Omalizumab for the treatment of chronic spontaneous urticaria in clinical practice

Chronic spontaneous urticaria (CSU) is a skin disease that predominantly affects adults, especially women aged 20 to 40 years, and is characterized by the recurrent appearance of localized or widespread wheals, angioedema or both, without apparent external trigger. 1 , 2 Severe CSU has a detrimental effect on the quality of life and is a frequent cause of absenteeism from school and work. [3] The pathogenesis of CSU is not well understood, and it appears to have an autoimmune cause in approximately one-third of patients. [4] Guidelines for the management of CSU recommend the use of second-generation antihistamines, with the addition of leukotriene receptor antagonists, cyclosporine, or omal…

High Flow Nasal Therapy Use in Patients with Acute Exacerbation of COPD and Bronchiectasis: A Feasibility Study

The efficacy and feasibility of high flow nasal therapy (HFNT) use in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and bronchiectasis is unknown. We performed a single-center, single-arm prospective observational study in patients with AECOPD, documented bronchiectasis, pH >= 7.35, respiratory rate (RR) >= 26 breaths/minute despite receiving maximal medical treatment and oxygen via face mask up to 10 L/m. Patients received HFNT (Airvo 2, Fisher & Paykel) at a gas flow of 50 L/min and FIO2 adjusted to maintain SpO(2) >= 92%. Dyspnea, rated by Borg scale, RR, arterial blood gases and mucus production (ranging from 1 to 3) were collected befor…

Author_Response_1 – Supplemental material for Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

Supplemental material, Author_Response_1 for Switching from omalizumab to mepolizumab: real-life experience from Southern Italy by Giovanna Elisiana Carpagnano, Corrado Pelaia, Maria D’Amato, Nunzio Crimi, Nicola Scichilone, Giulia Scioscia, Onofrio Resta, Cecilia Calabrese, Girolamo Pelaia, Carla Maria Irene Quarato and Maria Pia Foschino Barbaro in Therapeutic Advances in Respiratory Disease

The Arg/Arg polymorphism of the ADRB2 is associated with the severity of allergic asthma

Long-Term Domiciliary High-Flow Nasal Therapy in Patients with Bronchiectasis: A Preliminary Retrospective Observational Case-Control Study

High-flow nasal therapy (HFNT) provides several pathophysiological benefits in chronic respiratory disorders. We aimed to evaluate the effectiveness of long-term HFNT in patients with bronchiectasis (BE). Methods: This is a retrospective bicentric case-control study of outpatients with BE on optimized medical treatment with a severe exacerbation requiring hospitalization in the previous year. Patients on long-term home HFNT (cases) and patients on optimized medical treatment alone (controls) were matched by age, sex, bronchiectasis severity index, and exacerbations in the previous year. Data on BE exacerbations, hospitalizations/year, mucus features, respiratory symptoms, and pulmonary func…

Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the Severe Asthma Network in Italy (SANI)

According to the data derived from several national and international registries, including SANI (Severe Asthma Network Italy), and considering the strong impact that frequent or regular use of oral corticosteroid has on quality of life (QoL) of severe asthmatics, as well as on the costs for managing corticosteroid-related diseases, oral corticosteroid sparing up to withdrawal should be considered a primary outcome in the management of severe asthma. New biologics have clearly demonstrated that this effect is possible, with concomitant reduction in the rate of exacerbations and in symptom control. Then, there is no reason for using so frequently oral corticosteroid before having explored al…

Indacaterol/glycopyrronium/mometasone fixed dose combination for uncontrolled asthma

INTRODUCTION Asthma symptoms can be relieved through a maintenance treatment combining long-acting β2-agonist and inhaled corticosteroids (LABA/ICS). However, for patients with inadequately controlled asthma, the LABA/ICS combination might not be sufficient. Under these conditions, clinical guidelines recommend the administration of inhaled long-acting muscarinic antagonists (LAMA) as an add-on therapy to LABA/ICS to better control asthma and improve lung function. For nearly two decades, the only LAMA to be approved on the market has been tiotropium. AREAS COVERED We reviewed recent clinical studies evaluating the safety and efficacy of LABA/LAMA/ICS fixed dose combinations by searching Pu…

Reviewer_2_v.1 – Supplemental material for Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

Supplemental material, Reviewer_2_v.1 for Switching from omalizumab to mepolizumab: real-life experience from Southern Italy by Giovanna Elisiana Carpagnano, Corrado Pelaia, Maria D’Amato, Nunzio Crimi, Nicola Scichilone, Giulia Scioscia, Onofrio Resta, Cecilia Calabrese, Girolamo Pelaia, Carla Maria Irene Quarato and Maria Pia Foschino Barbaro in Therapeutic Advances in Respiratory Disease

Validation of Murray sputum purulence scale in the Italian Registry of Bronchiectasis (IRIDE)

Introduction: Murray sputum colour chart stratifies patients according to the presence of mucous (M), muco-purulent (MP) or purulent (P) sputum, and has not been validated in Bx yet. We aimed to validate this scale across a large Italian cohort of Bx patients. Methods: A secondary analysis of the IRIDE database was conducted including adults with Bx and daily sputum production enrolled across 13 Italian centres between 2014 and 2017. M vs. MP vs. P sputum producers were identified and clinical, functional and microbiological data were collected. Clinical outcomes during a two-year follow up period were evaluated in the Monza and Milan cohorts. A sensitivity analysis excluding COPD patients …

Higher serum levels of periostin and the risk of exacerbations in moderate asthmatics

BACKGROUND: In asthma, exacerbations and poor disease control are linked to airway allergic inflammation. Serum periostin has been proposed as a systemic biomarker of eosinophilic inflammation. This pilot study aims at evaluating whether in patients with moderate asthma, higher baseline levels of serum periostin are associated with a greater risk of exacerbation. METHODS: Fifteen outpatients with moderate allergic asthma were recruited. Serum concentrations of periostin were assessed (ELISA) at baseline, and the frequency of asthma exacerbations was recorded during a one-year follow-up. RESULTS: Patients (M/F: 10/5, mean age of 47.6 ± 11.0 years) had mean ACQ score of 5.5 ± 4.2 and FEV1%pre…

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 …

Cost-effectiveness of switching from omalizumab to mepolizumab in uncontrolled severe eosinophilic asthma

Background: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ quality of life and increased healthcare spending. Objectives: To assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics but not optimally controlled with OMA. Methods: Uncontrolled patients referred to 6 asthma clinics in south of Italy switched from OMA to MEP, were enrolled and followed-up to Jan 2020. Clinical information included blood eosinophil count, asthma control test (ACT), pulmonary function, IgE, exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, …

Effectiveness of benralizumab in severe eosinophilic asthma: Distinct sub-phenotypes of response identified by cluster analysis

Background: Benralizumab is effective in severe eosinophilic asthma (SEA), but suboptimal responses are observed in some patients. Although several factors have been associated with benralizumab response, no cluster analysis has yet been undertaken to identify different responsiveness sub-phenotypes. Objective: To identify SEA sub-phenotypes with differential responsiveness to benralizumab. Methods: One hundred and five patients diagnosed with SEA who had completed 6 months of benralizumab treatment were included in a hierarchical cluster analysis based on a set of clinical variables that can be easily collected in routine practice (age, age at disease onset, disease length, allergen sensit…

A double-blind, placebo-controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis

Fluticasone propionate aqueous nasal spray (FPANS) is a topically active glucocorticoid which has been successfully used for the treatment of seasonal allergic rhinitis (SAR). Topical levocabastine is a highly selective H1 antagonist which has been proposed as an alternative treatment of SAR. The purpose of this study was to compare the clinical efficacy of two topical nasal treatments, FPANS and levocabastine, in the treatment of SAR. Additionally, the effect of treatments on nasal inflammation was examined during natural pollen exposure. A group of 288 adolescent and adult patients with at least a 2-year history of SAR to seasonal pollens participated in a multicenter, doubleblind, double…

Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial

Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18–75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (…

Switching from omalizumab to mepolizumab: real-life experience from Southern Italy.

Background: Current availability of several biologic treatments for severe asthma makes it possible to choose the most appropriate for each patient. Sometimes a good percentage of patients with severe asthma may be eligible for biologics that target either the allergic phenotype or the eosinophilic one, but not all respond to that selected as first choice. The aim of our real-life study was to assess whether, for patients with severe eosinophilic allergic asthma, not previously controlled by the anti-IgE omalizumab, the shift to another biologic targeting interleukin-5, such as mepolizumab, may represent a good therapeutic choice. Methods: A total of 41 consecutive patients with severe, per…

Real-world experience with dupilumab in severe asthma: One-year data from an italian named patient program

Raffaele Campisi,1 Claudia Crimi,1 Santi Nolasco,2 Bianca Beghè,3 Leonardo Antonicelli,4 Gabriella Guarnieri,5 Nicola Scichilone,6 Morena Porto,2 Luigi Macchia,7 Giulia Scioscia,8 Maria Pia Foschino Barbaro,8 Alberto Papi,9 Nunzio Crimi1,2 1Respiratory Medicine Unit, A.O.U. Policlinico “G. Rodolico -San Marco”, Catania, Italy; 2Department of Clinical and Experimental Medicine, Section of Respiratory Diseases, University of Catania, Catania, Italy; 3Respiratory Medicine Unit, Department of Medicine, University of Modena and Reggio Emilia, Modena, Italy; 4Allergy Unit, Department of Internal Medicine, Ancona University Hospital, Ancona, Italy; 5Department of Car…

Benralizumab Effectiveness in Severe Eosinophilic Asthma with and without Chronic Rhinosinusitis with Nasal Polyps: A Real-World Multicenter Study

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) affects around 60% of patients with severe eosinophilic asthma (SEA). Benralizumab was recently approved for SEA add-on treatment. Objective: To assess the real-world effectiveness of benralizumab in SEA with or without CRSwNP. Methods: We conducted a multicenter observational study, including patients with SEA treated with benralizumab for 24 weeks in 12 Italian specialized facilities. Asthma exacerbations, Asthma Control Test (ACT), lung function, oral corticosteroid (OCS) dosage, and eosinophil and basophil count in peripheral blood were recorded at baseline and after 4, 12, and 24 weeks. The 22-item Sino-Nasal Outcome Test (S…

Clinical and economic consequences of switching from omalizumab to mepolizumab in uncontrolled severe eosinophilic asthma

AbstractSevere asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS), which worsen patients’ health and increase healthcare spending. The aim of this study was to assess the clinical and economic impact of switching from omalizumab (OMA) to mepolizumab (MEP) in patients eligible for both biologics, but not optimally controlled by omalizumab. We retrospectively enrolled uncontrolled severe asthmatic patients who switched from OMA to MEP during the last two years. Information included blood eosinophil count, asthma control test (ACT), spirometry, serum IgE, fractional exhaled nitric oxide (FeNO), OCS intake, drugs, exacerbations/hospitalizations, visits and diagno…

Severe asthma: One disease and multiple definitions

Abstract Introduction There is, so far, no universal definition of severe asthma. This definition usually relies on: number of exacerbations, inhaled therapy, need for oral corticosteroids, and respiratory function. The use of such parameters varies in the different definitions used. Thus, according to the parameters chosen, each patient may result in having severe asthma or not. The aim of this study was to evaluate how the choice of a specific definition of severe asthma can change the allocation of patients. Methods Data collected from the Severe Asthma Network Italy (SANI) registry were analyzed. All the patients included were then reclassified according to the definitions of U-BIOPRED,…

<p>Early management of COPD: where are we now and where do we go from here? A Delphi consensus project</p>

Purpose There is a lack of consensus on the most appropriate early diagnostic strategy, criteria for early access to treatment and follow-up approach for patients with COPD. Materials and methods A Delphi consensus project investigated the early management of COPD. We formulated two questionnaires for completion by pneumologists in Italy. Results A total of 207 specialists completed questionnaire 1 and 184 of them questionnaire 2, between November 2016 and October 2017. Early diagnosis of COPD was considered uncommon for 93.2% of the expert panel. Regardless of the definition of "early diagnosis" - a diagnosis made before the clinical manifestation of the disease for most responders (60.4%)…

Adherence to omalizumab: A multicenter “real-world” study

Background: Adherence to medications is crucial in patients with severe asthma in light of the negative clinical impact and costs of non-adherence. Adherence to omalizumab has not been well studied in real-world settings. The aim of this study was to assess adherence to omalizumab and evaluate treatment effectiveness in relation to adherence. Methods: This was a retrospective, observational, and multicenter real-world study. Omalizumab dose, timing of administration, and duration of treatment ( 4 years) were analyzed. Adherence was evaluated by examining rates of expected and missing doses. Good adherence (10% doses missed) were determined. For effectiveness in relation to adherence of omal…

Quality standards for the management of bronchiectasis in Italy: A national audit

Although historically considered a neglected disease, bronchiectasis has become a disease of renewed interest over recent decades in light of an increase in prevalence and a substantial burden on healthcare systems. In 2010, the British Thoracic Society (BTS) published guidelines on the management of bronchiectasis in adults, along with specific quality standards. To date, these represent the only quality standards available in Europe. These have been tested over a number of years in the UK with progressive improvements in the standard of care. No national guidelines are available in Italy and no indications on which guideline should be followed have been given by the Italian Society of Res…

Therapeutic effects of benralizumab assessed in patients with severe eosinophilic asthma: Real-life evaluation correlated with allergic and non-allergic phenotype expression

Corrado Pelaia,1 Claudia Crimi,2 Alida Benfante,3 Maria Filomena Caiaffa,4 Cecilia Calabrese,5 Giovanna Elisiana Carpagnano,6 Domenico Ciotta Jnr,7 Maria D’Amato,8 Luigi Macchia,9 Santi Nolasco,2 Girolamo Pelaia,1 Simona Pellegrino,7 Nicola Scichilone,3 Giulia Scioscia,10 Giuseppe Spadaro,11 Giuseppe Valenti,12 Alessandro Vatrella,7 Nunzio Crimi2 1Department of Health Sciences, University “Magna Graecia” of Catanzaro, Catanzaro, Italy; 2Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; 3Department of Biomedicine and Internal and Specialistic Medicine, University of Palermo, Palermo, Italy; 4Allergology and Clinical Immunol…

Reviewer_1_v.1 – Supplemental material for Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

Supplemental material, Reviewer_1_v.1 for Switching from omalizumab to mepolizumab: real-life experience from Southern Italy by Giovanna Elisiana Carpagnano, Corrado Pelaia, Maria D’Amato, Nunzio Crimi, Nicola Scichilone, Giulia Scioscia, Onofrio Resta, Cecilia Calabrese, Girolamo Pelaia, Carla Maria Irene Quarato and Maria Pia Foschino Barbaro in Therapeutic Advances in Respiratory Disease

Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life

Abstract Background and aims Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. Methods Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of workin…