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Disclaimer: CME certification for these activities has expired. All information is pertinent to the timeframe in which it was released.


Crohn's Disease Therapy:Contemporary Medicines And Modern Controversies


GOAL
To provide gastroenterologists and gastroenterology fellows with up-to-date information on the treatment of Crohn's disease.

TARGET AUDIENCE
This activity is designed for gastroenterologists and gastroenterology fellows. No prerequisites required.

LEARNING OBJECTIVES
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. At the conclusion of this activity, the participant should be able to:

  • Discuss the recent innovations in medical therapy for Crohn's disease, including tumor necrosis factor (TNF)-a antagonists, interleukin-12 antagonists, immunomodulator therapy, growth hormones, and thalidomide.
  • Predict response to TNF-a antagonists by assessing initial response rates, pharmacologic factors, and C-reactive protein levels.
  • Evaluate TNF-a antagonists, such as infliximab, certolizumab pegol, and adalimumab, by comparing mechanisms of action and efficacy data. 
  • Identify adverse events and the risks of TNF-a antagonists, in addition to which patients are more likely to benefit from which medication.

ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
The Johns Hopkins University School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

The estimated time to complete this educational activity: 2 hours.
Release date: August 15, 2006. Expiration date: August 15, 2008.

DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of The Johns Hopkins University School of Medicine name implies review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.

This program is supported by an educational grant from UCB Pharma.

Full Disclosure Policy Affecting CME Activities:
As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of Johns Hopkins University School of Medicine to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. The Program Director and Participating Faculty reported the following:

PROGRAM DIRECTOR

Theodore M. Bayless, MD
Professor of Medicine
Department of Gastroenterology
Sherlock Hibbs Professor of Inflammatory Bowel Disease
Director, Meyerhoff Digestive Disease CenterÐInflammatory Bowel Disease Center
Johns Hopkins University School of Medicine
Baltimore, Maryland
Dr Bayless reports serving as a consultant for Proctor and Gamble and receiving honoraria from Centocor Pharmaceuticals and Proctor and Gamble.

PARTICIPATING FACULTY

Stephen B. Hanauer, MD
Professor of Medicine and Clinical Pharmacology
Chief, Section of Gastroenterology and Nutrition
University of Chicago Hospitals
Chicago, Illinois
Dr Hanauer reports receiving grants/research support from Abbott Laboratories, Centocor Pharmaceuticals, and UCB Pharma; serving as a consultant for Abbott Laboratories, Centocor Pharmaceuticals, and UCB Pharma; and receiving honoraria from Abbott Laboratories, Centocor Pharmaceuticals, and UCB Pharma.

William J. Sandborn, MD
Professor of Medicine
Division of Gastroenterology and Hepatology
Mayo Clinic College of Medicine
Rochester, Minnesota
Dr Sandborn reports receiving grants/research support from Abbott Laboratories, Centocor Pharmaceuticals, and UCB Pharma; serving as a consultant for Abbott Laboratories, Centocor Pharmaceuticals, and UCB Pharma; and receiving honoraria from Abbott Laboratories, Centocor Pharmaceuticals, and UCB Pharma.

Bruce E. Sands, MD, MS
Assistant Professor of Medicine
Harvard Medical School
Medical Co-Director
Massachusetts General Hospital Crohn's and Colitis Center
Director, Clinical Research
Gastrointestinal Unit
Massachusetts General Hospital
Boston, Massachusetts
Dr Sands reports receiving grants/research support from Abbott Immunology, Berlex, Biogen-IDEC, Centocor Pharmaceuticals, Elan, Otsuka America, Proctor and Gamble, Prometheus Laboratories, Protein Design Laboratories Biopharma, Serono, Synta Pharmaceuticals, and Wyeth; serving as a consultant for Abbott Immunology, Berlex, Biogen-IDEC, Centocor Pharmaceuticals, Elan, Otsuka America, Proctor and Gamble, Prometheus Laboratories, Protein Design Laboratories Biopharma, Serono, Shire Pharmaceuticals, Solvay Pharmaceuticals, Synta Pharmaceuticals, and Wyeth; and receiving honoraria from Centocor Pharmaceuticals, Proctor and Gamble, Shire Pharmaceuticals, and Solvay Pharmaceuticals.

Notice: The audience is advised that articles in this CME activity contains reference(s) to unlabeled or unapproved uses of drugs or devices.

Dr Hanauer—adalimumab, certolizumab pegol, and infliximab.
Dr Sandborn—adalimumab, certolizumab pegol, and infliximab.
Dr Sands—adalimumab, certolizumab pegol, natalizumab, and sargramostim.

All other faculty have indicated that they have not referenced unlabeled/unapproved uses of drugs or devices. Johns Hopkins Advanced Studies in Medicine provides disclosure information from contributing authors, lead presenters, and participating faculty. Johns Hopkins Advanced Studies in Medicine does not provide disclosure information from authors of abstracts and poster presentations. The reader shall be advised that these contributors may or may not maintain financial relationships with pharmaceutical companies.

 

Crohn's Disease Therapy: Contemporary Medicines And Modern Controversies
Theodore M. Bayless, MD

Although Crohn's disease (CD) is not considered a fatal illness, it is a serious chronic inflammatory disease with considerable impact on daily activities and overall quality of life. CD is also associated with serious complications that often require hospitalization and surgery.

Because there is no cure for CD at present, the goal of medical therapy is to suppress the inflammatory response, thus inflamed intestinal tissue can heal, symptoms can be brought under control, and the frequency of disease flares can be reduced. Whereas conventional therapies, such as aminosalicylates, corticosteroids, and immunomodulators, are helpful in treating many patients with CD, they provide limited benefits and/or unacceptable side effects in many others.

Furthermore, these agents are not effective across the spectrum of CD. For example, steroids are useful in inducing rapid remission, but they are not effective in maintaining remission. Conversely, immunomodulators have a slow onset of action and are thus useful in maintaining remission, but not in inducing it. In addition, conventional therapies do not specifically target those parts of the immune system that are actively involved in inflammation. Clearly, other agents that do target the components of the inflammatory cascade are needed.

The introduction of the first tumor-necrosis factor (TNF) antagonist, which targets the pro-inflammatory cytokine TNF and has been shown to be effective in induction and maintenance of remission, represents a major advance in CD therapy, as does the development of additional TNF antagonists and other biologic agents. However, anti-TNF therapy is associated with immunogenicity, which increases the risk of infusion and injection-site reactions and appears to account for loss of response, in addition to a higher incidence of infections. Thus, the quest continues for the ideal drug, combination of drugs, sequence of drugs, or management strategy for patients with CD.

This issue of Johns Hopkins Advanced Studies in Medicine features a series of review articles in which 3 distinguished experts in inflammatory bowel disease address the safety and efficacy of TNF antagonists and other biologic therapies in CD, and explore the challenges associated with these strategies and with the overall management of CD.

Bruce E. Sands, MD, MS, opens the monograph with an overview of CD, conventional therapies, the current approach to treatment, and investigational therapies. In discussing the current approach to treatment, he reviews the role of standard therapies, describes the role of TNF in CD, explains how various TNF antagonists exert their anti-TNF and clinical effects, and addresses the unmet needs and challenges of anti-TNF therapy. He then focuses on several investigational agents that target other components of the inflammatory cascade, including interleukin (IL)-6 and IL-12 antagonists, antiÐinterferon-g antibodies, and colony-stimulating factors.

Stephen B. Hanauer, MD, follows with an article on predicting, assessing, and maintaining response to anti-TNF therapy. He addresses initial response rates to 3 TNF antagonists (infliximab, adalimumab, and certolizumab pegol), attenuated response, and mechanisms for loss of response during maintenance, with particular emphasis on immunogenicity and how to minimize the clinical impact of antibodies to these drugs. He also discusses the role of pharmacogenomics in predicting response and enhancing drug safety and efficacy, and reviews a number of strategies to monitor patients receiving anti-TNF therapy for immunogenicity and other toxicities.

William J. Sandborn, MD, closes the monograph with his article on the mechanism of action, efficacy, and safety of infliximab, adalimumab, and certolizu-mab pegol in the treatment of CD. Although studies have shown that these agents are generally safe and well tolerated, he points out that immunogenicity is the major safety issue and reminds clinicians of the need to assess the benefits of anti-TNF therapy against the risks. He also addresses whether certain patients are more likely to benefit from 1 TNF antagonist versus another and whether the route of administration affects safety and efficacy. He concludes with a summary of ongoing trials and what studies need to be done in the future in patients with CD.

Three abstracts, 1 each on recently presented results of studies evaluating infliximab, adalimumab, and certolizumab pegol, round out this issue of Johns Hopkins Advanced Studies in Medicine.

We hope the information presented in this publication provides some additional understanding of anti-TNF therapies for CD and that it will eventually lead to improved treatment of patients with the disease.





Johns Hopkins Advanced Studies in Medicine (ISSN-1558-0334), is published by Galen Publishing, LLC, d/b/a ASiM, PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2012 by Galen Publishing. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. ASiM is a registered trademark of The Healthcare Media Group, LLC.