Physicians' Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Acknowledgment of Commercial Support
This activity is supported by educational grants from Celgene Corporation and Sanofi Genzyme.
Community Practice Connections™: Interpreting the Therapeutic Landscape in Multiple Sclerosis. An Enduring CME Activity From A Live Symposium Presented at the 2019 ACTRIMS Meeting
Release Date: April 30, 2019
Expiration Date: April 30, 2020
Media: Internet - based
Community Practice Connections™: Interpreting the Therapeutic Landscape in Multiple Sclerosis. An Enduring CME Activity From A Live Symposium Presented at the 2019 ACTRIMS Meeting consists of clinical vignettes, short video interviews of leading experts in multiple sclerosis (MS), and brief summaries of clinical data related to these issues. The video interviews address answers to questions in clinical vignettes as well as questions commonly faced in the clinical practice setting.
Benefits of participating in Community Practice Connections™: Interpreting the Therapeutic Landscape in Multiple Sclerosis. An Enduring CME Activity From A Live Symposium Presented at the 2019 ACTRIMS Meeting include:
- Gain insights into important indicators of aggressive MS
- Expand knowledge of current and emerging therapies for MS
- Improve competence regarding the integration of newly approved therapies into the management of MS
- Learn the best strategies for engaging in shared decision making with patients with MS
CME Activity Table of Contents
- Module 1: Importance of Early Diagnosis and Effective Treatment of Aggressive MS
- Module 2: Current and Emerging Therapies and Shared Decision Making
- Evaluation and Request for Credit
Acknowledgement of Commercial Support
This activity is supported by educational grants from Celgene Corporation and Sanofi Genzyme.
Instructions for This Activity and Receiving Credit
This educational program is directed toward neurologists and MS subspecialists. Nurse practitioners, physician assistants, nurses, and other healthcare professionals involved in the treatment and management of patients with MS may also participate.
Upon successful completion of this educational program, you should be better prepared to:
- Identify key indicators of MS to improve early diagnosis and initiation of treatment for MS
- Analyze the efficacy and safety profile of disease-modifying therapies (DMTs) to develop individualized treatment plans for patients with MS
- Apply data from recent clinical trials on the role of DMTs in the existing treatment landscape and the potential for improving outcomes
- Apply knowledge of case-based challenges to develop data-driven treatment plans based on patient-specific needs
Faculty, Staff, and Planners’ Disclosures
Robert Bermel, MD, MBA
Mellen Center for Multiple Sclerosis at the Cleveland Clinic
Disclosures: Grant Research Support: Biogen, Genentech/Roche; Consultant: Biogen, Novartis, Sanofi Genzyme, Genentech/Roche.
Joseph R. Berger, MD, FACP, FAAN, FANA
Perelman School of Medicine at the University of Pennsylvania
Disclosures: Grant Research Support: Biogen Consultant: Alcimed, Amgen, Bayer, Biogen, Bristol-Myers Squibb, EMD Serono, Eisai, Genentech/Roche, Genzyme, Inhibikase, Johnson & Johnson, Millennium/Takeda, Novartis, Pfizer, Sanofi-Aventis, Excision Bio.
The staff of Physicians' Education Resource®, LLC (PER®), have no relevant financial relationships with commercial interests to disclose.
Disclosure Policy and Resolution of Conflicts of Interest (COI)
As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.
Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process
Off-Label Disclosure and Disclaimer
This CME/CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME/CE activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic or treatment options for a specific patient’s medical condition.
The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.
PER Pulse™ Recaps
1 of 3
This first of 3 PER Pulse™ Recaps from the 2019 Americas Committee for Treatment and Research in Multiple Sclerosis symposium focuses on evidence-based updates to the 2017 McDonald criteria for the diagnosis of multiple sclerosis (MS):
- Research regarding MS diagnosis, advances in magnetic resonance imaging (MRI), ocular coherence tomography, evoked potentials, and cerebrospinal fluid (CSF) were reviewed in detail to create evidence-based revisions to the McDonald criteria.1
- A diagnosis of MS can be made with demonstration of CSF oligonucleotide bands with other CSF parameters typical of MS with a typical clinically isolated syndrome and fulfillment of clinical or MRI criteria for dissemination in space (DIS).1-3
- Symptomatic and asymptomatic MRI lesions can be considered in the determination of DIS and dissemination in time. In addition, cortical and juxtacortical lesions are given the same weight to fulfill the MRI criteria for DIS. The 4 areas for typical lesions—periventricular, cortical/juxtacortical, infratentorial, and spinal cord—remain the same.4-7
- Diagnostic criteria for primary-progressive MS remain unchanged in the 2017 McDonald criteria but now include symptomatic and asymptomatic MRI lesions as well as cortical and juxtacortical lesions.8
- Phenotype designation is made once the diagnosis of MS is established. The recommendation is to combine the course of disease (ie, active or not, progressive or not, based on the prior year’s history) with the phenotype characterization to better represent temporal disease activity.9
- The 2017 McDonald criteria do not affect MS diagnoses based on earlier versions, nor do the updates affect currently approved therapies.1
- Thompson AJ, Banwell BL, Barkoff F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2.
- Tintore M, Rovira A, Brieva L, et al. Isolated demyelinating syndromes: comparison of CSF oligoclonal bands and different MR imaging criteria to predict conversion to CDMS. Mult Scler. 2001;7(6):359-363. doi: 10.1177/135245850100700603.
- Tintore M, Rovira A, Río J, et al. Defining high, medium and low impact prognostic factors for developing multiple sclerosis. Brain. 2015;138(pt 7):1863-1874. doi: 10.1093/brain/awv105.
- Flippi M, Rocca MA, Ciccareli O, et al; MAGNIMS Study Group. MRI criteria for the diagnosis of multiple sclerosis: MAGNIMS consensus guidelines. Lancet Neurol. 2016;15(3):292-303. doi: 10.1016/S1474-4422(15)00393-2.
- Brownlee WJ, Swanton JK, Miszkiel KA, Miller DH, Ciccarelli O. Should the symptomatic region be included in dissemination in space in MRI criteria for MS? Neurology. 2016;87(7):680-683. doi: 10.1212/WNL.0000000000002975.
- Tintore M, Otero-Romero S, Río J, et al. Contribution of the symptomatic lesion in establishing MS diagnosis and prognosis. Neurology. 2016;87(13):1368-1374. doi: 10.1212/WNL.0000000000003144.
- Filippi M, Rocca MA, Calabrese M, et al. Intracortical lesions: relevance for new MRI diagnostic criteria for multiple sclerosis. Neurology 2010;75(22):1988-9414. doi: 10.1212/WNL.0b013e3181ff96f6.
- Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011;69(2):292-302. doi: 10.1002/ana.22366.
- Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278-286. doi: 10.1212/WNL.0000000000000560.
2 of 3
This second of 3 PER Pulse™ Recaps from the 2019 Americas Committee for Treatment and Research in Multiple Sclerosis symposium focuses on current and emerging treatment strategies for multiple sclerosis (MS):
- Treatment for relapsing-remitting MS (RRMS) is typically initiated with first-line platform therapies followed by second-line, high-efficacy disease-modifying therapies (DMTs). Platform therapies include injectable interferons and glatiramer acetate and oral therapy with dimethyl fumarate and teriflunomide. In patients who progress to high disease activity despite treatment, a switch to a high-efficacy DMT is considered. Currently approved DMTs include the sphingosine-1-phosphate (S1P) receptor modulator fingolimod and the monoclonal antibodies natalizumab, alemtuzumab, and ocrelizumab.1
- Data regarding early intervention and sequencing of high-efficacy DMTs are emerging. Selecting appropriate DMT is challenging and warrants careful evaluation of the benefit–risk profile of each, paying attention to mechanism of action, pharmacokinetics, and pharmacodynamics of current therapy to avoid overlapping effects. Age, duration and severity of disease, disability status, route of administration, and family planning are also important considerations.2
- If an escalation approach to therapy is the strategy for moderate-to-severe disease activity at onset, close monitoring is required to ensure that the disease is under control, and an adequate washout period is required to encourage recovery of the targeted immune function before initiating the next DMT. Fingolimod (≥2 months) and natalizumab (≤16 weeks) have reversible and shorter times to immune system reconstitution and could be options for early sequencing.3
- Siponimod is the first oral FDA-approved treatment for active secondary-progressive multiple sclerosis (SPMS).4 The approval was based on results of the phase III EXPAND trial, the largest controlled study showing reduced risk of disease progression.5 It is approved across the MS spectrum for clinically isolated syndrome, RRMS, and active SPMS, with most patients not requiring a first dose observation.
- There are several ongoing clinical trials in MS, including those evaluating therapies directed at CD20 (ofatumumab), second-generation S1P modulators (ozanimod, ponesimod), oral cladribine, alternative dimethyl fumarates, autologous hematopoietic stem cell transplant, and Bruton tyrosine kinase inhibitors.
- Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014; 83(3):83278-286. doi: 10.1212/WNL.0000000000000560.
- Grand’Maison F, Yeung M, Morrow SA, et al. Sequencing of high-efficacy disease-modifying therapies in multiple sclerosis: perspectives and approaches. Neural Regen Res. 2018;13(11):1871-1874. doi: 10.4103/1673-5374.239432.
- Pardo G, Jones DE. The sequence of disease-modifying therapies in relapsing multiple sclerosis: safety and immunologic considerations. J Neurol. 2017;264(12):2351-2374. doi: 10.1007/s00415-017-8594-9.
- National Multiple Sclerosis Society. Disease-modifying therapies for MS. nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf. Published October 2018. Accessed March 26 2019.
- Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomized, phase 3 study [erratum in Lancet. 2018;392910160):2170. doi 10.1016/S0140-6736(18)32834-4.] Lancet. 391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6.
3 of 3
This third of 3 PER Pulse™ Recaps from the 2019 Americas Committee for Treatment and Research in Multiple Sclerosis symposium focuses on the importance of physician and patient communication and shared decision making for management of multiple sclerosis:
- Recent surveys have highlighted the importance of medication adherence for optimizing the efficacy of disease-modifying therapies (DMTs) and have highlighted challenges associated with inadequate treatment efficacy and tolerability of treatment, cost, access to new treatments, and compliance issues.1,2
- Individualizing treatment and engaging in shared decision making with patients are needed for patients to feel in control of their personal health goals.3,4 Factors to consider and discuss with patients include efficacy, safety, route of administration, adverse events, tolerability, dosing frequency, lifestyle, and financial concerns.5
- Receiving a major diagnosis is a stressful event for patients, and they may have a difficult time recalling information given to them at the time. Clinicians should provide a follow-up opportunity dedicated to counseling patients with a new diagnosis about specific treatment options with DMT.6-8
- Respecting patient preference is integral for ensuring acceptance and adherence to medication. Clinicians must review the benefits and risks with patients and engage in ongoing conversations regarding treatment throughout the disease course.9
- Evaluating barriers to adherence and discussing them with patients before initiating a DMT is good clinical practice and may improve outcomes.10,11
- Because of the potential risks to a fetus, discussing pregnancy with women is very important, and reproductive plans should be monitored throughout the course of the disease.12,13
- Burks J, Marshall TS, Ye X. Adherence to disease-modifying therapies and its impact on relapse, health resource utilization, and costs among patients with multiple sclerosis. Clinicoecon Outcomes Res. 2017;9:251-260. doi: 10.2147/CEOR.S130334.
- Tintoré M, Alexander M, Costello K, et al. The state of multiple sclerosis: current insight into the patient/health care provider relationship, treatment challenges, and satisfaction. Patient Prefer Adherence. 2016;11:33-45. doi: 10.2147/PPA.S115090.
- Reuben DB, Tinetti ME. Goal-oriented patient care—an alternative health outcomes paradigm. N Engl J Med. 2012;366(9):777-779. doi: 10.1056/NEJMp1113631.
- Barry MJ, Edgman-Levitan S. Shared decision making—pinnacle of patient-centered care. N Engl J Med. 2012;366(9):780-781. doi: 10.1056/NEJMp1109283.
- Happe LE. Choosing the best treatment for multiple sclerosis: comparative effectiveness, safety, and other factors involved in disease-modifying therapy choice. Am J Manag Care. 2013;19(suppl 17):s332-s342.
- Schofield T, Elwyn G, Edwards A, Visser A. Shared decision making. Patient Educ Couns. 2003;50(3):229-230.
- Johnson J. On receiving the diagnosis of multiple sclerosis: managing the transition. Mult Scler. 2003;9(1):82-88. doi: 10.1191/1352458503ms856oa.
- Ptacek JT, Eberhardt TL. Breaking bad news. A review of the literature. JAMA. 1996;276(6):496-502.
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations: disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777-788. doi: 10.1212/WNL.000000000000000005347.
- Katsarava Z, Ehlken B, Limmroth V, et al; C.A.R.E Study Group. Adherence and cost in multiple sclerosis patients treated with IM IFN beta-1a: impact of the CARE patient management program. BMC Neurol. 2015;15:170. doi: 10.1186/s12883-015-0426-x.
- Irwin DE, Cappell KA, Davis BM, Wu Y, Grinspan A, Gandhi SK. Differences in multiple sclerosis relapse rates based on patient adherence, average daily dose, and persistence with disease-modifying therapy: observations based on real-world data. Value Health. 2015;18(7):A764. doi: 10.1016/j.jval.2015.09.2504.
- Bove R, Alwan S, Friedman JM, et al. Management of multiple sclerosis during pregnancy and the reproductive years: a systematic review. Obstet Gynecol. 2014;124(6):1157-1168. doi: 10.1097/AOG.0000000000000541.
- Coyle PK. Management of women with multiple sclerosis through pregnancy and after childbirth. Ther Adv Neurol Disord. 2016;9(3):198-210. doi: 10.1177/1756285616631897.
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