How Can We Better Manage MS Patients Today?

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1 How Can We Better Manage MS Patients Today? A CME/CE Satellite Symposium Table of Contents CME/CE Information... 2 Program Overview... 3 Faculty Biographies... 4 Agenda 8:00 PM Introduction Douglas S. Goodin, MD 8:05 PM Overview of MS and Strategies for Personalized Treatment... 6 Douglas S. Goodin, MD 8:30 PM Partnering with Patients to Improve Adherence in MS...12 Amy Perrin Ross, MSN 8:50 PM Translating Science into Practice: Case Studies...18 Patricia K. Coyle, MD 9:20 PM Panel Discussion Faculty This independent CME/CE activity is supported by an educational grant from Bayer HealthCare. At the Intersection of Knowledge and Outcomes Since 1980 Education Initiative in Neurology Peer Review Directed by

2 How Can We Better Manage MS Patients Today? Target Audience This activity is designed for neurologists, nurse practitioners, physician assistants, nurses, pharmacists, and other healthcare providers who are involved in the treatment of patients with multiple sclerosis. Activity Goal The goal of this activity is to provide expert guidance to clinicians on FDA-approved multiple sclerosis therapies, focusing on early treatment; risk: benefit assessment; personalized treatment selection based on mechanisms of action, efficacy, and safety profiles of therapies; monitoring adherence; and practical application utilizing case-based discussions. Learning Objectives Assess the etiology, pathophysiology, and diagnosis of multiple sclerosis (MS) to determine optimal treatment approaches. Formulate treatment strategies for patients with MS, based on an understanding of mechanisms of action, safety, and efficacy, to slow/stabilize disease progression. Assess adherence to treatment and implement strategies to monitor patients to improve therapeutic outcomes. CME Information: Physicians Statement of Accreditation Projects In Knowledge is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Projects In Knowledge designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. CE Information: Nurses Projects In Knowledge (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 Upon completion of this course, participants will be awarded 1.50 nursing contact hour(s). DISCLAIMER: Accreditation refers to educational content only and does not imply ANCC, CBRN, or PIK endorsement of any commercial product or service. CE Information: Pharmacists Projects In Knowledge is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program has been planned and implemented in accordance with the ACPE Criteria for Quality and Interpretive Guidelines. This satellite symposium is worth up to 1.5 contact hours (0.15 CEUs). The ACPE Universal Activity Number assigned to this application-type activity is L01-P. Pharmacists should only claim credit commensurate with the extent of their participation in the activity. CME/CE Instructions To obtain credit for the live meeting: 1. Sign in at the registration desk. 2. Attend the live satellite symposium. 3. Complete the evaluation form. 4. Submit it to the event representative as you exit. 5. Your certificate will be ed to you within 4 weeks of the activity date. There is no fee for this activity. Disclosure Information The Disclosure Policy of Projects In Knowledge requires that presenters comply with the Standards for Commercial Support. All faculty are required to disclose any personal interest or relationship they or their spouse/partner have with the supporters of this activity or any commercial interest that is discussed in their presentation. This activity contains a discussion of off-label and investigational uses of multiple sclerosis therapies. For complete prescribing information on the products discussed during this CME/CE activity, please see your current Physicians Desk Reference (PDR). Patricia K. Coyle, MD has received grant/research support from Actelion Pharmaceuticals, Avanir Pharmaceuticals, and Novartis Pharmaceuticals Corporation; has received consulting fees from Acorda Therapeutics, Bayer HealthCare Pharmaceuticals, Biogen-Idec, and sanofi-aventis; has received honoraria from Bayer HealthCare Pharmaceuticals, Biogen Idec, and Novartis Pharmaceuticals Corporation; and has received fees for direct services from EMD Serono, Novartis Pharmaceuticals Corporation, Questcor Pharmaceuticals, and Teva Neuroscience. Douglas S. Goodin, MD has received consulting fees from Bayer HealthCare Pharmaceuticals, Novartis Pharmaceuticals Corporation, and Teva Neuroscience. Amy Perrin Ross, MSN has received honoraria from Acorda Therapeutics, Biogen Idec, Novartis Pharmaceuticals Corporation, Pfizer Inc, Questcor Pharmaceuticals, and Teva Neuroscience; and has received consulting fees from Acorda Therapeutics, Allergan, Bayer HealthCare Pharmaceuticals, EMD Serono, Genzyme Corporation, Novartis Pharmaceuticals Corporation, Pfizer Inc, Questcor Pharmaceuticals, sanofiaventis, and Teva Neuroscience. Peer Reviewer has disclosed no significant relationships. Lauren Cerruto (medical writer) has no significant relationships to disclose. Karen Gravelle, PhD (medical writer) has no significant relationships to disclose. Projects In Knowledge s staff members have no significant relationships to disclose. Conflicts of interest are thoroughly vetted by the Executive Committee of Projects In Knowledge. All conflicts are resolved prior to the beginning of the activity by the Trust In Knowledge peer review process. The opinions expressed in this activity are those of the faculty and do not necessarily reflect those of Projects In Knowledge. This CME/CE activity is provided by Projects In Knowledge solely as an educational service. Specific patient care decisions are the responsibility of the clinician caring for the patient. This independent CME/CE activity is supported by an educational grant from Bayer HealthCare. Projects In Knowledge is a registered trademark of Projects In Knowledge, Inc. 2

3 Program Overview Determining treatment for patients with multiple sclerosis (MS), while keeping in mind both clinical outcomes and adherence, is complicated by the expanding availability of diseasemodifying agents with different routes of administration and different side effects. Please join us for How Can We Better Manage MS Patients Today? a three-part discussion of optimal MS patient management with a panel of experts focusing on evidence-based treatment data, challenges in enhancing patient adherence, and practical approaches for personalizing treatment in a series of case studies. In discussing MS treatments, Douglas S. Goodin, MD, presents clinical data on the short-term efficacy/outcomes measures of approved agents, as well as long-term follow-up data, including exciting new results from a 21-year study demonstrating the long-term survival benefit of early treatment of MS with disease-modifying therapy. As in the case of other chronic diseases for which treatment slows disease progression but does not provide a cure, maintaining treatment adherence over the long term is crucial but challenging for patients with MS and their physicians. Amy Perrin Ross, MSN, addresses the obstacles in enhancing patient adherence, including the issues surrounding the selection of the most appropriate therapy for individual patients, the various reasons for patient nonadherence, and specific strategies for overcoming these barriers and facilitating adherence. Providing a hands-on, practical component to the discussion, Patricia K. Coyle, MD, presents a variety of real-life scenarios dealing with issues in diagnosis, determining when to initiate treatment, choosing among the different agents, and deciding what situations merit a change of therapy. The information discussed in this symposium will help you in the management of your patients with MS. 3

4 How Can We Better Manage MS Patients Today? Faculty Biographies CHAIR Douglas S. Goodin, MD Professor of Neurology Medical Director Multiple Sclerosis Center University of California, San Francisco San Francisco, California Dr. Goodin is professor of neurology at the University of California, San Francisco (UCSF) and director of the UCSF Multiple Sclerosis Center, positions he has held for the past 12 years. He received his medical degree from the University of California, Irvine, and did his residency at UCSF. Over his long career, Dr. Goodin has been active in a wide variety of professional organizations. Presently, he is a member of the board of directors of the Northern California Chapter of the National Multiple Sclerosis Society and a member of the Medical Advisory Board and Executive Committee of the National Multiple Sclerosis Society. Dr. Goodin has served on editorial boards and as an ad hoc reviewer for numerous journals and was the editor-in-chief of the International MS Journal. Dr. Goodin has received numerous accolades for his research and his role as an educator, including the Saul R. Korey Research Award from the American Academy of Neurology and three teaching awards for his leadership in a clinical preceptorship. Among his many publications, Dr. Goodin was a lead author on several AAN position papers, including guidelines for the use of diseasemodifying treatments in MS, the role of stress and trauma in MS disease pathogenesis, the value of MRI in MS diagnosis, the role of mitoxantrone in disease management, the impact of neutralizing antibodies on the efficacy of interferon treatment in MS, and the use of natalizumab in the treatment of MS. 4

5 FACulty FACulty Patricia K. Coyle, MD Acting Chair, Department of Neurology Director, MS Comprehensive Care Center Stony Brook University Stony Brook, New York Amy Perrin Ross, MSN Neuroscience Program Coordinator Department of Neurosciences Loyola University Chicago Maywood, Illinois Dr. Coyle is currently acting chair and professor of neurology at Stony Brook University School of Medicine, as well as the director of the Stony Brook Multiple Sclerosis Comprehensive Care Center. She received her medical degree at Johns Hopkins University School of Medicine in Baltimore, Maryland, where she also did a residency in neurology and completed a fellowship in neuroimmunology and neurovirology. Dr. Coyle is an internationally recognized expert on multiple sclerosis, neuroimmunology, and neurologic infectious diseases, such as Lyme disease, although her work also encompasses a wide range of other neurologic disorders, including amyotrophic lateral sclerosis (ALS), Huntington s disease, and myasthenia gravis. In addition to her teaching and research activities, she has held leadership positions at the American Board of Psychiatry and Neurology, the American Academy of Neurology, the American Neurological Association, and the National Multiple Sclerosis Society, and has served as an adviser to the Food and Drug Administration and the Institute of Medicine. A board-certified neuroscience nurse, Ms. Perrin Ross is the neuroscience program coordinator in the department of neurosciences at Loyola University Chicago in Maywood, Illinois. She received both a bachelor of science degree and a master of science degree in nursing from Loyola s Marcella Niehoff School of Nursing. Ms. Perrin Ross has more than 20 years of experience in clinical neuroscience research and has coordinated numerous clinical research trials in MS. In recognition of her contributions, Ms. Perrin Ross received the Nursing Research Award for excellence in clinical nursing research from the University of Arizona s College of Nursing in Tucson, Arizona. In addition to being the President-Elect of the International Organization of Multiple Sclerosis Nurses, Ms. Perrin Ross is a member of the Consortium of Multiple Sclerosis Centers, the International Organization of Multiple Sclerosis Nurses, and the Multiple Sclerosis Nursing International Certification Board; is a consultant for the National Multiple Sclerosis Society; and has served as a board member of the Consortium of Multiple Sclerosis Centers. She has also authored multiple articles and book chapters on MS and dementia. 5

6 How Can We Better Manage MS Patients Today? Overview of MS and Strategies for Personalized Treatment Douglas S. Goodin, MD Multiple sclerosis (MS) is a common neurologic condition affecting about 1.0 to 1.5 per 10 5 population in the United States. Typical symptoms include vision disturbances, fatigue, numbness, gait impairment, bladder/bowel dysfunction, dizziness/vertigo, pain, cognitive dysfunction, depression, and spasticity. MS is a disabling condition that has an early onset, usually at age 15 to 45 years. Diagnostic criteria for MS require evidence of central nervous system lesions that are disseminated in space as well as time. These criteria were recently updated such that it is now possible to make a diagnosis of MS earlier, with fewer MRIs, without compromising sensitivity and specificity. Patients with an initial episode that does not meet the diagnostic criteria are considered to have clinically isolated syndrome (CIS). In many cases, CIS is eventually diagnosed as MS, and it should be treated the same as MS. Early treatment of CIS with interferon beta, glatiramer acetate, or other disease-modifying therapy (DMT) has the potential to prevent or delay progression to clinically definite MS; early treatment of CIS/relapsingremitting MS may also improve quality of life, reduce longterm costs of care, and reduce cognitive impairment. FDA-approved DMTs for MS include interferon beta- 1b, interferon beta-1a in both subcutaneous (SC) and intramuscular (IM) formulations, glatiramer acetate, fingolimod, natalizumab, and mitoxantrone. Comparative studies have shown that both interferon beta-1b and SC interferon beta-1a are modestly more effective in preventing relapse than lower-dose IM interferon beta-1a and comparable in efficacy to glatiramer. Long-term follow-up data have shown that treatment with these injectable DMTs: Reduces relapse rates Reduces cumulative lesion burden on MRI Slows progression of disability May reduce risk of progression to secondaryprogressive MS In addition, a recent study with a 21-year follow-up of patients who participated in a clinical trial of interferon beta-1b reported improved survival among patients originally randomized to active treatment versus placebo. Of the 372 patients in the registration trial, 366 (98.4%) were identified at 21 years, of whom 81 had died. A majority of the deaths (78.3%) were from MS-related causes. However, treatment with interferon beta-1b 250 mcg SC q2d reduced the risk of death by nearly half (HR = 0.532; 95% CI ; P =.0173). Long-term follow-up of participants in other pivotal randomized controlled trials of interferon beta-1a and glatiramer acetate have reported similar benefits, although the conclusions that can be drawn from these other studies are quite limited due to the low case ascertainment rates. Injectable DMTs are generally well tolerated, including long term. Some of the most notable side effects of interferon beta include flu-like symptoms, depression, hepatic enzyme elevations, and alterations in blood cell counts. The most notable side effects of glatiramer acetate include an immediate postinjection reaction, injection-site reactions, lipoatrophy, dyspnea, and chest pain. Fingolimod, the first oral DMT, reduced annualized relapse rates by about half in phase III clinical trials; however, it has a number of safety concerns that should be weighed against its potential benefits and that require careful monitoring. These include bradycardia, atrioventricular block, hypertension, macular edema, reduction in pulmonary function, liver enzyme elevations, and reduced lymphocyte counts. Both natalizumab and mitoxantrone have potentially serious (ie, fatal) side effects. Consequently, they are often used only after other options have failed. The primary concern with natalizumab treatment is progressive multifocal leukoencephalopathy (PML), which is a potentially fatal brain infection caused by the JC virus. Related to this viral infection is the immune reconstitution inflammatory syndrome, which typically results from the removal of natalizumab during PML treatment. The presence or absence of JC virus antibody in the serum can be used to stratify patients according to their PML risk. Mitoxantrone is only rarely used in the United States because of its cardiac toxicity and the risk of treatment-related acute myelogenous leukemia and myelosuppression. A number of investigational DMTs are being evaluated for treatment of MS. Investigational oral small molecules include BAF312, dimethyl fumarate (BG-12), laquinimod, ONO-4641, and teriflunomide. Investigational monoclonal antibodies include alemtuzumab, daclizumab, ocrelizumab, and ofatumumab. Suggested Readings Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b vs once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective, randomised, multicenter study (INCOMIN). Lancet. 2002;359: Ford C, Goodman AD, Johnson K, et al. Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate. Mult Scler. 2010;16: Fox RJ, Rudick RA. Risk stratification and patient counseling for natalizumab in multiple sclerosis. Neurology. 2012;78: Goodin DS, Reder AT, Ebers GC, et al. Survival in MS: A randomized cohort study 21 years after the start of the pivotal IFN b-1b trial. Neurology. 2012;78: Kappos L, Radue E-W, O Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362: Lang C, Reiss C, Mäurer M. Natalizumab may improve cognition and mood in multiple sclerosis. Eur Neurol. 2012;67: Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011;69:

7 Slides produced as of May 22, 2012 (may not reflect final presentation) Slide 1 Slide 2 Slide 3 Slide 4 Slide 5 Slide 6 7

8 How Can We Better Manage MS Patients Today? Overview of MS and Strategies for Personalized Treatment Douglas S. Goodin, MD Slides produced as of May 22, 2012 (may not reflect final presentation) Comparisons of Therapies Slide 7 Slide 8 Slide 9 Slide 10 Slide 11 Slide 12 8

9 Slides produced as of May 22, 2012 (may not reflect final presentation) The Value of Early Treatment Long-Term Treatment Outcomes Slide 13 Slide 14 Slide 15 Slide 16 Safety and Tolerability Slide 17 Slide 18 9

10 How Can We Better Manage MS Patients Today? Overview of MS and Strategies for Personalized Treatment Douglas S. Goodin, MD Slides produced as of May 22, 2012 (may not reflect final presentation) Slide 19 Slide 20 Slide 21 Slide 22 Slide 23 Slide 24 10

11 Notes 11

12 How Can We Better Manage MS Patients Today? Partnering with Patients to Improve Adherence in MS Amy Perrin Ross, MSN The goals of treatment for patients with multiple sclerosis (MS) are to reduce the frequency and severity of relapses and the development of new/enhancing lesions on MRI, to delay disability progression, and to positively impact patient quality of life. Providing therapy that offers an acceptable balance of benefit and risk is important. In determining the most appropriate initial disease-modifying therapy for an individual patient, healthcare providers must take into consideration a number of factors, such as the patient s lifestyle, including his/her career and family roles and the need/desire to travel; plans for the future, such as a desire to become pregnant; and the patient s ability to self-inject. Successful therapy is based on a partnership with the patient in determining which therapy is best and in facilitating the patient s ability to adhere to treatment. This requires a thorough discussion with the patient and his/her family about the pros and cons of available medications, including their safety and possible long-term effects; the use of combination therapy; and how a proposed therapy will fit into the patient s lifestyle. As is the case with treatment of many chronic diseases, maintaining adherence to MS therapy over the long term is difficult, with nonadherence to MS treatment estimated at 50% to 70%. There are many factors that contribute to patient nonadherence, including continued MS symptoms suggesting that therapy is ineffective; lack of symptoms suggesting that treatment is unnecessary; treatment side effects; issues with injection administration, including fear of needles, injection-site reactions, and difficulty in comfortably incorporating treatment into the patient s lifestyle; insurance coverage; and physical/psychological problems, such as depression, visual disturbances, tremor, weakness, and fatigue, that may interfere with the patient s ability to follow the treatment regimen. Many of these issues arise in part from patients unrealistic expectations of treatment, and it is critical for healthcare providers to address these misperceptions and help patients establish realistic expectations if long-term disease management is to be successful. Patients should be informed that, although disease-modifying agents will not cure their MS, treatment can significantly reduce the rate and frequency of relapses and slow the progression of disease. Patients also need to understand that the occurrence of relapses while on treatment does not mean that therapy is ineffective and that the lack of relapses when not on treatment is not an indication that the disease is not progressing. In addition, the risks of delaying treatment or not receiving treatment should be explained. The advantages of early treatment versus delayed treatment including a delay in the onset of definite MS; reductions in annualized relapse rate, loss of brain volume, new or enlarging lesions and gadoliniumenhancing lesions and progression of disability; and enhanced performance on tests of cognitive function should be emphasized. Healthcare providers can also promote adherence by stressing the need for consistent administration of medication and providing strategies to deal with medication issues, including tips to manage treatment side effects and minimize local injection-site reactions, such as the use of medications prior to injection, site rotation, and instruction on correct injection mechanics. Finally, for therapy to be successful, patients must be ready to begin treatment, must believe that therapy can make a difference, must be willing to make a commitment to therapy, and must be well educated concerning both their disease and the agents used to treat it. Suggested Readings Brandes DW, Callender T, Lathi E, O Leary S. A review of disease-modifying therapies for MS: maximizing adherence and minimizing adverse events. Curr Med Res Opin. 2009;25: Costello K, Kennedy P, Scanzillo J. Recognizing nonadherence in patients with multiple sclerosis and maintaining treatment adherence in the long term. Medscape J Med. 2008;10:225. Lugaresi A. Addressing the need for increased adherence to multiple sclerosis therapy: can delivery technology enhance patient motivation? Expert Opin Drug Deliv. 2009;6: Perrin Ross A. Strategies for optimal disease management, adherence, and outcomes in multiple sclerosis patients. Neurology. 2008;71(suppl 3):S1-S2. Perrin Ross A. Tolerability, adherence, and patient outcomes. Neurology. 2008;71 (suppl 3)S21-S23. Saunders C, Caon C, Smrtka J, Shoemaker J. Factors that influence adherence and strategies to maintain adherence to injected therapies for patients with multiple sclerosis. J Neurosci Nurs. 2010;42(5 suppl):s10-s18. 12

13 Slides produced as of May 22, 2012 (may not reflect final presentation) Slide 1 Slide 2 Slide 3 Slide 4 Slide 5 Slide 6 13

14 How Can We Better Manage MS Patients Today? Partnering with Patients to Improve Adherence in MS Amy Perrin Ross, MSN Slides produced as of May 22, 2012 (may not reflect final presentation) Slide 7 Slide 8 Slide 9 Slide 10 Slide 11 Slide 12 14

15 Slides produced as of May 22, 2012 (may not reflect final presentation) Slide 13 Slide 14 Slide 15 Slide 16 Slide 17 Slide 18 15

16 How Can We Better Manage MS Patients Today? Partnering with Patients to Improve Adherence in MS Amy Perrin Ross, MSN Slides produced as of May 22, 2012 (may not reflect final presentation) Slide 19 Slide 20 Slide 21 Slide 22 Slide 23 Slide 24 16

17 Notes 17

18 How Can We Better Manage MS Patients Today? Translating Science into Practice: Case Studies Patricia K. Coyle, MD Slides produced as of May 22, 2012 (may not reflect final presentation) Notes Slide 1 Slide 2 18

19 Slides produced as of May 22, 2012 (may not reflect final presentation) Notes Slide 3 Slide 4 19

20 How Can We Better Manage MS Patients Today? Translating Science into Practice: Case Studies Patricia K. Coyle, MD Slides produced as of May 22, 2012 (may not reflect final presentation) Notes Slide 5 Slide 6 20

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