events line: 1300 134 237 for confidential and independent advice from a pharmacist 3
Clinical trials Australian New Zealand Clinical Trials Registry http://www.anzctr.org.au Recruiting/not yet recruiting Ethics status Retrospectvely/prospectively registered Up to date- has the trial been updated in the past 12 months To create awareness of research being undertaken To facilitate participation in trials Speak to your neurologist about new treatments and eligibility for trial participation Modifying the disease course Injectable Oral Infusions A number of immunomodulatory agents have important beneficial effects for patients with relapsing-remitting multiple sclerosis (RRMS) a decreased relapse rate slower accumulation of brain lesions on MRI Aim is to shorten the duration of acute exacerbations, decrease their frequency and provide symptomatic relief 4
Disease modifying therapy Patients with a diagnosis of definite RRMS should begin disease-modifying therapy These therapies are not a cure they are only partially effective for reducing the relapse rate, and whether all or any reduce disability progression is still under investigation. The choice of a specific agent should be individualised according to disease activity and patient values and preferences Natalizumab (Tysabri) 300mg intravenous infusion every month Immunotherapy: works by modifying the activity of the immune system Attaches to T-cells and prohibits them from crossing the blood brain barrier to attack the myelin or nerves Most often prescribed for people with relapsing-remitting MS 5
Natalizumab (Tysabri) Significantly reduces attack rates and improves severity Two major randomised-controlled trials AFFIRM SENTINEL Natalizumab (Tysabri) AFFIRM trial 942 patients with RRMS natalizumab 300 mg or placebo every 4 weeks for 2 years Results: Natalizumab associated with a significant (68%) reduction in annual relapse rate compared with placebo treatment at one year (0.26 versus 0.81) Significant reduction in sustained disability progression at two years (17 versus 29%) 6
Natalizumab (Tysabri) SENTINEL trial 1171 patients with relapsing MS who continued to experience disease activity despite interferon beta-1a treatment Natilizumab 300 mg or placebo every four weeks Results: Significant reduction in the risk of sustained disability progression at two years (23% versus 29%) Natalizumab (Tysabri) Must be prescribed by a neurologist On PBS Must be given in a specialised clinic/unit by a trained nurse Side effects: nausea, vomiting, dizziness, skin rashes 7
Natalizumab (Tysabri) Natalizumab treatment is associated with a risk of developing progressive multifocal leukoencephalopathy (PML) Estimated overall risk of PML with natalizumab is approximately 4.1 in 1000 patients treated Risk factors include: Anti-JCV antibody status Prior immunosuppressant treatment Duration of natalizumab exposure Testing for anti-jcv antibodies at baseline and after one year of natalizumab therapy Approved for monotherapy only Risk of PML 8
Alemtuzumab (Lemtrada) Monoclonal antibody: binds specifically to molecules present on the surface of cells Binds to surface of B and T cells in the immune system Once bound, the body s own immune system destroys those cells 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 Used to treat relapsing forms of MS in adults with active disease not recommended for patients with inactive disease or those who are stable on their current therapy Alemtuzumab (Lemtrada) IV infusion in two treatment courses one year apart First course consists of infusions given over five consecutive days Second course consists of infusions given over three days 9
Alemtuzumab (Lemtrada) CARE-MS I 550 adults with RRMS Alemtuzumab or subcutaneous interferon beta-1a (44 mcg three times per week) 12 mg IV daily for five days at the start of treatment and for three days at 12 months Two year data: alemtuzumab significantly reduced the proportion of patients with any relapse (22% versus 40%) Annualised relapse rate (0.18 versus 0.39) Alemtuzumab (Lemtrada) CARE-MS II 800 adults with RRMS and at least one relapse while on treatment with interferon beta-1a or glatiramer Two years: alemtuzumab significantly reduced the proportion of patients with any relapse (35% versus 53%) annual relapse rate (0.26 versus 0.52) Unlike CARE-MS I, the alemtuzumab group in CARE-MS II had a significantly lower rate of sustained accumulation of disability 10
Alemtuzumab (Lemtrada) Side effects Infusion related reactions in 90% of patients headache, rash, nausea, and fever Infections though generally not severe, were observed in two-thirds or more of patients Herpes viral infections occurred in 16 to 18 percent Autoimmune disorders Thyroid autoimmunity ITP Fingolimod (Gilenya) alters lymphocyte migration, resulting in sequestration of lymphocytes in lymph nodes 11
Fingolimod (Gilenya) FREEDOMS trial 1272 adults with RRMS Given either oral fingolimod (0.5 mg daily or 1.25 mg daily) or placebo Results at 2 years: The annual relapse rate was significantly reduced for both the high and low fingolimod groups compared with placebo (0.18, 0.16, and 0.40) Fingolimod treatment resulted in statistically significant reductions in both the risk of sustained disability progression and new lesions on brain MRI FREEDOMS extension trial, long-term fingolimod treatment was associated with reduced relapse rates and disability progression Fingolimod (Gilenya) TRANSFORMS trial 1200 adults with RRMS Oral fingolimod (0.5 mg daily or 1.25 mg daily) or intramuscular interferon beta-1a (30 mcg weekly) Results at 12 months: the annual relapse rate was significantly reduced in both the high and low dose fingolimod groups (0.20, 0.16, and 0.33, respectively) MRI measures also favoured fingolimod Progression of disability was infrequent in all three groups Extension phase of the TRANSFORMS trial supported a long-term benefit of fingolimod for maintaining a reduced relapse rate 12
Fingolimod (Gilenya) Adverse effects Common: headache, influenza, diarrhea, back pain, elevated liver enzymes, and cough Less common: bradyarrhythmia and atrioventricular block, macular edema, diminished respiratory function, and tumour development Contraindicated in patients with recent cardiac events TRANSFORMS Trial There were more serious adverse events in the fingolimod groups varicella-zoster infection, herpes simplex encephalitis 12 patients on fingolimod developed skin or breast cancer (versus one in interferon beta-1a group) 19 developed dose-related bradycardia or atrioventricular block (versus none assigned to interferon beta-1a) Fingolimod (Gilenya) First dose of fingolimod should be given in a setting where heart rate can be monitored and managed Baseline pulse and blood pressure should be measured These measurements should be repeated hourly for six hours after the first dose while the patient is observed for signs of bradycardia or atrioventricular block an ECG should be obtained at the end of the six hour observation period Overnight monitoring may be required in higher risk patients 13
Fingolimod (Gilenya) During fingolimod treatment (and for two months after stopping), patients should be monitored for symptoms and signs of infection, and live attenuated vaccines should be avoide Fingolimod is a possible teratogen and should be stopped two months prior to conception References UptoDate etg Mims MS Australia NPS 14
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Library & Publications In the Library & Publications section of our website you can find information about: MS Library services How to borrow both ebooks and print books on topics such as wellness, and managing multiple sclerosis and its symptoms Accessing our online library catalogue MS publications, including Intouch magazine, email newsletters, booklets and information sheets Visit our website for more information www.ms.org.au Multiple Sclerosis Limited Library & Publications Multiple Sclerosis Limited 16
NDIS Support The NDIS is the Biggest social reform changing the way supports and services are purchased and delivered for people with a disability The NDIS has commenced rolling out across NSW/ACT/Vic and Tasmania it will occur in different ways across the regions MS is here to help you understand what the NDIS means, and assist you to prepare for a planning meeting We have resources available on our website www.ms.org.au click on the large NDIS button MS is registered with NDIA to deliver Support Coordination, Residential Respite, Social Support Day Program (Vic) Exercise physiology and personal training (NSW) Specialist Continence Assessment (NSW), Physiotherapy and Occupational Therapy (NSW and Vic). Want to learn more? Please call MS Connect on 1800 042 138 Multiple Sclerosis Limited 17