Recognizing and Treating Multiple Sclerosis in the Primary Care

Setting

This activity is sponsored by Projects This activity is sponsored by Projects In Knowledge andIn Knowledge and supported by an supported by an educational grant provided by educational grant provided by Novartis Pharmaceuticals Novartis Pharmaceuticals Corporation.Corporation.

Target AudienceTarget Audience

This activity is designed for primary care This activity is designed for primary care physicians, nurse practitioners, and physicians, nurse practitioners, and physician assistants.physician assistants.

Activity GoalActivity Goal

The goal of this CME/CE activity is to The goal of this CME/CE activity is to provide an overview of the diagnosis and provide an overview of the diagnosis and management of multiple sclerosis management of multiple sclerosis appropriate to primary care settings.appropriate to primary care settings.

Learning ObjectiveLearning Objective

• Evaluate proposed etiologies and pathogenetic processes in MS in order to appropriately counsel patients and to form the basis of an understanding of drug mechanisms of action in MS

Learning ObjectiveLearning Objective

• Diagnose and classify MS in patients with neurologic symptoms, using clinical, radiologic, and other tools, in accordance with the revised McDonald Criteria

Learning ObjectiveLearning Objective

• Implement treatment early, including in patients with high-risk clinically isolated syndrome, in accordance with current data and FDA-approved indications, to prevent or delay conversion to clinically definite MS

Learning ObjectiveLearning Objective

• Formulate strategies for treatment of MS using currently available and emerging therapies to prevent relapse and progression of disability

Learning ObjectiveLearning Objective

• Integrate monitoring into the ongoing management of MS in order to assess and then ensure treatment response, adherence, toleration of therapy, and control of MS symptoms

CME Information: PhysiciansCME Information: Physicians

• Statement of AccreditationStatement of Accreditation– Projects In KnowledgeProjects In Knowledge®® is accredited by the is accredited by the

Accreditation Council for Continuing Medical Accreditation Council for Continuing Medical Education to provide continuing medical Education to provide continuing medical education for physicians.education for physicians.

CME Information: PhysiciansCME Information: Physicians

• Credit DesignationCredit Designation– Projects In Knowledge designates this Projects In Knowledge designates this

educational activity for a maximum of 4.0 educational activity for a maximum of 4.0 AMA PRA Category 1 Credits™. AMA PRA Category 1 Credits™. Physicians Physicians should only claim credit commensurate with should only claim credit commensurate with the extent of their participation in the activity.the extent of their participation in the activity.

CME Information: NursesCME Information: Nurses

• Statement of AccreditationStatement of Accreditation– Projects in KnowledgeProjects in Knowledge®® (PIK) is an approved provider of (PIK) is an approved provider of

continuing nursing education by the American Nurses continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.Credentialing Center’s Commission on Accreditation.

– Projects In Knowledge is also an approved provider by the Projects In Knowledge is also an approved provider by the California Board of Registered Nursing, Provider Number California Board of Registered Nursing, Provider Number CEP-15227. CEP-15227.

– This activity is approved for 4.0 nursing contact hour(s). This activity is approved for 4.0 nursing contact hour(s). Nurses should only claim credit commensurate with the Nurses should only claim credit commensurate with the extent of their participation in the activity.extent of their participation in the activity.

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

• Statement of Accreditation– Projects In Knowledge® is

accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

CE Information: Pharmacists

• Credit Designation– This program has been planned and implemented in

accordance with the ACPE Criteria for Quality and Interpretive Guidelines. This live meeting is worth up to 4.00 contact hours (0.4 CEUs). The ACPE Universal Program Number assigned to this activity is 0052-0000-10-391-L01-P.

– Pharmacists should only claim credit commensurate with the Pharmacists should only claim credit commensurate with the extent of their participation in the activity.extent of their participation in the activity.

– To obtain credit for this activity, you must sign in at the registration desk, attend the live event, complete the evaluation form, and submit it to event representatives as you exit.

Disclosure InformationDisclosure Information

• The Disclosure Policy of Projects In Knowledge requires that The Disclosure Policy of Projects In Knowledge requires that presenters comply with the Standards for Commercial Support. presenters comply with the Standards for Commercial Support. All faculty are required to disclose any personal interest or All faculty are required to disclose any personal interest or relationship they or their spouse/partner have with the relationship they or their spouse/partner have with the supporters of this activity or any commercial interest that is supporters of this activity or any commercial interest that is discussed in their presentation. Any discussions of discussed in their presentation. Any discussions of unlabeled/unapproved uses of drugs or devices will also be unlabeled/unapproved uses of drugs or devices will also be disclosed in the course materials.disclosed in the course materials.

• For complete prescribing information on the products discussed For complete prescribing information on the products discussed during this CME/CE activity, please see your current during this CME/CE activity, please see your current Physicians’ Physicians’ Desk Reference (PDR).Desk Reference (PDR).

Disclosure InformationDisclosure Information

Kate E. Kennedy, MN, ARNP, has received Kate E. Kennedy, MN, ARNP, has received consulting fees from Biogen Idec and Teva consulting fees from Biogen Idec and Teva

Neuroscience.Neuroscience.

Disclosure InformationDisclosure Information

Michele K. Mass, MD,Michele K. Mass, MD, has received consulting fees has received consulting fees from Biogen Idec.from Biogen Idec.

Disclosure InformationDisclosure Information

Becky J. Parks, MD,Becky J. Parks, MD, has received salary/honoraria has received salary/honoraria from Bayer Healthcare, Biogen Idec, EMD Serono, from Bayer Healthcare, Biogen Idec, EMD Serono,

Inc., and Teva Neuroscience; has received Inc., and Teva Neuroscience; has received consulting fees from Biogen Idec; and has consulting fees from Biogen Idec; and has

contracted research from Actelion Pharmaceuticals contracted research from Actelion Pharmaceuticals Ltd, BioMS Medical, and Novartis Pharmaceuticals.Ltd, BioMS Medical, and Novartis Pharmaceuticals.

Disclosure Information

• Medical writer Lauren A. Cerruto has no significant relationships to disclose

• Peer Reviewer 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

Contract for Mutual Responsibility in CME/CE

• Projects In Knowledge has developed the contract to demonstrate our commitment to providing the highest quality professional education to clinicians, and to help clinicians set educational goals to challenge and enhance their learning experience

• For more information on the contract,please go to:www.projectsinknowledge.com/Contract.html

Peer-reviewed content validationPeer-reviewed content validation Scientific integrity and objectivityScientific integrity and objectivity Evidence-based for effective clinical practiceEvidence-based for effective clinical practice Commitment to excellenceCommitment to excellence

Participant and Local Issues

ARS Polling

How familiar are you currently with how MS is diagnosed?

a) Veryb) Somewhatc) Not at all

How familiar are you currently with the revised McDonald criteria in assessing MS patients?

a) Veryb) Somewhatc) Not at all

ARS Polling

How familiar are you currently with the CMSC standardized protocol for performing MRIs?

a) Veryb) Somewhatc) Not at all

ARS Polling

How often do you currently order MRIs for patients you suspect have MS?

a) Alwaysb) Very oftenc) Sometimesd) Not very oftene) Never

ARS Polling

How often do you currently refer patients for further MS assessment/treatment at the time of a first clinical episode likely to be MS?

a) Always

b) Very often

c) Sometimes

d) Not very often

e) Never

ARS Polling

How often do you currently provide patients with strategies for managing common side effects of first-line MS therapies?

a) Always

b) Very often

c) Sometimes

d) Not very often

e) Never

ARS Polling

How often do you currently ask patients nonjudgmentally about adherence (eg, “How many injections have you missed in the past 2 months?”)?

a) Alwaysb) Very oftenc) Sometimesd) Not very oftene) Never

ARS Polling

How often do you currently recommend pharmacologic and nonpharmacologic therapies to manage bothersome MS symptoms (eg, fatigue, bladder dysfunction, spasticity)?

a) Alwaysb) Very oftenc) Sometimesd) Not very oftene) Never

ARS Polling

What Is Multiple Sclerosis?

• Chronic progressive autoimmune disease

• Immune system attacks the myelin sheath on nerve fibers in the brain and spinal cord (CNS)

• May lead to focal areas of damage, axon injury, axon transection, neurodegeneration, and subsequent scar or plaque formation

Nucleus

Soma

Dendrite

Myelin Sheath (With Axon Through It)

Schwann Cell

Node of Ranvier

Axon TerminalGraphic by Quasar Jarosz at en.Wikipedia.org

What the Primary Care Clinician Needs to Know About MS

• Common presenting symptoms of demyelinating disease

– For example, what is CIS, optic neuritis, brain stem syndrome, etc

• How the diagnosis of MS is made• Early symptoms that trigger need to refer patient to

neurologist• How to classify MS• How to manage treatment of MS/monitor MS patients

(and what to monitor for)• How to manage treatment side effects

PIK Survey of Clinicians in Oregon (N = 16)

57

29

0 014

0

10

20

30

40

50

60

120% 21%-40% 41%-60% 61%-80% 81%-100%

Res

po

nd

ents

(%

)

Proportion of Patients with MS

What percentage of your patients has MS? (n = 14)

PIK Survey of Clinicians in OregonGaps in Screening and Diagnosis (n = 15)

• 43% of respondents never or only sometimes assess patients for MS risk factors and 57% never or only sometimes screen at-risk patients

• 36% never/sometimes conduct differential diagnosis to rule out clinical variants of CNS demyelinating disease

• 80% are not using or only sometimes using revised McDonald criteria to assist in MS diagnosis

• A lack of knowledge regarding which patients are at risk, MS symptoms, and diagnostic criteria was listed as one of the biggest challenges to MS management; lack of available screening tools was another

PIK Survey of Clinicians in OregonGaps in Treatment (n = 15)

• 43% never or only sometimes consider early treatment of patients with CIS

• 40% never or only sometimes provide early treatment intervention for patients diagnosed with MS

• More than half (53%) never or only sometimes analyze mechanism of action, efficacy, and side effect/safety profile of MS treatments before selecting a treatment for their patients

PIK Survey of Clinicians in OregonGaps in Counseling/Monitoring (n = 15)

• 40% never or only sometimes monitor for CDMS in patients who have clinical symptoms and/or radiologic evidence suggesting MS

• Only one third always counsel patients on disease burden, adherence, side effects, and symptom management

• Only about half (47%) always monitor patients for response to treatment, adherence to therapy, occurrence and management of side effects, or change in MS status

– Yet noncompliance to therapy was listed as one of the biggest challenges to managing MS

PIK Survey of Clinicians in OregonSelf-Reported Level of Competence

n High to Very High

Very Low to Medium

Understand pathogenesis 8 13% 88%

Identify MS risk factors 8 50% 50%

Determine methodologies for diagnosis (MRI, revised McDonald)

8 38% 63%

Differentiate 4 major subtypes of MS 9 33% 66%

Assess selection of MS therapies, whom to treat, and when

8 13% 88%

Discuss MOA of approved/emerging therapies, differentiate which target T vs B cells, and translate understanding of MOA into practice when selecting therapy

10 10% 90%

PIK Survey of Clinicians in OregonSelf-Reported Level of Competence

n High to Very High

Very Low to Medium

Analyze efficacy, safety, potency, pros/cons, clinical considerations in prescribing approved MS therapies

8 38% 63%

Assess efficacy, safety, potency, pros/cons, clinical considerations of emerging MS therapies

8 0 100%

Contrast dosing, administration methods, frequency of administration, treatment considerations for currently available MS therapies

10 50% 50%

Compare dosing, administration methods, frequency of administration, treatment considerations for emerging MS therapies

9 33% 66%

PIK Survey of Clinicians in OregonSelf-Reported Level of Competence

n High to Very High

Very Low to Medium

Implement methods for monitoring and managing therapy-related side effects of current and emerging disease-modifying therapies in MS

8 38% 63%

Integrate methods for monitoring patients to ensure adherence to the prescribed MS treatment regimen

8 50% 50%

PIK Survey of Clinicians in OregonDesired Educational Programs in MS

• More than half the respondents wanted more education on:

– Risk factors

– Pathophysiology

– The 4 major subtypes (RRMS, SPMS, PRMS, PPMS)

– Differential diagnosis

– Advances in imaging methodologies and use of imaging in diagnosis and monitoring

PIK Survey of Clinicians in OregonDesired Educational Programs in MS

• More than half the respondents wanted more education on:

– Treatment of CIS

– Mechanisms of current and emerging therapies

– Efficacy, safety, and other considerations pertaining to emerging therapies

– Long-term effects of current/emerging therapies on disability, QOL, pharmacoeconomics, and patient outcomes

– Customized treatment strategies

Addressing Local Needs

• To address the needs identified in the local survey, this activity provides education regarding the following MS topics:– Risk factors– Pathogenesis– Diagnostic criteria– Role of imaging– Efficacy, safety, and initiation of current therapies– Efficacy and safety of emerging therapies– Monitoring for response, adherence, and tolerability of

therapy– Management of MS symptoms