The results of a randomized placebo-controlled trial show that the IL-1 receptor antagonist anakinra is safe and effective for the treatment of colchicine-resistant familial Mediterranean fever (FMF). The study enroled 25 adults receiving treatment with 1.5–3 mg colchicine per day, who were then randomly assigned to receive anakinra or placebo for 4 months. Among those treated with anakinra, the mean number of FMF attacks per patient per month was 1.7±1.7, compared with 3.5±1.9 among those who received placebo (P = 0.037). Six patients in the anakinra group had less than one FMF attack per month whereas no patients in the placebo group achieved this outcome (P = 0.005). The rate of adverse events was similar in both groups, and anakinra treatment also had a beneficial effect on quality of life.