Self Study - Module 2 - Examining the Evidence for Early Initiation of Disease-Modifying Therapy

Launch Date:
October 31, 2020
Expiration Date:
October 30, 2021
This second module focuses on the current clinical trial findings and real-world data regarding the long-term efficacy and safety of DMT for MS.

Edward Fox, MD, PhD, FAAN

Director, MS Clinic of Central Texas
Central Texas Neurology Consultants, PA
Clinical Associate Professor of Neurology 
University of Texas Dell Medical School
Round Rock, TX

Edward Fox, MD, PhD, FAAN, is Director of the Multiple Sclerosis (MS) Clinic of Central Texas and the founding partner of Central Texas Neurology Consultants in Round Rock, Texas. Dr Fox also has an appointment as Clinical Associate Professor of Neurology at the University of Texas Dell Medical School in Austin, Texas. After receiving a bachelor’s degree at Washington University in St. Louis, Missouri, he was enrolled in the Medical Scientist Training Program at Baylor College of Medicine in Houston, Texas, where he earned a dual medical degree and a doctorate in immunology for the thesis, “Growth Requirements of Human Suppressor T Lymphocytes.”

Since starting a private neurology practice in the Austin area in 1992, Dr Fox has been involved in numerous MS research protocols and is an international speaker on topics related to neuroimmunology. He is a Fellow of the American Academy of Neurology and his clinic has been designated a Center for Comprehensive MS Care by the National MS Society. Dr Fox is a longstanding member of the Consortium of MS Centers and is President-Elect of the Texas Neurological Society.

Stephanie A. Agrella, PhDc, MSN, RN, ANP-BC, MSCN

Director of Clinical Services
Multiple Sclerosis Clinic of Central Texas
Round Rock, TX

Stephanie A. Agrella is the Director of Clinical Services at the Multiple Sclerosis Clinic of Central Texas, in Round Rock, Texas, where she specializes in the assessment, diagnosis, and management of multiple sclerosis (MS). She graduated with Cum Laude honors from Kent State University College of Nursing in Kent, Ohio, with Bachelor of Science in Nursing and Master of Science in Nursing degrees. Ms Agrella is a PhD candidate in the nursing program at Saint Louis University, St. Louis, Missouri, and is currently working on her dissertation involving vitamin D and its impact on magnetic resonance imaging (MRI) activity in adults who have recently been diagnosed with MS. She is a board certified Adult Nurse Practitioner specializing in primary care, and has been working directly with patients living with MS since the early 2000s.

Ms Agrella is licensed by the International Organization of Multiple Sclerosis Nurses (IOMSN) Certification Board as an MS Certified Nurse (MSCN). In addition, she currently serves as Co-Chair of the organization’s Education Committee and previously served 2 terms as an IOMSN board member. She has served on the Awards and Nominations Committee, as the Liaison for the Multiple Sclerosis Nursing International Certification Board (MSNICB), and as the MSNICB nomination chair.
 
Stephanie is dedicated to working in the field of MS and spends the majority of her time providing direct healthcare to patients living with MS; she specializes in all aspects of patient care, with an emphasis on disease-modifying therapy and symptom management. Ms Agrella is also involved in research and has served as a sub-investigator on numerous MS-related clinical trials. She has presented on MS at many continuing medical education symposia, peer-to-peer presentations, journal clubs, professional conferences, and community-based patient gatherings, both within the community, nationally, and internationally. She has also published in several peer-reviewed journals on all aspects related to MS.

Jacquelyn L. Bainbridge, BSPharm, PharmD, FCCP, MSCS, FAES

Professor, Department of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences
Professor, Department of Neurology
Anschutz Medical Campus
University of Colorado
Aurora, CO

Jacquelyn L. Bainbridge, BSPharm, PharmD, FCCP, MSCS, FAES, is a Professor at the University of Colorado Anschutz Medical Campus, where she holds joint appointments in the Skaggs School of Pharmacy and Pharmaceutical Sciences, Department of Clinical Pharmacy, and the Department of Neurology in the School of Medicine. Dr Bainbridge received her doctorate in pharmacy from the University of Colorado in Denver, where she subsequently completed a specialty residency in neurology.

Dr Bainbridge is a Multiple Sclerosis Certified Specialist (MSCS) and is actively involved in clinical research in many areas of neurology, including epilepsy, multiple sclerosis (MS), Parkinson’s disease (PD), back pain, and cannabis. Currently, she is working on 2 clinical trials investigating cannabis for the treatment of back pain and PD sponsored by the Colorado Department of Public Health and Environment (CDPHE), as well as a synthetic cannabidiol (CBD) study involving patients with Fragile X syndrome. Dr Bainbridge is involved in 2 additional clinical trials sponsored by the CDPHE: one for back pain in patients not on opiates or on opiates with a dose reduction and cannabis treatment, and another study in patients with autism being treated with CBD for behavioral issues. Dr Bainbridge also continues to study the safety and efficacy of antiepileptic drugs in older adults. She was previously an investigator for several National Institutes of Health (NIH)-funded trials researching drugs that may be neuroprotective in PD. Dr Bainbridge has completed a clinical trial using a synthetic CBD product in patients with scleroderma.

She has published several articles in professional journals, including Epilepsia, Pharmacotherapy, and the American Journal of Health-System Pharmacy. She has reviewed and written several book chapters on MS, epilepsy, migraine, chronic pain, women’s issues, pharmacokinetics, and the practice of pharmacy. Dr Bainbridge is a frequent lecturer on topics of neurologic and pharmacologic interest, including chronic pain disorders, epilepsy, migraines, movement disorders, MS, neuroprotection, restless legs syndrome, and the administration of cannabis for therapeutic intent.

Dr Bainbridge is a member of numerous professional organizations, including the Epilepsy Foundation of Colorado, the American Academy of Neurology, the American Epilepsy Society, the Epilepsy Foundation of America, the American College of Clinical Pharmacy, the American Association of Colleges of Pharmacy, the Colorado Pharmacists Society, and the American Society of Health-System Pharmacists. She is the past president of the board of directors for the Restless Legs Syndrome Foundation and is a member of the Epilepsy Foundation of Colorado professional advisory board. Dr Bainbridge was elected as a Fellow of the American College of Clinical Pharmacy (FCCP) and a Fellow of the American Epilepsy Society (FAES), and has won several student preceptor and teaching awards.
1.
ASSESS clinical data on early initiation and long-term use of disease-modifying therapy (DMT) to reduce disability in patients with MS
2.
SELECT and INITIATE DMT early to reduce disability in patients with MS

PROGRAM TITLE
Following the Trail of Evidence to Individualize and Optimize Multiple Sclerosis Care
 
SPONSORSHIP & SUPPORT
This educational activity is jointly provided by the Consortium of Multiple Sclerosis Centers and International Organization of Multiple Sclerosis Nurses and Spire Learning. 
 
 
 
                                                       
This activity is supported by an educational grant from Genentech, a member of the Roche Group
 
PROGRAM OVERVIEW  
 
Multiple sclerosis (MS) is a chronic neurodegenerative autoimmune disease with a complex clinical course characterized by inflammation, demyelination, and axonal degeneration. Early diagnosis, early aggressive treatment, and monitoring of disease progression have emerged as key principles of effective MS management. The ever-expanding volume of clinical trial data and variations in the clinical endpoints have complicated therapeutic decision making. An optimal treatment is usually based on a personalized approach determined by an individual patient’s prognosis and treatment risks. Furthermore, current evidence is progressing to advance understanding of the role of biomarkers in early diagnosis, predicting disease progression, and assessing response to MS treatment.
 
TARGET AUDIENCE
This multidisciplinary educational initiative is targeted to clinicians who care for people with MS including neurologists, nurses, nurse practitioners, physician assistants, and pharmacists.
 
ACCREDITATION AND CREDIT DESIGNATION
In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Spire Learning. CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
 
Physicians: The CMSC designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
Nurses: This activity is awarded 2.0 contact hours of continuing nursing education credits (2.0 in the area of pharmacology). 
 
Pharmacists: This knowledge-based activity, UAN # JA4008165-9999-20-036-H01-P, qualifies for 2.0 contact hours (.2 CEUs) of continuing pharmacy education credit.
 
Upon successful completion of the activity, your CE credits will be submitted electronically to the NABP CPE Monitor service. For information about CPE Monitor, visit https://nabp.pharmacy/cpe-monitor-service/.
 
Paper certificates are not valid for pharmacy credit.
 
 
INSTRUCTIONS ON HOW TO RECEIVE CREDIT
There is no fee to participate in this activity. In order to receive CME/CE credit, you must:
  • Baseline Assessment
  • Modules 1,2, and 3
  • Final Assessment
  • Activity Evaluation
Your certificate can be printed immediately.
 
DISCLAIMER
CMSC and Spire Learning present this information for educational purposes only. The content is provided solely by faculty who have been selected because of recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. CMSC, IOMSN,  and Spire Learning, and the commercial supporters assume no liability for the information herein.
 
COPYRIGHT STATEMENT
Copyright © 2020 by Spire Learning, LLC and its Licensors. All rights reserved. No part of this publication or activity may be reproduced or transmitted in any form, by any means, without prior written permission of Spire Learning, LLC. Spire Learning, LLC and CMSC will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication or activity, including any claims related to the products, drugs, or services mentioned herein.
 
LEVELS OF EVIDENCE 
Level of evidence and obligation were assessed by the American Academy of Neurology (AAN) guidelines using a Delphi process and assigning the following scores:
 
Level A is the strongest recommendation level and is denoted by use of the helping verb must. These recommendations are rare, as they are based on high confidence in the evidence and require both a high magnitude of benefit and low risk
• Must (not) prescribe, offer (treatment); Must (not) test, counsel, monitor (screen, diagnose); Must avoid (causation)
 
Level B corresponds to the helping verb should. Such recommendations are more common, as the requirements are less stringent but still based on the evidence and benefit−risk profile 
• Should (not) offer, prescribe; Should (not) test, counsel, monitor; Should avoid
 
Level C, which corresponds to the helping verb may, represents the lowest allowable recommendation level the AAN considers useful within the scope of clinical practice and can accommodate the highest degree of practice variation
• May offer, prescribe; May test, counsel, monitor, educate; May avoid; May choose not to offer, prescribe; May choose not to test, counsel, monitor
 
OFF-LABEL STATEMENT
This educational activity may contain discussion of published and/or investigational uses of therapies that are not indicated by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Further, participants are encouraged to consult appropriate resources for any product or device mentioned in this program.
 
CONFLICT OF INTEREST STATEMENT
According to the disclosure policy of the CMSC, all faculty, planning committee members, editors, managers, and other individuals who are in a position to control content are required to disclose any relevant relationships with any commercial interests related to this activity. The existence of these interests or relationships alone is not viewed as implying bias or decreasing the value of the presentation. All educational materials are reviewed for fair balance, scientific objectivity, and levels of evidence.
 
PRIVACY STATEMENT
Spire Learning, LLC is committed to protecting the privacy of personal information from our participants and educational collaborators. Spire maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse, or alteration of personal information.
 
Collection and use of your personal information
The submission of certain personally identifiable information is necessary to award and track the credits participants may earn after completing an activity. Required items include first name, last name, degree, and email address. These items are necessary. Participants are also required to complete an evaluation of each activity. All evaluative information submitted is collected and retained, and used by Spire Learning, LLC to continuously improve the learning experience.
 
Spire Learning, LLC will not transfer, sell, or share personal information with outside parties or otherwise disclose personal information unless required to in a legal process. Spire will retain your personal data only for the period necessary to accomplish the stated purposes and to comply with applicable laws.
 
 
EDUCATIONAL PLANNING COMMITTEE
 
Consortium of Multiple Sclerosis Centers (CMSC)
June Halper, MSN, APN-C, MSCN, FAAN, Chief Executive Officer has disclosed no relevant financial relationships with any commercial interests. 
 
Spire Learning
Jeanne Prater
Shareholder (spouse/partner): Johnson & Johnson
Employee (spouse/partner): Novo Nordisk
 
Chris Washburn, PhD
Employee (spouse/partner): Janssen Pharmaceuticals, Inc
 
Lisa Colombo has disclosed no relevant financial relationships with any commercial interests.
 
Contact Information: If you have any questions relating to the accreditation of this activity, please contact Lisa Colombo, Spire Learning, lcolombo@spirelearning.com.
 
All planning committee members also served as reviewers.
 
Reviewers
June Halper, MSN, APN-C, MSCN, FAAN
CEO, Consortium of Multiple Sclerosis Centers
Hackensack, NJ
 
Laurie Scudder, DNP, NP, served as a planner and reviewer for this activity. She has disclosed no relevant financial relationships.
 
All other CMSC and Spire staff who are in a position to influence content have disclosed no relevant financial relationships.
 
 
FACULTY CO-CHAIRS
 
Edward Fox, MD, PhD, FAAN
Director, MS Clinic of Central Texas
Central Texas Neurology Consultants, PA
Clinical Associate Professor of Neurology 
University of Texas Dell Medical School
Round Rock, TX
 
Disclosure Statement: 
Advisory Board – for marketing purposes: Biogen Inc; EMD Serono, Inc; Genentech, Inc; Novartis; Roche
Advisory Board – for scientific information: Biogen Inc; Celgene Corp; EMD Serono, Inc; Genentech, Inc; Novartis; Roche
Consultant – for marketing purposes: Biogen Inc; EMD Serono, Inc; Genentech, Inc; Novartis; Roche
Consultant – for clinical trial design: Biogen Inc; Celgene Corp; EMD Serono, Inc; Genentech, Inc; Novartis; Roche
Grant Recipient/Research Support: Biogen Inc; Celgene Corp; Chugai Pharmaceutical Co; EMD Serono, Inc; Genentech, Inc; MedDay Pharmaceuticals; Novartis; Roche; Sanofi Genzyme; TG Therapeutics, Inc
Speaker’s Bureau: Biogen Inc; EMD Serono, Inc; Genentech, Inc; Novartis; Roche; Sanofi Genzyme; Teva Pharmaceuticals
 
Stephanie A. Agrella, PhDc, MSN, RN, ANP-BC, MSCN 
Director of Clinical Services
Multiple Sclerosis Clinic of Central Texas
Round Rock, TX
 
Disclosure Statement: 
Consulting Fees: Biogen Inc; Bristol Myers Squibb; EMD Serono, Inc; Genentech, Inc; Genzyme 
Speaker’s Bureau: Biogen, Inc; Bristol Myers Squibb; EMD Serono, Inc; Genentech, Inc; Genzyme; Novartis; Viela Bio
 
Jacquelyn L. Bainbridge, BSPharm, PharmD, FCCP, MSCS, FAES
Professor, Department of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences
Professor, Department of Neurology
Anschutz Medical Campus
University of Colorado
Aurora, CO
 
Disclosure Statement:
Advisory Board: Genentech, Inc