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.
The food supply chain is a critical infrastructure that is an attractive target for terrorist attacks. Despite its importance, relatively little research has focused on improving the security of the food supply chain infrastructure. This is largely due to a lack of awareness on the part of food supply chain stakeholders and authorities about the threats. This paper describes a methodology for assessing the risk associated with threats to the food supply chain, with the goal of enhancing awareness and helping develop appropriate security measures.
Abstract:The food supply chain has been recognised by the USA and the EU as a critical infrastructure, and it should be considered a target for possible terrorist attacks. In this paper, we present a methodological approach developed within the EU project SecuFood to evaluate the risk associated with this threat. The usefulness of the approach is related to the improvement of the analysis of food supply chain risk in terms of the potential threats, the vulnerability of the system, and the effectiveness of counter measures.The followed approach is based on identifying biological and chemical hazards, analysing those biological and chemical agents, and determining the risk level they present in the main phases of the food supply chain.We consider the feasibility of an attack (what we call likelihood), taking into account the accessibility and manageability of the contamination agents, the vulnerability of the supply chain for specific products, and the possible adverse consequences.
The food supply chain could became a dangerous weapon in the hands of enemies, for this reason the strategies developed to fight food adulteration (food safety) should be complemented with specific actions devoted to improve food "security" in the sense of food defence. This paper illustrate the methodological approach used in the EU project SecuFood to analyze threats, vulnerabilities and countermeasures existing in major European countries about what concerns deliberate attacks and manipulations of food.
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