The North-Western Italian experience with anti IL-5 therapy and comparison with regulatory trials.

Juan Carlos Ivancevich Friday, 07 December 2018 12:27
Original research. Open Access
Diego BagnascoManlio MilaneseGiovanni RollaCarlo LombardiCaterina BuccaEnrico HefflerGiorgio Walter Canonica and Giovanni Passalacqua Email author

Abstract

Background

The severe forms of asthma represent a major burden, because of severity of symptoms, costs and impact on everyday life. Recently, Mepolizumab (MEP) was approved and marketed for the treatment of hypereosinophilic severe asthma. This anti-IL-5 monoclonal antibody reduced exacerbation rates and oral corticosteroid (OCS) use in well selected patients. The aim of this study was to evaluate the characteristics of patients receiving MEP in a real-life setting. Thus, we describe a retrospective analysis of patients treated with MEP in six centres in North Western Italy, including those who participated in the main regulatory trials.

Methods

The baseline data, before prescription, from six North Western Italy severe asthma clinics, between June 1st 2017 and December 31st 2017, were evaluated. The collected real-life data were then compared with those of SIRUS, MENSA, DREAM and MUSCA trials.

Results

Sixty-five patients were included (45% female; mean age 56 years; age range 19–84). Main observed differences with regulatory trials could be observed in eosinophils blood count at baseline, where the mean of our real-life patients (653 cells/μL) was overall higher than the one of all trials (240 cells/μL, 296 cells/μL, 253 cells/μL; p <  0.0001). The incidence of polyposis was also significantly higher in our sample (72% vs. 24%, 49%, 10%, 19%; p <  0.0001). The daily average dose of OCS was lower in our real-life patients (9 mg), if compared with SIRIUS (13.7 mg), MENSA (13.2) and MUSCA (13), and similar to the data published in DREAM (10.8).

Conclusions

The comparison of real-life patients' characteristics with regulatory trials, displayed several apparent discrepancies. The demographic and clinical aspects were similar in all groups, whereas other features (eosinophil count, pulmonary function FEV1%) differed. These data, for the first time, could represent a basis for a more accurate prescription of the drug.

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Effectiveness of benralizumab for allergic and eosinophilic predominant asthma following negative initial results with omalizumab

Juan Carlos Ivancevich Monday, 03 December 2018 21:51

Abstract: A 64‐year‐old woman, who had presented with a 30‐year history of refractory asthma, and been treated with anti‐allergic drug therapy, inhaled corticosteroids, a long‐acting beta‐agonist, and a long‐acting muscarinic antagonist. She had been characterized as an allergic, eosinophilic asthmatic. Although omalizumab was tried initially, it was found to be insufficient. We began treatment with benralizumab. The asthma symptom control and sinusitis were improved immediately. Benralizumab was effective for overlapping patient population following negative initial results with omalizumab.

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2018 Diagnosis and Management of Difficult-to-treat and Severe Asthma in adolescent and adult patients

Juan Carlos Ivancevich Wednesday, 21 November 2018 23:46

The goal of this Pocket Guide is to provide a practical summary for health professionals about how to identify, assess and manage difficult-to-treat and severe asthma in adolescents and adults. It is intended for use by general practitioners (GPs, primary care physicians), pulmonary specialists and other health professionals involved in the management of people with asthma.

The recommendations in this Pocket Guide were based on evidence where good quality systematic reviews or randomized controlled trials or, lacking these, robust observational data, were available, and on consensus by expert clinicians and researchers, where not. Development of the Pocket Guide and decision tree included extensive collaboration with experts in human-centered design to enhance the utility of these resources for end-users. This means translating existing high level lowcharts and text-based information to a more detailed visual format, and applying information architecture and diagramming principles.

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Non-eosinophilic asthma: current perspectives.

Juan Carlos Ivancevich Tuesday, 27 November 2018 14:09
Asthma Allergy. 2018 Oct 29;11:267-281. doi: 10.2147/JAA.S153097. eCollection 2018.

Abstract

Although non-eosinophilic asthma (NEA) is not the best known and most prevalent asthma phenotype, its importance cannot be underestimated. NEA is characterized by airway inflammation with the absence of eosinophils, subsequent to activation of non-predominant type 2 immunologic pathways. This phenotype, which possibly includes several not well-defined subphenotypes, is defined by an eosinophil count <2% in sputum. NEA has been associated with environmental and/or host factors, such as smoking cigarettes, pollution, work-related agents, infections, and obesity. These risk factors, alone or in conjunction, can activate specific cellular and molecular pathways leading to non-type 2 inflammation. The most relevant clinical trait of NEA is its poor response to standard asthma treatments, especially to inhaled corticosteroids, leading to a higher severity of disease and to difficult-to-control asthma. Indeed, NEA constitutes about 50% of severe asthma cases. Since most current and forthcoming biologic therapies specifically target type 2 asthma phenotypes, such as uncontrolled severe eosinophilic or allergic asthma, there is a dramatic lack of effective treatments for uncontrolled non-type 2 asthma. Research efforts are now focusing on elucidating the phenotypes underlying the non-type 2 asthma, and several studies are being conducted with new drugs and biologics aiming to develop effective strategies for this type of asthma, and various immunologic pathways are being scrutinized to optimize efficacy and to abolish possible adverse effects.

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Effects of Macrolide Treatment during the Hospitalization of Children with Childhood Wheezing Disease: A Systematic Review and Meta-Analysis

Juan Carlos Ivancevich Friday, 16 November 2018 23:15
J. Clin. Med. 20187(11), 432; https://doi.org/10.3390/jcm7110432
 
Abstract
Children are susceptible to a variety of respiratory infections. Wheezing is a common sign presented by children with respiratory infections. Asthma, bronchiolitis, and bronchitis are common causes of childhood wheezing disease (CWD) and are regarded as overlapping disease spectra. Macrolides are common antimicrobial agents with anti-inflammatory effects. We conducted a comprehensive literature search and a systematic review of studies that investigated the influences of macrolide treatment on CWD. The primary outcomes were the impact of macrolides on hospitalization courses of patients with CWD. Data pertaining to the study population, macrolide treatment, hospital courses, and recurrences were analyzed. Twenty-three studies with a combined study population of 2210 patients were included in the systematic review. Any kind of benefit from macrolide treatment was observed in approximately two-thirds of the studies (15/23). Eight studies were included in the meta-analysis to investigate the influence of macrolides on the length of stay (LOS), duration of oxygen demand (DOD), symptoms and signs of respiratory distress, and re-admission rates. Although the benefits of macrolide treatment were reported in several of the studies, no significant differences in LOS, DOD, symptoms and signs of respiratory distress, or re-admission rates were observed in patients undergoing macrolide treatment. In conclusion, any kind of benefit of macrolide treatment was observed in approximately two-thirds of the studies; however, no obvious benefits of macrolide treatment were observed in the hospitalization courses of children with CWD. The routine use of macrolides to improve the hospitalization course of children with CWD is not suggested. 
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Editor: Juan C. Ivancevich, MD

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