Supplementary Online Content

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Supplementary Online Content"

Transcription

1 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 multiple sclerosis. JAMA. doi: /jama etable. Comparison of Expanded Disability Status Scale (EDSS), Neurologic Rating Scale (NRS), and Multiple Sclerosis Functional Composite (MSFC) Score efigure 1. Total T2 Lesion Burden in Brain Pretransplant Compared With Last Posttranplant MRI efigure 2. Effect of Type of MS, Disease Duration, and Transplant Hospitalization Fever on Pre- and Posttransplant Neurologic Disability This supplementary material has been provided by the authors to give readers additional information about their work.

2 etable. Comparison of Expanded Disability Status Scale (EDSS), Neurologic Rating Scale (NRS), and Multiple Sclerosis Functional Composite (MSFC) Score Scale Level of measurement Disablement domain ordinal impairment / disability NRS # ordinal impairment 22 items based on the neurological examination MSFC & interval impairment / (continuous) disability Components Range Meaningful change eight functional systems 0 (normal status) -10 (death due 1 point in the combined with to MS) lower part of the assessment of scale (0-5.5) and ambulation (walking up 0.5 point in the to 500 meters) upper parts of the scale ( ) 100 (normal) to 0 (very impaired) 10 points arm function (9-Hole Peg Test), leg function (25- Foot walk) and cognitive (Faced Auditory Serial Addition Test). Individual scores are combined to create a single score (Z-Score) that can be used to detect change over time N/A The Z-score is a standardized number representing how close a test result is to the mean of a standard or reference population to which the result is compared. It is expressed in units of standard deviation. The Z-score is obtained by subtracting the mean of the reference population from the test result and then dividing by the standard deviation of the reference population. A Z-score of 0 means the score is the same as the mean. A Z-score can also be positive or negative, indicating improvement or worsening relation to baseline 20% change Abbreviations: EDSS, Expanded Disability Status Scale; MSFC, Multiple Sclerosis Functional Composite; N/A, not applicable; NRS, Neurologic Rating Scale.

3 @ Kurtzke J F. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology, 1983; 33: # Sipe JC, Knobler RL, Braheny SL, Rice GP, Panitch HS, Oldstone MB. A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology 1984, 34: & Fischer JS, Rudick RA, Cutter GR, Reingold SC. The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Multiple Sclerosis 1999, 5:

4 efigure 1. Total T2 Lesion Burden in Brain Pretransplant Compared With Last Posttransplant MRI Abbreviation: T2LV, T2-weighted lesion volume. Each vertical line represents T2LV in pretransplant MRI (solid diamond) compared with T2LV on last posttransplant MRI (end of straight line) for a single patient.

5 efigure 2. Effect of Type of MS, Disease Duration, and Transplant Hospitalization Fever on Pre- and Posttransplant Neurologic Disability EDSS versus RRMS or SPMS RRMS SPMS EDSS EDSS mo 1 yr 2yr 3yr 4yr 5yr SPMS n= RRMS n= EDSS vs pre HSCT disease duration < or = 120 mo > 120 mo 0 6 mo 1 yr 2 yr 3 yr 4 yr 5 yr > 120 mo n= < 120 mo n= EDSS Fever during HSCT versus EDSS < or = 38 > mo 1 yr 2 yr 3 yr 4 yr 5 yr > 38.5 n= <38 n= Time zero is pre-transplant values. Values are mean EDSS. Vertical lines represent 95% confidence intervals. Fever is in degree Celsius (data only on patients with fever < C or >

6 C), EDSS = Expanded Disability Status Scale, HSCT = hematopoietic stem cell transplantation, mo = months, RRMS = relapsing remitting multiple sclerosis, SPMS = secondary progressive multiple sclerosis, yr = years

A New MS Consortium for A New MS Clinical Outcome Measure

A New MS Consortium for A New MS Clinical Outcome Measure A New MS Consortium for A New MS Clinical Outcome Measure Nicholas G. LaRocca, Ph.D. Richard Rudick, M.D. Lynn Hudson, Ph.D. Co-Directors, MSOAC American Academy of Neurology March 20 th, 2013 The problem

More information

Sensitive and reproducible clinical rating

Sensitive and reproducible clinical rating CLINICAL AND MRI MARKERS OF MS DISEASE PROGRESSION * Richard A. Rudick, MD ABSTRACT Sensitive and reproducible measures of multiple sclerosis (MS) severity and progression are important in the treatment

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

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

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

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

Immunoablative therapy with autologous hematopoietic stem cell transplantation in the treatment of poor risk multiple sclerosis

Immunoablative therapy with autologous hematopoietic stem cell transplantation in the treatment of poor risk multiple sclerosis Immunoablative therapy with autologous hematopoietic stem cell transplantation in the treatment of poor risk multiple sclerosis T Kozák, P Lhotáková Department of Clinical Haematology, 3r d School of Medicine,

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 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

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

Disease Modifying Therapies (DMTs) in Multiple Sclerosis

Disease Modifying Therapies (DMTs) in Multiple Sclerosis Disease Modifying Therapies (DMTs) in Multiple Sclerosis Gary Stobbe, MD Medical Director, MS Project ECHO Clinical Assistant Professor, UW Neurology Conflict of Interest Dr. Stobbe has no conflicts of

More information

transplantation with neurological disability and other clinical outcomes in patients with MS.

transplantation with neurological disability and other clinical outcomes in patients with MS. Research Preliminary Communication Association of Nonmyeloablative Hematopoietic Stem Cell Transplantation With Neurological Disability in Patients With Relapsing-Remitting Multiple Sclerosis Richard K.

More information

NHS BOURNEMOUTH AND POOLE AND NHS DORSET

NHS BOURNEMOUTH AND POOLE AND NHS DORSET NHS BOURNEMOUTH AND POOLE AND NHS DORSET COMMISSIONING STATEMENT ON THE USE OF BETA-INTERFERON IN RELAPSING-REMITTING MULTIPLE SCLEROSIS OR SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS, WHERE RELAPSES ARE

More information

Issues Regarding Use of Placebo in MS Drug Trials. Peter Scott Chin, MD Novartis Pharmaceuticals Corporation

Issues Regarding Use of Placebo in MS Drug Trials. Peter Scott Chin, MD Novartis Pharmaceuticals Corporation Issues Regarding Use of Placebo in MS Drug Trials Peter Scott Chin, MD Novartis Pharmaceuticals Corporation Context of the Guidance The draft EMA Guidance mentions placebo as a comparator for superiority

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

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

Study Design. Date: March 11, 2003 Reviewer: Jawahar Tiwari, Ph.D. Ellis Unger, M.D. Ghanshyam Gupta, Ph.D. Chief, Therapeutics Evaluation Branch

Study Design. Date: March 11, 2003 Reviewer: Jawahar Tiwari, Ph.D. Ellis Unger, M.D. Ghanshyam Gupta, Ph.D. Chief, Therapeutics Evaluation Branch BLA: STN 103471 Betaseron (Interferon β-1b) for the treatment of secondary progressive multiple sclerosis. Submission dated June 29, 1998. Chiron Corp. Date: March 11, 2003 Reviewer: Jawahar Tiwari, Ph.D.

More information

Managing Relapsing Remitting MS Risks & benefits of emerging therapies. Dr Mike Boggild The Walton Centre

Managing Relapsing Remitting MS Risks & benefits of emerging therapies. Dr Mike Boggild The Walton Centre Managing Relapsing Remitting MS Risks & benefits of emerging therapies Dr Mike Boggild The Walton Centre MS: Facts and figures Affects 1 in 800 in the UK Commonest cause of acquired neurological disability

More information

New perception of disability including cognition, fatigue, pain and other impairments related to MS

New perception of disability including cognition, fatigue, pain and other impairments related to MS New perception of disability including cognition, fatigue, pain and other impairments related to MS Diego Cadavid, MD Director, MS Clinical Development Biogen Idec 1 Need for clarity on terminology for

More information

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

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

More information

Laquinimod Polman, C. et al. Neurology 2005;64:987-991

Laquinimod Polman, C. et al. Neurology 2005;64:987-991 Laquinimod Polman, C. et al. Neurology 2005;64:987-991 Multicenter, double-blind, randomized trial, patients with RR MS received 0.1 mg or 0.3 mg laquinimod or placebo as three daily tablets for 24 weeks

More information

Personalised Medicine in MS

Personalised Medicine in MS Personalised Medicine in MS Supportive Evidence from Therapeutic Trials Ludwig Kappos Neurology and Department of Biomedicine University Hospital CH-4031 Basel LKappos@uhbs.ch Established partially effective

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

Supplementary webappendix

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

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

SammyJo s MS-LDN Timeline

SammyJo s MS-LDN Timeline SammyJo s MS-LDN Timeline Better 1 Stop all other meds 4/4 2 EDSS Disability Scale 3 3 3.5 3.5 3.5 3.5 4 4 4 4 4.5 5 5_ 6 7 8 Start LDN 2/4 6.5 7 9 Worse 1 Steroids Copaxone Novan trone Avonex Steroid

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

Immunex Corporation Novantrone (Mitoxantrone HCL) P&CNS Advisory Committee Briefing Document. Page 020

Immunex Corporation Novantrone (Mitoxantrone HCL) P&CNS Advisory Committee Briefing Document. Page 020 Page 020 4.0 Efficacy of Mitoxantrone in Multiple Sclerosis The efficacy of mitoxantrone in MS was demonstrated in two well-designed, randomized trials: Studies 901 and 902. The study design and efficacy

More information

NCRM Clinical Trial on MS. Michael Gilkey, MBA, MS Acting Executive Director

NCRM Clinical Trial on MS. Michael Gilkey, MBA, MS Acting Executive Director NCRM Clinical Trial on MS Michael Gilkey, MBA, MS Acting Executive Director MS MSC Clinical Trial Study Design: Investigator-run, open-label, Phase 1 safety study Treatment: Up to 2 x 106 cells per kg

More information

Interferons (Avonex, Betaferon, Rebif ) for relapsing remitting multiple sclerosis (RRMS)

Interferons (Avonex, Betaferon, Rebif ) for relapsing remitting multiple sclerosis (RRMS) Interferons (Avonex, Betaferon, Rebif ) for relapsing remitting multiple sclerosis (RRMS) Review Question: What happens when people with RRMS take interferons? The short answer: This review found that

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

Development of a multiple sclerosis functional composite as a clinical trial outcome measure

Development of a multiple sclerosis functional composite as a clinical trial outcome measure Brain (1999), 122, 871 882 Development of a multiple sclerosis functional composite as a clinical trial outcome measure Gary R. Cutter, 1 Monika L. Baier, 1 Richard A. Rudick, 2 Diane L. Cookfair, 3 Jill

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

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

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 15 September 2005 Doc. Ref. EMEA/CHMP/EWP/561/98 Rev 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT

More information

There are currently 4 US Food and Drug

There are currently 4 US Food and Drug DISEASE-MODIFYING THERAPIES IN RELAPSING-REMITTING MULTIPLE SCLEROSIS* Benjamin M. Greenberg, MD, MHS ABSTRACT Four major disease-modifying therapies are discussed within the context of relapsing and remitting

More information

Survey of 267 Patients Using Low Dose Naltrexone for Multiple Sclerosis

Survey of 267 Patients Using Low Dose Naltrexone for Multiple Sclerosis Survey of 267 Patients Using Low Dose Naltrexone for Multiple Sclerosis Summary In order to stimulate interest among other academic researchers in LDN trials for MS, an online patient tracking system has

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

Patients with confirmed relapse 111 26 (23.4 %) 104 16 (15.4 %) 1.52 [0.87; 2.67] p = 0.143 Probability of a relapse by week 96

Patients with confirmed relapse 111 26 (23.4 %) 104 16 (15.4 %) 1.52 [0.87; 2.67] p = 0.143 Probability of a relapse by week 96 Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in

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

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

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

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

SECTION 2. Section 2 Multiple Sclerosis (MS) Drug Coverage

SECTION 2. Section 2 Multiple Sclerosis (MS) Drug Coverage SECTION 2 Multiple Sclerosis (MS) Drug Coverage Section 2 Multiple Sclerosis (MS) Drug Coverage ALBERTA HEALTH AND WELLNESS DRUG BENEFIT LIST Selected Drug Products used in the treatment of patients with

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

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

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

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

LONG TERM HYPERBARIC OXYGENATION (HBO) RETARDS PROGRESSION IN MULTIPLE SCLEROSIS PATIENTS

LONG TERM HYPERBARIC OXYGENATION (HBO) RETARDS PROGRESSION IN MULTIPLE SCLEROSIS PATIENTS LONG TERM HYPERBARIC OXYGENATION (HBO) RETARDS PROGRESSION IN MULTIPLE SCLEROSIS PATIENTS Abstract: Analysis of703 MS patients showed that 300 HBO treatments (about one treatment a fortnight over 10-13

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

RELAPSE MANAGEMENT. Pauline Shaw MS Nurse Specialist 25 th June 2010

RELAPSE MANAGEMENT. Pauline Shaw MS Nurse Specialist 25 th June 2010 RELAPSE MANAGEMENT Pauline Shaw MS Nurse Specialist 25 th June 2010 AIMS OF SESSION Relapsing/Remitting MS Definition of relapse/relapse rate Relapse Management NICE Guidelines Regional Clinical Guidelines

More information

Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients

Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients 2005; 11: 626 /634 www.multiplesclerosisjournal.com Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients RA Rudick*,1, GR Cutter 2, M Baier 3, B Weinstock-Guttman

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

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

- Patients treated with alemtuzumab in CARE-MS II were more than twice as likely to experience disability improvement compared to Rebif -

- Patients treated with alemtuzumab in CARE-MS II were more than twice as likely to experience disability improvement compared to Rebif - PRESS RELEASE Significant Improvement in Disability Scores Observed in Multiple Sclerosis Patients Who Received Lemtrada TM* (Alemtuzumab) Compared With Rebif in Phase lll Trial - Patients treated with

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

Imaging Spinal Cord in MS: Current Practice & Future Directions

Imaging Spinal Cord in MS: Current Practice & Future Directions Imaging Spinal Cord in MS: Current Practice & Future Directions Robert T. Naismith, MD Washington University St. Louis, MO PVA Summit 2013 Disclosures Dr. Simon has nothing to disclose. Dr. Naismith has

More information

Progress in MS: Current and Emerging Therapies

Progress in MS: Current and Emerging Therapies Progress in MS: Current and Emerging Therapies Presented by: Dr. Kathryn Giles, MD MSc FRCPC The MS Society gratefully acknowledges the grant received from Biogen Idec Canada, which makes possible the

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency London, 16 November 2006 Doc. Ref. CPMP/EWP/561/98 Rev. 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE

More information

Coping with Symptoms of Multiple Sclerosis

Coping with Symptoms of Multiple Sclerosis Coping with Symptoms of Multiple Sclerosis Josée Poirier B. Sc. Nursing, MSCN Outline What Is a Pseudo exacerbation? Awareness Advancement of Treatments Treatment of Symptoms Uhthoff s Phenomenon What

More information

Interferons (Avonex, Betaferon, Rebif ) for secondary progressive multiple sclerosis (SPMS)

Interferons (Avonex, Betaferon, Rebif ) for secondary progressive multiple sclerosis (SPMS) Interferons (Avonex, Betaferon, Rebif ) for secondary progressive multiple sclerosis (SPMS) Review Question: What happens when people with SPMS take interferons? The short answer: This review found that

More information

Clinical trials of multiple sclerosis monitored with enhanced MRI: new sample size calculations based on large data sets

Clinical trials of multiple sclerosis monitored with enhanced MRI: new sample size calculations based on large data sets 494 J Neurol Neurosurg Psychiatry 21;7:494 499 Clinical trials of multiple sclerosis monitored with enhanced MRI: new sample size calculations based on large data sets M P Sormani, D H Miller, G Comi,

More information

How to evaluate medications in Multiple Sclerosis when placebo controlled RCTs are not feasible

How to evaluate medications in Multiple Sclerosis when placebo controlled RCTs are not feasible University of Florence Dept. of Neurosciences Careggi University Hospital Dept of Neurosciences How to evaluate medications in Multiple Sclerosis when placebo controlled RCTs are not feasible Luca Massacesi,

More information

Review Date: March 2012. Issue Status: Approved Issue No: 2 Issue Date: March 2010

Review Date: March 2012. Issue Status: Approved Issue No: 2 Issue Date: March 2010 Title: Multiple Sclerosis guidelines for the use of beta-interferon, glatiramer acetate, natalizumab, mitoxantrone and other disease Authors Name: Dr P Talbot Contact Name: Dr Paul Talbot Contact Phone

More information

Approved Beta Interferons in Relapsing-Remitting Multiple sclerosis: Is There an Odd One Out?

Approved Beta Interferons in Relapsing-Remitting Multiple sclerosis: Is There an Odd One Out? Journal of Central Nervous System Disease Review Open Access Full open access to this and thousands of other papers at http://www.la-press.com. Approved Beta Interferons in Relapsing-Remitting Multiple

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

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

LONG-TERM BENEFITS OF EARLY TREATMENT IN MULTIPLE SCLEROSIS: AN INVESTIGATION UTILIZING A NOVEL DATA COLLECTION TECHNIQUE DEVON S. CONWAY, M.D.

LONG-TERM BENEFITS OF EARLY TREATMENT IN MULTIPLE SCLEROSIS: AN INVESTIGATION UTILIZING A NOVEL DATA COLLECTION TECHNIQUE DEVON S. CONWAY, M.D. LONG-TERM BENEFITS OF EARLY TREATMENT IN MULTIPLE SCLEROSIS: AN INVESTIGATION UTILIZING A NOVEL DATA COLLECTION TECHNIQUE by DEVON S. CONWAY, M.D. Submitted in partial fulfillment of the requirements For

More information

Clinical Department of Neurology, Innsbruck Medical University, Austria 1

Clinical Department of Neurology, Innsbruck Medical University, Austria 1 CHAPTER 6 LEVEL S OF SERUM IGM ANTIBODY AGAINST NATIVE REFOLDED MOG PREDICT RESPONSIVENESS TO CORTICOSTEROIDS FOR TRE ATMENT OF ACUTE MULTIPLE SCLEROSIS REL APSES Michael Khalil 1, Bettina Kuenz, Andreas

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

My MS prog-blog. The ezine for people with progressive MS Issue 2, June/ July 2015

My MS prog-blog. The ezine for people with progressive MS Issue 2, June/ July 2015 My MS prog-blog The ezine for people with progressive MS Issue 2, June/ July 2015 Hello and welcome to the second edition of my new free ezine for progressive MSers. My name is Ian Cook. I m an MSer from

More information

Held, Heigenhauser, Shang, Kappos, Polman: Predicting the On-Study Relapse Rate for Multiple Sclerosis Patients in Clinical Trials

Held, Heigenhauser, Shang, Kappos, Polman: Predicting the On-Study Relapse Rate for Multiple Sclerosis Patients in Clinical Trials Held, Heigenhauser, Shang, Kappos, Polman: Predicting the On-Study Relapse Rate for Multiple Sclerosis Patients in Clinical Trials Sonderforschungsbereich 386, Paper 430 (2005) Online unter: http://epub.ub.uni-muenchen.de/

More information

National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook

National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook National MS Society Information Sourcebook www.nationalmssociety.org/sourcebook Chemotherapy The literal meaning of the term chemotherapy is to treat with a chemical agent, but the term generally refers

More information

Using the MS Clinical Course Descriptions in Clinical Practice

Using the MS Clinical Course Descriptions in Clinical Practice Using the MS Clinical Course Descriptions in Clinical Practice Mark J. Tullman, MD Director of Clinical Research The MS Center for Innovations in Care Missouri Baptist Medical Center Disclosures Consultant/speaking

More information

Alemtuzumab for treating relapsing-remitting multiple sclerosis

Alemtuzumab for treating relapsing-remitting multiple sclerosis Alemtuzumab for treating relapsing-remitting multiple Issued: May 2014 guidance.nice.org.uk/ta NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE to produce technology

More information

Copaxone for multiple sclerosis (RRMS)

Copaxone for multiple sclerosis (RRMS) Copaxone for multiple sclerosis (RRMS) Review Question: What is the effect of Copaxone in people with RRMS and SPMS/PPMS? The short answer: The research suggests that for people with RRMS and SPMS/PPMS,

More information

Commissioning Policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS).

Commissioning Policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS). Commissioning Policy: Disease Modifying Therapies for patients with Multiple Sclerosis (MS). Reference No: Version: 1 Ratified by: EMSCGP029V1 EMSCG Board Date ratified: 25/09/2009 Name of originator/author:

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

Stage A & C Sample Data Collection Form

Stage A & C Sample Data Collection Form Stage A & C Sample Data Collection Form Instructions: Review a minimum of 20 patient charts (or another number determined to be appropriate) from patients most recently admitted, and complete this Data

More information

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background:

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background: 1.0 Abstract Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA Keywords Rationale and Background: This abbreviated clinical study report is based on a clinical surveillance

More information

New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents

New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents William Tyor, M.D. Chief, Neurology Atlanta VA Medical Center Professor, Department of Neurology Emory University School of Medicine

More information

The New England Journal of Medicine

The New England Journal of Medicine The New England Journal of Medicine Copyright, 2, by the Massachusetts Medical Society VOLUME 343 N OVEMBER 16, 2 NUMBER 2 RELAPSES AND PROGRESSION OF DISABILITY IN MULTIPLE SCLEROSIS CHRISTIAN CONFAVREUX,

More information

Multiple Sclerosis: An imaging review and update on new treatments.

Multiple Sclerosis: An imaging review and update on new treatments. Multiple Sclerosis: An imaging review and update on new treatments. Dr Marcus Likeman Consultant Neuroradiologist North Bristol NHS Trust Bristol Royal Hospital for Children MRI appearances - White Matter

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

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

PROCEEDINGS TREATING RELAPSING-REMITTING MULTIPLE SCLEROSIS II: STRATEGIES FOR PATIENTS NOT RESPONDING TO PRIMARY TREATMENTS *

PROCEEDINGS TREATING RELAPSING-REMITTING MULTIPLE SCLEROSIS II: STRATEGIES FOR PATIENTS NOT RESPONDING TO PRIMARY TREATMENTS * TREATING RELAPSING-REMITTING MULTIPLE SCLEROSIS II: STRATEGIES FOR PATIENTS NOT RESPONDING TO PRIMARY TREATMENTS * Jeffrey L. Bennett, MD, PhD ABSTRACT Many patients with multiple sclerosis (MS) will eventually

More information

ORIGINAL CONTRIBUTION. Effects of Interferon Beta-1b on Black Holes in Multiple Sclerosis Over a 6-Year Period With Monthly Evaluations

ORIGINAL CONTRIBUTION. Effects of Interferon Beta-1b on Black Holes in Multiple Sclerosis Over a 6-Year Period With Monthly Evaluations ORIGINAL CONTRIBUTION Effects of Interferon Beta-1b on Black Holes in Multiple Sclerosis Over a 6-Year Period With Monthly Evaluations Francesca Bagnato, MD; Shiva Gupta, BA; Nancy D. Richert, MD, PhD;

More information

News on modifying diseases therapies. Michel CLANET CHU Toulouse France ECTRIMS

News on modifying diseases therapies. Michel CLANET CHU Toulouse France ECTRIMS News on modifying diseases therapies Michel CLANET CHU Toulouse France ECTRIMS Current treatment strategies Future oral treatments Future non oral treatments Drug safety and risks CIS at risk of MS Active

More information

Voting for your top research questions Survey

Voting for your top research questions Survey MS Priority Setting Partnership Voting for your top research questions Survey Prioritising important research questions for multiple sclerosis a partnership between people affected by MS and healthcare

More information

Which injectable medication should I take for relapsing-remitting multiple sclerosis?

Which injectable medication should I take for relapsing-remitting multiple sclerosis? Which injectable medication should I take for relapsing-remitting multiple sclerosis? A decision aid to discuss options with your doctor This decision aid is for you if you: Have multiple sclerosis Have

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

For a full list of MS Trust publications, to sign up for Open Door and much more visit our website at www.mstrust.org.uk

For a full list of MS Trust publications, to sign up for Open Door and much more visit our website at www.mstrust.org.uk Stem cell therapy We hope you find the information in this factsheet helpful. If you would like to speak with someone about any aspect of MS, contact the MS Trust information team and they will help find

More information

AUBAGIO (teriflunomide) oral tablet

AUBAGIO (teriflunomide) oral tablet AUBAGIO (teriflunomide) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy

More information

MSTAC Initial Application

MSTAC Initial Application MSTAC Initial Application Please send applications to: Facsimile 04 916 7571 Further Contact Details: Address The Co-ordinator MSTAC PHARMAC P O Box 10-254 WELLINGTON Phone 04 460 4990 Email mstaccoordinator@pharmac.govt.nz

More information

Haematopoietic stem cell transplantation in MS

Haematopoietic stem cell transplantation in MS jan fagius, neurologkliniken Haematopoietic ti stem cell transplantation in MS Living with MS: Today and tomorrow, Göteborg Oct 12, 2010 Jan Fagius, Dept of Neurology Akademiska sjukhuset / University

More information

Autologous non-myeloablative hematopoietic stem cell transplantation for

Autologous non-myeloablative hematopoietic stem cell transplantation for Autologous non-myeloablative hematopoietic stem cell transplantation for relapsing-remitting multiple sclerosis Richard K Burt MD 1, Yvonne Loh MD 1, Bruce Cohen MD 2, Dusan Stefosky MD 3, Roumen Balabanov

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

More information

Mellen Center Approaches: Identifying and managing cognitive disorders in MS

Mellen Center Approaches: Identifying and managing cognitive disorders in MS Mellen Center Approaches: Identifying and managing cognitive disorders in MS Framework: Cognitive dysfunction is common in the MS population. It affects quality of life and correlates with worsened disease

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

N Tubridy, H J Ader, F Barkhof, A J Thompson, D H Miller

N Tubridy, H J Ader, F Barkhof, A J Thompson, D H Miller 50 J Neurol Neurosurg Psychiatry 1998;64:50 55 Exploratory treatment trials in multiple sclerosis using MRI: sample size calculations for relapsing-remitting and secondary progressive subgroups using placebo

More information