Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study

J. Sota, A. Vitale, A. Insalaco, P. Sfriso, G. Lopalco, G. Emmi, M. Cattalini, R. Manna, R. Cimaz, R. Priori, R. Talarico, G. de Marchi, M. Frassi, R. Gallizzi, A. Soriano, M. Alessio, D. Cammelli, M.C. Maggio, S. Gentileschi, R. MarcolongoF. La Torre, C. Fabiani, S. Colafrancesco, F. Ricci, P. Galozzi, O. Viapiana, E. Verrecchia, M. Pardeo, L. Cerrito, E. Cavallaro, A.N. Olivieri, G. Paolazzi, G. Vitiello, A. Maier, E. Silvestri, C. Stagnaro, G. Valesini, M. Mosca, S. de Vita, A. Tincani, G. Lapadula, B. Frediani, F. De Benedetti, F. Iannone, L. Punzi, C. Salvarani, M. Galeazzi, R. Angotti, M. Messina, D. Rigante

Research output: Contribution to journalArticlepeer-review


A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24.39 ± 27.04 months, 89 adverse events (AE) were recorded; 13 (14.61%) were classified as serious AE (sAE). The overall estimated rate of AE and sAE was 8.4 per 100 patients/year. Safety concerns were more frequent among patients aged ≥ 65 years compared with patients <16 years (p = 0.002). No differences were detected in the frequency of safety concerns between monotherapy and combination therapy with immunosuppressants (p = 0.055), but a significant difference was observed when injection site reactions were excluded from AE (p = 0.01). No differences were identified in relation to gender (p = 0.462), different lines of biologic therapy (p = 0.775), and different dosages (p = 0.70 ANA; p = 0.39 CAN). The overall drug retention rate was significantly different according to the occurrence of safety concerns (p value <0.0001); distinguishing between ANA and CAN, significance was maintained only for ANA (p <0.0001 ANA; p > 0.05 CAN). Treatment duration was the only variable associated with onset of AE (OR = 0.399 [C.I. 0.250–0.638], p = 0.0001). ANA and CAN have shown an excellent safety profile; the risk for AE and sAE tends to decrease over time from the start of IL-1 inhibition. © 2018, International League of Associations for Rheumatology (ILAR).
Original languageEnglish
Pages (from-to)2233-2240
Number of pages8
JournalClinical Rheumatology
Issue number8
Publication statusPublished - 2018


  • anakinra
  • canakinumab
  • immunosuppressive agent
  • liver enzyme, aged
  • anaphylaxis
  • Article
  • bacterial infection
  • breathing disorder
  • clinical practice
  • cohort analysis
  • drug safety
  • drug withdrawal
  • female
  • flu like syndrome
  • follow up
  • gastrointestinal disease
  • hematologic disease
  • herpes simplex keratitis
  • human
  • infection
  • injection site reaction
  • macrophage activation syndrome
  • major clinical study
  • male
  • monotherapy
  • myocarditis
  • neutropenia
  • observational study
  • pleura mesothelioma
  • priority journal
  • rash
  • retrospective study
  • side effect
  • thrombophlebitis
  • treatment duration


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