Clinical Issues in Chronic Pain by Integritas Communications

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an independent medical education grant from Regeneron Pharmaceuticals, Inc. and Teva Branded Pharmaceutical Products R&D, Inc. An official independent commercially supported satellite symposium held in conjunction with the American Academy of Pain Medicineâ&#x20AC;&#x2122;s 34th Annual Meeting and Pre-Meeting Activities.

CME/MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

FACULTY FACULTY

Charles E. Argoff, MD Professor of Neurology Albany Medical College Director, Comprehensive Pain Center Albany Medical Center Albany, New York

Dr. Charles Argoff is Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York. He is a member of the American Academy of Neurology, the International Association for the Study of Pain, the American Academy of Pain Medicine, and the American Pain Society, among other professional organizations. Dr. Argoff is one of the editors of the recently published textbook Rajâ&#x20AC;&#x2122;s Practical Management of Pain, Fourth Edition. Coauthor of Defeat Chronic Pain Now, a recently published book for people with chronic pain, he has also recently released the third edition of Pain Management Secrets. Dr. Argoff received his medical degree from Northwestern University Medical School in Chicago, Illinois. He completed his medical internship in internal medicine and residency in neurology at Stony Brook University in New York and a fellowship in neurology at the National Institutes of Health in Bethesda, Maryland.

Alfonso E. Bello, MD FACULTY

Clinical Associate Professor of Medicine University of Illinois College of Medicine at Chicago Physician, Rheumatology and Interventional Pain Management Director of Rheumatology Research Illinois Bone & Joint Institute Glenview, Illinois Dr. Alfonso E. Bello is a Clinical Associate Professor of Medicine at the University of Illinois College of Medicine at Chicago. Board-certified in rheumatology and pain medicine, he is also a Consulting Associate in the Department of Medicine at Duke University Medical Center in Durham, North Carolina. He is a partner in the Illinois Bone & Joint Institute, LLC, in Glenview, Illinois, where he is the Director of Rheumatology Research. Dr. Bello graduated from DePauw University in Greencastle, Indiana, with a Bachelor of Arts in Chemistry in 1986. He then attended and graduated from the University of Illinois College of Medicine in 1990. He completed an Internal Medicine residency at Lutheran General Hospital in Park Ridge, Illinois, in 1993 and an academic fellowship in Rheumatology at Duke University Medical Center in 1996. While at Duke he received a Masters of Health Science in Biostatistics and Clinical Trial Design. He also received the Senior Rheumatology Scholar Award from the American College of Rheumatology in 1996. Dr. Bello has authored multiple publications in the area of arthritis therapeutics. He has also participated as a member of the American College of Rheumatology (ACR) Pain Management Task Force and has been a moderator of the Pain Therapeutics Section at the ACR National Meetings. He was the sole American in a select committee that developed osteoarthritis treatment guidelines for Mexico. Dr. Bello is an active member of his community of Glenview, Illinois, currently serving as a soccer coach for FC Mirage and on the medical staff for the Chicago marathon. He has also served our country, attaining the rank of Commander in the US Public Health Service and the US Coast Guard as a Medical Officer.

Jeffrey A. Gudin, MD

FACULTY

Director Pain Management and Wellness Center Englewood Hospital and Medical Center Englewood, New Jersey Dr. Jeffrey Gudin received his medical degree from Albany Medical College in Albany, New York. Following a transitional internship in surgery, medicine, and anesthesiology at St. Barnabas Medical Center in Livingston, New Jersey, he completed his residency in anesthesiology at the Yale University School of Medicine and his fellowship at the Yale Center for Pain Management in New Haven, Connecticut. While in New Haven, Dr. Gudin also trained in addiction medicine and directed a substance abuse treatment center. For the last 12 years, Dr. Gudin has been the Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center, a Mount Sinai University School of Medicine teaching affiliate in New Jersey. He remains active in teaching and research, and has lectured internationally on a variety of topics in pain management, palliative care, and addiction medicine. Dr. Gudin has dedicated his career to promoting education in pain management. He attends and has presented at the American Pain Society, the American Academy of Pain Management (AAPM), the 2012 AAPM Safe Opioid Prescribing Course, the American Academy of Physical Medicine and Rehabilitation, and many other national venues. Dr. Gudin serves as a consultant to state medical boards on challenging cases, as well as to industry on novel analgesic products and risk management associated with opioids. Dr. Gudin is recognized nationally as a leader in pain management. He is an experienced researcher, consultant, speaker, and speaker trainer. He has collaborated with numerous initiatives to enhance responsible prescribing and the safe use of opioid pain medications.

Egilius L.H. Spierings, MD, PhD FACULTY

Clinical Professor of Neurology & Craniofacial Pain Tufts University Schools of Medicine & Dental Medicine Boston, Massachusetts Founder, Medical Director, and Principal Investigator MedVadis Research Watertown, Massachusetts

Dr. Egilius Spierings is a graduate of the Erasmus University in Rotterdam, The Netherlands, where he received his medical degree in 1978 and his PhD in experimental pharmacology in 1980. As a doctoral student in pharmacology, he validated the animal experimental migraine model that was subsequently used by Glaxo to develop sumatriptan. He trained in neurology at the University Hospital Dijkzigt in Rotterdam, The Netherlands, with extensive training in neurosurgery and psychiatry. He trained in headache management with John R. Graham, MD, at The Headache Research Foundation in Boston, Massachusetts. Dr. Graham was Harold G. Wolffâ&#x20AC;&#x2122;s first assistant in headache research at New York HospitalCornell University Medical College in New York, New York. He worked in headache management for more than half a century and contributed significantly to our understanding and treatment of headache. Dr. Spierings has been involved in headache research since he was a medical student, now over 40 years ago. He has been involved in headache management since he became a neurologist in 1985. His neurological practice has always been dedicated to headache and face pain. He described hemicrania continua as an indomethacin-responsive headache syndrome, developed the highdose verapamil treatment of cluster headache, and conceptualized the parallel theory of migraine pathogenesis. More recently, his interest has been in the comorbidities of chronic migraine for which he coined the term, systemic endocrine-metabolic disorder. Dr. Spierings has lectured extensively, including more than 100 hospital grand rounds, published approximately 300 research and educational papers as well as 10 books, and organized more than 20 symposia. Dr. Spierings has participated as an investigator in migraine-related clinical trial research since 1980. He has performed clinical trials with all nine triptans for migraine abortion of which ultimately seven came to market. Since 2012, he has been conducting clinical trials with the calcitonin gene-related peptide (CGRP) antibodies for the preventive treatment of episodic and chronic migraine. Across the four antibodies, he has treated approximately 200 patients, some of them already for 4 years.

TARGET AUDIENCE

The educational design of this activity addresses the needs of pain specialists and other clinicians involved in the management of patients with chronic osteoarthritic or low back pain.

Chronic pain affects 100 million Americans and has significant health and socioeconomic repercussions.1 Appropriate pain management can improve patient quality of life and overall outcomes and also reduce health care costs.1 Although nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are often prescribed to manage chronic pain, both analgesic classes are associated with risks and are not appropriate for all patients. 2-4 The search for additional treatment options with novel mechanisms of action has resulted in some focus on nerve growth factor (NGF) as a potential therapeutic target.5 In this Clinical Issuesâ&#x201E;˘ symposium, an expert panel will examine the pathophysiologic roles of NGF in osteoarthritis and low back pain, and clinical trial data for emerging antiNGF therapies.6,7 Learners will leave this engaging discussion with an increased understanding of current and future techniques for pain management.

REFERENCES

1. Institute of Medicine Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011. https://www.ncbi.nlm.nih.gov/books/NBK92519/. Accessed March 21, 2018. 2. Dowell D, et al. CDC [Centers for Disease Control and Prevention] Guideline for Prescribing Opioids for Chronic Painâ&#x20AC;&#x201D;United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49. 3. Johnsen SP, et al. Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch Intern Med. 2005;165(9):978-984. 4. Whelton A. Renal and related cardiovascular effects of conventional and COX-2-specific NSAIDs and non-NSAID analgesics. Am J Ther. 2000;7(2):63-74. 5. Malfait AM, Miller RJ. Emerging targets for the management of osteoarthritis pain. Curr Osteoporos Rep. 2016;14(6):260-268. 6. Denk F, et al. Nerve growth factor and pain mechanisms. Annu Rev Neurosci. 2017;40:307-325. 7. Miller RE, et al. Current status of nerve growth factor antibodies for the treatment of osteoarthritis pain. Clin Exp Rheumatol. 2017;35(suppl 107[5]):85-87.

PREAMBLE

STATEMENT OF NEED/PROGRAM OVERVIEW

EDUCATIONAL OBJECTIVES

After completing this activity, the participant should be better able to: •• Discuss the pathophysiologic underpinnings of chronic osteoarthritic and low back pain with a focus on contributions from NGF •• Educate patients about limitations in efficacy, and personal and public risks associated with currently available pharmacologic treatment options for chronic osteoarthritic or low back pain

PREAMBLE

•• Describe the mechanistic rationales and clinical evidence for emerging analgesic strategies designed to inhibit NGF signaling

PHYSICIAN ACCREDITATION STATEMENT

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians. This CME/CE activity complies with all requirements of the federal Physician Payment Sunshine Act. If a reportable event is associated with this activity, the accredited provider managing the program will provide the appropriate physician data to the Open Payments database.

PHYSICIAN CREDIT DESIGNATION

Global Education Group designates this live activity 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.

GLOBAL CONTACT INFORMATION

For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

INSTRUCTIONS TO RECEIVE CREDIT

In order to receive credit for this activity, the participant must attend the program and complete the program evaluation.

FEE INFORMATION & REFUND/ CANCELLATION POLICY There is no fee for this educational activity.

Global requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflicts of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations. The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Charles E. Argoff, MD Consultant: Eli Lilly and Company, Pfizer Inc.; Stock Shareholder: Pfizer Inc. Alfonso E. Bello, MD Consultant: Horizon Pharma plc; Honoraria: Celgene Corporation, Horizon Pharma plc, Mallinckrodt Pharmaceuticals plc, Pfizer Inc.; Speakers Bureau: Celgene Corporation, Horizon Pharma plc, Mallinckrodt Pharmaceuticals plc, Pfizer Inc. Jeffrey A. Gudin, MD Consultant: BioDelivery Sciences International, Inc., Daiichi-Sankyo, Inc., Inspirion Delivery Sciences LLC, Nektar Therapeutics, Pernix Therapeutic Holdings, Inc., Quest; Speakers Bureau: Collegium Pharmaceutical, Inc., Daiichi-Sankyo, Inc., Purdue Pharma L.P., Salix Pharmaceuticals Egilius L.H. Spierings, MD, PhD Consultant: Alder BioPharmaceuticals, Inc., Amgen Inc., Eli Lilly and Company; Grant/ Research: Alder BioPharmaceuticals, Inc., Amgen Inc., Pfizer Inc., Teva Pharmaceuticals USA; Speakers Bureau: Amgen Inc.; Stock Shareholder: Zosano Pharma Corporation

PREAMBLE

DISCLOSURE OF CONFLICTS OF INTEREST

PREAMBLE

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Ashley Marostica, RN, MSN

Nothing to disclose

Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Liddy Knight

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

DISCLOSURE OF UNLABELED USE

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturerâ&#x20AC;&#x2122;s product information, and comparison with recommendations of other authorities.

SLIDES

GUIDELINES »»Chronic opioid therapy for chronic non-cancer pain: a review and comparison of treatment guidelines. Cheung CW, et al. Pain Physician. 2014;17(5):401-414. https://www.ncbi.nlm.nih.gov/pubmed/25247898

»»CDC guideline for prescribing opioids for chronic pain— United States, 2016. Dowell D, et al. JAMA. 2016;315(15):1624-1645. https://www.ncbi.nlm.nih.gov/pubmed/26977696

PATIENT RESOURCES »»American Chronic Pain Association Information about conditions, management tools, advocacy, and support. https://www.theacpa.org/

»»Centers for Disease Control and Prevention Educational materials for patients about chronic pain and taking opioids. https://www.cdc.gov/drugoverdose/patients/index.html

»»International Association for the Study of Pain

RESOURCE CENTER

List of local and national organizations dedicated to pain management, as well as a library of videos and articles for patient support. https://www.iasp-pain.org/PatientResources?navItemNumber=678

»»U.S. Pain Foundation Source for education, support, and advocacy for patients living with pain. https://www.uspainfoundation.org/

CLINICAL ASSESSMENT TOOLS »»Pain BC Collection of assessment tools to measure pain, pain-related anxiety, pain-related depression, and pain outcomes. https://www.painbc.ca/health-care-providers/assessment-tools

»»Pain Disability Index Assess level of disruption in daily life caused by chronic pain. http://www.med.umich.edu/1info/FHP/practiceguides/pain/detpdi.pdf

»»Roland Morris Disability Questionnaire Questionnaire to assess low back pain. http://www.rmdq.org/

»»WOMAC Osteoarthritis Index Scale to assess both knee and hip osteoarthritis pain. http://www.womac.org/

SUGGESTED READING »»Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis.

RESOURCE CENTER

Birbara C, et al. J Pain Res. 2018;11:151-164. https://www.ncbi.nlm.nih.gov/pubmed/29386912

»»Nerve growth factor and pain mechanisms. Denk F, et al. Annu Rev Neurosci. 2017;40:307-325. https://www.ncbi.nlm.nih.gov/pubmed/28441116

»»Novel class of pain drugs based on antagonism of NGF. Hefti FF, et al. Trends Pharmacol Sci. 2006;27(2):85-91. https://www.ncbi.nlm.nih.gov/pubmed/16376998

»»Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Institute of Medicine. Washington, DC: National Academies Press (US); 2011. https://www.ncbi.nlm.nih.gov/pubmed/22553896

»»Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Kivitz AJ, et al. Pain. 2013;154(7):1009-1021. https://www.ncbi.nlm.nih.gov/pubmed/23628600

»»NGF—the TrkA to successful pain treatment. Kumar V, Mahal BA. J Pain Res. 2012;5:279-287. https://www.ncbi.nlm.nih.gov/pubmed/23028238

»»Emerging targets for the management of osteoarthritis pain. Malfait AM, Miller RJ. Curr Osteoporos Rep. 2016;14(6):260-268. https://www.ncbi.nlm.nih.gov/pubmed/27730452

»»Current status of nerve growth factor antibodies for the treatment of osteoarthritis pain. Miller RE, et al. Clin Exp Rheumatol. 2017;35 (suppl 107[5]):85-87. https://www.ncbi.nlm.nih.gov/pubmed/28967370

»»The discriminative validity of “nociceptive,” “peripheral neuropathic,” and “central sensitization” as mechanisms-based classifications of musculoskeletal pain.

RESOURCE CENTER

Smart KM, et al. Clin J Pain. 2011;27(8):655-663. https://www.ncbi.nlm.nih.gov/pubmed/21471812

»»Fasinumab (REGN475), an antibody against nerve growth factor for the treatment of pain: results from a double-blind, placebo-controlled exploratory study in osteoarthritis of the knee. Tiseo PJ, et al. Pain. 2014;155(7):1245-1252. https://www.ncbi.nlm.nih.gov/pubmed/24686255

»»What is this thing called pain? Woolf CJ. J Clin Invest. 2010;120(11):3742-3744. https://www.ncbi.nlm.nih.gov/pubmed/21041955

Please visit the CLINICAL RESOURCE CENTER for additional information and resources

ExchangeCME.com/NGFResources

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