• European cytokine network · Jan 2003

    Randomized Controlled Trial Comparative Study Clinical Trial

    Anti-inflammatory response after infusion of p55 soluble tumor necrosis factor receptor fusion protein for severe sepsis.

    • Vincent L Butty, Pascale Roux-Lombard, Jorge Garbino, Jean-Michel Dayer, Bara Ricou, and Geneva Sepsis Network.
    • Department of Anesthesiology, Pharmacology and Surgical Intensive Care, Geneva University Hospital, 1211 Geneva 14, Switzerland.
    • Eur. Cytokine Netw. 2003 Jan 1;14(1):15-9.

    ObjectivesTo investigate the effects of Lenercept , a recombinant soluble TNF receptor p55 fused to an immunoglobulin heavy chain IgG1, on the balance of pro- and anti-inflammatory mediators in sepsis.DesignPost hoc analysis of a subgroup of patients enrolled in a multicenter phase III, prospective, double-blind, placebo-controlled, randomized study of Lenercept in severe sepsis.SettingSurgical and medical intensive care units, and postoperative recovery room of a tertiary care teaching hospital.PatientsA total of 57 patients were enrolled in the multicenter study in our center.InterventionSeptic patients were randomly assigned to receive either Lenercept 0.125 mg/kg or placebo. The patients were followed for up to 28 days after randomization.Measurements And Main ResultsCirculating levels of TNF-alpha, IL-6, TNFsR75 and IL-1Ra were measured before and after treatment. The two groups were comparable with regard to age, gender and diagnosis distribution. The total level of TNF-alpha increased significantly in treated patients, compared to patients receiving placebo. The levels of the other inflammatory mediators did not differ between the two groupsConclusionsLenercept -treated patients experienced a protracted TNF-alpha half-life, leading to higher total TNF-alpha levels throughout the study. However, the treatment had no effects on anti-inflammatory mediators. Therefore, peripheral inflammatory processes might not have been significantly modified by the treatment. This might account for the lack of efficacy this treatment in septic patients

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