Fatal asthma; is it still an epidemic?

Asthma mortality has declined since the 1980s. Nevertheless the World Health Organization (WHO) identified asthma as responsible for 225.000 deaths worldwide in 2005, and 430.000 fatal cases are expected by 2030. Some unexpected and concentrated fatal asthma events all occurred between 2013 and 2015 in Veneto, a North Eastern region of Italy, which prompted a more in-depth investigation of characteristics and risk factors

Safety of uSCIT-MPL-4: prevalence and risk factors of systemic reactions in real life

Aim: We assessed the safety of allergoid adjuvanted by monophosphoryl lipid A (uSCIT-MPL-4) in a real-life setting. Materials & methods: Patients treated with uSCIT-MPL-4 were followed-up for 1 year. Systemic reactions (SRs) were registered and the association with potential risk factors was evaluated. Results: 2929 patients were included. Grade 0, 1, 2, 3 and 4 SR reactions were observed respectively in 3.3, 1.5, 0.31, 0.07 and 0.07% of patients. A significant association was detected between Grade >= 1 SRs and: female gender, number of administrations, previous local reactions. Conclusion: uSCIT-MPL-4 is safe. Local reactions should be accurately assessed as they may represent a risk factor for Grade >= 1 SRs, together with gender and number of doses/year

Trends and determinants of Emergency Room admissions for asthma: A retrospective evaluation in Northeast Italy

Background: Asthma still represents a cause of death and hospital admissions worldwide. Our study aimed at analyzing the trend of Emergency Room (ER) asthma admissions in Northeast Italy in order to investigate the relevance of specific patient-related determinants and environmental triggers (pollens, mold spores, and pollutants).Methods: Retrospective data from admissions for asthma exacerbations registered between the years 2013 and 2015 in two main ERs in Northeast Italy were collected. Data about patients' age, sex and nationality were recorded. Classification of disease severity followed the current Italian ER triage scoring system (white: no need for emergency treatment; green: need for fast treatment; yellow: severe condition; red: life-threatening condition). Data on pollen/mold spore counts and pollutants were analyzed.Results: Overall, 1745 ER admissions for asthma were registered, with a persistent and significant increase year by year. A slight prevalence of females and patients over 50 years old was observed. Immigrants accounted for 32%, 36% and 26% of admissions respectively in 2013, 2014 and 2015. The prevalence of immigrants' admissions was significantly higher when comparing the relative ratio of immigrant populations/Italian nationals (p < 0.05). The admissions were coded as follows: white, 6.30%; green, 35.36%; yellow, 39.37%; red, 18.97%. People aged >= 50 years were more frequently admitted with a red code, but the trend was not statistically significant (p = 0,0815). By contrast, amongst immigrants there was a higher prevalence of white and green codes observed in comparison with Italian nationals. Grass pollen peak and PM10 high levels represented environmental determinants of ER admissions increase.Conclusions: The increasing rate of asthma-related ER admissions highlights the need for implementing asthma control strategies. Investigating the traits of patients referring to ER for asthma exacerbations, as well as environmental-related determinants, may help in identifying at-risk individuals and in orienting preventive strategies accordingly. Immigrants represent the most vulnerable sub-population, and their potential difficulties in accessing treatments and health services should be specifically addressed. Overall, implementing patient education in order to improve treatment adherence, as well as providing an asthma action plan to every asthmatic patient, continue to be the most urgent needs

How far from correct is the use of adrenaline auto-injectors? A survey in Italian patients

Self-administered adrenaline through an auto-injector is the main out-of-hospital treatment for anaphylaxis, and patients should be trained to promptly and correctly use the device. The aim of the study was to verify the proper use of the device and the correct drug administration, and to identify possible misuse by patients. In seven Italian Allergy clinics, patients who were previously provided with self-injectable adrenaline were recruited at the follow-up visit required for the renewal of their prescription. All patients completed a questionnaire covering details of their allergic reactions, and knowledge of the device. The correct use was verified by the physician using a trainer with a four-step examination. 242 patients were included; 46 patients (18 %) did not always carry the auto-injector, and 35 patients (14 %) reported situations in which they were doubtful about whether to use adrenaline. Only 39 % of patients properly managed the device, while some patients (6 %) failed in all four steps. The majority of patients considered it appropriate to use adrenaline at the onset of respiratory symptoms (56 %). The factor most closely related to proper use of the device was the education of the patient (p = 0.03), while age and the time from first prescription did not affect the ability to properly use the auto-injector. Even though accurate training is conducted, many patients are still unable to properly use the adrenaline auto-injector in case of anaphylaxis. Allergists should review the instructions provided to the patients every time a renewal of the auto-injector is prescribed

Chronic Urticaria Patient Perspective (CUPP): The First Validated Tool for Assessing Quality of Life in Clinical Practice

Background There is a need for validated tools to assess health-related quality of life (HRQoL) in routine clinical practice. Objective The aim of this study was to validate the Chronic Urticaria Patient Perspective (CUPP) for assessment of patients with chronic urticaria (CU) in clinical practice. Methods A provisional CUPP was developed from candidate items identified by following an iterative process in a retrospective analysis of 249 Chronic Urticaria Quality of Life Questionnaire questionnaires. The psychometric properties of the CUPP were then tested on a sample of patients enrolled in 13 Italian centers. Results The study population in the validation phase comprised 152 patients. The 10-item version of the CUPP showed satisfactory internal consistency (Cronbach's alpha values of 0.76 at visit 1 and 0.90 at visit 2), good criteria, and discriminative and convergent validity. Reliability was assessed in 34 patients with no changes in health (Global Rating Scale = 0 at visit 2) and was satisfactory (CCC [concordance correlation coefficient] = 0.9). Changes in CUPP scores were significantly associated with changes in Urticaria Activity Score (UAS)-Hive count (r = 0.36, P <.001), UAS-Itch severity (r = 0.48, P <.001), and UAS-Total score (r = 0.342, P <.001), all of which indicated good responsiveness. The minimal important difference was 1.5. Conclusions CUPP is a simple 10-question tool with good psychometric properties that provides a valid, reliable, and standardized measurement of HRQoL in patients with CU

The Severe Asthma Network in Italy: Findings and Perspectives

Background: Severe Asthma Network in Italy (SANI) is a registry of patients recruited by accredited centers on severe asthma. Objective: To analyze epidemiological, clinical, inflammatory, functional, and treatment characteristics of severe asthmatics from the SANI registry. Methods: All consecutive patients with severe asthma were included into the registry, without exclusion criteria to have real-life data on demographics, asthma control, treatments (including biologics), inflammatory biomarkers, and comorbidities. Results: A total of 437 patients (mean age: 54.1 years, 57.2% females, 70.7% atopics, 94.5% in Global Initiative for Asthma severity step V) were enrolled into the study. The mean annual exacerbation rate was 3.75. The mean blood eosinophil level was 536.7 cells/mcL, and the average serum total IgE was 470.3 kU/L. Approximately 64% of patients were on regular oral corticosteroid treatment, 57% with omalizumab and 11.2% with mepolizumab. Most common comorbidities were rhinitis, nasal polyposis, and bronchiectasis. Patients with nasal polyposis had higher age of disease onset, higher blood eosinophil count, and lower frequency of atopy and atopic eczema. Bronchiectasis was associated with more frequent severe exacerbations, higher blood eosinophils, and total IgE. Stratifying patients, those with late-onset asthma were less frequently atopic (with less frequent allergic rhinitis and food allergy), and more frequently with nasal polyposis and higher serum total IgE levels. Conclusions: This study revealed a high frequency of relevant comorbidities and that a substantial proportion of patients have late-onset asthma; all these features define specific different disease phenotypes. Severe asthma complexity and comorbidities require multidisciplinary approaches, led by specifically trained pulmonologists and allergists

Shadow cost of oral corticosteroids-related adverse events: A pharmacoeconomic evaluation applied to real-life data from the Severe Asthma Network in Italy (SANI) registry

Background: Asthma is one of the most common non-communicable respiratory diseases, affecting about 6% of the general population. Severe asthma, even if afflicts a minority of asthmatics, drives the majority of costs of the disease. The aim of this study is to create a pharmacoeconomic model to predict the costs of corticosteroid-related adverse events in severe asthmatics and applying it to the first published epidemiologic data from the Severe Asthma Network in Italy (SANI) registry. Methods: The analysis was conducted from the perspective of the Italian National Healthcare System (INHS). Model inputs, derived from literature, included: asthma epidemiology data, frequency of adverse events, percentage of severe asthma treated with OCS and adverse event cost (Diagnosis-Related Group (DRG) national tariffs). We estimated costs per different patient groups: non-asthma controls, mild/moderate and severe asthmatics. Final results report estimated direct cost per patient and total direct cost for overall target population, showing economic impact related to corticosteroid complication. Results: Based on epidemiological data input, in Italy, asthmatic subjects resulted about 3,999,600, of which 199,980 with severe asthma. The number of patients with severe asthma OCS-treated was estimated at 123,988. Compared to the non-asthma control cohort and to that with moderate asthma annual cost per severe asthmatic patient resulted respectively about €892 and €606 higher, showing a corticosteroids shadow cost ranging from 45% to 30%.Applying the cost per patient to the target population identified for Italy, the budget impact model estimated a total annual cost related to OCS-related adverse events of €242.7 million for severe asthmatics. In respect with non-asthmatic and moderate population, an incremental expenditure of about € 110.6 million and €75.2, respectively, were shown. Conclusions: Our study provides the first estimates of additional healthcare costs related to corticosteroid induced adverse events in severe asthma patient. Budget impact model results highlighted the relevant economic impact of OCS-related adverse events in severe asthma patients. The future extrapolation of additional data from SANI registry will support the development of a model to investigate the role of corticosteroids sparing drugs. Keywords: Severe asthma, Oral corticosteroids, Adverse events, Pharmacoeconomy, Costs, Diabetes, Glaucoma, Obesity, Bone fracture, Chronic kidney diseas