Management of the Breakthrough Patient

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
	Differentiating perfect or near-perfect responders to platform therapy from those who are clearly non-responders poses no difficulty for clinicians. The lines between these categories and those who fall in between is an area of much difficulty, however. When to label a patient a suboptimal responder, a non-responder or one in transition to progressive disease and when to add or switch therapy is a difficult decision for most care providers, with no clear consensus even among MS specialists. Three MS specialists will give their opinions of the options for the less-than-optimal responder: when to consider a therapeutic change; whether and what to add as additional therapy, including various immunosuppressants as well as IV immunoglobulin; whether there is any role for switching among IFNs.

Goal Statement
	This program will help the viewer understand the controversies in the long-term management of MS patients who continue to have what may be described as an unacceptable number of recurrences.

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: Summarize a working, clinical definition of suboptimal response to disease-modifying MS therapy (DMT). Outline three factors that may be used to assess the success or failure of DMT. Discuss the clinical factors used in assessing sub-optimal responses. Discuss the imaging studies used in assessing sub-optimal responses. Outline various therapeutic changes that may be undertaken in a breakthrough patient.

Faculty:
	Andrew D. Goodman, MD Associate Professor of Neurology University of Rochester Medical Center Dr. Andrew D. Goodman, is an associate professor of neurology, chief of the neuroimmunology unit and director of the Multiple Sclerosis Center at the University of Rochester Medical Center in Rochester, New York. A graduate of Rutgers College and the University of Medicine and Dentistry of New Jersey, he did residency training in internal medicine and neurology at Mount Sinai Medical Center in New York City. Dr. Goodman completed a research fellowship in the neuroimmunology branch at the National Institutes of Health. Numerous publications reflect his interests in the immunology and virology of multiple sclerosis as well as clinical and experimental therapeutics research. Dr. Goodman is a past chair of the multiple sclerosis section of the American Academy of Neurology. He currently serves the National Multiple Sclerosis Society as deputy medical officer, chair of the long-term care committee and member of the executive committee of the medical advisory board. Khurram Bashir, MD, MPH Assistant Professor of Neurology University of Alabama at Birmingham Medical School Dr. Khurram Bashir earned his MD and his BS in medicine from King Edward Medical College in Lahore, Pakistan. He obtained his MPH in epidemiology from the University of Alabama at Birmingham. He completed an internal medicine internship at Southern Illinois University at Springfield as well as a combined internal medicine and neurology residency. He completed a neuroimmunology and multiple sclerosis fellowship under the leadership of Dr. John N. Whitaker at the University of Alabama at Birmingham department of neurology and currently serves as an assistant professor of neurology there. Today Dr. Bashir is the director of the neuroimmunology and multiple sclerosis division within the department of neurology and is director of the Multiple Sclerosis Center at the University of Alabama at Birmingham. He also serves as medical director for the Multiple Sclerosis Clinic at Birmingham’s Veterans’ Medical Center, for the National MS Society Second Opinion Clinic for the University of Alabama at Birmingham and for the National MS Society, Alabama Chapter. Syed Rizvi, MD Clinical Assistant Professor of Clinical Neurosciences Brown Medical School In addition to his position as a clinical assistant professor of clinical neurosciences at Brown Medical School, Syed Rizvi, MD, is the director of the Multiple Sclerosis Center at Rhode Island Hospital and serves on the medical staff for Rhode Island Hospital, Women and Infants Hospital and Newport Hospital. Dr. Rizvi earned his MD at Dow Medical College and completed his residency and his fellowship in neuroimmunology and multiple sclerosis at Stony Brook University Hospital of the State University of New York. Frederick E. Munschauer III, MD (Editorial Consultant) University at Buffalo School of Medicine and Biomedical Sciences Frederick E. Munschauer III, MD, is the director of the Research Center for Stroke and Heart Disease at Kaleida Health in Buffalo, NY, and his primary research interests are vascular disease prevention, healthcare delivery and multiple sclerosis. Dr. Munschauer is involved in a number of clinical trials funded by the National Institutes of Health as well as the pharmaceutical industry. His research has been published in Clinical Therapeutics, Stroke, Neurology and Annals of Neurology. Dr. Munschauer is an associate professor of clinical neurology and internal medicine at the State University of New York at Buffalo School of Medicine.

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 credits 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: Dr. Andrew Goodman: Type of financial relationship: Consulting Fees, Fees for Non-CME Services and Contracted Research for Biogen IDEC, Pfizer, Berlex, Serono, Teva, Acorda. Dr. Khurram Bashir: Type of financial relationship: Fees for Non-CME Services and Contracted Research for Biogen IDEC, Elan, Pfizer, Berlex, Serono, Teva, Neuroscience. Dr. Syed Rizvi: Type of financial relationship: Consulting Fees, Fees for Non-CME Services and Contracted Research for Biogen IDEC, Berlex, Serono, Teva, Genentech, NIH. Frederick E. Munschauer III, MD: Type of financial relationship: Fees for Non-CME Services and Contracted Research for Biogen IDEC, Bristol Myers, Pfizer, Sanofi, Serono. 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 with financial interests 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 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..