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.

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.

Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study / Sota, Jurgen; Vitale, Antonio; Insalaco, Antonella; Sfriso, Paolo; Lopalco, Giuseppe; Emmi, Giacomo; Cattalini, Marco; Manna, Raffaele; Cimaz, Rolando; Priori, Roberta; Talarico, Rosaria; de Marchi, Ginevra; Frassi, Micol; Gallizzi, Romina; Soriano, Alessandra; Alessio, Maria; Cammelli, Daniele; Maggio, Maria Cristina; Gentileschi, Stefano; Marcolongo, Renzo; La Torre, Francesco; Fabiani, Claudia; Colafrancesco, Serena; Ricci, Francesca; Galozzi, Paola; Viapiana, Ombretta; Verrecchia, Elena; Pardeo, Manuela; Cerrito, Lucia; Cavallaro, Elena; Olivieri, Alma Nunzia; Paolazzi, Giuseppe; Vitiello, Gianfranco; Maier, Armin; Silvestri, Elena; Stagnaro, Chiara; Valesini, Guido; Mosca, Marta; de Vita, Salvatore; Tincani, Angela; Lapadula, Giovanni; Frediani, Bruno; De Benedetti, Fabrizio; Iannone, Florenzo; Punzi, Leonardo; Salvarani, Carlo; Galeazzi, Mauro; Angotti, Rossella; Messina, Mario; Tosi, Gian Marco; Rigante, Donato; Cantarini, Luca. - In: CLINICAL RHEUMATOLOGY. - ISSN 1434-9949. - 37:8(2018), pp. 2233-2240. [10.1007/s10067-018-4119-x]

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

Salvarani, Carlo;
2018

Abstract

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.
17-mag-2018
37
8
2233
2240
Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study / Sota, Jurgen; Vitale, Antonio; Insalaco, Antonella; Sfriso, Paolo; Lopalco, Giuseppe; Emmi, Giacomo; Cattalini, Marco; Manna, Raffaele; Cimaz, Rolando; Priori, Roberta; Talarico, Rosaria; de Marchi, Ginevra; Frassi, Micol; Gallizzi, Romina; Soriano, Alessandra; Alessio, Maria; Cammelli, Daniele; Maggio, Maria Cristina; Gentileschi, Stefano; Marcolongo, Renzo; La Torre, Francesco; Fabiani, Claudia; Colafrancesco, Serena; Ricci, Francesca; Galozzi, Paola; Viapiana, Ombretta; Verrecchia, Elena; Pardeo, Manuela; Cerrito, Lucia; Cavallaro, Elena; Olivieri, Alma Nunzia; Paolazzi, Giuseppe; Vitiello, Gianfranco; Maier, Armin; Silvestri, Elena; Stagnaro, Chiara; Valesini, Guido; Mosca, Marta; de Vita, Salvatore; Tincani, Angela; Lapadula, Giovanni; Frediani, Bruno; De Benedetti, Fabrizio; Iannone, Florenzo; Punzi, Leonardo; Salvarani, Carlo; Galeazzi, Mauro; Angotti, Rossella; Messina, Mario; Tosi, Gian Marco; Rigante, Donato; Cantarini, Luca. - In: CLINICAL RHEUMATOLOGY. - ISSN 1434-9949. - 37:8(2018), pp. 2233-2240. [10.1007/s10067-018-4119-x]
Sota, Jurgen; Vitale, Antonio; Insalaco, Antonella; Sfriso, Paolo; Lopalco, Giuseppe; Emmi, Giacomo; Cattalini, Marco; Manna, Raffaele; Cimaz, Rolando; Priori, Roberta; Talarico, Rosaria; de Marchi, Ginevra; Frassi, Micol; Gallizzi, Romina; Soriano, Alessandra; Alessio, Maria; Cammelli, Daniele; Maggio, Maria Cristina; Gentileschi, Stefano; Marcolongo, Renzo; La Torre, Francesco; Fabiani, Claudia; Colafrancesco, Serena; Ricci, Francesca; Galozzi, Paola; Viapiana, Ombretta; Verrecchia, Elena; Pardeo, Manuela; Cerrito, Lucia; Cavallaro, Elena; Olivieri, Alma Nunzia; Paolazzi, Giuseppe; Vitiello, Gianfranco; Maier, Armin; Silvestri, Elena; Stagnaro, Chiara; Valesini, Guido; Mosca, Marta; de Vita, Salvatore; Tincani, Angela; Lapadula, Giovanni; Frediani, Bruno; De Benedetti, Fabrizio; Iannone, Florenzo; Punzi, Leonardo; Salvarani, Carlo; Galeazzi, Mauro; Angotti, Rossella; Messina, Mario; Tosi, Gian Marco; Rigante, Donato; Cantarini, Luca
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