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



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

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

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

Progress in MS: Current and Emerging Therapies

Growth in revenue from MS drugs has been driven largely by price increases over the last several years.

Understanding How Existing and Emerging MS Therapies Work

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

A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market

Disease Modifying Therapies for MS

Medication Policy Manual. Topic: Gilenya, fingolimod Date of Origin: November 22, 2010

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

A neurologist would assess your eligibility and suitability for the DMTs.

Uncertainty in Benefit and Risk: Tysabri (natalizumab)

MEDICAL ASSISTANCE BULLETIN

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

Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis

Disease Modifying Therapies for MS

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

Multiple Sclerosis. Current and Future Players. GDHC1009FPR/ Published March 2013

New treatments in MS What s here and what s nearly here

New and Emerging Immunotherapies for Multiple Sclerosis: Oral Agents

Patient Group Input to CADTH

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

Medication Policy Manual. Topic: Plegridy, peginterferon beta-1a Date of Origin: December 12, 2014

Adrienne Boissy, MD, MA

How Can We Better Manage MS Patients Today?

The submission positioned dimethyl fumarate as a first-line treatment option.

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

PharmaPoint: Multiple Sclerosis - United Kingdom Drug Forecast and Market Analysis to Multiple

Disease Modifying Therapies (DMTs) in Multiple Sclerosis

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

Original Policy Date

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

fingolimod, 0.5mg, hard capsules (Gilenya ) SMC No. (992/14) Novartis Pharmaceuticals UK

Lemtrada (alemtuzumab)

MEDICAL POLICY STATEMENT

Information About Medicines for Multiple Sclerosis

Biogen Global Medical Grants Office Multiple Sclerosis: Areas of Interest

Multiple sclerosis disease-modifying drugs second line treatments

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

Multiple Sclerosis Drug Discoveries - What the Future Holds

The MS Disease- Modifying Medications GENERAL INFORMATION

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

This article is a CME/CE certified activity. To earn credit for this activity visit:

Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants

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

this 7^ day of September 2014 by Randall S. Gregg Special Deputy Director

1. Comparative effectiveness of alemtuzumab

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

Study Support Materials Cover Sheet

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

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

SCOPE of Pain: Safe and Competent Opioid Prescribing Education

Multiple Sclerosis. Global Drug Forecast and Market Analysis to 2022 Event-Driven Update. GDHC34PIDR / Published April 2013

Winter Changing landscapes, pipeline products and plan sponsor impact

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

Target Audience VHA/DoD physicians, nurses, pharmacists, and dieticians involved in the care of patients with chronic kidney disease.

fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya ) SMC No. (763/12) Novartis Pharmaceuticals UK Ltd

Mood Disorders in PD: What s New?

Veterans Health Administration Employee Education System. And. VACO Office of Quality and Safety, Evidenced Based Practice And

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

Novel therapeutic approaches in multiple sclerosis Neuroprotective and remyelinating agents, the future of clinical trials in MS?

Information about medicines for multiple sclerosis

Advances in Headache Management

National Multiple Sclerosis Society. Disease Modification in Multiple Sclerosis. Current as of January 2, 2013

How To Use A Drug In Multiple Sclerosis

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

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis

How to S.E.A.R.C.H. SM for the Right MS Therapy For You!

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

The MS Disease- Modifying Medications

Disease modifying drug therapy

MS Treatments Aubagio TM

Genzyme s Multiple Sclerosis Franchise Featured at AAN

FastTest. You ve read the book now test yourself

National MS Society Information Sourcebook

Has the medication received FDA approval? Yes the FDA approved dimethyl fumarate on March 27, 2013.

Disease modifying drug therapy. what you need to know

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

Advances in B Cell Biology:

PCORI Workshop on Treatment for Multiple Sclerosis. Breakout Group Topics and Questions Draft

Advances in Stroke Care

Current and future options of MS treatment Prof. Dr. Karl Vass, AKH Wien

Transcription:

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 Context: Multiple Sclerosis in Practice Expert Commentary This activity is supported in part by an educational grant from Teva Pharmaceuticals

Multiple Sclerosis Clinical Context Series The goal of this program is to provide upto-date information and multiple perspectives on the pathogenesis, symptoms, risk factors, and complications of multiple sclerosis as well as current and emerging treatments and best practices in the management of multiple sclerosis.

Multiple Sclerosis Clinical Context Series Target Audience Multiple sclerosis physician specialists, community neurologists, advanced practice healthcare professionals, primary care physicians, multiple sclerosis nurse specialists, nurse practitioners, physician assistants, pharmacists, and other allied health professionals involved in the care of patients with multiple sclerosis.

Activity Learning Objective Upon successful completion of this educational program, participants should be able to: Review the relevance and significance of the activity in the broader context of clinical care.

CME Information: Physicians Statement of Accreditation This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Projects In Knowledge and MedPage Today. Projects In Knowledge is accredited by the ACCME to provide continuing medical education for physicians.

CME Information Credit Designation Projects In Knowledge designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CME Information: Physicians Credit for Family Physicians MedPage Today "News-Based CME" has been reviewed and is acceptable for up to 2098 Elective credits by the American Academy of Family Physicians. AAFP accreditation begins January 1, 2013. Term of approval is for one year from this date. Each article is approved for 0.5 Elective credits. Credit may be claimed for one year from the date of each article.

CE Information: Nurses Statement of Accreditation Projects In Knowledge, Inc. (PIK) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation. Projects In Knowledge is also an approved provider by the California Board of Registered Nursing, Provider Number CEP-15227. This activity is approved for 0.50 nursing contact hours. There is no fee for this activity. DISCLAIMER: Accreditation refers to educational content only and does not imply ANCC, CBRN, or PIK endorsement of any commercial product or service.

Discussant Jeffrey Cohen, MD, PhD, Professor, Cleveland Clinic Lerner College of Medicine Director, Experimental Therapeutics Program Mellen Center for MS Treatment and Research Neurological Institute Cleveland Clinic Cleveland, OH

Disclosure Information Jeffrey Cohen, MD, PhD, has disclosed the following relevant financial relationships: Received Research Support: Biogen Idec; Genzyme; Novartis; Receptos; Teva Neuroscience Consulting/Advisory Board/DSMB: Teva Neuroscience This activity may review off-label or investigational information without any recommendation on their use.

Disclosure Information Robert Jasmer, Associate Clinical Professor of Medicine, University of California San Francisco; John Gever; and Dorothy Caputo, MA, BSN, RN, Nurse Planner, have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity. The staffs of Projects In Knowledge and MedPage Today have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

MS Drugs: Current Landscape First disease-modifying treatments: interferons and glatiramer acetate Effective, generally well tolerated, but not ideal Injection site reactions Flu-like symptoms with interferons Efficacy only modest Patients just don t like injections

Current Oral Drugs Fingolimod Oral Generally well tolerated But, rare serious side effects n Bradycardia at first dose n Macular edema n Liver abnormalities n Infection potential Teriflunomide

Natalizumab Given by infusion Very potent Well tolerated by most patients But, risk of PML

Need for a Treatment Algorithm Wide range of medications available now or in the near future A logical treatment algorithm for matching individual patients with the most appropriate drug is needed Not available yet, but may soon with help from biomarker data

Future Directions: Progressive MS Previous treatments focused on preventing relapses and lesion activity None clearly effective in preventing or slowing progressive forms of MS New treatments should be directed at this unmet need

Statins Recent study found that simvastatin improved outcomes in secondary progressive MS Earlier studies of statins have shown conflicting results Anti-inflammatory effect, plus possibly a tissue-preserving or tissue-repairing effect Statins warrant more study in progressive MS

Cell Therapies Hematopoietic stem cell transplant has been used to tame severe attacks. Other approaches now under study include adult stem cells, particularly mesenchymal stem cells.

Diagnostic/Prognostic Aids MRI has been extremely helpful for assessing patients with relapsing MS No comparable methodology now available for neuroprotective or repair strategies Looking at DTI, MTI, OCT; all show promise for measuring tissue integrity Already being used as endpoints in early studies of cell-based therapies

Alemtuzumab In the Nearer Term Long-acting infusion drug; given annually Double-edged sword : long action is convenient but raises concern about reversibility of adverse effects Causes autoimmunity in a few patients n Manifested as thyroid disease, more rarely thrombocytopenia or glomerular basement membrane disease Probably manageable with close monitoring

In the Nearer Term (cont d) S1P Modulators Fingolimod was first in class Others now in development Cardiac side effects are a class effect But, 2 nd -generation drugs can be titrated such that starting doses can be low Also relatively short-acting These features should keep serious cardiac effects to a minimum

In the Nearer Term (cont d) BG-12 (Dimethyl fumarate) Very few significant safety issues in trials Many patients show flushing or GI effects early on therapy; how much of a problem remains unknown May have potential for tissue preservation but this is unconfirmed

Summary Identify the current therapies for MS and their limitations Recognize that treatments to prevent or slow progressive forms of MS remain a major unmet need Discuss with patients the pros and cons of new MS treatments now in development, including alemtuzumab, BG-12, 2 nd -generation S1P modulators, and cell therapies