The Norwegian Multiple Sclerosis Registry and Biobank

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "The Norwegian Multiple Sclerosis Registry and Biobank"

Transcription

1 Acta Neurol Scand 2015: 132 (Suppl. 199): DOI: /ane John Wiley & Sons A/S. Published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA Review Article The Norwegian Multiple Sclerosis Registry and Biobank Myhr K-M, Grytten N, Torkildsen Ø, Wergeland S, Bø L, Aarseth JH. The Norwegian Multiple Sclerosis Registry and Biobank. Acta Neurol Scand 2015: 132 (Suppl. 199): John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system with unknown cause and various benefits from disease modifying therapies. Systematic recording of data into national MS registries is therefore needed to optimize treatment and define the pathogenesis of the disease. The Norwegian MS Registry and Biobank was established for systematic collection of clinical and epidemiological data, as well as biological samples. Data collection is based on informed consent from the individual patients and recordings by treating neurologists. All researchers have, by application, access to data and biological samples from the Norwegian Multiple Sclerosis Registry and Biobank. By this combined effort from both patients and healthcare personnel, the Registry and Biobank aims to facilitate research for improved understanding of disease mechanisms and improved health care in MS. K.-M. Myhr 1,2, N. Grytten 2,3, Ø. Torkildsen 2,3, S. Wergeland 2,3, L. Bø 2,3, J. H. Aarseth 1,2 1 Norwegian Multiple Sclerosis Registry and Biobank, Department of Neurology, Haukeland University Hospital, Bergen, Norway; 2 KG Jebsen MS Research Centre, Department of Clinical Medicine, University of Bergen, Bergen, Norway; 3 Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Bergen, Norway Key words: multiple sclerosis; registry; biobank K.-M. Myhr, Norwegian Multiple Sclerosis Registry and Biobank, Department of Neurology, Haukeland University Hospital, 5021 Bergen, Norway Tel.: / Fax: Accepted for publication January 4, 2015 Introduction Multiple sclerosis (MS) is one of the major causes of neurological disability in young people, reduces life expectancy by 8 10 years (1, 2), and generates high costs to society (3). The disease is caused by a complex interplay between genetic and environmental risk factors (4), and the diagnosis is based on disease history, clinical examination, magnetic resonance imaging (MRI), and cerebrospinal fluid (CSF) analyses (5). Although no curable treatment is available, disease modifying therapies reduce disease activity, but the efficacy of available therapies varies between patients with apparently similar demographic and clinical characteristics (6). Thus, biomarkers to predict disease prognosis and treatment response are needed for personalized treatment strategies to improve health care in MS. Biomarkers may also help researchers to define the pathogenesis of the disease and contribute to the development of new treatment strategies. The Norwegian MS Registry and Biobank was therefore established to improve health care for patients with MS, by optimizing treatment, and to facilitate research aiming at defining the cause of the disease (7). The Norwegian Multiple Sclerosis Registry and Biobank The Norwegian MS Registry was approved by the Regional Committee for Research Ethics and granted license from the Norwegian Data Protection Authority in Enrollment, based on written informed consent from the individual patient, was initiated in The registration was performed by the local neurologist responsible for diagnosis and treatment of the patients and included from the beginning three different register paper forms; one for basic information on diagnosis and demographic factors, and two forms for treatment initiation and follow-up. During 2007, the registry was expanded to include a biobank of blood samples (DNA and serum) and cerebrospinal fluid collected during the diagnostic procedure, and brain tissue obtained at autopsy. Its name was accordingly changed to the Norwegian MS Registry and Biobank (8). The registry has been included in the Norwegian program for Medical Quality Registries (http://www.kvalitetsregistre.no/kvalitetsregistre/) and was recently adapted for web-based online registration at Norwegian Health Network (Norsk Helsenett; https://mrs.nhn.no/). The 24

2 The Norwegian Multiple Sclerosis Registry and Biobank registry is located at the Norwegian MS Competence Centre at Haukeland University Hospital in Bergen (9). The CSF and tissue biobank samples are stored at Haukeland University Hospital, and the DNA and serum samples are stored at the Norwegian Institute of Public Health in Oslo. The aims of the registry are to provide quality control of diagnosis and treatment of patients with MS and also to supply data and biological samples for MS research. All researchers have, by application, access to data and biological samples. Applications are evaluated by the registry s board of representatives from the four Regional Health Authorities, The Norwegian Institute of Public Health, and the Norwegian MS Society. The registry is funded by the Norwegian health authorities, through The Western Norway Regional Health Authority. The Norwegian Research Council, by the NevroNor research program, funded the initial phase for the biobank collection ( ). Registry variables The registry collects individual data on demography and results from diagnostic procedures, as well as risk factors and treatment. Data on clinical and magnetic resonance imaging (MRI) disease activity are registered at least once yearly (10 16). Information related to possible risk factors in addition to comorbidity and concomitant treatments are also included (Table 1). Separate modules for patient-reported outcome (PRO) and patient-reported evaluation (PRE) of the healthcare service are currently being developed. Registry data in MS research Several epidemiological research projects have benefited from the data recorded at the registry. A linkage study of the MS registry and the Medical Birth Registry of Norway showed a significantly lower mean birthweight in term births by women with established MS compared to those with pregnancy before MS onset and diagnosis (17). Grytten et al. (1) reported a median survival from onset of 41 years compared to 49 years in the corresponding population, and standardized mortality ratio (SMR) analyses showed a 2.7-fold increased risk of death among patients MS from Hordaland County, Western Norway. Analysis of relative mortality ratio (RMR) among patients with MS showed that women had higher relative mortality than men. Data from the MS registry were also included in a study on offshore workers in the Norwegian upstream petroleum industry, Table 1 Variables included in the Norwegian Multiple Sclerosis Registry and Biobank Demographics and diagnostic evaluation Person identification/demographics Name and identification number Year of birth Gender Informed consent Diagnosis Year of onset Year of diagnosis Disease course Onset symptoms Number of relapses or progressive symptoms at diagnosis Number of signs of neurological dysfunction at diagnosis Magnetic resonance imaging (MRI) at diagnosis Evoked potentials at diagnosis Cerebrospinal fluid (CSF)-analyses at diagnosis Disease modifying treatment and follow-up Ongoing treatment Any previous medication and reason for changes Any reason for no treatment Any side effects Neutralizing antibody analysis during interferon beta and natalizumab treatment JC-virus screening and JCV-index during natalizumab treatment Disease activity and clinical scoring Any relapse and any relapse treatment is recorded MRI examination, total lesion load (categorized) and diagnosis, and appearance of new lesions Expanded Disability Status Scale [EDSS, (10)] Multiple Sclerosis Functional Composite [MSFC, (11)] Symbol Digit Modalities Test [SDMT, (12)] Symptom checklist, including the presence of symptoms and any treatment of those Patient-reported outcome measures Fatigue Severity Scale [FSS, (13)] Multiple Sclerosis Impact Scale [MSIS-29, (14,15)] Health-related quality of life assessment by EuroQol-5D [EQ-5D, (16)] Other variables Comorbidity Concomitant medication Family members with MS Previous Epstein-Barr virus infection and/or infectious mononucleosis Serum vitamin D levels Smoking habits Vital signs which showed no increased risk of MS compared with the general working population in Norway after adjustment for education (18). Education 25

3 Myhr et al. analysis, however, showed a marked and linear inverse relationship between level of education and the risk of MS in the total study population (18). Registry data have been included in analyses of month of birth and gender differences in MS incidence (19 22). The registry activity has also inspired several Norwegian researchers to conduct local and regional projects on epidemiological studies of MS prevalence and incidence (23, 24). The Norwegian contribution to the large international case control study on environmental risk factors in MS (EnvIMS) was based on the Norwegian MS registry (25). Results from this study have shown that obesity from childhood until young adulthood increases the risk, while exposure to sunlight and the use of cod-liver oil especially during adolescence may reduce the risk of developing MS (26 28). The EnvIMS study has also provided evidence for an association between infectious mononucleosis and an increased risk of MS, independent of season, and therefore also probably independent of serum levels of vitamin D (29). DNA samples obtained from the registry biobank have contributed to numerous studies of genetic risk factors in MS (30 44). Current status and future perspectives The registry has currently included close to 6000 patients. Most data are from prevalent cases, but longitudinal data on treatment and clinical and MRI disease activity will grow rapidly with increasing use of web-based online registration. The biobank includes about 2200 samples of patient DNA, 700 family member control samples, about 300 CSF samples, and tissue samples from about 80 MS brains. The web-based MS registry aims to be a userfriendly tool in the neurologist s everyday clinical practice. The registry provides an intuitive and yet comprehensive graphic interface of all relevant variables in a typical MS consultation. It generates a report of essential information that can be included in the electronic patient record. The web-based MS registry also provides information on all patients with MS on an institutional, department or treating physician level. In the future, we also aim to include modules for online recording of patient-reported outcome measures. A future prospect for the new web-based system is to generate close to complete follow-up data sets of patients that can be used for quality control of individual diagnosis and treatment. Hence, the registry would improve utilization of healthcare services and increase access to medical treatment to all patients fulfilling the criteria for disease modifying treatment (45). The registry would, by the symptom checklist, also promote optimal evaluation and initiation of symptomatic treatment. A systematic recording of treatment effects and possible adverse events would also significantly contribute to safety evaluation of new medications. The Norwegian MS Registry and Biobank will actively seek participation in collaborative initiatives, such as the European MS Registry (EUReMS) (46), and hopefully also with the other Scandinavian MS registries in Sweden and Denmark (47, 48). Acknowledgments and source of funding The Norwegian Multiple Sclerosis Registry and Biobank receive funding from The Western Norway Regional Health Authority and have received funding from the Norwegian Research Council (NevroNor) for biobank sample collection. Conflict of interest KMM has received honoraria for lecturing, participation in advisory boards or pharmaceutical company sponsored clinical trials, and travel support from Allergan, Almirall, Bayer Schering, Biogen Idec, Genzyme/Sanofi Aventis, Merck-Serono, Novartis, and/or TEVA. NG reports no conflict of interests. ØT has served on a scientific advisory board for Biogen Idec and received speaker honoraria and travel grants from Genzyme, Merck-Serono, Novartis, and Biogen Idec SW has received honoraria for lecturing, and travel support from Novartis, Biogen Idec, Merc-Serono, and Alexion. LB has received honoraria for lecturing, participation in advisory boards or pharmaceutical company sponsored clinical trials, and travel support from Allergan, Almirall, Bayer Schering, Biogen Idec, Genzyme/Sanofi Aventis, Merck-Serono, Novartis, and/or TEVA. JAA has received honoraria for lecturing from Novartis. References 1. GRYTTEN T, LIE SA, AARSETH JH, NYLAND H, MYHR KM. Survival and cause of death in multiple sclerosis: results from a 50-year follow-up in Western Norway. Mult Scler 2008;14: MYHR KM, RIISE T, VEDELER C et al. Disability and prognosis in multiple sclerosis: demographic and clinical variables important for the ability to walk and awarding of disability pension. Mult Scler 2001;7: SVENDSEN B, MYHR KM, NYLAND H, AARSETH JH. The cost of multiple sclerosis in Norway. Eur J Health Econ 2012;13: COMPSTON A, COLES A. Multiple sclerosis. Lancet 2008;372: POLMAN CH, REINGOLD SC, BANWELL B et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 2011;69: SORENSEN PS. New management algorithms in multiple sclerosis. Curr Opin Neurol 2014;27:

4 The Norwegian Multiple Sclerosis Registry and Biobank 7. MYHR KM, GRYTTEN N, AARSETH JH. The Norwegian Multiple Sclerosis Registry and Biobank. Acta Neurol Scand Suppl 2012;195: HARBO HF, MØRK S, VEDELER C, MYHR KM. Multiple sclerosis biobank established. Tidsskr Nor Laegeforen 2007;127: MYHR KM, GRYTTEN N, AARSETH JH, NYLAND H. The Norwegian Multiple Sclerosis National Competence Centre and National Multiple Sclerosis registry a resource for clinical practice and research. Acta Neurol Scand Suppl 2006;183: KURTZKE JF. Rating neurological impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983;33: FISCHER JS, JACK AJ, KNICKER JE et al. Administration and scoring manual for the multiple sclerosis functional composite measure (MSFC). New York: Demos Medical Publishing Inc, SMITH A. Symbol digit modalities test: manual. Los Angeles, CA: Western Psychological Services, KRUPP LB, LAROCCA NG, MUIR-NASH J, STEINBERG AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989;46: HOBART J, LAMPING D, FITZPATRICK R, RIAZI A, THOMPSON A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain 2001;124: SMEDAL T, JOHANSEN HH, MYHR KM, STRAND LI. Psychometric properties of a Norwegian version of Multiple Sclerosis Impact Scale (MSIS-29). Acta Neurol Scand 2010;122: RABIN R, DE C. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001 l;33: DAHL J, MYHR KM, DALTVEIT AK, GILHUS NE. Pregnancy, delivery and birth outcome in different stages of maternal multiple sclerosis. J Neurol 2008;255: RIISE T, KIRKELEIT J, AARSETH JH et al. Risk of MS is not associated with exposure to crude oil, but increases with low level of education. Mult Scler 2011;17: GRYTTEN N, TORKILDSEN Ø, AARSETH JH et al. Month of birth as a latitude-dependent risk factor for multiple sclerosis in Norway. Mult Scler 2013;19: TORKILDSEN O, AARSETH J, BENJAMINSEN E et al. Month of birth and risk of multiple sclerosis: confounding and adjustments. Ann Clin Transl Neurol 2014;1: TORKILDSEN O, AARSETH J, CELIUS EG et al. Reply to comment: month of birth and risk of multiple sclerosis: confounding and adjustments. Ann Clin Transl Neurol 2014;1: KAMPMAN MT, AARSETH JH, GRYTTEN N et al. Sex ratio of multiple sclerosis in persons born from 1930 to 1979 and its relation to latitude in Norway. J Neurol 2013;260: MIDGARD R. Incidence and prevalence of multiple sclerosis in Norway. Acta Neurol Scand 2012;126(Suppl. 195): BERG-HANSEN P, MOEN S, HARBO H, CELIUS E. High prevalence and no latitude gradient of multiple sclerosis in Norway. Mult Scler 2014;20: PUGLIATTI M, CASETTA I, DRULOVIC J et al. A questionnaire for multinational case-control studies of environmental risk factors in multiple sclerosis (EnvIMS-Q). Acta Neurol Scand 2012;126(Suppl. 195): WESNES K, RIISE T, CASETTA I et al. Body size and the risk of multiple sclerosis in Norway and Italy: the EnvIMS study. Mult Scler 2015;21: BJØRNEVIK K, RIISE T, CASETTA I et al. Sun exposure and multiple sclerosis risk in Norway and Italy: the EnvIMS study. Mult Scler 2014;20: CORTESE M, RIISE T, BJØRNEVIK K et al. Timing of cod liver oil use as a vitamin D source and multiple sclerosis risk in Norway: the EnvIMS study. Multiple Sclerosis Journal 2014;20: LOSSIUS A, RIISE T, PUGLIATTI M et al. Season of infectious mononucleosis and risk of multiple sclerosis at different latitudes; the EnvIMS Study. Mult Scler 2014;20: LORENTZEN AR, MELUM E, ELLINGHAUS E et al. Association to the Glypican-5 gene in multiple sclerosis. J Neuroimmunol 2010;226: MERO IL, LORENTZEN AR, BAN M et al. A rare variant of the TYK2 gene is confirmed to be associated with multiple sclerosis. Eur J Hum Genet 2010;18: MERO IL, BAN M, LORENTZEN AR et al. Exploring the CLEC16A gene reveals a MS-associated variant with correlation to the relative expression of CLEC16A isoforms in thymus. Genes Immun 2011;12: SØNDERGAARD HB, SELLEBJERG F, HILLERT J et al. Alterations in KLRB1 gene expression and a Scandinavian multiple sclerosis association study of the KLRB1 SNP rs Eur J Hum Genet 2011;19: International Multiple Sclerosis Genetics Consortium (IMSGC), Wellcome Trust Case Control Consortium 2 (WTCCC2). Genetic risk and a primary role for cellmediated immune mechanisms in multiple sclerosis. Nature 2011;476: MERO IL, SMESTAD C, LIE BA et al. Polymorphisms of the BDNF gene show neither association with multiple sclerosis susceptibility nor clinical course. J Neuroimmunol 2012;244: International Multiple Sclerosis Genetics Consortium (IMSGC), BEECHAM AH, PATSOPOULOS NA et al. Analysis of immune-related loci identifies 48 new susceptibility variants for multiple sclerosis. Nat Genet 2013;45: LEONE MA, BARIZZONE N, ESPOSITO F et al. Association of genetic markers with CSF oligoclonal bands in multiple sclerosis patients. PLoS ONE 2013;8:e International Multiple Sclerosis Genetics Consortium. Network-based multiple sclerosis pathway analysis with GWAS data from 15,000 cases and 30,000 controls. Am J Hum Genet 2013;92: MECHELLI R, UMETON R, POLICANO C et al. A candidate-interactome aggregate analysis of genome-wide association data in multiple sclerosis. PLoS ONE 2013;8: e MERO IL, GUSTAVSEN MW, SÆTHER HS et al. Oligoclonal band status in Scandinavian multiple sclerosis patients is associated with specific genetic risk alleles. PLoS ONE 2013;8:e BAN M, CAILLIER S, MERO IL et al. No evidence of association between mutant alleles of the CYP27B1 gene and multiple sclerosis. Ann Neurol 2013;73: SUNDAL C, BAKER M, KARRENBAUER V et al. Hereditary diffuse leukoencephalopathy with spheroids with phenotype of primary progressive multiple sclerosis. Eur J Neurol 2015;22: WESTERLIND H, IMRELL K, RAMANUJAM R et al. Identityby-descent mapping in a Scandinavian multiple sclerosis cohort. Eur J Hum Genet 2015;23: GUSTAVSEN MW, VIKEN MK, CELIUS EG et al. Oligoclonal band phenotypes in MS differ in their HLA class II association, while specific KIR ligands at HLA class I 27

5 Myhr et al. show association to MS in general. J Neuroimmunol 2014;274: TORKILDSEN Ø, GRYTTEN N, MYHR KM. Immunomodulatory treatment of multiple sclerosis in Norway. Acta Neurol Scand Suppl 2007;187: PUGLIATTI M, ESKIC D, MIKOLCI C T et al. Assess, compare and enhance the status of people with MS in Europe: a European Register for Multiple Sclerosis (EUReMS). Acta Neurol Scand 2012;126(Suppl. 195): ANDERSEN O. From the Gothenburg Cohort to the Swedish MS Registry. Acta Neurol Scand 2012;126(Suppl. 195): KOCH-HENRIKSEN N, STENAGER E, LAURSEN B. The use of epidemiological multiple sclerosis registers in research: the Danish MS Registry. Acta Neurol Scand 2012;126 (Suppl. 195):

Time trends in the incidence and prevalence of multiple sclerosis in Norway during eight decades

Time trends in the incidence and prevalence of multiple sclerosis in Norway during eight decades Acta Neurol Scand 2015: 132 (Suppl. 199): 29 36 DOI: 10.1111/ane.12428 2015 The Authors. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA Review Article Time

More information

The Swedish MS registry clinical support tool and scientific resource

The Swedish MS registry clinical support tool and scientific resource Acta Neurol Scand 2015: 132 (Suppl. 199): 11 19 DOI: 10.1111/ane.12425 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA Review Article The Swedish MS registry

More information

Accuracy in Space and Time: Diagnosing Multiple Sclerosis. 2012 Genzyme Corporation, a Sanofi company.

Accuracy in Space and Time: Diagnosing Multiple Sclerosis. 2012 Genzyme Corporation, a Sanofi company. Accuracy in Space and Time: Diagnosing Multiple Sclerosis 2012 Genzyme Corporation, a Sanofi company. Brought All rights to reserved. you by www.msatrium.com, MS.US.PO876.1012 your gateway to MS knowledge.

More information

Revised (2009) Association of British Neurologists guidelines for prescribing in multiple sclerosis

Revised (2009) Association of British Neurologists guidelines for prescribing in multiple sclerosis Revised (2009) guidelines for prescribing in multiple sclerosis INTRODUCTION In January 2001, the (ABN) first published guidelines for the use of licensed disease modifying treatments (ß-interferon and

More information

A blood sample will be collected annually for up to 2 years for JCV antibody testing.

A blood sample will be collected annually for up to 2 years for JCV antibody testing. Mellen Center Currently Enrolling Non-Treatment Trials STRATIFY-2 JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri Primary Investigator:

More information

Multiple Sclerosis (MS) Aprile Royal, Novartis Pharma Canada Inc. September 21, 2011 Toronto, ON

Multiple Sclerosis (MS) Aprile Royal, Novartis Pharma Canada Inc. September 21, 2011 Toronto, ON Multiple Sclerosis (MS) Aprile Royal, Novartis Pharma Canada Inc. September 21, 2011 Toronto, ON First-line DMTs Reduce Relapse Frequency by ~30% vs. Placebo Frequency of relapse with various DMTs, based

More information

ß-interferon and. ABN Guidelines for 2007 Treatment of Multiple Sclerosis with. Glatiramer Acetate

ß-interferon and. ABN Guidelines for 2007 Treatment of Multiple Sclerosis with. Glatiramer Acetate ABN Guidelines for 2007 Treatment of Multiple Sclerosis with ß-interferon and Glatiramer Acetate Published by the Association of British Neurologists Ormond House, 27 Boswell Street, London WC1N 3JZ Contents

More information

chapter 3.1 Chapter 3.1 Clinical scales in progressive MS: predicting long-term disability LVAE Bosma, JJ Kragt, DL Knol, CH Polman, BMJ Uitdehaag

chapter 3.1 Chapter 3.1 Clinical scales in progressive MS: predicting long-term disability LVAE Bosma, JJ Kragt, DL Knol, CH Polman, BMJ Uitdehaag chapter 3.1 Chapter 3.1 Clinical scales in progressive MS: predicting long-term disability LVAE Bosma, JJ Kragt, DL Knol, CH Polman, BMJ Uitdehaag Multiple Sclerosis 2012;18:345-350 Chapter 3.1 Abstract

More information

Disclosures. Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics

Disclosures. Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics Mitzi Joi Williams, MD Neurologist MS Center of Atlanta, Atlanta, GA Disclosures Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics

More information

MULTIMODAL THERAPY FOR MS- ASSOCIATED COGNITIVE DYSFUNCTION

MULTIMODAL THERAPY FOR MS- ASSOCIATED COGNITIVE DYSFUNCTION MULTIMODAL THERAPY FOR MS- ASSOCIATED COGNITIVE DYSFUNCTION Michael K. Racke, MD Professor and Chairman in Neurology The Helen C. Kurtz Chair in Neurology Department of Neurology Ohio State University

More information

MRI in Differential Diagnosis

MRI in Differential Diagnosis MRI in Differential Diagnosis Jill Conway, MD, MA, MSCE Director, Carolinas MS Center Clerkship Director, UNCSOM-Charlotte Campus Charlotte, NC DISCLOSURES Speaking, consulting, and/or advisory boards

More information

TYSABRI Risk Management Plan. Carmen Bozic, MD Vice President Drug Safety and Risk Management Biogen Idec Inc

TYSABRI Risk Management Plan. Carmen Bozic, MD Vice President Drug Safety and Risk Management Biogen Idec Inc 76 TYSABRI Risk Management Plan Carmen Bozic, MD Vice President Drug Safety and Risk Management Biogen Idec Inc 77 Presentation Outline Overview and Goals of Plan Risk Minimization Plan Risk Assessment

More information

Relapsing-remitting multiple sclerosis Ambulatory with or without aid

Relapsing-remitting multiple sclerosis Ambulatory with or without aid AVONEX/BETASERON/COPAXONE/EXTAVIA/GILENYA/REBIF/TYSABRI Applicant must be covered on an Alberta Government sponsored drug program. Page 1 of 5 PATIENT INFMATION Surname First Name Middle Initial Sex Date

More information

Treatment in Relapsing MS: Choosing Among the Options. Donald Negroski, MD

Treatment in Relapsing MS: Choosing Among the Options. Donald Negroski, MD Treatment in Relapsing MS: Choosing Among the Options Donald Negroski, MD Disclosures Research Grants Educational activities and lectures Consulting or other services including Continuing Medical Education

More information

The importance of early intervention clinician perspective. Øivind Grytten Torkildsen

The importance of early intervention clinician perspective. Øivind Grytten Torkildsen The importance of early intervention clinician perspective Øivind Grytten Torkildsen «You can never diagnose MS too late» Neuroradiologist from Norway, early 1990s Prognosis in untreated MS Early diagnosis

More information

MULTIPLE SCLEROSIS. Megan Snyder INTRODUCTION TO EPIDEMOLOGY

MULTIPLE SCLEROSIS. Megan Snyder INTRODUCTION TO EPIDEMOLOGY MULTIPLE SCLEROSIS Megan Snyder INTRODUCTION TO EPIDEMOLOGY Snyder 1 Personal Connection to Multiple Sclerosis Multiple sclerosis (MS) is an extremely painful disease of which not enough is understood.

More information

The Nuts and Bolts of Multiple Sclerosis. Rebecca Milholland, M.D., Ph.D. Center for Neurosciences

The Nuts and Bolts of Multiple Sclerosis. Rebecca Milholland, M.D., Ph.D. Center for Neurosciences The Nuts and Bolts of Multiple Sclerosis Rebecca Milholland, M.D., Ph.D. Center for Neurosciences Objectives Discuss which patients are at risk for Multiple Sclerosis Discuss the diagnostic criteria for

More information

Medication Policy Manual. Topic: Betaseron, Extavia, interferon beta-1b Date of Origin: June 18, 2004

Medication Policy Manual. Topic: Betaseron, Extavia, interferon beta-1b Date of Origin: June 18, 2004 Medication Policy Manual Policy No: dru108 Topic: Betaseron, Extavia, interferon beta-1b Date of Origin: June 18, 2004 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective

More information

Biogen Global Medical Grants Office Multiple Sclerosis: Areas of Interest

Biogen Global Medical Grants Office Multiple Sclerosis: Areas of Interest Biogen Global Medical Grants Office Multiple Sclerosis: Areas of Interest Cycle C June 2, 2015 1 Introduction The landscape for the treatment of relapsing Multiple Sclerosis (MS) has quickly evolved over

More information

Treatment guidelines for relapsing MS and the two step approach for disease modifying therapy

Treatment guidelines for relapsing MS and the two step approach for disease modifying therapy Treatment guidelines for relapsing MS and the two step approach for disease modifying therapy Klaus Schmierer, PhD FRCP Blizard Institute, Barts and The London School of Medicine & Dentistry Barts Health

More information

06/06/2012. The Impact of Multiple Sclerosis in the Pacific Northwest. James Bowen, MD. Swedish Neuroscience Institute

06/06/2012. The Impact of Multiple Sclerosis in the Pacific Northwest. James Bowen, MD. Swedish Neuroscience Institute The Impact of Multiple Sclerosis in the Pacific Northwest James Bowen, MD Multiple Sclerosis Center Multiple Sclerosis Center Swedish Neuroscience Institute 1 2 Motor Symptoms of MS Weakness Spasticity

More information

Multiple Sclerosis: a NZ Perspective. Dr Deborah Mason Neurologist Christchurch Hospital

Multiple Sclerosis: a NZ Perspective. Dr Deborah Mason Neurologist Christchurch Hospital Multiple Sclerosis: a NZ Perspective Dr Deborah Mason Neurologist Christchurch Hospital Multiple Sclerosis in NZ What is MS Epidemiology of MS in NZ Impact of the disease on PwMS Genetic and Environmental

More information

What is Multiple Sclerosis? Gener al information

What is Multiple Sclerosis? Gener al information What is Multiple Sclerosis? Gener al information Kim, diagnosed in 1986 What is MS? Multiple sclerosis (or MS) is a chronic, often disabling disease that attacks the central nervous system (brain and spinal

More information

43. MULTIPLE SCLEROSIS

43. MULTIPLE SCLEROSIS Guidelines to be followed by centres, services and units in order to be designated as Reference Centres, Services and Units of the National Health System, as agreed by the Interterritorial Board 43. MULTIPLE

More information

EMA and Progressive Multifocal Leukoencephalopathy.

EMA and Progressive Multifocal Leukoencephalopathy. EMA and Progressive Multifocal Leukoencephalopathy. ENCePP Plenary, London 23 November 2011 Presented by: Henry Fitt Head of Coordination & Networking, Pharmacovigilance & Risk Management An agency of

More information

Summary chapter 2 chapter 2

Summary chapter 2 chapter 2 Summary Multiple Sclerosis (MS) is a chronic disease of the brain and the spinal cord. The cause of MS is unknown. MS usually starts in young adulthood. In the course of the disease progression of neurological

More information

Optimization of treatment with interferon beta in multiple sclerosis. Usefulness of automatic system application criteria

Optimization of treatment with interferon beta in multiple sclerosis. Usefulness of automatic system application criteria Optimization of treatment with interferon beta in multiple sclerosis. Usefulness of automatic system application criteria AUTHORS Juan Luis Ruiz-Peña, Pablo Duque, and Guillermo Izquierdo Address: Unidad

More information

Ulf Kallweit, MD; Ilijas Jelcic, MD; Nathalie Braun, MD, PhD; Heike Fischer, MD; Björn Zörner,

Ulf Kallweit, MD; Ilijas Jelcic, MD; Nathalie Braun, MD, PhD; Heike Fischer, MD; Björn Zörner, Sustained efficacy of Natalizumab in the treatment of relapsing-remitting multiple sclerosis independent of disease activity and disability at baseline: real-life data from a Swiss cohort Ulf Kallweit,

More information

The cost of multiple sclerosis in Norway

The cost of multiple sclerosis in Norway Eur J Health Econ DOI 10.1007/s10198-010-0286-7 ORIGINAL PAPER The cost of multiple sclerosis in Norway B. Svendsen K.-M. Myhr H. Nyland J. H. Aarseth Received: 6 August 2009 / Accepted: 29 October 2010

More information

Advances towards Remote Assessment of Disease and Relapse in Multiple Sclerosis

Advances towards Remote Assessment of Disease and Relapse in Multiple Sclerosis Advances towards Remote Assessment of Disease and Relapse in Multiple Sclerosis Jane Rhodes March 31 st 2016 CAMD Digital Biomarkers Conference Baltimore, MD Emerging technology for the enhancement of

More information

Treatment Optimization in MS: When to Start, When to Shift, when to Stop

Treatment Optimization in MS: When to Start, When to Shift, when to Stop Treatment Optimization in MS: When to Start, When to Shift, when to Stop Mark S. Freedman MSc MD FAAN FANA FRCPC Director, Multiple Sclerosis Research Unit University of Ottawa Sr. Scientist, Ottawa Hospital

More information

Clinical Commissioning Policy: Disease Modifying Therapies For patients With Multiple Sclerosis (MS) December 2012. Reference : NHSCB/D4/c/1

Clinical Commissioning Policy: Disease Modifying Therapies For patients With Multiple Sclerosis (MS) December 2012. Reference : NHSCB/D4/c/1 Clinical Commissioning Policy: Disease Modifying Therapies For patients With Multiple Sclerosis (MS) December 2012 Reference : NHSCB/D4/c/1 NHS Commissioning Board Clinical Commissioning Policy: Disease

More information

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Update: MRI in Multiple sclerosis

Update: MRI in Multiple sclerosis Nyt indenfor MS ved MR Update: MRI in Multiple sclerosis Hartwig Roman Siebner Danish Research Centre for Magnetic Resonance (DRCMR) Copenhagen University Hospital Hvidovre Dansk Radiologisk Selskabs 10.

More information

MRI Case Studies: Multiple Sclerosis and MS Mimics

MRI Case Studies: Multiple Sclerosis and MS Mimics MRI Case Studies: Multiple Sclerosis and MS Mimics Jill Conway, MD, MA, MSCE Director, Carolinas MS Center Clerkship Director, UNCSOM-Charlotte Campus Charlotte, NC DISCLOSURES Speaking, consulting, and/or

More information

Conflict of Interest Declaration. Overview of New Medications for Multiple Sclerosis. Assessment Question. Objectives 4/1/2011

Conflict of Interest Declaration. Overview of New Medications for Multiple Sclerosis. Assessment Question. Objectives 4/1/2011 Conflict of Interest Declaration Overview of New Medications for Multiple Sclerosis I or my spouse have no actual or potential conflict of interest in relation to this activity. Crystal Obering, Pharm.D.,

More information

PCORI Workshop on Treatment for Multiple Sclerosis. Breakout Group Topics and Questions Draft 3-27-15

PCORI Workshop on Treatment for Multiple Sclerosis. Breakout Group Topics and Questions Draft 3-27-15 PCORI Workshop on Treatment for Multiple Sclerosis Breakout Group Topics and Questions Draft 3-27-15 Group 1 - Comparison across DMTs, including differential effects in subgroups Consolidated straw man

More information

25-hydroxyvitamin D: from bone and mineral to general health marker

25-hydroxyvitamin D: from bone and mineral to general health marker DIABETES 25 OH Vitamin D TOTAL Assay 25-hydroxyvitamin D: from bone and mineral to general health marker FOR OUTSIDE THE US AND CANADA ONLY Vitamin D Receptors Brain Heart Breast Colon Pancreas Prostate

More information

Natalizumab (Tysabri)

Natalizumab (Tysabri) Natalizumab (Tysabri) Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Natalizumab (Tysabri) Date of issue: July 2010 Review date: July 2011 Contents Section

More information

FastTest. You ve read the book... ... now test yourself

FastTest. You ve read the book... ... now test yourself FastTest You ve read the book...... now test yourself To ensure you have learned the key points that will improve your patient care, read the authors questions below. The answers will refer you back to

More information

Multiple Sclerosis in Practice. An Expert Commentary With Jeffrey Cohen, MD, PhD A Clinical Context Report

Multiple Sclerosis in Practice. An Expert Commentary With Jeffrey Cohen, MD, PhD A Clinical Context Report Multiple Sclerosis in Practice An Expert Commentary With Jeffrey Cohen, MD, PhD A Clinical Context Report Clinical Context: Multiple Sclerosis in Practice Expert Commentary Jointly Sponsored by: and Clinical

More information

Version History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author

Version History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields

More information

2.1 Who first described NMO?

2.1 Who first described NMO? History & Discovery 54 2 History & Discovery 2.1 Who first described NMO? 2.2 What is the difference between NMO and Multiple Sclerosis? 2.3 How common is NMO? 2.4 Who is affected by NMO? 2.1 Who first

More information

Progress in the field: therapeutic improvements for all patients?

Progress in the field: therapeutic improvements for all patients? Progress in the field: therapeutic improvements for all patients? Krzysztof Selmaj, Department of Neurology, Medical University of Lodz, PL Warsaw 15 May, 2015 Main features of MS Inflammation Demyelination

More information

GENETIC STUDIES OF AUTOIMMUNE DISEASES. Benedicte Alexandre Lie Institute of Immunology Rikshospitalet University Hospital

GENETIC STUDIES OF AUTOIMMUNE DISEASES. Benedicte Alexandre Lie Institute of Immunology Rikshospitalet University Hospital GENETIC STUDIES OF AUTOIMMUNE DISEASES Benedicte Alexandre Lie Institute of Immunology Rikshospitalet University Hospital Autoimmune diseases Affects approximately 5 % of the population Results from an

More information

Rational basis for early treatment in MS. Bonaventura Casanova Estruch Unitat d Esclerosi Múltiple Hospital Universitari la Fe València

Rational basis for early treatment in MS. Bonaventura Casanova Estruch Unitat d Esclerosi Múltiple Hospital Universitari la Fe València Rational basis for early treatment in MS Bonaventura Casanova Estruch Unitat d Esclerosi Múltiple Hospital Universitari la Fe València Bonaventura Casanova Department of Neurology University Hospital La

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Proposed Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Proposed Health Technology Appraisal Daclizumab for treating relapsing-remitting multiple Draft scope (pre-referral) Draft remit/appraisal objective To

More information

Recruitment Start date: April 2010 End date: Recruitment will continue until enrolment is fully completed

Recruitment Start date: April 2010 End date: Recruitment will continue until enrolment is fully completed Apitope study The study drug (ATX-MS-1467) is a new investigational drug being tested as a potential treatment for relapsing forms of multiple sclerosis (RMS). The term investigational drug means it has

More information

Big Data for Population Health and Personalised Medicine through EMR Linkages

Big Data for Population Health and Personalised Medicine through EMR Linkages Big Data for Population Health and Personalised Medicine through EMR Linkages Zheng-Ming CHEN Professor of Epidemiology Nuffield Dept. of Population Health, University of Oxford Big Data for Health Policy

More information

Vitamin D and MS. Gavin Giovannoni

Vitamin D and MS. Gavin Giovannoni Vitamin D and MS Gavin Giovannoni Latitude This article was published in McAlpine s Multiple Sclerosis 4 th edition. Compston A. ed. London Churchill Livingstone Elsevier 2006;55 Fig 1.33 Copyright Elsevier

More information

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required

More information

Economic Evaluation of Natalizumab (Tysabri) for the treatment of relapsing remitting multiple sclerosis that is rapidly evolving and severe or

Economic Evaluation of Natalizumab (Tysabri) for the treatment of relapsing remitting multiple sclerosis that is rapidly evolving and severe or Economic Evaluation of Natalizumab (Tysabri) for the treatment of relapsing remitting multiple sclerosis that is rapidly evolving and severe or sub-optimally treated Summary In January 2007 Biogen Idec

More information

Progress and Prospects in Ovarian Cancer Screening and Prevention

Progress and Prospects in Ovarian Cancer Screening and Prevention Progress and Prospects in Ovarian Cancer Screening and Prevention Rebecca Stone, MD MS Assistant Professor Kelly Gynecologic Oncology Service The Johns Hopkins Hospital 1 No Disclosures 4/12/2016 2 Ovarian

More information

Supplementary appendix

Supplementary appendix Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Gold R, Giovannoni G, Selmaj K, et al, for

More information

MEDICAL ASSISTANCE BULLETIN

MEDICAL ASSISTANCE BULLETIN ISSUE DATE May 11, 2015 SUBJECT EFFECTIVE DATE May 18, 2015 MEDICAL ASSISTANCE BULLETIN NUMBER *See below BY Prior Authorization of Multiple Sclerosis Agents Pharmacy Service Leesa M. Allen, Deputy Secretary

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website. It is provided for patients and healthcare professionals to increase the transparency of

More information

Advanced Multiple Sclerosis: Progressive MS Epidemiology

Advanced Multiple Sclerosis: Progressive MS Epidemiology Advanced Multiple Sclerosis: Progressive MS Epidemiology CMSC 2007-Washington, DC Mitchell T. Wallin, MD, MPH Associate Director-Clinical Care VA MS Center of Excellence-East East Associate Professor of

More information

Research Article The Communication of Multiple Sclerosis Diagnosis: The Patients Perspective

Research Article The Communication of Multiple Sclerosis Diagnosis: The Patients Perspective Multiple Sclerosis International Volume 2015, Article ID 353828, 7 pages http://dx.doi.org/10.1155/2015/353828 Research Article The Communication of Multiple Sclerosis Diagnosis: The Patients Perspective

More information

Clinical Trials of Disease Modifying Treatments

Clinical Trials of Disease Modifying Treatments MS CENTER CLINICAL RESEARCH The UCSF MS Center is an internationally recognized leader in multiple sclerosis clinical research. We conduct clinical trials involving the use of experimental treatments,

More information

CNS DEMYLINATING DISORDERS

CNS DEMYLINATING DISORDERS CNS DEMYLINATING DISORDERS Multiple sclerosis A Dutch saint named Lidwina, who died in 1433, may have been one of the first known MS patients. After she fell while ice skating, she developed symptoms such

More information

OHTAC Recommendation

OHTAC Recommendation OHTAC Recommendation Multiple Sclerosis and Chronic Cerebrospinal Venous Insufficiency Presented to the Ontario Health Technology Advisory Committee in May 2010 May 2010 Issue Background A review on the

More information

Understanding. Multiple Sclerosis. Tim, diagnosed in 2004.

Understanding. Multiple Sclerosis. Tim, diagnosed in 2004. Understanding Multiple Sclerosis Tim, diagnosed in 2004. What Is Multiple Sclerosis? Multiple sclerosis (MS) is a neurologic disorder that affects the central nervous system (CNS). The CNS includes the

More information

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 11, 2015 Next Review Date: December 2016 Effective Date: January

More information

Integrating New Treatments: A Case Based Approach

Integrating New Treatments: A Case Based Approach Integrating New Treatments: A Case Based Approach JILL CONWAY, MD, MA, MSCE DIRECTOR, MS CENTER DIRECTOR, NEUROLOGY CLERKSHIP AT UNCSOM- CHARLOTTE CAMPUS CAROLINAS HEALTHCARE CENTER Objectives Provide

More information

Summary HTA. Interferons and Natalizumab for Multiple Sclerosis Clar C, Velasco-Garrido M, Gericke C. HTA-Report Summary

Summary HTA. Interferons and Natalizumab for Multiple Sclerosis Clar C, Velasco-Garrido M, Gericke C. HTA-Report Summary Summary HTA HTA-Report Summary Interferons and Natalizumab for Multiple Sclerosis Clar C, Velasco-Garrido M, Gericke C Health policy background Multiple sclerosis (MS) is a chronic inflammatory disease

More information

Linking biobanks to registries: Why and how? Anne Barton

Linking biobanks to registries: Why and how? Anne Barton Linking biobanks to registries: Why and how? Anne Barton Biobanks why should we collect samples? Anti-TNF treatment in RA Cost approx. 8,000/person/year 30-40% RA patients do not respond Rare, serious

More information

Clinically isolated syndrome (CIS)

Clinically isolated syndrome (CIS) Clinically isolated syndrome (CIS) Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 We hope you find the information in this factsheet helpful. If you would

More information

Guidance for evaluation of new neurological symptoms in patients receiving TYSABRI

Guidance for evaluation of new neurological symptoms in patients receiving TYSABRI Guidance for evaluation of new neurological symptoms in patients receiving TYSABRI Background information Progressive multifocal leukoencephalopathy (PML) PML is a demyelinating disease that attacks the

More information

A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market

A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market Launch of Several Pipeline Oral Products Could Diminish the Market for Injectable Therapies NEC3-52 November 2014 Contents

More information

Original Policy Date

Original Policy Date MP 5.01.20 Tysabri (natalizumab) Medical Policy Section Prescription Drug Issue 12:2013 Original Policy Date 12:2013 Last Review Status/Date Local Policy/12:2013 Return to Medical Policy Index Disclaimer

More information

Multiple sclerosis information

Multiple sclerosis information Multiple sclerosis information for health and social care professionals MS: an overview Diagnosis Types of MS Prognosis A multidisciplinary approach to MS care Self-management Relapse and drug therapies

More information

Lemtrada (alemtuzumab)

Lemtrada (alemtuzumab) Lemtrada (alemtuzumab) Policy Number: 5.02.517 Last Review: 08/2015 Origination: 08/2015 Next Review: 08/2016 Policy BCBSKC will provide coverage for Lemtrada (alemtuzumab) when it is determined to be

More information

Multiple Sclerosis Therapeutics to 2019 - Treatment Diversification, Increasing Efficacy, and Pipeline Innovation Combine to Drive Growth

Multiple Sclerosis Therapeutics to 2019 - Treatment Diversification, Increasing Efficacy, and Pipeline Innovation Combine to Drive Growth Brochure More information from http://www.researchandmarkets.com/reports/2640803/ Multiple Sclerosis Therapeutics to 2019 - Treatment Diversification, Increasing Efficacy, and Pipeline Innovation Combine

More information

High Nationwide Incidence of Multiple Sclerosis in Sweden

High Nationwide Incidence of Multiple Sclerosis in Sweden High Nationwide Incidence of Multiple Sclerosis in Sweden Cecilia Ahlgren 1, Anders Odén 2, Jan Lycke 1 * 1 Department of Clinical Neuroscience and Rehabilitation, Institute of Neuroscience and Physiology,

More information

Natalizumab for the treatment of adults with highly active relapsing remitting multiple sclerosis

Natalizumab for the treatment of adults with highly active relapsing remitting multiple sclerosis Natalizumab for the treatment of adults with highly active relapsing remitting multiple sclerosis Premeeting briefing This briefing presents major issues arising from the manufacturer s submission, Evidence

More information

Version History. Previous Versions. for secondary progressive MS (SPMS) Policy Title. Drugs for MS.Drug facts box Interferon beta 1b

Version History. Previous Versions. for secondary progressive MS (SPMS) Policy Title. Drugs for MS.Drug facts box Interferon beta 1b Version History Policy Title Drugs for MS.Drug facts box Interferon beta 1b for secondary progressive MS (SPMS) Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review

More information

Relapsing Remitting Multiple Sclerosis Treated with Interferon Beta-1a: Immunological and Short-Term Brain Volume Changes

Relapsing Remitting Multiple Sclerosis Treated with Interferon Beta-1a: Immunological and Short-Term Brain Volume Changes Relapsing Remitting Multiple Sclerosis Treated with Interferon Beta-1a: Immunological and Short-Term Brain Volume Changes MG Dwyer, 1 R Zivadinov, 1 Y Tao, 2 X Zhang, 2 C Kennedy, 1 N Bergsland, 1 D Ramasamy,

More information

CBT IN THE CITY. adjusted to the news of being with MS? April 2013. Experts at your fingertips call now. Check out our new services in you local area

CBT IN THE CITY. adjusted to the news of being with MS? April 2013. Experts at your fingertips call now. Check out our new services in you local area April 2013 Experts at your fingertips call now CBT IN THE CITY Check out our new services in you local area contents. A message from Susie, Information Multiple Sclerosis CBT can make a difference on the

More information

Vitamin D. Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353

Vitamin D. Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Vitamin D Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Vitamin D Date of issue: February 2010 Review date: February 2011 Contents 1. Introduction 1 2.

More information

Multiple Sclerosis: A Rehabilitation Perspective

Multiple Sclerosis: A Rehabilitation Perspective Multiple Sclerosis: A Rehabilitation Perspective MICHELLE H. CAMERON, MD, PT Department of Neurology OHSU & Portland VA TED R. BROWN, MD, MPH Evergreen HealthCare 2012 Disclosures Dr Cameron: Has received

More information

INTERNAL MEDICINE - PEDIATRICS

INTERNAL MEDICINE - PEDIATRICS Rev. Med. Chir. Soc. Med. Nat., Iaşi 2013 vol. 118, no. 1 INTERNAL MEDICINE - PEDIATRICS UPDATES MULTIPLE SCLEROSIS AND PREGNANCY C. D. Popescu University of Medicine and Pharmacy Grigore T. Popa - Iaşi

More information

Donna Graves, M.D. Assistant Professor University of Texas Southwestern Multiple Sclerosis Clinic

Donna Graves, M.D. Assistant Professor University of Texas Southwestern Multiple Sclerosis Clinic Donna Graves, M.D. Assistant Professor University of Texas Southwestern Multiple Sclerosis Clinic I have received honoraria from Teva pharmaceuticals, Novartis, and Bayer pharmaceuticals. Obtaining CME

More information

Measurement Issues in Short Term Clinical Trials. Brian Healy, PhD

Measurement Issues in Short Term Clinical Trials. Brian Healy, PhD Measurement Issues in Short Term Clinical Trials Brian Healy, PhD Overview n In order to iden>fy treatment effects or predictors of disease course, measurement of disease course is required n Although

More information

National Cancer Institute Research on Childhood Cancers. In the United States in 2005, approximately 9,510 children under age 15 will be

National Cancer Institute Research on Childhood Cancers. In the United States in 2005, approximately 9,510 children under age 15 will be CANCER FACTS N a t i o n a l C a n c e r I n s t i t u t e N a t i o n a l I n s t i t u t e s o f H e a l t h D e p a r t m e n t o f H e a l t h a n d H u m a n S e r v i c e s National Cancer Institute

More information

Critical Illness Claim - Physician s Statement Multiple Sclerosis

Critical Illness Claim - Physician s Statement Multiple Sclerosis AVIVA LTD 4 Shenton Way #01-01, SGX Centre 2, Singapore 068807 Telephone: 6827 7988 Fax: 6827 7900 Company Reg. No. 196900499K Critical Illness Claim - Physician s Statement Multiple Sclerosis SECTION

More information

Decisions relating to Multiple Sclerosis treatments

Decisions relating to Multiple Sclerosis treatments 10 October 2014 Decisions relating to Multiple Sclerosis treatments PHARMAC is pleased to announce that, from 1 November 2014, it will: list fingolimod (Gilenya); list natalizumab (Tysabri); and change

More information

FSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies

FSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies FSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies Raymond A. Huml, MS, DVM, RAC Executive Director, Head, Global Biosimilars Business Development and Strategic Planning, Quintiles

More information

Committee Approval Date: December 12, 2014 Next Review Date: December 2015

Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Medication Policy Manual Policy No: dru299 Topic: Tecfidera, dimethyl fumarate Date of Origin: May 16, 2013 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Genzyme s Multiple Sclerosis Franchise Featured at AAN

Genzyme s Multiple Sclerosis Franchise Featured at AAN PRESS RELEASE Genzyme s Multiple Sclerosis Franchise Featured at AAN - Multiple Presentations Highlight Continuing Progress of AUBAGIO and LEMTRADA Programs - Paris, France March 13, 2013 Sanofi (EURONEXT:

More information

Oxford University Hospitals. NHS Trust. Department of Neurology Natalizumab (Tysabri) for Multiple Sclerosis. Information for patients

Oxford University Hospitals. NHS Trust. Department of Neurology Natalizumab (Tysabri) for Multiple Sclerosis. Information for patients Oxford University Hospitals NHS Trust Department of Neurology Natalizumab (Tysabri) for Multiple Sclerosis Information for patients page 2 What is Natalizumab and what is it used for? Natalizumab is an

More information

Prospects for Vaccines against Hepatitis C Viruses. T. Jake Liang. M.D. Liver Diseases Branch NIDDK, NIH, HHS

Prospects for Vaccines against Hepatitis C Viruses. T. Jake Liang. M.D. Liver Diseases Branch NIDDK, NIH, HHS Prospects for Vaccines against Hepatitis C Viruses T. Jake Liang. M.D. Liver Diseases Branch NIDDK, NIH, HHS HCV Vaccine Prevention strategies Protective immunity Barriers and solutions Vaccine candidates

More information

Fasting Serum Triglycerides Predict New Onset Diabetes Mellitus Independent of Physical Fitness

Fasting Serum Triglycerides Predict New Onset Diabetes Mellitus Independent of Physical Fitness Fasting Serum Triglycerides Predict New Onset Diabetes Mellitus Independent of Physical Fitness A 35 year follow-up of apparently healthy men Per Torger Skretteberg, MD (1), Anette Nordeide Grytten (2),

More information

Innovation Platform: Sudden Cardiac Death

Innovation Platform: Sudden Cardiac Death Innovation Platform: Sudden Cardiac Death Prof. dr. Bart Loeys CRC Antwerp General Assembly VzW Board of Directors Strategic Advisory Board Staff: 1 executive director 1 ICT manager 1 financial administration

More information

Ontario Reimburses CIS Indication for REBIF, a First-Line Treatment for Multiple Sclerosis

Ontario Reimburses CIS Indication for REBIF, a First-Line Treatment for Multiple Sclerosis May 25, 2015 Contact: Shikha Virdi 905-919-0200 ext. 5504 Ontario Reimburses CIS Indication for REBIF, a First-Line Treatment for Multiple Sclerosis Rebif now reimbursed under Ontario Drug Benefit Program

More information

PCORI Scientific Program Area: Assessment of Prevention, Diagnosis and Treatment Options

PCORI Scientific Program Area: Assessment of Prevention, Diagnosis and Treatment Options Research Prioritization Topic Brief Topic 18: Multiple Sclerosis Comparative effectiveness of treatment programs for recurring/remitting multiple sclerosis (MS). PCORI Scientific Program Area: Assessment

More information

Supplementary Online Content

Supplementary Online Content Supplementary Online Content Burt RK, Balabanov R, Han X, et al. Association of nonmyeloablative hematopoietic stem cell transplantation with neurological disability in patients with relapsing-remitting

More information

Autoimmunity and immunemediated. FOCiS. Lecture outline

Autoimmunity and immunemediated. FOCiS. Lecture outline 1 Autoimmunity and immunemediated inflammatory diseases Abul K. Abbas, MD UCSF FOCiS 2 Lecture outline Pathogenesis of autoimmunity: why selftolerance fails Genetics of autoimmune diseases Therapeutic

More information

MS Treatments Gilenya

MS Treatments Gilenya 1 MSology Essentials Series Gilenya (fingolimod) Developed by MSology with the invaluable assistance of multiple sclerosis nurse advisors: Trudy Campbell Dalhousie MS Research Unit, Capital Health, Halifax,

More information

Key words: Vitamin D Production, Vitamin D Deficiency, and Vitamin D Treatment

Key words: Vitamin D Production, Vitamin D Deficiency, and Vitamin D Treatment Title: Vitamin D Author: Kerry Lynn Kuffenkam Date: 4-29-09 Key words: Vitamin D Production, Vitamin D Deficiency, and Vitamin D Treatment Abstract: Since the term Vitamin D contains the word vitamin most

More information

Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence

Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence 1.0 Abstract Title Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients with Psoriasis Severe or Moderate with Adalimumab Treatment (TOGETHER). Keywords Psoriasis,

More information