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

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

2 Clinical Context: Multiple Sclerosis in Practice Expert Commentary Jointly Sponsored by: and

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

4 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.

5 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.

6 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.

7 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.

8 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.

9 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, 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.

10 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 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.

11 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

12 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.

13 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.

14 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

15 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

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

17 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

18 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

19 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

20 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.

21 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

22 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

23 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

24 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

25 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

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