Case Reports of Heart Failure after Therapy with a Tumor Necrosis Factor Antagonist

Case Reports of Heart Failure after Therapy with a Tumor Necrosis Factor Antagonist

Hyon J. Kwon, PharmD, MPH;
Timothy R. Coté, MD, MPH;
Michael S. Cuffe, MD;
Judith M. Kramer, MD, MS; and
M Miles Braun, MD, MPH

From the U.S. Food and Drug Administration, Rockville, Maryland, and Duke Clinical Research Institute, Durham, North Carolina.

Abstract

Background: Etanercept and infliximab are U.S. Food and Drug Administration–approved tumor necrosis factor (TNF) antagonists.

Objective: To describe adverse event reports of heart failure after TNF antagonist therapy.

Design: Case series.

Setting: The U.S. Food and Drug Administration's MedWatch program.

Patients: 47 patients who developed new or worsening heart failure during TNF antagonist therapy.

Measurements: Clinical and laboratory reports.

Results: After TNF antagonist therapy, 38 patients developed new-onset heart failure and 9 patients experienced heart failure exacerbation. Of the 38 patients with new-onset heart failure, 19 (50%) had no identifiable risk factors. Ten patients younger than 50 years of age developed new-onset heart failure after receiving TNF antagonists. After TNF antagonist therapy was discontinued and heart failure therapy was started in these 10 patients, 3 had complete resolution of heart failure, 6 improved, and 1 died.

Conclusion: In a fraction of patients, TNF antagonists might induce new-onset heart failure or exacerbate existing disease.

Article and Author Information

Acknowledgments: The authors thank Ellis Unger, MD, and Jeffrey N. Siegel, MD, for their help and advice in reviewing the manuscript.
Grant Support: In part by Dr. Kwon's appointment to the Research Fellowship Program at the Center for Biologics Evaluation and Research, administered by Oak Ridge Associated Universities through a contract with the U.S. Food and Drug Administration.
Potential Financial Conflicts of Interest:Consultancies: M.S. Cuffe (Wyeth); Honoraria: M.S. Cuffe (Wyeth).
Requests for Single Reprints: Hyon J. Kwon, PharmD, MPH, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200S, HFM-224, Rockville, MD 20852; e-mail, kwon{at}cber.fda.gov.
Current Author Addresses: Drs. Kwon, Coté, and Braun: Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200S, HFM-224, Rockville, MD 20852.
Dr. Cuffe: Duke University Medical Center, Box 3850, Durham, NC 27710.
Dr. Kramer: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.
Author Contributions: Conception and design: H.J. Kwon, M.S. Cuffe, M.M. Braun.
Analysis and interpretation of the data: H.J. Kwon, T.R. Coté, M.S. Cuffe, J.M. Kramer, M.M. Braun.
Drafting of the article: H.J. Kwon, M.S. Cuffe.
Critical revision of the article for important intellectual content: H.J. Kwon, T.R. Coté, M.S. Cuffe, J.M. Kramer, M.M. Braun.
Final approval of the article: H.J. Kwon, T.R. Coté, M.S. Cuffe, J.M. Kramer, M.M. Braun.
Administrative, technical, or logistic support: H.J. Kwon.
Collection and assembly of data: H.J. Kwon.