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.
| Original language | English |
|---|---|
| Number of pages | 8 |
| Journal | Clinical Rheumatology |
| DOIs | |
| Publication status | E-pub ahead of print - May 17 2018 |
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Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice : a nationwide multicenter retrospective observational study. / “Working Group” of Systemic Autoinflammatory Diseases of SIR (Italian Society of Rheumatology).
In: Clinical Rheumatology, 17.05.2018.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice
T2 - a nationwide multicenter retrospective observational study
AU - “Working Group” of Systemic Autoinflammatory Diseases of SIR (Italian Society of Rheumatology)
AU - Sota, Jurgen
AU - Vitale, Antonio
AU - Insalaco, Antonella
AU - Sfriso, Paolo
AU - Lopalco, Giuseppe
AU - Emmi, Giacomo
AU - Cattalini, Marco
AU - Manna, Raffaele
AU - Cimaz, Rolando
AU - Priori, Roberta
AU - Talarico, Rosaria
AU - de Marchi, Ginevra
AU - Frassi, Micol
AU - Gallizzi, Romina
AU - Soriano, Alessandra
AU - Alessio, Maria
AU - Cammelli, Daniele
AU - Maggio, Maria Cristina
AU - Gentileschi, Stefano
AU - Marcolongo, Renzo
AU - La Torre, Francesco
AU - Fabiani, Claudia
AU - Colafrancesco, Serena
AU - Ricci, Francesca
AU - Galozzi, Paola
AU - Viapiana, Ombretta
AU - Verrecchia, Elena
AU - Pardeo, Manuela
AU - Cerrito, Lucia
AU - Cavallaro, Elena
AU - Olivieri, Alma Nunzia
AU - Paolazzi, Giuseppe
AU - Vitiello, Gianfranco
AU - Maier, Armin
AU - Silvestri, Elena
AU - Stagnaro, Chiara
AU - Valesini, Guido
AU - Mosca, Marta
AU - de Vita, Salvatore
AU - Tincani, Angela
AU - Lapadula, Giovanni
AU - Frediani, Bruno
AU - De Benedetti, Fabrizio
AU - Iannone, Florenzo
AU - Punzi, Leonardo
AU - Salvarani, Carlo
AU - Galeazzi, Mauro
AU - Angotti, Rossella
AU - Messina, Mario
AU - Tosi, Gian Marco
PY - 2018/5/17
Y1 - 2018/5/17
N2 - 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.
AB - 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.
U2 - 10.1007/s10067-018-4119-x
DO - 10.1007/s10067-018-4119-x
M3 - Article
C2 - 29770930
JO - Clinical Rheumatology
JF - Clinical Rheumatology
SN - 0770-3198
ER -