1 The therapeutic use of IL-1 receptor antagonist (IL-1ra) has also been studied, first, in an endotoxaemia model in rabbits, where a highly significant mortality benefit was seen, 56 and then in two large clinical trials, where no significant effect was seen. 25 57 The first reported study in 1994 looked at 893 patients with sepsis syndrome and showed no mortality benefit of recombinant human (rh) IL-1ra. 25 However, a retrospective analysis suggested that treatment with rhIL-1ra resulted in a dose-related increase in survival time in those patients with sepsis who had organ dysfunction (i.e. those with severe sepsis), a predicted risk of mortality of 24% or greater, or both.
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