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Previous Volume 334:1697-1702 June 27, 1996 Number 26 Next

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ABSTRACT

Background A recombinant, soluble fusion protein that is a dimer of an extracellular portion of the human tumor necrosis factor (TNF) receptor and the Fc portion of IgG1 (TNFR:Fc) binds and neutralizes TNF- and prevents death in animal models of bacteremia and endotoxemia.

Methods To evaluate the safety and efficacy of TNFR:Fc in the treatment of septic shock, we conducted a randomized, double-blind, placebo-controlled, multicenter trial. A total of 141 patients were randomly assigned to receive either placebo or a single intravenous infusion of one of three doses of TNFR:Fc (0.15, 0.45, or 1.5 mg per kilogram of body weight). The primary end point was mortality from all causes at 28 days.

Results There were 10 deaths among the 33 patients in the placebo group (30 percent mortality), 9 deaths among the 30 patients receiving the low dose of TNFR:Fc (30 percent mortality), 14 deaths among the 29 receiving the middle dose (48 percent mortality), and 26 deaths among the 49 receiving the high dose (53 percent mortality) (P = 0.02 for the dose–response relation). Base-line differences in the severity of illness did not account for the increased mortality in the groups receiving the higher doses of TNFR:Fc.

Conclusions In patients with septic shock, treatment with the TNFR:Fc fusion protein does not reduce mortality, and higher doses appear to be associated with increased mortality.

Source Information

From the Department of Pulmonary and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland (C.J.F.); the Research and Development Division, Immunex Corporation, Seattle (J.M.A.); the Department of Medicine, Brown University School of Medicine and Memorial Hospital of Rhode Island, Pawtucket (S.M.O.); the Department of Surgery, Cornell University Medical Center, New York (S.F.L.); the Sections of Pulmonary and Critical Care Medicine, Rush–Presbyterian–St. Luke's Medical Center, Chicago (R.A.B.); the Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, D.C. (J.C.S.); the Department of Medicine, University of California, Los Angeles (E.A.); the Department of Medicine, University of Miami and Veterans Affairs Medical Center, Miami (R.M.H.S.); and the Department of Surgery, Mt. Sinai Medical Center, New York (E.B.).

Address reprint requests to Dr. Fisher at the Critical Care Research Unit, Department of Pulmonary and Critical Care Medicine, Mail Code G-62, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195.

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Tumor Necrosis Factor Receptor:Fc Fusion Protein in Septic Shock
Whiteley M. S., Glauser M.-P., Cohen J., Fisher C. J., Agosti J. M., Opal S. M.
Extract | Full Text  
N Engl J Med 1996; 335:1607-1609, Nov 21, 1996. Correspondence

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