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)

Research output: Contribution to journalArticle

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 languageEnglish
Number of pages8
JournalClinical Rheumatology
DOIs
Publication statusE-pub ahead of print - May 17 2018

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Interleukin 1 Receptor Antagonist Protein
Interleukin-1
Observational Studies
Retrospective Studies
Safety
Therapeutics
Demography
canakinumab

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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 journalArticle

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title = "Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study",
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.",
author = "{“Working Group” of Systemic Autoinflammatory Diseases of SIR (Italian Society of Rheumatology)} and Jurgen Sota and Antonio Vitale and Antonella Insalaco and Paolo Sfriso and Giuseppe Lopalco and Giacomo Emmi and Marco Cattalini and Raffaele Manna and Rolando Cimaz and Roberta Priori and Rosaria Talarico and {de Marchi}, Ginevra and Micol Frassi and Romina Gallizzi and Alessandra Soriano and Maria Alessio and Daniele Cammelli and Maggio, {Maria Cristina} and Stefano Gentileschi and Renzo Marcolongo and {La Torre}, Francesco and Claudia Fabiani and Serena Colafrancesco and Francesca Ricci and Paola Galozzi and Ombretta Viapiana and Elena Verrecchia and Manuela Pardeo and Lucia Cerrito and Elena Cavallaro and Olivieri, {Alma Nunzia} and Giuseppe Paolazzi and Gianfranco Vitiello and Armin Maier and Elena Silvestri and Chiara Stagnaro and Guido Valesini and Marta Mosca and {de Vita}, Salvatore and Angela Tincani and Giovanni Lapadula and Bruno Frediani and {De Benedetti}, Fabrizio and Florenzo Iannone and Leonardo Punzi and Carlo Salvarani and Mauro Galeazzi and Rossella Angotti and Mario Messina and Tosi, {Gian Marco}",
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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 -