Influence of an anti-tumor necrosis factor monoclonal antibody on cytokine levels in patients with sepsis

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Abstract

Objectives

To determine the safety, pharmacokinetics, and activity of an anti-tumor necrosis factor (TNF)-α monoclonal antibody in severe sepsis.

Design

Open-label, prospective, phase II multicenter trial with escalating doses of a murine monoclonal antibody (CB0006).

Setting

Twelve academic medical center intensive care units in the United States and Europe.

Patients

Eighty patients with severe sepsis or septic shock who received standard supportive care and antimicrobial therapy in addition to the anti-TNF antibody.

Interventions

Patients were treated intravenously with one of four dosing regimens with CB0006: 0.1 mg/kg, 1.0 mg/kg, 10 mg/kg or two doses of 1 mg/kg 24 hrs apart.

Measurements and Main Results

The murine monoclonal anti-TNF antibody was well tolerated despite the development of anti-murine antibodies in 98% of patients. No survival benefit was found for the total study population, but patients with increased circulating TNF

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