on June 9, 2003
Circulation. 2003
Published online before print June 9, 2003, doi: 10.1161/01.CIR.0000077913.60364.D2
Published online before print June 9, 2003, doi: 10.1161/01.CIR.0000077913.60364.D2
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© American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Infliximab, a Chimeric Monoclonal Antibody to Tumor Necrosis Factor-
, in Patients With Moderate-to-Severe Heart Failure
Results of the Anti-TNF Therapy Against Congestive Heart failure (ATTACH) Trial
From The Lindner Center and Ohio Heart Health Center, Cincinnati, Ohio (E.S.C.); the Division of Circulatory Physiology, Columbia University College of Physicians and Surgeons, New York, NY (M.P.); Cardiac, Vascular, and Pulmonary Clinical Research and Development, Centocor, Malvern, Pa (K.H.L., A.A.F.); the Department of Medicine, University of Texas Health Science Center and Texas Heart Institute, Houston (J.T.W.); and the Collaborative Organization for Research Endeavors (CORE) (J.T.W.).
Correspondence to Eugene S. Chung, MD, The Lindner Center for Research and Education, 2123 Auburn Ave, Suite 424, Cincinnati, OH 45219. E-mail chunge{at}ohioheart.org
Background– Preclinical and preliminary clinical data have suggested that tumor necrosis factor-
(TNF) may play a role in the evolution and progression of heart failure and that inhibition of TNF may favorably modify the course of the disease. We evaluated the efficacy and safety of infliximab, a chimeric monoclonal antibody to TNF, in patients with moderate-to-severe heart failure.
Methods and Results– One hundred fifty patients with stable New York Heart Association class III or IV heart failure and left ventricular ejection fraction ≤35% were randomly assigned to receive placebo (n=49), infliximab 5 mg/kg (n=50), or infliximab 10 mg/kg (n=51) at 0, 2, and 6 weeks after randomization and were followed-up prospectively for 28 weeks. Neither dose of infliximab improved clinical status at 14 weeks, the primary endpoint of the study, despite suppression of inflammatory markers (C-reactive protein and interleukin-6) and a modest increase in ejection fraction in the patients receiving 5 mg/kg (P=0.013). Furthermore, after 28 weeks, 13, 10, and 20 patients were hospitalized for any reason in the placebo, 5 mg/kg infliximab, and 10 mg/kg infliximab groups, respectively. The combined risk of death from any cause or hospitalization for heart failure through 28 weeks was increased in the patients randomized to 10 mg/kg infliximab (hazard ratio 2.84, 95% confidence interval 1.01 to 7.97; nominal P=0.043).
Conclusions– Short-term TNF antagonism with infliximab did not improve and high doses (10 mg/kg) adversely affected the clinical condition of patients with moderate-to-severe chronic heart failure.
Key Words: heart failure • proteins • antibodies
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J. Ledingham, C. Deighton, and on behalf of the British Society for Rheumatology Update on the British Society for Rheumatology guidelines for prescribing TNF{alpha} blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001) Rheumatology, February 1, 2005; 44(2): 157 - 163. [Full Text] [PDF]
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J. J.V. McMurray and M. A. Pfeffer The year in heart failure J. Am. Coll. Cardiol., December 21, 2004; 44(12): 2398 - 2405. [Full Text] [PDF]
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M. Satoh, J. Iwasaka, M. Nakamura, T. Akatsu, Y. Shimoda, and K. Hiramori Increased expression of tumor necrosis factor-{alpha} converting enzyme and tumor necrosis factor-{alpha} in peripheral blood mononuclear cells in patients with advanced congestive heart failure Eur J Heart Fail, December 1, 2004; 6(7): 869 - 875. [Abstract] [Full Text] [PDF]
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K L Hyrich, A J Silman, K D Watson, and D P M Symmons Anti-tumour necrosis factor {alpha} therapy in rheumatoid arthritis: an update on safety Ann Rheum Dis, December 1, 2004; 63(12): 1538 - 1543. [Abstract] [Full Text] [PDF]
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U. C. Sharma, S. Pokharel, T. J. van Brakel, J. H. van Berlo, J. P.M. Cleutjens, B. Schroen, S. Andre, H. J.G.M. Crijns, H.-J. Gabius, J. Maessen, et al. Galectin-3 Marks Activated Macrophages in Failure-Prone Hypertrophied Hearts and Contributes to Cardiac Dysfunction Circulation, November 9, 2004; 110(19): 3121 - 3128. [Abstract] [Full Text] [PDF]
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M. Bourraindeloup, C. Adamy, G. Candiani, M. Cailleret, M.-C. Bourin, T. Badoual, J. B. Su, S. Adubeiro, F. Roudot-Thoraval, J.-L. Dubois-Rande, et al. N-Acetylcysteine Treatment Normalizes Serum Tumor Necrosis Factor-{alpha} Level and Hinders the Progression of Cardiac Injury in Hypertensive Rats Circulation, October 5, 2004; 110(14): 2003 - 2009. [Abstract] [Full Text] [PDF]
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G. W. Moe, J. Marin-Garcia, A. Konig, M. Goldenthal, X. Lu, and Q. Feng In vivo TNF-{alpha} inhibition ameliorates cardiac mitochondrial dysfunction, oxidative stress, and apoptosis in experimental heart failure Am J Physiol Heart Circ Physiol, October 1, 2004; 287(4): H1813 - H1820. [Abstract] [Full Text] [PDF]
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G. Torre-Amione, F. Sestier, B. Radovancevic, and J. Young Effects of a novel immune modulation therapy in patients with advanced chronic heart failure: Results of a randomized, controlled, phase II trial J. Am. Coll. Cardiol., September 15, 2004; 44(6): 1181 - 1186. [Abstract] [Full Text] [PDF]
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J. Braun and J. Sieper Biological therapies in the spondyloarthritides--the current state Rheumatology, September 1, 2004; 43(9): 1072 - 1084. [Abstract] [Full Text] [PDF]
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J. Springer, D. O. Okonko, S. D. Anker, M. Li, C. Zheng, T. Kawada, M. Sugimachi, K. Sunagawa, and T. Sato Vagal Nerve Stimulation in Chronic Heart Failure: An Antiinflammatory Intervention? * Response Circulation, July 27, 2004; 110(4): e34 - e34. [Full Text] [PDF]
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R. Mills and D. L. Bhatt The yin and yang of arterial inflammation J. Am. Coll. Cardiol., July 7, 2004; 44(1): 50 - 52. [Full Text] [PDF]
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G F Ferraccioli and E Gremese Autoantibodies and thrombophilia in RA: TNF{alpha} and TNF{alpha} blockers Ann Rheum Dis, June 1, 2004; 63(6): 613 - 615. [Full Text]
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D. L. Mann, J. J.V. McMurray, M. Packer, K. Swedberg, J. S. Borer, W. S. Colucci, J. Djian, H. Drexler, A. Feldman, L. Kober, et al. Targeted Anticytokine Therapy in Patients With Chronic Heart Failure: Results of the Randomized Etanercept Worldwide Evaluation (RENEWAL) Circulation, April 6, 2004; 109(13): 1594 - 1602. [Abstract] [Full Text] [PDF]
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