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Benralizumab is a humanized monoclonal antibody which binds to the α subunit of the interleukin-5 (IL-5) receptor and to the FcγRIIIa receptor expressed by natural killer cells, thus suppressing the pro-eosinophil actions of IL-5 and triggering eosinophil apoptosis via the very effective mechanism of antibody-dependent cell-mediated cytotoxicity (ADCC). Because of its recent approval and introduction in clinical practice for the add-on biological therapy of severe eosinophilic asthma, real-life investigations are still lacking. In this regard, our present real-life study refers to 13 patients with severe allergic eosinophilic asthma, currently under treatment with benralizumab at the Respiratory Unit of "Magna Græcia" University Hospital located in Catanzaro, Italy. Already 4 weeks after the first subcutaneous injection of benralizumab at the dosage of 30 mg, blood eosinophil count rapidly dropped down from 814.7 ± 292.3 cells/μL to 51.3 ± 97.5 cells/μL (p < 0.0001). This relevant hematologic change was associated with quick and significant increases in asthma control test (ACT) score (from 15.31 ± 2.78 to 21.15 ± 3.58; p < 0.0001), pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ) (from 1441 ± 757.9 mL to 1887 ± 837.3 mL; p < 0.001), and morning peak expiratory flow (PEF) (from 4.21 ± 2.20 to 5.33 ± 1.99 L/sec; p < 0.01). Furthermore, the marked improvement in global health status experienced by our patients allowed them to progressively lower and then completely interrupt, within 4 weeks, their daily intake of oral corticosteroids (OCS), which thereby fell from 15.58 ± 8.30 to 0 mg (p < 0.0001) of prednisone. Therefore, such preliminary results suggest that in patients with severe allergic eosinophilic asthma benralizumab can exert, within a real-life context, a very rapid and effective therapeutic action, already detectable 4 weeks after the first drug administration., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Omalizumab is a humanized monoclonal antibody which binds to human immunoglobulins E (IgE), thus preventing their interactions with both high affinity and low affinity IgE receptors. Therefore, omalizumab is currently recommended for add-on biological therapy of uncontrolled allergic asthma, mainly characterized by type 2 airway eosinophilic inflammation. Because omalizumab has been the first, and for a long time the only available monoclonal antibody for add-on treatment of type 2 asthma, some long-term studies have been published which provide a clear evidence of the therapeutic effectiveness of the anti-IgE pharmacological strategy. Within this context, the present single-centre observational study refers to 15 patients with severe allergic asthma, treated with omalizumab for at least 5 years at the Respiratory Unit of "Magna Græcia" University Hospital located in Catanzaro, Italy. In these asthmatic subjects we observed significant increases in asthma control test (ACT) score, with respect to baseline (14.60 ± 2.97), after 1 year (19.20 ± 2.98; p < 0.0001) and 5 years (21.67 ± 2.38; p < 0.0001) of add-on treatment with omalizumab. More importantly, omalizumab significantly lowered the number of annual asthma exacerbations (baseline: 3.66 ± 2.01) after 1 year (0.83 ± 1.14; p < 0.0001) and 5 years (0.63 ± 0.99; p < 0.0001), respectively. This excellent therapeutic outcome made it possible to drastically decrease the daily oral intake of prednisone (baseline: 22.50 ± 5.17 mg) after 1 year (1.83 ± 4.06 mg; p < 0.0001), as well as after 5 years (1.66 ± 3.61 mg; p < 0.0001). With regard to lung function, omalizumab significantly and persistently enhanced FEV 1 (baseline: 1636 ± 628.4 mL) after 1 year (2000 ± 679.7 mL; p < 0.05) and 5 years (1929 ± 564.8 mL; p < 0.05), respectively. Such relevant clinical and functional improvements were associated with reductions of blood eosinophil counts (baseline: 646.0 ± 458.9 cells/μl), already detectable after 1 year (512.7 ± 327.8 cells/μl; not significant), which reached the threshold of statistical significance after 5 years (326.0 ± 171.8 cells/μl; p < 0.05). Therefore, these real-life data referring to our single-centre observational investigation further corroborate the long-term therapeutic ability of omalizumab to improve several clinical, functional and haematological signatures of severe type 2 asthma., (Copyright © 2018. Published by Elsevier Ltd.)

Mepolizumab is a humanized monoclonal antibody which targets interleukin-5 (IL-5) and is nowadays available in many countries for add-on biological therapy of severe eosinophilic asthma. Although the approval of mepolizumab use in clinical practice has been made possible by several successful pre-marketing controlled trials, so far only a very few studies have been performed in a real-life setting. Within such a context, our present observational investigation refers to 14 patients with refractory eosinophilic asthma, currently treated with mepolizumab at the Respiratory Unit of "Magna Græcia" University Hospital located in Catanzaro, Italy, whose anti-IL-5 treatment began between June 2017 and January 2018. These patients experienced a significant increase in asthma control test (ACT) score, that was evaluated at baseline (13.64 ± 3.00), as well as after 4 weeks (18.86 ± 3.15; p < 0.0001) and 24 weeks (20.07 ± 1.94; p < 0.0001) of add-on therapy with mepolizumab. This relevant improvement in symptom control was paralleled by a dramatic fall of blood eosinophil numbers, counted at baseline (647.1 ± 274.7 cells/μl), and at the 4th (147.8 ± 66.5 cells/μl; p < 0.0001) and 24th week (98.6 ± 40.3 cells/μl; p < 0.0001) after starting add-on treatment with mepolizumab. These changes were associated with significant and stable increases in FEV 1 , which was recorded at baseline (1389 ± 454.3 mL), as well as after 4 weeks (1711 ± 482.3 mL; p < 0.001) and 24 weeks (1701 ± 456.0 mL; p < 0.01). Moreover, in comparison to the 6 months preceding the beginning of treatment with mepolizumab, after 24 weeks of anti-IL-5 therapy significant decreases were detected with regard to exacerbation numbers (from 3.64 ± 1.86 to 1.0 ± 0.78; p < 0.001) and oral intake of prednisone (from 24.11 ± 10.36 mg/day to 1.78 ± 3.82 mg/day). Therefore, these preliminary data referring to our single-centre observational study corroborate, in a real-life environment, the efficacy of mepolizumab for treatment of patients with exacerbation-prone, corticosteroid-refractory, severe eosinophilic asthma., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Asthma considerably impairs patients' quality of life and increases healthcare costs. Severity, morbidity, and degree of disease control are the major drivers of its clinical and economic impact. National scientific societies are required to monitor the application of international guidelines and to adopt strategies to improve disease control and better allocate resources., Aim: to provide a detailed picture of the characteristics of asthma patients and modalities of asthma management by specialists in Italy and to develop recommendations for the daily management of asthma in a specialist setting., Method: A quantitative research program was implemented. Data were collected using an ad hoc questionnaire developed by a group of specialists selected by the Italian Pneumology Society/Italian Respiratory Society., Results: The records of 557 patients were analyzed. In the next few years, specialists are expected to focus their activity patients with more severe disease and will be responsible for selection of patients for personalized biological therapy; however, only 20% of patients attending Italian specialist surgery can be considered severe. In 84.4% of cases, the visit was a follow-up visit requested in 82.2% of cases by the specialist him/herself. The Asthma Control Test is used only in 65% of patients. When available, a significant association has been observed between the test score and asthma control as judged by the physician, although concordance was only moderate (κ = 0.68). Asthma was considered uncontrolled by the specialist managing the case in 29.1% of patients; nevertheless, treatment was not stepped up in uncontrolled or partly controlled patients (modified in only 37.2% of patients)., Conclusions: The results of this survey support re-evaluation of asthma management by Italian specialists. More resources should be made available for the initial visit and for more severely ill patients. In addition, more extensive use should be made of validated tools, and available drugs should be used more appropriately., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Inhaled glucocorticoids are the mainstay of asthma treatment. Indeed, such therapeutic agents effectively interfere with many pathogenic circuits underpinning asthma. Among these drugs, during the last decades budesonide has been probably the most used molecule in both experimental studies and clinical practice. Therefore, a large body of evidence clearly shows that budesonide, either alone or in combination with long-acting bronchodilators, provides a successful control of asthma in many patients ranging throughout the overall spectrum of disease severity. These excellent therapeutic properties of budesonide basically depend on its molecular mechanisms of action, capable of inhibiting within the airways the activity of multiple immune-inflammatory and structural cells involved in asthma pathobiology., (Copyright © 2016 Elsevier Ltd. All rights reserved.)