• A Boillot, G Capellier, E Racadot, J Wijdenes, P Herve, and F Barale.
• Department of Anaesthesiology and Intensive Care, University Hospital, Besançon, France.
• Clin Intensive Care. 1995 Jan 1; 6 (2): 52-6.

ObjectiveTo determine the safety and pharmacokinetics of an anti-tumour necrosis factor (TNF alpha) monoclonal antibody in the treatment of septic shock, and to evaluate the biological evolution of cytokine response.DesignOpen-label, prospective, pilot trial with escalating doses of a murine monoclonal antibody (B-C7) directed against TNF alpha.SettingUniversity medical centre intensive care unit.PatientsNine patients with septic shock, who received standard supportive care and antimicrobial therapy in addition to the anti-TNF alpha antibody.InterventionsPatients were treated intravenously with one of three escalating doses of B-C7 monoclonal antibody (MoAb): 0.4 mg/kg, 0.8 mg/kg, 1 mg/kg.ResultsMoAb was well tolerated despite the development of human anti-mouse antibodies (HAMA) for each patient; B-C7 plasma levels were dose-dependent. At study entry, TNF alpha and IL-6 levels were detected in six and seven patients respectively; IL-1 levels were low and interferon-gamma was undetectable.ConclusionsNo side effects were noted during treatment regardless of the dose used; however, further studies are needed to determine the clinical efficacy of this agent in septic shock.

20 keywords...

hide…