Mepolizumab effectiveness on small airway obstruction, corticosteroid sparing and maintenance therapy step-down in real life

Background: Mepolizumab (MEP) has been recently introduced to treat severe eosinophilic asthma. Trials have demonstrated a significant effectiveness in this asthma phenotype. We evaluated MEP efficacy on lung function, symptoms, asthma exacerbations, biologic markers, steroid dependence and controller treatment level in real-life. Methods: We retrospectively analyzed 134 severe asthmatics (61 males; mean age 58.3 ± 11; mean FEV1%:72 ± 21), treated with MEP for at least 6 months (mean duration:10.9 ± 3.7 months). Results: FEV1% improved significantly after MEP. Mean FEF25-75 also increased from 37.4 ± 25.4% to 47.2 ± 27.2% (p < 0.0001). Mean baseline blood eosinophil level was 712 ± 731/μ…

Author_Response_1 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

Supplemental material, Author_Response_1 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

Day and Night Control of COPD and Role of Pharmacotherapy: A Review

Abstract The topic of 24-hour management of COPD is related to day-to-night symptoms management, specific follow-up and patients’ adherence to therapy. COPD symptoms strongly vary during day and night, being worse in the night and early morning. This variability is not always adequately considered in the trials. Night-time symptoms are predictive of higher mortality and more frequent exacerbations; therefore, they should be a target of therapy. During night-time, in COPD patients the supine position is responsible for a different thoracic physiology; moreover, during some sleep phases the vagal stimulation determines increased bronchial secretions, increased blood flow in the bronchial circ…

Corrigendum to “Healthcare costs of the SATisfaction and adherence to COPD treatment (SAT) study follow-up” [Respir. Med. 153 (2019) 68–75]

Healthcare costs of the SATisfaction and adherence to COPD treatment (SAT)study follow-up

Abstract Background Chronic obstructive pulmonary disease (COPD) is characterised by recurring exacerbations. We estimated the costs of healthcare resources for COPD management funded by the Italian National Healthcare Service (INHS) for one year. Methods We examined the demographic, clinical, and economic variables at enrolment and follow-up visits (at 6 and 12 months) of COPD patients participating in the SAT study and referred to 20 Italian pulmonary centres with different institutional characteristics. Costs were expressed in Euro (€) 2018. A random effects log-linear panel regression model was performed to predict the average cost per patient. Results Most of the centres were public in…

What drives inhaler prescription for asthma patients? Results from a real-life retrospective analysis

Abstract Background The choice of inhaler device for asthma patients depends upon multiple attributes. We investigated factors that may drive general practitioners (GPs) and respiratory specialists in the prescription of inhaler devices for asthma patients who initiated inhalation therapy. Methods We retrospectively analysed prescriptions by GPs and respiratory specialists to asthma patients commencing inhaled corticosteroid/long-acting β2-agonist combination therapy available as both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs). Patient characteristics were compared by device and multivariate analysis was used to model the likelihood of receiving a pMDI as oppos…

Exploring the Relationship between Disease Awareness and Outcomes in Patients with Chronic Obstructive Pulmonary Disease

<b><i>Background:</i></b> Disease awareness is a challenge in the management of chronic obstructive pulmonary disease (COPD). <b><i>Objectives:</i></b> The aim of this analysis was to explore the association between COPD optimal and suboptimal awareness, clinical parameters, and the following patient-reported outcomes: modified Medical Research Council (mMRC), Treatment Satisfaction Questionnaire (TSQM-9), COPD Assessment Test (CAT), Morisky Medication-Taking Adherence Scale (MMAS-4), and Brief Illness Perception Questionnaire (B-IPQ). <b><i>Methods:</i></b> This post hoc analysis of the SAT study included all enrolled …

Cost-description and multiple imputation of missing values: theSATisfaction and adherence to COPD treatment(SAT) study

Aim:This article reports on a retrospective quarterly cost description (CD) performed on 401 patients with stable chronic obstructive pulmonary disease (COPD) at enrolment in the national, multicen...

Reviewer_2_v.1 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

Supplemental material, Reviewer_2_v.1 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

The hidden burden of severe asthma: from patient perspective to new opportunities for clinicians

Severe asthma is an important topic in respiratory diseases, due to its high impact on morbidity and mortality as well as on health-care resources. The many challenges that still exist in the management of the most difficult-to-treat forms of the disease, and the acknowledgement of the existence of unexplored areas in the pathophysiological mechanisms and the therapeutic targets represent an opportunity to gather experts in the field with the immediate goals to summarize current understanding about the natural history of severe asthma and to identify gaps in knowledge and research opportunities, with the aim to contribute to improved medical care and health outcomes. This article is a conse…

Late Breaking Abstract - Relationship between clinical features and mortality in a cohort of COPD patients

Background: Chronic obstructive pulmonary disease (COPD) is a progressive disease with poor outcomes, including a high mortality. GULP is a multicenter Italian study that described clinical characteristics, exacerbation rates and survival of a cohort of COPD patients, as part of AstraZeneca’s AvoidEX program. Aims and objectives: To evaluate whether the clinical profile of subjects enrolled in the GULP study predicts mortality on a period of 3 years. Methods: Post-hoc analysis of an observational, multicenter, retrospective study. Patients were stratified according to survival status: alive (A) and dead (D). Clinical characteristics, comorbidities and exacerbation rates were reported in the…

Asthma management in a specialist setting: Results of an Italian Respiratory Society survey.

Abstract 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…

Withdrawal of inhaled corticosteroids in COPD: A meta-analysis

Background Conflicting findings exist on the benefit of withdrawal of inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD). We performed a quantitative synthesis in order to assess real impact of ICS discontinuation in COPD patients. Methods We carried out a meta-analysis via random-effects model on the available clinical evidence to evaluate the effect of ICS discontinuation in COPD. Randomized clinical trials and observational real-life studies investigating the effects of ICS withdrawal on the risk of COPD exacerbation, lung function (forced expiratory volume in 1 s [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]) were identified by sear…

LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review

Paola Rogliani,1 Luigino Calzetta,1 Fulvio Braido,2 Mario Cazzola,1 Enrico Clini,3 Girolamo Pelaia,4 Andrea Rossi,5 Nicola Scichilone,6 Fabiano Di Marco7 1Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy; 2Department of Internal Medicine, IRCCS San Martino Genoa University Hospital, Genoa, Italy; 3Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy; 4Department of Medical and Surgical Sciences, Section of Respiratory Diseases, Magna Græcia University, Catanzaro, Italy; 5Pulmonary Unit, University of Verona, Verona, Italy; 6Department of Internal Medicine, University of Palermo, Palermo, Ital…

Disease awareness in patients with COPD: measurement and extent

Ilaria Baiardini,1 Paola Rogliani,2 Pierachille Santus,3 Angelo G Corsico,4 Marco Contoli,5 Nicola Scichilone,6 Fabiano Di Marco,7 Patrizia Lessi,8 Carla Scognamillo,8 Giorgia Molinengo,9 Fabio Ferri,10 Vincenzo Patella,11 Giuseppe Fiorentino,12 Mauro Carone,13 Fulvio Braido14 1Department of Biomedical Sciences, Humanitas University, Milan, Italy; 2Respiratory Unit, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy; 3Department of Biomedical and Clinical Sciences (DIBIC), University of Milan, Milan, Italy; 4Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; 5Department of Medical Sciences, University of F…

Use of ICS in COPD: From Blockbuster Medicine to Precision Medicine

Chronic obstructive pulmonary disease (COPD) is a major cause of mortality worldwide, whose burden is expected to increase in the next decades, because of numerous risk factors, including the aging of the population. COPD is both preventable and treatable by an effective management including risk factor reduction, prevention, assessment, and treatment of acute exacerbations and co-morbidities. The available agents approved for COPD treatment are long-acting or ultra-long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) bronchodilators, as well as inhaled corticosteroids (ICS) in combination with LABAs. ICS use has been restricted only to selected COPD patients by th…

Contoli_et_al_Additional_file20190924 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

Supplemental material, Contoli_et_al_Additional_file20190924 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

Clinical and Functional Characteristics of COPD Patients Across GOLD Classifications: Results of a Multicenter Observational Study.

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease. The severity grading systems proposed by the Global initiative for Chronic Obstructive Lung Disease (GOLD) have changed over time. The aim of the study was to evaluate if the different GOLD classifications can capture the complexity of the disease by investigating the distribution of lung function and clinical parameters across the GOLD classification systems. This was an observational, retrospective, multicentre study. COPD patients were stratified according to the GOLD severity grading proposed in the 2007, and to the ABCD assessment tool present in the 2011, and 2017 versions of the initiative. Data from body plethy…

<p>Day and Night Control of COPD and Role of Pharmacotherapy: A Review</p>

The topic of 24-hour management of COPD is related to day-to-night symptoms management, specific follow-up and patients' adherence to therapy. COPD symptoms strongly vary during day and night, being worse in the night and early morning. This variability is not always adequately considered in the trials. Night-time symptoms are predictive of higher mortality and more frequent exacerbations; therefore, they should be a target of therapy. During night-time, in COPD patients the supine position is responsible for a different thoracic physiology; moreover, during some sleep phases the vagal stimulation determines increased bronchial secretions, increased blood flow in the bronchial circulation (…

Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

Background: Understanding the level of patients’ satisfaction with treatment and its determinants have the potential to impact therapeutic management and clinical outcome in chronic conditions such as chronic obstructive pulmonary disease (COPD). Methods: A national, multicenter, longitudinal, observational study of COPD from 20 Italian pulmonary centers to explore patients’ satisfaction to treatment [assessed by the Treatment Satisfaction Questionnaire, 9 items (TSQM-9)] and association with clinical parameters [including dyspnea score, COPD Assessment Test (CAT) score, exacerbation rate], adherence to treatment [Morisky Medication-Taking Adherence Scale (MMAS-4)], illness perception [eval…

Reviewer_1_v.1 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

Supplemental material, Reviewer_1_v.1 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

LABA/LAMA fixed-dose combinations in patients with COPD: A systematic review

Paola Rogliani,1 Luigino Calzetta,1 Fulvio Braido,2 Mario Cazzola,1 Enrico Clini,3 Girolamo Pelaia,4 Andrea Rossi,5 Nicola Scichilone,6 Fabiano Di Marco7 1Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy; 2Department of Internal Medicine, IRCCS San Martino Genoa University Hospital, Genoa, Italy; 3Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy; 4Department of Medical and Surgical Sciences, Section of Respiratory Diseases, Magna Græcia University, Catanzaro, Italy; 5Pulmonary Unit, University of Verona, Verona, Italy; 6Department of Internal Medicine, University of Palermo, Palermo, Italy; 7…

Late Breaking Abstract - Validation of a tool for the assessment of disease awareness (DA) in COPD

Background: DA could influence adherence to treatment and outcomes. No validated tools are available to assess DA in COPD Aims: To generate a tool able to explore DA in COPD patients, the Disease Awareness in COPD Questionnaire (DACQ) Methods: A 2-step Delphi approach was used to develop a questionnaire that was tested for validity in a cohort of COPD patients of an Italian observational, multicenter, prospective study (SAT study - NCT02689492) Results: Consensus on a 27-item provisional questionnaire was obtained with 2 Delphi rounds. Factor analysis showed a 4-factor solution accounting for 35% of variance; each factor (disease acceptance, awareness of treatment needs, disease knowledge, …

Age does not affect the efficacy of anti-IL-5/IL-5R in severe asthmatics

Background: Healthcare decisions made on the basis of insufficient evidence may potentially have ineffective or even harmful consequences. The proportion of older ages (over 65 years) in randomized controlled trials (RCTs) for severe asthma is not enough to establish whether anti-IL-5/IL-5R therapies are equally effective in the elderly as in younger subjects. Methods: In order to assess the relationship between age and the efficacy of anti-IL-5 monoclonal antibodies (mABs) with respect to the risk of exacerbations and changes in FEV1, a meta-regression analysis via random-effect method was carried out by plotting the effect estimates (outcome variables) resulting from the pairwise meta-ana…

Supplementary_Material – Supplemental material for Cost-description and multiple imputation of missing values: the SATisfaction and adherence to COPD treatment (SAT) study

Supplemental material, Supplementary_Material for Cost-description and multiple imputation of missing values: the SATisfaction and adherence to COPD treatment (SAT) study by Carlo Lazzaro, Fabiano Di Marco, Nicola Scichilone, Fulvio Braido, Marco Contoli, Paola Rogliani, Pierachille Santus, Valentina Acciai, Carla Scognamillo, Irene Olivi and Angelo Guido Corsico in Global & Regional Health Technology Assessment