Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real life clinical practice: a nationwide multicenter retrospective observational study
| Autor: | Sota, J, Vitale, A, Insalaco, A, Sfriso, P, Lopalco, G, Emmi, G, Cattalini, M, Manna, R, Cimaz, R, Priori, R, Talarico, R, de Marchi, G, Frassi, M, Gallizzi, R, Soriano, A, Alessio, M, Cammelli, D, Maggio, Mc, Gentileschi, S, Marcolongo, R, La Torre, F, Fabiani, C, Colafrancesco, S, Ricci, F, Galozzi, P, Viapiana, O, Verrecchia, E, Pardeo, M, Cerrito, L, Cavallaro, E, Olivieri, An, Paolazzi, G, Vitiello, G, Maier, A, Silvestri, E, Stagnaro, C, Valesini, G, Mosca, M, de Vita, S, Tincani, A, Lapadula, G, Frediani, B, De Benedetti, F, Iannone, F, Punzi, L, Salvarani, C, Galeazzi, M, Angotti, R, Messina, M, Tosi, Gm, Rigante, D, Cantarini, L, 'Working Group' of Systemic Autoinflammatory Diseases of SIR (Italian Society of, Rheumatology). |
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| Přispěvatelé: | Sota, J., Vitale, A., Insalaco, A., Sfriso, P., Lopalco, G., Emmi, G., Cattalini, M., Manna, R., Cimaz, R., Priori, R., Talarico, R., de Marchi, G., Frassi, M., Gallizzi, R., Soriano, A., Alessio, M., Cammelli, D., Maggio, M. C., Gentileschi, S., Marcolongo, R., La Torre, F., Fabiani, C., Colafrancesco, S., Ricci, F., Galozzi, P., Viapiana, O., Verrecchia, E., Pardeo, M., Cerrito, L., Cavallaro, E., Olivieri, A. N., Paolazzi, G., Vitiello, G., Maier, A., Silvestri, E., Stagnaro, C., Valesini, G., Mosca, M., de Vita, S., Tincani, A., Lapadula, G., Frediani, B., De Benedetti, F., Iannone, F., Punzi, L., Salvarani, C., Galeazzi, M., Angotti, R., Messina, M., Tosi, G. M., Rigante, D., Cantarini, L., 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 |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Anakinra
Autoinflammatory disorders Canakinumab Interleukin-1 Safety profile 0301 basic medicine Male Settore MED/16 - REUMATOLOGIA 0302 clinical medicine Retrospective Studie Rheumatology Child Antibodies Monoclonal General Medicine Middle Aged Treatment Outcome Autoinflammation Female Cohort study medicine.drug Human Adult medicine.medical_specialty Adolescent Logistic Model Neutropenia Antibodies Monoclonal Humanized Autoimmune Disease Autoimmune Diseases 03 medical and health sciences Young Adult Internal medicine Injection site reaction medicine Humans Anakinra Autoinflammatory disorders Canakinumab Interleukin-1 Safety profile Adolescent Adult Antibodies Monoclonal Antibodies Monoclonal Humanized Autoimmune Diseases Child Female Humans Interleukin 1 Receptor Antagonist Protein Logistic Models Male Middle Aged Retrospective Studies Treatment Outcome Young Adult Adverse effect Retrospective Studies 030203 arthritis & rheumatology business.industry Retrospective cohort study medicine.disease Interleukin 1 Receptor Antagonist Protein Logistic Models 030104 developmental biology Autoinflammatory disorder Observational study business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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