Background: Interleukin (IL)-1 inhibitors have been suggested as possible therapeutic options in a large number of old and new clinical entities characterized by an IL-1 driven pathogenesis. Objectives: To perform a nationwide snapshot of the on-label and off-label use of anakinra (ANA) and canakinumab (CAN) for different conditions both in children and adults. Methods: We retrospectively collected demographic, clinical, and therapeutic data from both adult and pediatric patients treated with IL-1 inhibitors from January 2008 to July 2016. Results: Five hundred and twenty-six treatment courses given to 475 patients (195 males, 280 females; 111 children and 364 adults) were evaluated. ANA was administered in 421 (80.04%) courses, CAN in 105 (19.96%). Sixty-two (32.1%) patients had been treated with both agents. IL-1 inhibitors were employed in 38 different indications (37 with ANA, 16 with CAN). Off-label use was more frequent for ANA than CAN (p < 0.0001). ANA was employed as first-line biologic approach in 323 (76.7%) cases, while CAN in 37 cases (35.2%). IL-1 inhibitors were associated with corticosteroids in 285 (54.18%) courses and disease modifying anti-rheumatic drugs (DMARDs) in 156 (29.65%). ANA dosage ranged from 30 to 200 mg/day (or 1.0-2.0 mg/kg/day) among adults and 2-4 mg/kg/day among children; regarding CAN, the most frequently used posologies were 150mg every 8 weeks, 150mg every 4 weeks and 150mg every 6 weeks. The frequency of failure was higher among patients treated with ANA at a dosage of 100 mg/day than those treated with 2 mg/kg/day (p = 0.03). Seventy-six patients (14.4%) reported an adverse event (AE) and 10 (1.9%) a severe AE. AEs occurred more frequently after the age of 65 compared to both children and patients aged between 16 and 65 (p = 0.003 and p = 0.03, respectively). Conclusions: IL-1 inhibitors are mostly used off-label, especially ANA, during adulthood. The high frequency of good clinical responses suggests that IL-1 inhibitors are used with awareness of pathogenetic mechanisms; adult healthcare physicians generally employ standard dosages, while pediatricians are more prone in using a weight-based posology. Dose adjustments and switching between different agents showed to be effective treatment strategies. Our data confirm the good safety profile of IL-1 inhibitors.
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|Data di pubblicazione:||2016|
|Titolo:||A Snapshot on the On-Label and Off-Label Use of the Interleukin-1 Inhibitors in Italy among Rheumatologists and Pediatric Rheumatologists: A Nationwide Multi-Center Retrospective Observational Study|
|Autori:||Vitale, Antonio; Insalaco, Antonella; Sfriso, Paolo; Lopalco, Giuseppe; Emmi, Giacomo; Cattalini, Marco; Manna, Raffaele; Cimaz, Rolando; Priori, Roberta; Talarico, Rosaria; Gentileschi, Stefano; de Marchi, Ginevra; Frassi, Micol; Gallizzi, Romina; Soriano, Alessandra; Alessio, Maria; Cammelli, Daniele; Maggio, Maria C; 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 N; 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; Rigante, Donato; Cantarini, Luca|
|Digital Object Identifier (DOI):||10.3389/fphar.2016.00380|
|Appare nelle tipologie:||Articolo su rivista|
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