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

Maria Cristina Maggio, Maria Alessio, Rosaria Talarico, Elena Verrecchia, Romina Gallizzi, Alessandra Soriano, Francesco La Torre, Giacomo Emmi, Alma Nunzia Olivieri, Armin Maier, Serena Colafrancesco, Elena Silvestri, Paola Galozzi, Antonio Vitale, Chiara Stagnaro, Rossella Angotti, Mario Messina, Giuseppe Lopalco, Donato Rigante, Jurgen SotaLucia Cerrito, Gianfranco Vitiello, Guido Valesini, Elena Cavallaro, Stefano Gentileschi, Francesca Ricci, Armin Maier, Raffaele Manna, Guido Valesini, Renzo Marcolongo, Giuseppe Paolazzi, Manuela Pardeo, Ombretta Viapiana, Antonella Insalaco, Micol Frassi, Daniele Cammelli, Marco Cattalini, Paolo Sfriso, Claudia Fabiani, Florenzo Iannone, Bruno Frediani, Roberta Priori, Giovanni Lapadula, Raffaele Manna, Mauro Galeazzi, Leonardo Punzi, Guido Valesini, Rolando Cimaz, Fabrizio De Benedetti, Angela Tincani, Marta Mosca, Gian Marco Tosi, Ginevra De Marchi, Salvatore De Vita, Carlo Salvarani, Renzo Marcolongo, Luca Cantarini

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54 Citations (Scopus)


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.
Original languageEnglish
Pages (from-to)2233-2240
Number of pages8
JournalClinical Rheumatology
Publication statusPublished - 2018

All Science Journal Classification (ASJC) codes

  • Rheumatology


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