Safety and efficacy of anti-interleukin-1 treatment in 40 patients, followed in a single centre, with AA amyloidosis secondary to familial Mediterranean fever

Objective. The main devastating complication of FMF is AA amyloidosis. Approximately 10-15% of the patients are either intolerant or have an insufficient response to colchicine treatment. The most promising alternative treatment approach is anti-IL-1 agents. The aim of this study was to evaluate the efficacy and safety of anti-IL-1 therapy in FMF amyloidosis. Methods. Forty-four patients with amyloidosis who had been treated with anti-IL-1 agents, anakinra and/or canakinumab, were assessed retrospectively for efficacy and safety. Five patients were on haemodialysis and four had received a renal transplant. Results. The mean duration of anti-IL-1 treatment was 21.4 (18)months. Among 35 patients who were not on dialysis, renal function was maintained or improved in 79.4% but deteriorated in 20.6%. Patients with creatinine levels below 1.5 mg/di at onset benefitted more from IL-1 inhibition with regard to their kidney functions and acute phase reactants. No additional side effects were observed in patients with renal replacement treatments. The major side effect of anakinra was injection-site reaction observed in four patients. Conclusion. Anti-IL-1 agents are well tolerated and effective in the treatment of amyloidosis secondary to FMF, including patients on dialysis and renal transplant recipients. This approach may improve the lifespan of transplanted kidneys in FMF patients.