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Importance of Assessing Immunocompetence in Biologic Drug Development

Estimated Time of Completion

30 minutes

Overview

Recently, there has been an increased focus on the impact of biologic agents on infectious complications and immunocompetence. Biologic agents are associated with a small but significant risk of certain types of infection, including common respiratory, skin, and soft tissue infections and several others. It is important for clinicians who use biologic therapeutics to be facile in the management of a wide array of infectious complications.

Another important educational need is how current and forthcoming biologic therapies affect immunologic memory and a patient's capacity to respond to an immunologic challenge.

These educational needs will be addressed in a series of presentations that focus on the following points.

• The importance of assessing immunocompetence
• The long-term relative risks of serious bacterial and opportunistic infections among biologics
• The effects of biologic agents on humoral immunity, immunoglobulins, and vaccine response
• Preventive and therapeutic strategies for infectious complications of biologic therapies

This activity will strengthen the ability of health care professionals to manage the constant challenge of balancing therapeutic immune suppression and the risk of infectious complications.

Objectives

At the conclusion of this activity, the participant will be able to:

1. Define immunocompetence and cite the issues associated with its assessment.
2. Summarize examples of various opportunistic infections associated with biologic therapies.
3. Identify the role of preclinical immunologic and genetic models in assessing immunocompetence.

Target Audience

This activity is intended for rheumatologists, immunologists, and allied health care professionals, including nurses, nurse practitioners, and physician assistants, who care for patients with autoimmune diseases.

Accreditation

The Cleveland Clinic Foundation Center for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Cleveland Clinic Foundation Center for Continuing Education designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Participants claiming CME credit from this activity may submit the credit hours to the American Osteopathic Association Continuing Medical Education for Category 2 credit.

Activity Director and Author

Leonard H. Calabrese, DO
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
  of Case Western Reserve University
RJ Fasenmyer Chair of Clinical Immunology
Theodore F Classen DO Chair of Osteopathic Research and Education
Vice Chairman, Department of Rheumatic and Immunologic Diseases
Cleveland, Ohio

Faculty Disclosure

In accordance with the Standards for Commercial Support issued by the Accreditation Council for Continuing Medical Education (ACCME), The Cleveland Clinic Foundation Center for Continuing Education requires resolution of all faculty conflicts of interest to ensure CME activities are free of commercial bias.

The following faculty have indicated that they may have a relationship, which in the context of their presentation(s), could be perceived as a potential conflict of interest: