OBJECTIVES: New onset heart failure (HF) has been associated with the use of TNF-alpha 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-alpha 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-alpha antagonists compared to those unexposed, larger cohorts are needed to provide more precise risk estimates and permit adjustment for potential confounding.
OBJECTIVES: New onset heart failure (HF) has been associated with the use of TNF-alpha 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 CDpatients 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 CDpatients 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-alpha antagonist-treated RA and CDpatients 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 CDpatients. Although there was an increased relative risk of incident, HF that was not statistically significant among those exposed to TNF-alpha antagonists compared to those unexposed, larger cohorts are needed to provide more precise risk estimates and permit adjustment for potential confounding.
Authors: Cynthia S Crowson; Paulo J Nicola; Hilal Maradit Kremers; W Michael O'Fallon; Terry M Therneau; Steven J Jacobsen; Veronique L Roger; Karla V Ballman; Sherine E Gabriel Journal: Arthritis Rheum Date: 2005-10
Authors: Paulo J Nicola; Cynthia S Crowson; Hilal Maradit-Kremers; Karla V Ballman; Véronique L Roger; Steven J Jacobsen; Sherine E Gabriel Journal: Arthritis Rheum Date: 2006-01
Authors: Paulo J Nicola; Hilal Maradit-Kremers; Véronique L Roger; Steven J Jacobsen; Cynthia S Crowson; Karla V Ballman; Sherine E Gabriel Journal: Arthritis Rheum Date: 2005-02
Authors: Matteo Cesari; Brenda W J H Penninx; Anne B Newman; Stephen B Kritchevsky; Barbara J Nicklas; Kim Sutton-Tyrrell; Russell P Tracy; Susan M Rubin; Tamara B Harris; Marco Pahor Journal: Am J Cardiol Date: 2003-09-01 Impact factor: 2.778
Authors: Jane S Saczynski; Susan E Andrade; Leslie R Harrold; Jennifer Tjia; Sarah L Cutrona; Katherine S Dodd; Robert J Goldberg; Jerry H Gurwitz Journal: Pharmacoepidemiol Drug Saf Date: 2012-01 Impact factor: 2.890
Authors: Maria I Danila; Nivedita M Patkar; Jeffrey R Curtis; Kenneth G Saag; Gim Gee Teng Journal: Curr Opin Rheumatol Date: 2008-05 Impact factor: 5.006