Rheumatology Advance Access originally published online on October 15, 2007
Rheumatology 2007 46(11):1688-1693; doi:10.1093/rheumatology/kem212
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Published by Oxford University 2007.
Heart failure among younger rheumatoid arthritis and Crohn's patients exposed to TNF-
antagonists
Center for Education and Research on Therapeutics of Musculoskeletal Disorders, The University of Alabama at Birmingham, Birmingham, AL, 1Center for Education and Research on Therapeutics of Cardiovascular Diseases, Duke University, Durham, NC, 2Center for Health Care Policy and Evaluation, Eden Prairie, MN and 3Food and Drug Administration, Rockville, MD, USA
Correspondence to: M. Miles Braun, MD MPH, Director, Division of Epidemiology and Associate Director for Research, OBE, CBER, FDA, HFM-220, 1401 Rockville Pike, Rockville, MD 20852, USA. E-mail: braunm{at}cber.fda.gov
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Abstract |
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Objectives. New onset heart failure (HF) has been associated with the use of TNF-
antagonists etanercept and infliximab based upon spontaneous adverse event reports. HF clinical trials of these agents were stopped early due to futility or worsening of existing HF. A potential association between etanercept and infliximab and new onset HF has been studied minimally at a population level.
Methods. Using administrative claims from a large U.S. health care organization, we identified rheumatoid arthritis (RA) and Crohn's disease (CD) patients receiving infliximab or etanercept (exposed), and comparator cohorts of RA and CD patients receiving non-biologic immunosuppressives (unexposed). We studied adults < 50 years to reduce potential confounding related to common age-related comorbidities. Based on abstracted medical records of suspected HF cases, a physician panel adjudicated cases as definite, possible or no HF.
Results. Among 4018 RA and CD patients with mean duration follow-up of 18 months, 9 of 33 suspected HF cases (identified using claims data) were adjudicated as definite (n = 5) or possible (n = 4) HF. The relative risk of HF among TNF- antagonist-treated RA and CD patients was 4.3 and 1.2, respectively (P = NS for both). The absolute difference in cumulative incidence of HF among infliximab or etanercept-exposed compared to unexposed patients was 3.4 and 0.3 cases per 1000 persons for RA and CD (P = NS), respectively, yielding a number needed to harm of 294 for RA and 3333 for CD.
Conclusion. We found only a small number of presumed HF cases (n = 9, or 0.2%) in a large population of relatively young RA and CD patients. Although there was an increased relative risk of incident, HF that was not statistically significant among those exposed to TNF- antagonists compared to those unexposed, larger cohorts are needed to provide more precise risk estimates and permit adjustment for potential confounding.
KEY WORDS: Heart failure, rheumatoid arthritis, Crohn's disease, infliximab, etanercept, TNF- antagonists, adverse events
Submitted 9 April 2007;
revised version accepted 9 July 2007.
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