ORIGINAL ARTICLE Efficacy and safety profile of anti-interleukin-1 treatment in Behçet’ s disease: a multicenter retrospective study Giacomo Emmi 1 & Rosaria Talarico 2 & Giuseppe Lopalco 3 & Rolando Cimaz 4 & Fabrizio Cantini 5 & Ombretta Viapiana 6 & Ignazio Olivieri 7 & Matteo Goldoni 8 & Antonio Vitale 9 & Elena Silvestri 1 & Domenico Prisco 1 & Giovanni Lapadula 3 & Mauro Galeazzi 9 & Florenzo Iannone 3 & Luca Cantarini 9,10 Received: 28 May 2015 /Accepted: 30 June 2015 # International League of Associations for Rheumatology (ILAR) 2015 Abstract Growing data have provided encouraging results on the use of interleukin (IL)-1 inhibitors in Behçet’ s disease (BD). This study was aimed at reporting the largest experience with anti-IL-1 agents in BD patients. We evaluated 30 BD patients receiving treatment with anti-IL-1 agents. The prima- ry aims of the study were to evaluate the efficacy of anakinra (ANA) and canakinumab (CAN) in a cohort of BD. The sec- ondary aims were to evaluate the overall safety profile of the treatments, explore the timing of response to therapy and any adjustment of dosage and frequency of drugs studied, and investigate predictive factors of response to therapy. The fre- quency of first line therapy was 90 % with ANA and 10 % with CAN. The overall number of subjects in complete remis- sion after 12 months of therapy with anti-IL-1 drugs was 13: 6 maintained the initial therapy regimen, 1 maintained the same initial anti-IL-1 drug with further therapeutic adjustments, and the remaining 6 shifted from ANA to CAN. Among them, 3 used CAN for at least 12 months without therapeutic adjust- ments, 1 had therapeutic adjustments, and 3 had an overall history of a 12-month complete remission. Adverse events (AEs) were reported in 15 % patients who received ANA, represented in all cases by local cutaneous reactions, while no AE were observed in patients who received CAN; we did not observe any serious AEs (SAEs) during the follow-up period. Our data have confirmed that the use of anti-IL-1β drugs is efficacious and safe with an overall acceptable reten- tion on treatment. Keywords Anakinra . Anti-interleukin-1 . Behçet’ s disease . Biologics . Canakinumab . Therapy This is from the Autoinflammatory Diseases’ Working Group of the Italian Society of Rheumatology (SIR). Giacomo Emmi and Rosaria Talarico contributed equally to this work. * Luca Cantarini cantariniluca@hotmail.com 1 Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy 2 Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy 3 Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy 4 Neurofarba Department, University of Florence and AOU Meyer, Florence, Italy 5 Division of Rheumatology, Hospital of Prato, Prato, Italy 6 Unit of Rheumatology, University of Verona, Verona, Italy 7 Rheumatology Department of Lucania, San Carlo Hospital of Potenza, Potenza, Italy 8 Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy 9 Research Center of Systemic Autoinflammatory Diseases and Behçet’ s Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy 10 Rheumatology Unit, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Policlinico Le Scotte, Viale Bracci 1, 53100 Siena, Italy Clin Rheumatol DOI 10.1007/s10067-015-3004-0