CME Activity : Safety and Comorbidity of Biologic Therapeutics in Inflammatory Arthritis

DESCRIPTION

Chronic inflammatory joint diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing Spondylitis are highly destructive and disabling diseases that affect millions of individuals in the US and worldwide. Fortunately, treatment of these conditions has advanced tremendously in the last decade, largely because of the development of targeted biological therapies and a more aggressive management approach.  Patients are experiencing less pain and joint damage and thus higher quality of life as a result of these treatment strategies.

Exciting emerging data, at least in rheumatoid arthritis, suggest that cardiovascular risk may be reduced, and life span prolonged, as a result of more aggressive treatment.  Given the complexities of treatment options available, today’s this activity will provide clinicians with cutting edge information to enable them to choose and monitor treatment strategies that achieve maximal improvement of their patients without incurring undue risk.

WHO SHOULD ATTEND

This activity is intended for rheumatologists.

OBJECTIVES

After viewing this activity, the participant will demonstrate the ability to:

  • Identify the spectrum of therapeutic agents currently approved for the treatment of inflammatory arthritis
  • Identify the systemic effects of inflammation – e.g. on hematopoieses, metabolic pathways, atherosclerosis – in patients with chronic inflammatory arthritis
  • Distinguish the types of infectious risk that are enhanced by biological therapies for inflammatory arthritis
  • Define the types of malignancy risk that may be enhanced by chronic inflammation itself as well as by biological therapies

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 3.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity was approved on May 15, 2010.
Released: May 15, 2010        Expires:  May 14, 2013

Policy on Speaker and PROVIDER Disclosure

It is the policy of the Johns Hopkins University School of Medicine that the speaker and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentation(s).  The Johns Hopkins University School of Medicine OCME has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity.

Notice About Off-Label Use Presentations

The Johns Hopkins University School of Medicine/Safety and Comorbidity Considerations of Biologic Therapeutics in Inflammatory Arthritis may include presentations on drugs or devices, or use of drugs or devices, that have not been approved by the Food and Drug Administration (FDA) or have been approved by the FDA for specific uses only.  The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice.
The Johns Hopkins University School of Medicine is committed to the free exchange of medical education.  Inclusion of any presentation in this program, including presentations on off-label uses, does not imply an endorsement by Johns Hopkins of the uses, products, or techniques presented.

AMERICANS WITH DISABILITIES ACT

The Johns Hopkins University School of Medicine complies with the legal requirements of the ADA and the rules and regulations thereof.

COPYRIGHT INFORMATION

All rights reserved.  No part of this syllabus may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embodied in articles or reviews.

What you should know about gifts to physicians from industry
Gift giving from the pharmaceutical, device and medical equipment industries to physicians has long been a customary practice.  But when gift giving is not practiced within established ethical boundaries, the perception of conflict of interest is raised.  All physicians and physicians in training should adhere to the AMA Code of Medical Ethics, Opinion 8.061, “Gifts to Physicians from Industry” which can be found under the AMA Code of Medical Ethics at www.ama-assn.org/go/ethicalgifts.

Johns Hopkins faculty, staff, employees, students, and trainees must adhere to the more restrictive Johns Hopkins Medicine Policy on Interaction with Industry that can be found on HopkinsMedicine.org by clicking Research > For Our Researchers > Research Affairs Offices > Office of Policy Coordination > Policy on Interaction with Industry or directly through this link http://www.hopkinsmedicine.org/Research/OPC/Policy_Industry_Interaction.

FULL DISCLOSURE POLICY AFFECTING CME ACTIVITIES

NAME COMPANY
Clifton Bingham, III, MD Grant/Research Support:
Abbott, Amgen, Bristol-Myers-Squibb, Centocor, Genentech, Roche, UCB
Consultant:
Celgene, Centocor, Genentech, Roche, Serono,  UCB
Alan Matsumoto, MD Consultant: Abbott, Genentech

All other speakers have indicated that they have not received financial support for consultation, research or evaluation or have a financial interest relevant to their presentation.

Note:  Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution which receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

OFF-LABEL PRODUCT DISCUSSION

The following speakers have disclosed that their presentation will reference unlabeled/unapproved uses of drugs or products:

NAME  PRODUCT
Clifton Bingham, III, MD Clinical trials showing use of Rituximab and Tocilizumab in early RA and MTX inadequate responders will be shown, but not is made that these are not FDA-approved indications. There is also discussion of agents in development for RA: CP690550, INCB018424, Fostamatinib, Ocrelizumab, Ofatumumab,TRU-015, Atacicept, Briobacept, Belimumab, LY21273998.

All other speakers have indicated that they will not reference unlabeled/unapproved uses of drugs or products.

ACKNOWLEDGEMENT

We wish to acknowledge the following company that has provided an educational grant in support of this activity: Abbott

Lecture Titles and objectives

Current Therapies for Rheumatoid Arthritis
Objectives: After viewing this lecture, the participant will demonstrate the ability to–
Identify the spectrum of therapeutic agents currently approved for the treatment of inflammatory arthritis; summarize the molecular pathways involved in rheumatoid arthritis and select agents that target those pathways; describe the efficacy of biological agents in the treatment of RA
Clifton Bingham, III, MD
Associate Professor of Medicine

The Phenotypic Presentation of Systemic Inflammation
Objective:
After viewing this lecture, the participant will demonstrate the ability to–
Define the mechanism links between systemic inflammation and clinical phenotypes
Jon Giles, MD
Assistant Professor of Medicine

Biologic DMARDs and Infection Risk
Objectives:
After viewing this lecture, the participant will demonstrate the ability to—
Describe the types of infections that occur in patients treated with biological therapy; recognize the risk of serious and opportunistic and granulomatous infections in randomized clinical trials and observational registries; develop strategies for vaccinations and screening for infections in patients treated with biological agents
William Bishai, MD
Professor of Medicine; Co-Director, Center for Tuberculosis Research

Biologic Use and Malignancy
Objectives:
After viewing this lecture, the participant will demonstrate the ability to—
Identify evidence based information to assess the risk of malignancy associated with biologic therapy in patients with inflammatory arthritis
Alan Matsumoto, MD
Assistant Professor of Medicine

TO RECEIVE CME CREDIT:

To obtain CME Credits for this activity, you must register online at http://www.hopkinscme.edu/CourseDetail.aspx/80022119 . After you have registered and paid the $35 registration fee, please follow the steps given on the website to complete your post-test.

A Certificate of Credits will be given upon passing the post-test with a score of at least 70% or better.  Registrations will not be accepted after June 30, 2013.

Notice to physicians regarding future correspondence:  As part of our ongoing efforts to provide you with exemplary education, you will be mailed an outcome survey in a few months.  Please share with us what you have learned by participating in this activity and how you have implemented this information into your practice.

Activity

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Updated: July 25, 2012

Arthritis Center

About Arthritis Center

Founded in 1998, the Arthritis Center at Johns Hopkins is dedicated to providing quality education to patients and healthcare providers alike.