Update on Natalizumab

Sponsored by the Postgraduate Institute for Medicine

	Release date: January 2006 Expiration date: January 2007 Estimated time to complete activity: 1 hour This educational program is supported through an educational grant from Biogen IDEC and Elan Pharmaceuticals Inc.

Program Overview
	Important recent data (two-year follow up from the AFFIRM trial, presented at AAN; two-year follow up from the SENTINEL trial, presented at ECTRIMS) has emerged on the safety and efficacy of natalizumab, but this data may have been overlooked following the voluntary suspension of natalizumab in February, 2005. This suspension was in response to reports of the development of progressive multifocal leukoencephalopathy (PML) in three patients taking natalizumab and additional immunosuppressants. This program will provide a review of PML and its relationship both to MS and to immunosuppressant therapies. A discussion by the participants on their current view of natalizumab and targeted antibody immunotherapies in general, will follow along with a discussion of the screenings and safeguards necessary should natalizumab return to market.

Goal Statement
	This program will help the viewer understand the results of recent clinical trials regarding safety and efficacy of natalizumab, provide an update on the issue of progressive multifocal leukoencephalopathy and discuss the risks vs. the benefits of targeted antibody immunotherapies.

Target Audience
	This activity has been designed to meet the educational needs of physicians involved in the management of patients with multiple sclerosis.

Learning Objectives
	At the conclusion of this activity, participants should be able to: Outline the recent efficacy data regarding natalizumab Outline the recent safety data regarding natalizumab Discuss the issue of progressive multifocal leukoencephalopathy (PML) as it may relate to natalizumab use Discuss the risks and the benefits of targeted antibody immunotherapies

Faculty:
	J. Theodore Phillips, Jr., MD, PhD (Program Chair) Director, Multiple Sclerosis Center at Texas Neurology Clinical Associate Professor of Neurology University of Texas Southwestern Medical Center Ted Phillips, MD, PhD, is the director of the Multiple Sclerosis Center at Texas Neurology in Dallas. He serves as a clinical associate professor of neurology at the University of Texas Southwestern Medical Center and serves as an attending neurologist at Baylor University Medical Center in Dallas. Dr. Phillips is a graduate of the University of Texas at Austin with special honors in chemistry. He received his MD and his PhD in immunology and completed neurology residency training from the University of Texas Southwestern Medical Center at Dallas. He is a principal developer of a national registry for MS (MSTRAC) and is a principal investigator in several ongoing clinical treatment trials in MS. Robert Fox, MD Staff Neurologist & Medical Director Cleveland Clinic Foundation Robert Fox, MD, received his undergraduate degree from Amherst College and his medical degree from Johns Hopkins University. He pursued residency training in neurology at the Hospital of the University of Pennsylvania in Philadelphia. He completed clinical training as a Potiker Fellow at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic Foundation, where he now continues as a staff neurologist. He is also the director of the Mellen Center MS tissue donation program. Igor J. Koralnik, MD Associate Professor of Neurology Harvard Medical School Igor J. Koralnik, MD, is an associate professor of neurology at Harvard Medical School and director of the HIV/Neurology Center at Beth Israel Deaconess Medical Center. Dr. Koralnik earned his MD at the University of Geneva Medical School, and he held his internship and residency in internal medicine at Geneva University Hospital. Dr. Koralnik conducted his residency in neurology in the Harvard-Longwood Neurology Training Program at Harvard Medical School and a post-doctoral fellowship in molecular biology of retroviruses at the National Institutes of Health. With specialties in neuro-infectious diseases and neuroAIDS, Dr. Koralnik is the author of numerous peer-reviewed publications. The focus of Dr. Koralnik’s research program is progressive multifocal leukoencephalopathy and its etiologic agent, the polyomavirus JC.

Instructions for Credit
	Physician Continuing Education Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Postgraduate Institute for Medicine (PIM) and Healthology. The Postgraduate Institute for Medicine (PIM) is accredited by the ACCME to provide continuing medical education for physicians. Credit Designation Postgraduate Institute for Medicine designates this educational activity for a maximum of 1.0 category 1 credit toward the AMA Physician's Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity. Fee Information There is no fee for this educational activity. Disclosure of Conflicts of Interest Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity and patient care recommendations. PIM is committed to providing its learners with high-quality CME activities and related materials that promote improvements of quality in healthcare and not a specific proprietary business interest of a commercial interest. The following faculty reported a real or apparent conflict of interest: J. Theodore Phillips, Jr., MD, PhD: Type of financial relationship: Consulting Fees, Fees for Non-CME Services and Contracted Research for: Teva, Genzyme, Biogen IDEC, Neurocrine Biosciences and Protein Design Laboratories. Robert Fox, MD: Type of financial relationship: Consulting Fees, Fees for Non-CME Services and Contracted Research for: Centocor, Genentech, Merck, Serono, Questcor, Teva, Biogen IDEC and Neuroscience. Igor J. Koralnik MD: Type of financial relationship: Consulting Fees for: Berlax, Biogen IDEC. The following planners and managers reported a real or apparent conflict of interest: Thomas Maxwell Mundy, MD (Healthology) No financial interest/relationships relating to the topic of this activity. Jan Hixon, RN, BSN, MA (PIM) No financial interest/relationships relating to the topic of this activity.


Method of Participation
	There are no fees for participating and receiving CME credit for this activity. During the period January 2006 through January 2007, participants must: 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) complete the post-test by recording the best answer to each question in the answer key on the evaluation form; and 4) complete the evaluation form. A statement of credit will be issued only upon receipt of a completed activity evaluation form and a completed post-test with a score of 70 percent or better. Your statement of credit will be mailed to you within three weeks.

Media
	Internet

Disclosure of Unlabeled Use
	This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Postgraduate Institute for Medicine (PIM), Healthology Inc. and Biogen IDEC and Elan Pharmaceuticals Inc. 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 PIM, Healthology Inc. and Biogen IDEC and Elan Pharmaceuticals Inc. 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 or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information and comparison with recommendations of other authorities. Produced by Healthology Inc. © 2006 Sponsored by the Postgraduate Institute for Medicine Supported through an educational grant from Biogen IDEC and Elan Pharmaceuticals Inc.