Program Overview

Therapeutic drug monitoring and pharmacokinetic/pharmacodynamics guided dosing is an important concept in optimal management of patients with inflammatory bowel disease. Assessment of TPMT levels can help guide use of azathioprine, and data are emerging on the role of using metabolites to guide dosing and identify patients at risk of adverse events. In addition, trough levels of anti-TNF levels can guide treatment planning for patients receiving anti-TNF, and for secondary non-responders there is increasing interest in the role of anti-drug antibodies.

These concepts are rapidly evolving, but many require careful consideration and, if used in the clinic, should be used as part of a wider consideration which includes clinical assessment, standard laboratory data, and patient informed choice.

Educational Objectives

After completing this activity, the participant should be better able to:

  • Explain how TPMT testing can be used to individualize therapy with thiopurines in inflammatory bowel disease (IBD)
  • Evaluate the role of therapeutic drug monitoring and laboratory testing (e.g. CBC) to guide dosing and assess for toxicity with thiopurines for IBD
  • Assess the limitations and strengths of the evidence that therapeutic drug monitoring can guide the optimization of anti-TNF therapy
  • Describe how to optimize the use measurement of anti-drug antibody levels and serum drug levels to guide management of patients currently receiving anti-TNF therapy
  • Provide appropriate care and counsel for patients and their families.

Target Audience

This activity has been designed to meet the educational needs of gastroenterologists and registered nurses who are responsible for the care of patients with inflammatory bowel disease (IBD). Other healthcare providers who care for patients with IBD may also find the content of interest.

Release Date: February 15, 2016
Expiration Date: February 15, 2017

Faculty

William J. Sandborn, MD (Moderator)
Chief, Division of Gastroenterology
Professor of Medicine, Chief, Division of Gastroenterology
University of California San Diego
La Jolla, CA

Biography





Marla C. Dubinsky, MD
Professor of Pediatrics
Chief, Pediatric Gastroenterology, Hepatology and Nutrition
Co-Director, Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center
Icahn School of Medicine, Mount Sinai Hospital
New York, NY

Biography




Gary R. Lichtenstein, MD
Professor of Medicine
Raymond and Ruth Perelman School of Medicine
of the University of Pennsylvania
Director, Center for Inflammatory Bowel Disease
University of Pennsylvania
Philadelphia, PA

Biography



Gary Lichtenstein is the Director of the Inflammatory Bowel Disease Center, and a Professor of Medicine in the Gastrointestinal Division of the Department of Medicine at the Hospital of the University of Pennsylvania, and the University of Pennsylvania School of Medicine in Philadelphia, PA.

Dr. Lichtenstein earned his medical degree from the Mount Sinai School of Medicine, in New York, NY. He then completed his internship and residency in Internal Medicine at Duke University Medical Center, in Durham, NC. He also served a fellowship in Gastroenterology at the Hospital of the University of Pennsylvania, of the University Of Pennsylvania School Of Medicine. His current research interests encompass investigational therapies for the treatment of ulcerative colitis (UC) and Crohn's disease (CD), as well his research has had a significant focus on the safety of current and future medical therapy. Dr. Lichtenstein has received numerous research grants focusing on these areas, and has served as the national/international principal investigator evaluating novel agents for therapeutic trials in the treatment of UC and CD.

A Fellow of the American Gastroenterological Association (AGA), the American College of Physicians (ACP), and the American College of Gastroenterology (ACG), Dr. Lichtenstein has been listed in "Best Doctors in America" (inflammatory bowel disease), and has served as Medical Secretary for the American Board of Internal Medicine, Gastroenterology Section. He holds membership and committee positions in many professional societies at a national level, including the American Gastroenterological Association (AGA), where he has served as the Vice-Chair of the Clinical Practice Committee and Practice Economics Committee, and where he has served as Chair of the Clinical Practice Committee. For the American Society for Gastrointestinal Endoscopy (ASGE) he has served on the Committee on Training, and with the American College of Gastroenterology he has served on the Education Committee, Programs Committee, and the Nominations Committee. He recently served as a member of the Research Committee. He has been the Chair of the Abstract Review Committee for Inflammatory Bowel Disease for the American College of Gastroenterology. He is also a member of the Crohn's and Colitis Foundation of America (CCFA), where he served at the national level as the Chair of the Membership Committee of the Clinical Research Alliance, he has served on the National Grants Review Committee, and the National Physician Education Committee. He additionally is a longstanding member of the American College of Physicians (ACP) and the American Medical Association (AMA).

Dr. Lichtenstein has received numerous awards including the award for the top specialist in the University of Pennsylvania Health system - the Louis A. Duhring Award. He is the recipient of the Christina and Marie Lindback Award - the top teaching award in the entire University of Pennsylvania. He has also received the medical school teaching award - the Penn Pearls Award. He has received the Department of Medicine Housestaff teaching award - the Donald B. Martin Teaching Award. He has received the Gastroenterology Division teaching award - the Sidney Cohen Teaching Award. He is listed in "The Best Doctors in America" - Inflammatory Bowel Disease, and in Philadelphia Magazine he is Listed among top Gastroenterologists for elderly in Philadelphia, and Listed among top Gastroenterologists in Philadelphia (Special Focus: Inflammatory Bowel Disease). He is the recipient of the CCFA Physician of the Year Award: Philadelphia and Delaware Valley Chapters.

In addition to having served on the Editorial Board of the journals Gastroenterology, American Journal of Gastroenterology, Inflammatory Bowel Diseases, World Journal of Gastroenterology, and Digestive Diseases and Sciences, Dr. Lichtenstein serves as a former writer of Selected Summaries in the journal Gastroenterology, and served as the section editor of Selected Summaries, and the section editor of Print and Media Review, in Gastroenterology for a 5 year term. He also has, and currently serves as a reviewer for such journals as The New England Journal of Medicine, Gastroenterology, The Lancet, the Annals of Internal Medicine, Gut, Journal of Parenteral and Enteral Nutrition, the American Journal of Gastroenterology, the World Journal of Gastroenterology, and the Journal of Clinical Gastroenterology. He is the executive editor of a newly PubMed indexed journal Gastroenterology and Hepatology, and serves as associate editor of Therapeutic Advances in Gastroenterology, The Physician and Sportsmedicine, and Clinical Investigation, and is currently Assistant Editor-in-Chief of the World Journal of Gastroenterology. An invited lecturer at the local, national, and international levels, Dr. Lichtenstein is the author or coauthor of more than 325 peer-reviewed primary articles and chapters, and he has presented over 250 abstracts and edited 18 books.

Close Biography

Syllabus Disclosure Statement

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:

Name of Faculty or Presenter

Reported Financial Relationship

William J. Sandborn, MD

Consulting: AbbVie Laboratories, Janssen, Prometheus Labs, Takeda, UCB Pharma

Fees for Non-CME/CE: Takeda

Contracted Research: AbbVie Laboratories, Janssen, Prometheus Labs, Takeda, UCB

Marla C. Dubinsky, MD

Consulting: AbbVie Laboratories, Genentech, Janssen, Prometheus Labs, Shire Pharmaceuticals, Takeda, UCB, Pfizer

Gary R. Lichtenstein, MD

Consulting: Abbott Corporation/Abbvie, Actavis, Alaven, Ferring, Hospira, Janssen Orthobiotech, Luitpold/American Regent, Pfizer Pharmaceuticals, Prometheus Laboratories, Inc., Salix Pharmaceuticals, Santarus, Shire Pharmaceuticals, Takeda, UCB, Warner Chilcotte

Royalty: SLACK, Inc.

Contracted Research: Ferring, Janssen Orthobiotech, Prometheus Laboratories, Inc., Salix Pharmaceuticals, Santarus, Shire Pharmaceuticals, UCB, Warner Chilcotte

Other: Clinical Advances in Gastroenterology, Gastroenterology and Hepatology (Gastro-Hep Communications), Ironwood, Luitpold/American Regent, McMahon Publishing, Springer Science and Business Media, Up-To-Date, Warner Chilcotte

The planners and managers reported the following financial relationships or relationships they or their spouse/life partner have with commercial interests related to the content of this continuing education activity:

The following PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, RN, BSN, and Jan Schultz, RN, MSN, CHCP, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

The following SCI planners and managers, Ian Morgan, MSc, and Elena Urso, BSc, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity or any amount during the past 12 months.

Accreditation


Physician Continuing Medical Education

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 Postgraduate Institute for Medicine and Strategic Consultants International. The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation
The Postgraduate Institute for Medicine designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education

Credit Designation
This educational activity for 1.2 contact hours is provided by Postgraduate Institute for Medicine.

Accreditation Statement
Postgraduate Institute for Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

Estimated Time to Complete Activity: 1.25 hours

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 planners of this activity 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 the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Method of Participation and Request for Credit

There are no fees for participating and receiving CME/CE credit for this activity. To successfully earn credit, participants must complete the activity online during the valid credit period. Follow these steps to earn CME/CE credit:

  1. Read the target audience, learning objectives, and author disclosures.
  2. View the educational content online
  3. Upon completion of the activity, complete the online posttest and Activity Evaluation to provide feedback for future programming.

Upon successful completion of the posttest, with a passing score of 75% or better, and the online Evaluation form, you will have immediate access to a CME/CE certificate to print or save for your files.

If you have any questions regarding the CME/CE certification for this activity, please contact Postgraduate Institute for Medicine at: information@pimed.com or (303) 799-1930.

Media: Internet

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 and/or dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

This activity is supported by an educational grant from UCB, Inc.

 
This activity is jointly provided by
Postgraduate Institute for Medicine and Strategic Consultants International.