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10.3389/fphar.2016.00380

http://scihub22266oqcxt.onion/10.3389/fphar.2016.00380
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C5076463!5076463!27822185
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suck abstract from ncbi


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pmid27822185      Front+Pharmacol 2016 ; 7 (ä): ä
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  • 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 #MMPMID27822185
  • Vitale A; Insalaco A; Sfriso P; Lopalco G; Emmi G; Cattalini M; Manna R; Cimaz R; Priori R; Talarico R; Gentileschi S; de Marchi G; Frassi M; Gallizzi R; Soriano A; Alessio M; Cammelli D; Maggio MC; 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; Rigante D; Cantarini L
  • Front Pharmacol 2016[]; 7 (ä): ä PMID27822185show ga
  • 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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