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

  1. Hyon J. Kwon, PharmD, MPH;
  2. Timothy R. Coté, MD, MPH;
  3. Michael S. Cuffe, MD;
  4. Judith M. Kramer, MD, MS; and
  5. M Miles Braun, MD, MPH
  1. 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.

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