Food and Drug Administration

Center for Drug Evaluation and Research

Arthritis Advisory Committee

Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD

August 17, 2001

Safety Updates:

Enbrel Ô (etanercept), Immunex,

RemicadeÔ (infliximab) Centocor

Consultants

CDER: CBER:

Steven B. Abramson, M.D. Michael F. Iademarco, MD, MPH

Chairman of Rheumatology and Medicine Associate Director for Science

Hospital for Joint Diseases Division of Tuberculosis Elimination

301 East 17th Street National Center for HIV, TB, STD Prevention

New York, New York 10003 Centers for Disease Control and Prevention

MS E-10, 1600 Clifton Road

Janet D. Elashoff, Ph.D. Atlanta, Georgia 30333

Director, Division of Biostatistics

Cedars-Sinai Medical Center Joseph Keane, MD

8700 Beverly Boulevard Assistant Professor

Los Angeles, California 90048 Pulmonary Center, R-304

Boston University School of Medicine

Patient Representative: 80 E. Concord Street

Leona M. Malone, MSW Boston, Massachusetts 02118

8D Lexington Lane East

Palm Beach Gardens, Florida 33418 Julie M. Vose, M.D.

Professor and Vice Chairman

David Wofsy, M.D. Department of Internal Medicine

Professor of Medicine University of Nebraska Medical Center

Director, Clinical Trials Center 983332 Nebraska Medical Center

Department of Medicine Omaha, Nebraska 68198-3332

Division of Rheumatology

University of California at San Francisco

VA Medical Center

4150 Clement Drive, Building 2, Room 531

San Francisco, California 94121