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Despite several therapeutic choices, 10-20% of patients with severe uncontrolled asthma do not respond to maximal best standard treatments, leading to a healthcare expenditure of up to 80% of overall costs for asthma. Today, there are new important therapeutic strategies, both pharmacological and interventional, that can result in improvement of severe asthma management, such as omalizumab, bronchial thermoplasty and other biological drugs, for example, mepolizumab, reslizumab and benralizumab. The availability of these new treatments and the increasing knowledge of the different asthmatic phenotypes and endotypes makes correct patient selection increasingly complex and important. In this article, we discuss the features of benralizumab compared with other anti-interleukin-5 biologics and omalizumab, the identification of appropriate patients, the safety profile and future developments., (© The Author(s), 2016.)

Introduction: Fully 80% of asthma-related deaths occur in patients with uncontrolled disease and 50% of all costs are attributable to this subgroup. Although asthma is costly, direct costs and loss of productivity have only recently been extensively studied, partly as a result of the introduction of new and more costly treatment options. A 5-year population-based budget impact model in the perspective of the Emilia Romagna of Italy regional healthcare service compared the impact of adding adjuvant bronchial thermoplasty (BT) for a population of patients with severe, uncontrolled asthma treated with standard care (SC) with or without adjuvant omalizumab (OMAL)., Methods: The model compared the budget impact of two scenarios: the first examined a population treated either with SC alone or with administration of OMAL concurrent to SC; the second examined a population treated either with SC alone or with either the concurrent administration of OMAL or BT., Results: The cost for treating asthmatics patients in Emilia Romagna with BT would require 17.7 million Euros during the initial year; these costs would be offset by savings of 1 million Euros, 10.5 million Euros, and up to 19.2 million Euros during third, fourth, and fifth years, respectively., Conclusion: Despite the increase in direct costs, the complementary treatment of patients with either BT or OMAL in addition to SC may not only help the clinician to meet the needs of a greater number of patients, but also decreases emergency room visits and hospitalizations, as well as generates economic savings in the longer term.

Objectives: The aim of this study was to assess the stability of the effectiveness of omalizumab as add-on treatment in 11 patients with severe persistent allergic asthma followed for 4 years. Secondary outcomes were safety and economic impact, in terms of use of healthcare resources., Methods: This retrospective study was designed to analyse a series of patients with severe allergic asthma treated with omalizumab. Patients were initially enrolled as part of the CIGE025A2425 international multicentre clinical trial. At the end (week 32), 11 responsive patients went on to complete the study and continued omalizumab treatment until June 2010. The monitoring visits coincided with the timescales planned for administering the drug and for the follow up. To estimate the economic impact, the PRE-POST treatment comparison was obtained by comparing the annual pretreatment costs with an annual average of the 4-year posttreatment period costs, Results: After 4 years, 81.8% of patients showed a good/excellent Global Evaluation of Treatment Effectiveness scale score and 81.2% showed an excellent increase (>1.5) in the Asthma Quality of Life Questionnaire score. The average forced expiratory volume in one second (FEV(1)) at 4 years was 75.3% compared with the predicted normal value for each patient, with a net increase (p = 0.009) compared with baseline FEV(1) values (58.6%). The frequency of serious exacerbations dropped by 94.7% compared with the pretreatment period, while mild-moderate exacerbations fell by 41.8%. A reduction in costs was observed for hospital admissions (97.3%), visits to emergency department (ED) (97.5%) and mild-moderate exacerbations (84%). The average cost reduction of concomitant drugs remained at 36%., Conclusions: This study confirms the effectiveness and reliability of omalizumab over the long term, while providing an excellent safety profile. The additional cost due the use of omalizumab was offset by the medium- and long-term savings associated with the reduction in hospital admissions and access to ED.

Unlabelled: Omalizumab is an anti-IgE monoclonal antibody available since 2006 for the treatment of GINA step 4 asthma. We studied a 41-year old male who has been suffering from severe steroid-resistant asthma with severe co-morbidity and treated with Omalizumab. He was found to be non-responder to the treatment until the 48th week, starting from which we began to see a distinct improvement in the symptoms and all the correlated parameters, in addition to remission of the co-existent allergy to milk., Conclusions: we wish to point out the late response to Omalizumab, which occurred way beyond the times envisaged in literature. It seems possible that some patients are late responders to the drug.

Asthma is thought to be a Th2 disease while sarcoidosis is considered a Th1 granulomatous disorder. Organising pneumonia is a histologic pattern of lung injury. When it has no recognisable cause it is defined as cryptogenic organising pneumonia. We herein report the case of a patient with recurrent and steroid sensitive organising pneumonia associated with chronic sarcoidosis in an atopic, moderate persistent asthmatic patient. Each disease has been documented with transbronchial biopsies and recurrence of organising pneumonia was suggested by clinical features and by follow up HRCT which shows distinctive signs even in associated disease. Steroids are the mainstay of therapy for these disorders and especially for the consolidated processes typical of organising pneumonia but prognostic indices for relapse and progression are lacking.

Francesco Menzella, Mirco Lusuardi, Gloria Montanari, Carla Galeone, Nicola Facciolongo, Luigi ZucchiDepartment of Cardio-Thoracic-Vascular and Intensive Care Medicine, Pneumology Unit, IRCCS – Arcispedale Santa Maria Nuova, Reggio Emilia, ItalyAbstract: Asthma is a chronic inflammatory disorder of the airways with variable clinical severity from very mild and occasional symptoms to recurrent critical exacerbations, at risk of fatal or near-fatal outcome, in a small percentage of patients. Within the different inflammatory cascades involved in asthma, eosinophils play a central role in the pathogenesis and largely influence disease severity. Interleukin-5 (IL-5) is the main cytokine controlling eosinophil activity and proliferation at the site of inflammation. Mepolizumab was the first biological humanized anti-IL-5 monoclonal antibody tested in randomized clinical trials on eosinophilic asthma and other eosinophilic diseases. On the basis of several positive clinical efficacy data, it has recently been approved by the US Food and Drug Administration for the treatment of severe eosinophilic asthma. Unfortunately, high costs are at present a critical issue. Future studies will probably help in the correct selection of a potential “responder phenotype”, allowing the prescription of this promising therapy to appropriate patients and best define cost-effectiveness issues.Keywords: asthma, mepolizumab, phenotype, IL-5, effectiveness, biomarkers