In patients with colchicine-resistant familial Mediterranean fever (crFMF), open-label treatment with canakinumab (150 or 300 mg every 4 or 8 weeks, with individually adjusted dose regimens) continued to control disease activity from week 40 in the phase III CLUSTER trial. During a 72-week period (weeks 41 to 113 of the trial), >90% of the treated patients experienced no flares or had one flare, whereas a median of 17.5 flares per year was reported for the patients before entering the trial. The median C-reactive protein serum values remained low, and no new or unexpected adverse events were reported.