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2. Sustained Effectiveness of Benralizumab in Naïve and Biologics-Experienced Severe Eosinophilic Asthma Patients: Results from the ANANKE Study

Author

Cameli P, Aliani M, Altieri E, Bracciale P, Brussino L, Caiaffa MF, Canonica GW, Caruso C, Centanni S, D'Amato M, De Michele F, Del Giacco S, Di Marco F, Pelaia G, Rogliani P, Romagnoli M, Schino P, Schroeder JW, Senna G, Vultaggio A, Benci M, Boarino S, and Menzella F

Subjects
benralizumab, asthma, eosinophils, switch, long-term, Immunologic diseases. Allergy, RC581-607
Abstract

Paolo Cameli,1 Maria Aliani,2 Elena Altieri,3 Pietro Bracciale,4 Luisa Brussino,5 Maria Filomena Caiaffa,6 Giorgio Walter Canonica,7,8 Cristiano Caruso,9 Stefano Centanni,10 Maria D’Amato,11 Fausto De Michele,12 Stefano Del Giacco,13 Fabiano Di Marco,14 Girolamo Pelaia,15 Paola Rogliani,16,17 Micaela Romagnoli,18 Pietro Schino,19 Jan Walter Schroeder,20 Gianenrico Senna,21 Alessandra Vultaggio,22 Marco Benci,23 Silvia Boarino,24 Francesco Menzella25 1Respiratory Diseases Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy; 2UO Pneumologia e Pneumologia Riabilitativa, ICS Maugeri, IRCCS Bari, Bari, Italy; 3Reparto di Pneumologia, P.O. Garbagnate Milanese, Garbagnate Milanese (MI), Italy; 4Reparto di Pneumologia, Ospedale Ostuni, Ostuni (BR), Italy; 5Dipartimento di Scienze Mediche, Università degli Studi di Torino; SCDU Immunologia e Allergologia, AO Ordine Mauriziano Umberto I, Torino, Italy; 6Cattedra e Scuola di Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche, Università di Foggia, Foggia, Italy; 7Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy; 8Personalized Medicine Center: Asthma and Allergology, Humanitas Research Hospital, Rozzano (MI), Italy; 9Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy; 10Respiratory Unit ASST Santi Paolo e Carlo, Department of Health Sciences Universita’ degli Studi di Milano, Milano, Italy; 11UOSD Malattie Respiratorie “Federico II”, Ospedale Monaldi, AO Dei Colli, Napoli, Italy; 12UOC Pneumologia e Fisiopatologia Respiratoria, AORN A. Cardarelli, Napoli, Italy; 13Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; 14Department of Health Sciences, Università Degli Studi Di Milano, Pneumologia, ASST Papa Giovanni XXIII, Bergamo, Italy; 15Dipartimento di Scienze della Salute, Università Magna Graecia, Catanzaro, Italy; 16Division of Respiratory Medicine, University Hospital “Tor Vergata”, Roma, Italy; 17Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome “Tor Vergata”, Roma, Italy; 18UOC Pneumologia, AULSS 2 Marca Trevigiana, Treviso, Italy; 19Fisiopatologia Respiratoria, Ospedale Generale Regionale, Ente Ecclesiastico “F. Miulli”, Acquaviva delle Fonti (BA), Italy; 20Allergy and Clinical Immunology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy; 21Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy; 22Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Firenze, Italy; 23Medical Affairs R&I, AstraZeneca, Milano, Italy; 24Medical Evidence R&I, AstraZeneca, Milano, Italy; 25Pulmonology Unit, Ospedale “S. Valentino”, AULSS 2 Marca Trevigiana, Montebelluna (TV), ItalyCorrespondence: Paolo Cameli, Respiratory Diseases Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy, Email paolo.cameli@unisi.itPurpose: Severe eosinophilic asthma (SEA) patients often present overlapping inflammatory features rendering them eligible for multiple biologic therapies; switching biologic treatment is a strategy adopted to optimize asthma control when patients show partial or no response to previous biologics.Patients and Methods: ANANKE is a retrospective, multicenter Italian study (NCT04272463). Here, we outline the characteristics and long-term clinical outcomes in naïve-to-biologics and biologics-experienced patients treated with benralizumab for up to 96 weeks. Bio-experienced patients were split into omalizumab and mepolizumab subsets according to the type of biologic previously used.Results: A total of 124 (76.5%) naïve and 38 (23.5%) bio-experienced patients were evaluated at index date; 13 patients (34.2%) switched from mepolizumab, 21 patients (55.3%) switched from omalizumab, and four patients (10.5%) received both biologics. The mepolizumab subset was characterized by the longest SEA duration (median of 4.6 years), the highest prevalence of chronic rhinosinusitis with nasal polyposis (CRSwNP) (76.5%), and the greatest oral corticosteroid (OCS) daily dosage (median of 25 mg prednisone equivalent). The omalizumab group showed the highest severe annual exacerbation rate (AER) (1.70). At 96 weeks, treatment with benralizumab reduced any and severe AER by more than 87% and 94%, respectively, across all groups. Lung function was overall preserved, with major improvements observed in the mepolizumab group, which also revealed a 100% drop of the median OCS dose. Asthma Control Test (ACT) score improved in the naïve group while its increment was more variable in bio-experienced patients; among these, a marked difference was noticed between omalizumab and mepolizumab subsets (median ACT score of 23.5 and 18, respectively).Conclusion: Benralizumab promotes durable and profound clinical benefits in naïve and bio-experienced groups, indicating that a nearly complete depletion of eosinophils is highly beneficial in the control of SEA, independently of previous biologic use.Keywords: benralizumab, asthma, eosinophils, switch, long-term

Published
2024

3. Diagnosis and Management of Allergic Rhinitis in Asthmatic Children

Author

Tenero L, Vaia R, Ferrante G, Maule M, Venditto L, Piacentini G, Senna G, and Caminati M

Subjects
asthma, asthma control, rhinitis, immunotherapy, personalized medicine, Immunologic diseases. Allergy, RC581-607
Abstract

Laura Tenero,1 Rachele Vaia,2 Giuliana Ferrante,1 Matteo Maule,3 Laura Venditto,1 Giorgio Piacentini,1 Gianenrico Senna,2,3 Marco Caminati3 1Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, Pediatric Clinic, University of Verona, Verona, Italy; 2Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy; 3Department of Medicine, University of Verona, Verona, ItalyCorrespondence: Marco Caminati, Department of Medicine, University of Verona, Piazzala L.A. Scuro, 10, Verona, 37134, Italy, Email marco.caminati@univr.itAbstract: Allergic rhinitis (AR) is a common upper airways inflammatory condition especially in paediatric population; its burden potentially impacts on quality of life, quality of sleep and daily performance, which can be difficult to perceive but not less relevant in the middle-long term. The present review aims to provide an updated overview on AR epidemiology, diagnosis and with a special focus on its connections with bronchial asthma. In fact, when considering asthmatic pediatric population, AR is probably the most important risk factor for asthma onset and the most impactful extra-bronchial determinant of asthma control. Under this perspective, allergen immunotherapy (AIT) should always be considered in the light of a precision medicine approach. In fact, AIT does represent a unique opportunity to specifically interfere with AR immunological background, improve both AR and bronchial asthma control and prevent allergic disease evolution. Verifying the patient’s eligibility to that option should be considered as a priority for every physician managing children suffering from AR, especially when associated with bronchial asthma.Keywords: asthma, asthma control, rhinitis, immunotherapy, personalized medicine

Published
2023

4. Clinical Features and Efficacy of Benralizumab in Patients with Blood Eosinophil Count Between 300 and 450 Cells/mm3: A Post Hoc Analysis from the ANANKE Study

Author

Senna G, Aliani M, Altieri E, Bracciale P, Brussino L, Caiaffa MF, Cameli P, Canonica GW, Caruso C, D'Amato M, De Michele F, Del Giacco S, Di Marco F, Menzella F, Pelaia G, Rogliani P, Romagnoli M, Schino P, Schroeder JW, Vultaggio A, Rizzoli S, Zullo A, Boarino S, Palmisano M, Rossi A, Vitiello G, and Centanni S

Subjects
severe eosinophilic asthma, blood eosinophil count, benralizumab, observational, real-world evidence, real-life, Immunologic diseases. Allergy, RC581-607
Abstract

Gianenrico Senna,1,2 Maria Aliani,3 Elena Altieri,4 Pietro Bracciale,5 Luisa Brussino,6 Maria Filomena Caiaffa,7 Paolo Cameli,8 Giorgio Walter Canonica,9,10 Cristiano Caruso,11 Maria D’Amato,12 Fausto De Michele,13 Stefano Del Giacco,14 Fabiano Di Marco,15 Francesco Menzella,16 Girolamo Pelaia,17 Paola Rogliani,18,19 Micaela Romagnoli,20 Pietro Schino,21 Jan Walter Schroeder,22 Alessandra Vultaggio,23 Sara Rizzoli,24 Alessandro Zullo,24 Silvia Boarino,25 Marilena Palmisano,26 Alessandra Rossi,26 Gianfranco Vitiello,26 Stefano Centanni27 1Department of Medicine, University of Verona, Verona, Italy; 2Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy; 3UO Pneumologia e Pneumologia Riabilitativa, ICS Maugeri, IRCCS Bari, Bari, Italy; 4Reparto di Pneumologia, P.O., Garbagnate Milanese, Italy; 5Reparto di Pneumologia, Ospedale Ostuni, Ostuni, BR, Italy; 6Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I, Torino, Italy; 7Cattedra e Scuola di Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche, Università di Foggia, Foggia, Italy; 8Respiratory Diseases and Lung Transplantation, Department of Medical and Surgical Sciences & Neurosciences, Siena University Hospital, Siena, Italy; 9Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy; 10Personalized Medicine Center: Asthma and Allergology, Humanitas Research Hospital, Rozzano, MI, Italy; 11Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy; 12UOSD Malattie Respiratorie “Federico II”, Ospedale Monaldi, AO Dei Colli, Napoli, Italy; 13UOC Pneumologia e Fisiopatologia Respiratoria, AORN A. Cardarelli, Napoli, Italy; 14Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; 15Department of Health Sciences, Università Degli Studi Di Milano, Pneumologia, ASST Papa Giovanni XXIII, Bergamo, Italy; 16UOC Pneumologia, Ospedale “S. Valentino”, AULSS 2 Marca Trevigiana, Montebelluna, TV, Italy; 17Dipartimento di Scienze della Salute, Università Magna Graecia, Catanzaro, Italy; 18Division of Respiratory Medicine, University Hospital “Tor Vergata”, Roma, Italy; 19Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome “Tor Vergata”, Roma, Italy; 20UOC Pneumologia, ULSS 2 Marca Trevigiana, Treviso, Italy; 21Fisiopatologia Respiratoria, Ospedale Generale Regionale, Ente Ecclesiastico “F. Miulli”, Acquaviva delle Fonti, BA, Italy; 22Allergy and Clinical Immunology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy; 23Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Firenze, Italy; 24Medineos Observational Research - An IQVIA Company, Modena, Italy; 25Medical Evidence R&I, AstraZeneca, Milano, Italy; 26Medical Affairs R&I, AstraZeneca, Milano, Italy; 27Respiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Milano, ItalyCorrespondence: Marilena Palmisano, Medical Affairs R&I, AstraZeneca, Milano, Italy, Email marilena.palmisano@astrazeneca.comPurpose: Benralizumab effectively reduces severe eosinophilic asthma (SEA) exacerbations in patients with a wide range of baseline blood eosinophil count (BEC). Patients included in real-world studies are often characterized by high mean/median BEC, while patients with BEC close to 300 cells/mm3 are poorly represented. This post hoc analysis from the Italian study ANANKE aims to define the clinical features and corroborate the efficacy of benralizumab in real world in the BEC 300– 450 cells/mm3 subset of patients.Patients and Methods: Post hoc analysis of the Italian, multicenter, observational, retrospective real-life study ANANKE (NCT04272463). Baseline clinical and laboratory characteristics were collected in the 12 months prior to benralizumab treatment and presented for a BEC 300– 450 cells/mm3 subgroup of patients. Change over time of BEC, annualized exacerbation rate (AER), asthma control (ACT), lung function and oral corticosteroid (OCS) use at 16, 24 and 48 weeks after benralizumab introduction were collected.Results: A total of 164 patients were analyzed, 34 of whom with a BEC of 300– 450 cells/mm3. This subgroup was more likely to be female (64.7%), with lower rates of severe exacerbations at baseline when compared to the total population (0.69 vs 1.01). After 48 weeks of benralizumab treatment, the BEC 300– 450 subset showed similar reductions in AER (− 94.8% vs − 92.2%) and OCS use (median dose reduction of 100% in both groups), as well as improvement in ACT score (median scores 22.5 vs 22) and lung function (pre-BD FEV1: +200 mL vs +300 mL) when compared to the total population. No discontinuations for safety reasons were registered.Conclusion: At baseline, apart from lower severe exacerbation rate, the BEC 300– 450 cells/mm3 subset of patients is comparable to the total population prescribed with benralizumab. In this real-life study, benralizumab is as effective in BEC 300– 450 patients as in the total population.Keywords: severe eosinophilic asthma, blood eosinophil count, benralizumab, observational, real-world evidence, real-life

Published
2022

5. Chronic rhinosinusitis with nasal polyposis and biological agents: the ARIA-ITALY Survey

Author

Lombardi, C., primary, Passalacqua, G., additional, Menzella, F., additional, Mauritz Canevari, R.F, additional, Danesi, G., additional, Pusateri, A.M., additional, Carone, M., additional, Vancheri, C., additional, Di Marco, F., additional, Micheletto, C., additional, Manzotti, G., additional, Di Gioacchino, M, additional, Bilò, M.B, additional, Gelardi, M, additional, Senna, G, additional, Canonica, G.W, additional, and Italy Panel, ARIA, additional

Published
2024
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6. Organization, Clinical and Management Indicators on the First Year of Activity of an Outpatient Clinic Dedicated to the Diagnosis and Treatment of Severe Asthma in Italy

Author

Tognella S, Micheletto C, Roggeri A, Polese G, Artioli D, Senna G, Caminati M, and Roggeri DP

Subjects
asthma, severe, multidisciplinary, outpatient, Immunologic diseases. Allergy, RC581-607
Abstract

Silvia Tognella,1 Claudio Micheletto,2 Alessandro Roggeri,3 Guido Polese,4 Denise Artioli,1 Gianenrico Senna,5 Marco Caminati,5,6 Daniela Paola Roggeri3 1Pulmonology Unit, Mater Salutis Hospital, Legnago (Verona), Italy; 2Pulmonology Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; 3ProCure Solutions, Nembro, Bergamo, Italy; 4Pulmonology Unit, Magalini Hospital, Villafranca (Verona), Italy; 5Asthma Center and Allergy Unit, Verona University Hospital, Verona, Italy; 6Department of Medicine, Allergy and Clinical Immunology Section, University of Verona and Verona University Hospital, Verona, 37134, ItalyCorrespondence: Alessandro RoggeriProCure Solutions, Via Camozzi 1/C, Nembro, 24027, BG, ItalyTel +39 035 521121Email alessandro.roggeri@procuresolutions.itPurpose: A Regional Technical Commission was set in 2017 by Veneto region (Italy) to provide opinions and recommendations on drug prescriptions and to implement treatment-pathway guidelines for severe asthma. In this observational study, we describe the first structured, integrated, multidisciplinary, patient-centered outpatient clinic for the care of severe-asthma patients in Italy, and characterize patients referring to the center for specialist visits.Patients and Methods: To characterize patients that accessed the outpatient clinic in 2018, data on demographic characteristics, treatments, severity of asthma, phenotypes, and relevant comorbidities by phenotype were collected. Use of biologic agents and indicators of the performance of the outpatient clinic were described.Results: A structured multidisciplinary outpatient pathway for taking charge of patients and for administration and monitoring of biological agents was developed. A total of 146 patients accessed the outpatient clinic in 2018: 62.3% had uncontrolled asthma upon admission and 27.4% were already being treated with biologic agents. Among patients with uncontrolled asthma, 66% had severe uncontrolled asthma, 22% had moderate–severe uncontrolled asthma, and 12% had mild–moderate uncontrolled asthma. Main asthma phenotypes in uncontrolled-asthma patients were allergic (58% of patients), eosinophilic (22%), allergic plus eosinophilic (10%) and non-atopic asthma (10%). Among patients affected by severe asthma, 47% had allergic asthma, 28% had eosinophilic asthma, 13% had allergic plus eosinophilic asthma, and 12% had non-atopic asthma. Nasal polyps were more frequent in eosinophilic and allergic plus eosinophilic asthma, while gastro-esophageal reflux disease was more frequent in non-atopic asthma.Conclusion: This structure of an outpatient clinic for the treatment of severe asthma, with its dedicated pathway and multidisciplinary approach, may allow a stricter control of asthma and optimization of therapies, as well as minimization of drug misuse.Keywords: asthma, severe, multidisciplinary, outpatient

Published
2021

7. Uncontrolled Asthma: Unmet Needs in the Management of Patients

Author

Caminati M, Vaia R, Furci F, Guarnieri G, and Senna G

Subjects
asthma, asthma control, severe asthma, mild to moderate asthma, telemedicine, personalized medicine, Immunologic diseases. Allergy, RC581-607
Abstract

Marco Caminati,1 Rachele Vaia,1 Fabiana Furci,2 Gabriella Guarnieri,3 Gianenrico Senna1,2 1Department of Medicine, University of Verona, Verona, Italy; 2Allergy Unit and Asthma Center, University of Verona and Verona University Hospital, Verona, Italy; 3Respiratory Pathophysiology Unit, Department of Cardiological, Thoracic and Vascular Sciences, University of Padua, Padua, ItalyCorrespondence: Marco CaminatiDepartment of Medicine, University of Verona and Verona University Hospital, Piazzala L.A. Scuro 10, Verona, 37134, ItalyEmail marco.caminati@univr.itAbstract: The recent scientific research has provided clinicians with the tools for substantially upgrading the standard of care in the field of bronchial asthma. Nevertheless, satisfactory asthma control still remains an unmet need worldwide. Identifying the major determinants of poor control in different asthma severity levels represents the first step towards the improvement of the overall patients’ management. The present review aims to provide an overview of the main unmet needs in asthma control and of the potential tools for overcoming the issue. Implementing a personalized medicine approach is essential, not only in terms of pharmacological treatments, biologic drugs or sophisticated biomarkers. In fact, exploring the complex profile of each patient, from his inflammation phenotype to his preferences and expectations, may help in filling the gap between the big potential of currently available treatments and the overall unsatisfactory asthma control. Telemedicine and e-health technologies may provide a strategy to both optimize disease assessment on a regular basis and enhance patients’ empowerment in managing their asthma. Increasing patients’ awareness as well as the physicians’ knowledge about asthma phenotypes and treatment options besides corticosteroid probably represent the key and more difficult goals of all the players involved in asthma management at every level.Keywords: asthma, asthma control, severe asthma, mild to moderate asthma, telemedicine, personalized medicine

Published
2021

8. Frequency of Tiotropium Bromide Use and Clinical Features of Patients with Severe Asthma in a Real-Life Setting: Data from the Severe Asthma Network in Italy (SANI) Registry

Author

Puggioni F, Brussino L, Canonica GW, Blasi F, Paggiaro P, Caminati M, Latorre M, Heffler E, and Senna G

Subjects
severe asthma, registry, long-acting muscarinic antagonists, real-life., Immunologic diseases. Allergy, RC581-607
Abstract

Francesca Puggioni,1,2 Luisa Brussino,3 Giorgio Walter Canonica,1,2 Francesco Blasi,4,5 Pierluigi Paggiaro,6 Marco Caminati,7,8 Manuela Latorre,6 Enrico Heffler,1,2 Gianenrico Senna7,8 On behalf of the Severe Asthma Network in Italy (SANI) group1Personalized Medicine, Asthma and Allergy – Humanitas Clinical and Research Center, IRCCS – Rozzano (MI), Milan, Italy; 2Department of Biomedical Sciences, Humanitas University – Pieve Emanuele (MI), Milan, Italy; 3Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I – Torino, Torino, Italy; 4Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; 5Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy; 6Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy; 7Department of Medicine, University of Verona, Verona, Italy; 8Allergy Unit and Asthma Center, Verona University Hospital, Verona, Verona, ItalyCorrespondence: Enrico HefflerPersonalized Medicine, Asthma and Allergy, Istituto Clinico Humanitas, Milan, ItalyTel +39 0288247013Fax + 39 0282246484Email enrico.heffler@hunimed.euPurpose: Patients with uncontrolled asthma despite high doses of inhaled corticosteroid therapy plus another controller are defined as severe asthmatics. Tiotropium bromide respimat (TBR) is the only long-acting muscarinic antagonists (LAMA) approved for severe asthma. The aim of this study was to explore the frequency of severe asthmatics treated with TBR and characterize their clinical features in a real-life, registry-based setting.Materials and Methods: Baseline data from the Severe Asthma Network in Italy (SANI) registry have been analyzed to determine the use of TBR and other LAMA, and to compare clinical, functional and inflammatory features associated with the use of LAMA.Results: Among a total of 698 enrolled patients, 35.9% were treated with LAMA (23.3% TBR, 4.5% tiotropium bromide handihaler, 4.5% aclidinium, 3.4% glycopyrronium bromide 0.3% umeclidinium bromide). Age of asthma onset was higher in patients taking LAMA, whom, compared to others were more frequently former smokers. They also had a higher annual exacerbation rate, experienced worst asthma control, worst disease-related quality of life and poorer lung function. Bronchiectasis was more frequently found in LAMA users (25.9% vs 13.1%).Conclusion: TBR is still underused in severe asthma in a real-life setting, while a relevant proportion of patients are treated with other LAMA that are not approved for severe asthma treatment. Patients taking LAMA have features characteristic of even more severe asthma.Keywords: severe asthma, registry, long-acting muscarinic antagonists, real-ligfe

Published
2020

10. New horizons for the treatment of severe, eosinophilic asthma: benralizumab, a novel precision biologic

Author

Caminati M, Bagnasco D, Vaia R, and Senna G

Subjects
Benralizumab efficacy, benralizumab safety, benralizumab mechanism of action, anti IL-5 mAbs, severe asthma, eosinophilic asthma, Medicine (General), R5-920
Abstract

Marco Caminati,1,2 Diego Bagnasco,3 Rachele Vaia,2 Gianenrico Senna11Asthma Center and Allergy Unit, Verona University Hospital, Verona, Italy; 2Department of Medicine, School of Specialization in Allergy and Clinical Immunology, University of Verona, Verona, Italy; 3Allergy & Respiratory Diseases, DIMI Department of Internal Medicine, University of Genoa, Genoa, ItalyAbstract: In the last decades, the increasing evidence concerning inflammation mechanisms underlying severe eosinophilic asthma has highlighted new potential therapeutic targets and has paved the way to new selective biologic drugs. Understanding the mechanism of action and the clinical outcomes of a particular drug along with the clinical and biological characteristics of the patient population for which that drug was intended may ensure appropriate selection of patients that will respond to that drug. Under this perspective, the present review will focus on the mechanisms of action and clinical evidence of benralizumab as a treatment option for severe eosinophilic asthma, in order to provide a concise overview and a reference for clinical practice. Benralizumab is a fully humanized afucosylated IgG1κ mAb that binds to an epitope on IL-5 Rα, and inhibits IL-5 signaling. Benralizumab also sustains antibody-directed cell-mediated cytotoxicity (ADCC) of eosinophils and basophils and consequently depletes IL-5Rα-expressing cells. As a result, it is responsible for a substantial depletion of blood, tissue, and bone marrow eosinophilia. This unique mechanism of action may account for a more complete and rapid action profile. Randomized clinical trials have demonstrated that benralizumab provides an optimal safety profile, and is able to significantly reduce asthma exacerbations, oral steroid intake, and to improve lung function. Some clinical predictors of enhanced clinical response to benralizumab have also been identified, including: a level of blood eosinophils ≥300 μL−1, oral steroids use, the presence of nasal polyposis, FVC

Published
2019

13. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

18. A hierarchical cluster analysis of the psycological impact of the COVID-19 pandemic on Italian severe asthma patients

Author

Guarnieri, G, Chiurato, L, Baiardini, I, Caminati, M, Senna, G, Scarpa, B, and Vianello, A

Subjects
Pulmonary and Respiratory Medicine, biologic treatment, Pediatrics, Perinatology and Child Health, Immunology and Allergy, PGWBI, anti-Sars-Cov-2 vaccine, anxiety
Abstract

In the context of COVID-19 pandemic, a consistent medical concern raised among severe asthma patients, though the studies excluded an increased risk of severe disease as well as an increased susceptibility. The aim of the study was to apply the Psychological General Well-Being Index (PGWBI) questionnaire to severe asthmatics during the COVID-19 pandemic and to evaluate the data with a hierarchical cluster analysis. 114 severe asthmatics were asked to respond anonymously to the PGWBI questionnaire. The patients underwent a lung functional test, fractional exhaled nitric oxide (FeNO) measurement, Asthma Control Test (ACT), and Asthma Control Questionnaire (ACQ6). A hierarchical cluster analysis was performed using an agglomerative approach and complete linkage to evaluate the results. The study population predominantly included female (60%), middle-aged patients, with normal lung function parameters, mild signs of airway, and satisfactory asthma control. The PGWBI score (82.46 ± 16.53) of the study population showed a good state of psychological well-being and was similar to that of a representative sample of healthy adult Italian subjects. Thus, Hierarchical cluster analysis identified 3 groups of patients: Cluster 1 (32%), Cluster 2 (64%), and Cluster 3 (4%). Whilst the Cluster 2 patients’ PGWBI score fell within the normal range, the Cluster 1 patients had a significantly lower total score (68.57 ± 7.2; p < 0.05), suggesting moderate distress. The Cluster 3 patients presented a total score markedly low. Although the majority of the severe asthma patients studied demonstrated good mental well-being during the COVID-19 pandemic, some did indeed show moderate to severe psychological distress.

Published
2023
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19. Persistence of both reversible airway obstruction and higher blood eosinophils may predict lung function decline in severe asthma

Author

Sposato B., Scalese M., Ricci A., Rogliani P., Paggiaro P., Migliorini M. G., Di Tomassi M., Olivieri C., Perrella A., Camiciottoli G., Maselli R., Pelaia G., Busceti M. T., Sabato E., Cagnazzo M. G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Caiaffa M. F., Berra A., Calabrese C., Stanziola A. A., Schino P., Di Gioacchino M., Cazzola M., Segreti A., Pastorello E. A., Scibilia G., Vianello A., Marchi M. R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Matucci A., Vultaggio A., Maggi E., Maestrelli P., Guarnieri G., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Macchia L., Bellia V., Scichilone N., Novelli F., Latorre M., Vergura L., Masieri S., Rosati Y., Milanese M., Folletti I., Pio R., Pio A., Maccari U., Maggiorelli C., Scala R., Vignale L., Pulera N., Carpagnano G. E., Foschino Barbaro M. P., Sposato B., Scalese M., Ricci A., Rogliani P., Paggiaro P., Migliorini M.G., Di Tomassi M., Olivieri C., Perrella A., Camiciottoli G., Maselli R., Pelaia G., Busceti M.T., Sabato E., Cagnazzo M.G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Caiaffa M.F., Berra A., Calabrese C., Stanziola A.A., Schino P., Di Gioacchino M., Cazzola M., Segreti A., Pastorello E.A., Scibilia G., Vianello A., Marchi M.R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Matucci A., Vultaggio A., Maggi E., Maestrelli P., Guarnieri G., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Macchia L., Bellia V., Scichilone N., Novelli F., Latorre M., Vergura L., Masieri S., Rosati Y., Milanese M., Folletti I., Pio R., Pio A., Maccari U., Maggiorelli C., Scala R., Vignale L., Pulera N., Carpagnano G.E., Foschino Barbaro M.P., Sposato, B., Scalese, M., Ricci, A., Rogliani, P., Paggiaro, P., Migliorini, M. G., Di Tomassi, M., Olivieri, C., Perrella, A., Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M. T., Sabato, E., Cagnazzo, M. G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Caiaffa, M. F., Berra, A., Calabrese, C., Stanziola, A. A., Schino, P., Di Gioacchino, M., Cazzola, M., Segreti, A., Pastorello, E. A., Scibilia, G., Vianello, A., Marchi, M. R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Scichilone, N., Novelli, F., Latorre, M., Vergura, L., Masieri, S., Rosati, Y., Milanese, M., Folletti, I., Pio, R., Pio, A., Maccari, U., Maggiorelli, C., Scala, R., Vignale, L., Pulera, N., Carpagnano, G. E., Foschino Barbaro, M. P., and Et, Al

Subjects
Pulmonary and Respiratory Medicine, severe asthma, medicine.medical_specialty, medicine.drug_class, Severe asthma, Eosinophil, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Gastroenterology, Persistence (computer science), 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Bronchodilator, allergic asthma, blood eosinophil, bronchodilator reversibility, lung function decline, severe asthma, salbutamol, Forced Expiratory Volume, medicine, Settore MED/10, Immunology and Allergy, Humans, 030212 general & internal medicine, Blood eosinophil, Lung, Genetics (clinical), Lung function, Bronchodilator Agent, allergic asthma, blood eosinophil, bronchodilator reversibility, lung function decline, salbutamol, bronchodilator agents, eosinophils, forced expiratory volume, humans, lung, airway obstruction, asthma, business.industry, Airway obstruction, medicine.disease, Asthma, Bronchodilator Agents, Airway Obstruction, Eosinophils, 030228 respiratory system, Salbutamol, Blood eosinophils, business, medicine.drug, Human
Abstract

Objective: This study analysed whether the persistence of both reversible airway obstruction (RAO) and elevated BE counts was associated to reduced asthma control and accelerated lung function decline in treated severe asthmatics. Methods: About 202 severe asthmatics were studied after 12–120months of step-5 treatment associated to anti-IgE therapy. Following treatments, reversibility tests, after inhaling 400 mcg of Salbutamol, were performed. FEV1>12% or ≤12% changes differentiated RAO+ from RAO− subjects. Blood eosinophil (BE) counts after treatment were considered. Results: Pre-/post-treatment bronchodilator FEV1% and ACT were lower (61% [50–71], 74.4% [62.5–83.7] and 20[18–22]), whereas BE were higher (380 cells/µl [170–590]) in RAO+ compared to RAO− subjects (77% [64–88], p=0.0001, 81.8% [66.1–94.3], p=0.0001, 21[18–23], p=0.045 and 230 cells/µl [80–360], p=0.003). A negative relationship between SABA-induced FEV1% changes and pre-bronchodilator FEV1% (β=−0.551%; p=0.0001) and ACT (β=−0.059; p=0.038) was found. Conversely, post-treatment BE levels were positively related (β=145.565 cells/µl; p=0.003) to FEV1>12% increases. A rising trend of pre-/post-bronchodilator FEV1% in time was observed in RAO− subjects with BE300 cells/µl reaching lower values after more than 36months of step-5 treatment (59.6% [39.9–72.1] vs 74[66.5–89.2] of RAO+ individuals with BE300 cells/µl [p=0.009]). Conclusion: Persistent SABA-induced FEV1>12%, especially when associated to BE>300 cells/ml, may be a marker of accelerated lung function decline in severe asthmatics despite maximal step-5 treatment. The highest bronchodilation associated to the lowest BE levels should be the main goal of asthma treatment to prevent such decline.

Published
2020

20. Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: Evidences from the Severe Asthma Network Italy (SANI) registry

Author

Canonica, Gw, Blasi, F., Paggiaro, PL. Senna G. E., Passalacqua, G., Spanevello, A., Aliberti, S., Bagnasco, D., Bonavia, M. Bonini M., Bucca, C., Brussino, L., Caiaffa, M. F., Calabrese, C., Camiciottoli, G., Caminati, M., Carpagnano, G. E., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D’Alo, S., D’Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino Barbaro, M. P., Guarnieri, G., Guida, G., Latorre, M., Lo Cicero, S., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montagn, i. M., Montuschi, P., Nucera, E., Parente, R., Patella, V., Pelaia, G., Pini, L., Puggioni, F., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Spadaro, G., Yacoub, Mr., Vianello, A., Viviano, V., Zappa, M. C., Heffler, E., Canonica, G. W., Malvezzi, L., Blasi, F., Paggiaro, P., Mantero, M., Senna, G., Heffler, E., Bonavia, M., Caiaffa, P., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alo, S., D'Amato, M., Del Giacco, S., Favero, E., Farsi, A., Foschino, B. P. M., Guarnieri, G., Latorre, M., Lombardi, C., Macchia, L., Menzella, F., Milanese, M., Montuschi, P., Nucera, E., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardolo, F. L. M., Ricciardi, L., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Yacoub, M. R., Zappa, M. C., Canonica G.W., Malvezzi L., Blasi F., Paggiaro P., Mantero M., Senna G., Heffler E., Bonavia M., Caiaffa P., Calabrese C., Camiciottoli G., Caruso C., Centanni S., Conte M.E., Corsico A.G., Cosmi L., Costantino M.T., Crimi N., D'Alo S., D'Amato M., Del Giacco S., Favero E., Farsi A., Foschino B.P.M., Guarnieri G., Guida G., Latorre M., Lombardi C., Macchia L., Menzella F., Milanese M., Montuschi P., Nucera E., Parente R., Passalacqua G., Patella V., Pelaia G., Pini L., Ricciardolo F.L.M., Ricciardi L., Richeldi L., Ridolo E., Rolla G., Santus P., Scichilone N., Solidoro P., Spadaro G., Spanevello A., Vianello A., Yacoub M.R., and Zappa M.C.

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Severe asthma, Databases, Factual, Administration, Oral, Comorbidity, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Nitric Oxide, Severity of Illness Index, Comorbidities, Oral corticosteroid, Adrenal Cortex Hormones, Internal medicine, Severity of illness, Oral corticosteroids, medicine, Prevalence, Nasal polyps, Humans, Registries, Sinusitis, Asthma, Aged, Rhinitis, Internet, Bronchiectasis, business.industry, Nasal polyp, Settore MED/09 - MEDICINA INTERNA, Atopic dermatitis, Middle Aged, medicine.disease, Comorbidities, Nasal polyps, Oral corticosteroids, Severe asthma, Italy, Concomitant, Chronic Disease, Disease Progression, Female, Comorbiditie, business
Abstract

Background The clinical and laboratory features of patients enrolled in the Severe Asthma Network in Italy (SANI) registry, a web-based observatory collecting demographic, clinical, functional and inflammatory data of patients with severe asthma were evaluated, with a special emphasis to chronic rhinosinusitis with nasal polyposis (CRSwNP). Methods For each eligible patients the following information has been collected: demographic data, clinical features, asthma control in the previous month according to the GINA (Global INitiative for Asthma) Guidelines and standardized questionnaires, concomitant regular and on demand treatments and inflammatory markers. Results 695 patients with severe asthma enrolled in 66 SANI centers were analyzed. The prevalence of chronic rhinosinusitis with nasal polyposis was 40.6%. Atopic dermatitis and bronchiectasis was significantly more frequent in patients with CRSwNP than in subjects without nasal polyposis; similarly, FeNO values are significantly higher in subject with CRSwNP than in patients without nasal polyposis. Finally, patients with CRSwNP had a significantly higher number of asthma exacerbations per year, more days on oral corticosteroids and were more likely to be OCS long term users. Conclusion OCS sparing is needed in patients with severe asthma, mainly in subjects with CRSwNP, adopting adequate strategies such as a better adherence to the treatment with inhaled therapy according to the GINA recommendations, the use of biologic agents and a multidisciplinary approach of the patient.

Published
2020

21. Clinical features associated with a doctor-diagnosis of bronchiectasis in the Severe Asthma Network in Italy (SANI) registry

Author

Malipiero, G., Paoletti, G., Blasi, F., Paggiaro, P., Senna, G., Latorre, M., Caminati, M., Carpagnano, G. E., Crimi, N., Spanevello, A., Aliberti, S., Canonica, G. W., Heffler, E., Bonavia, M., Bucca, C., Caiaffa, M. F., Calabrese, C., Camiciottoli, G, Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., D'Alo, S., D'Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino, B. M. P., Guarnieri, G., Guida, G., Lo Cicero, S., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montuschi, P., Montagni, M., Nucera, E., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Vianello, A., Viviano, V., Yacoub, M. R., and Zappa, M. C.

Subjects
Pulmonary and Respiratory Medicine, Severe asthma, Pediatrics, medicine.medical_specialty, bronchiectasis, macromolecular substances, registry, phenotypes, real-life, 03 medical and health sciences, 0302 clinical medicine, immune system diseases, Humans, Immunology and Allergy, Medicine, Registries, 030212 general & internal medicine, Bronchiectasis, business.industry, musculoskeletal, neural, and ocular physiology, Public Health, Environmental and Occupational Health, medicine.disease, Asthma, respiratory tract diseases, Italy, nervous system, 030228 respiratory system, Quality of Life, business
Abstract

Several severe asthma comorbidities have been identified: an emerging one is bronchiectasis. We evaluated the frequency of bronchiectasis on severe asthma in a real-life setting, through the 'Severe Asthma Network Italy' (SANI) registry.SANI registry encompasses demographic, clinical, functional and inflammatory data of Italian severe asthmatics. Data obtained by the enrolled patients were analyzed, focusing the attention on those patients with concomitant clinically relevant bronchiectasis.About 15.5% patients have bronchiectasis. Bronchiectasis diagnosis was associated with a higher prevalence of chronic rhinosinusitis with nasal polyps (54.6% vs. 38%, p = 0.001) and higher serum IgE levels (673.4 vs. 412.1 kUI/L, p = 0.013). Patients with bronchiectasis had worse asthma control (ACT: 16.7 vs 18.2, p = 0.013), worse quality of life (AQLQ: 4.08 vs. 4.60, p = 0.02) and lower lung function (FEVsevere asthma associated with bronchiectasis represents a particularly severe asthma variant, possibly driven by an eosinophilic endotype. We, therefore, suggest that bronchiectasis should necessarily be assessed in severe asthmatic patients.

Published
2020

23. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

Author

Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P. M., Fantini M. P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P.M., Fantini M.P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Luxi, N., Giovanazzi, A., Capuano, A., Crisafulli, S., Cutroneo, P. M., Fantini, M. P., Ferrajolo, C., Moretti, U., Poluzzi, E., Raschi, E., Ravaldi, C., Reno, C., Tuccori, M., Vannacci, A., Zanoni, G., Trifiro, G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., and Montresor V.

Subjects
Allergy, IMPACT, COVID-19 Vaccine, Breastfeeding, Review Article, Toxicology, Settore MED/42 - Igiene Generale E Applicata, CLINICAL CHARACTERISTICS, Pregnancy, Pharmacology (medical), Pregnancy Complications, Infectious, Child, OUTCOMES, education.field_of_study, CANCER, Vaccination, Europe, CORONAVIRUS DISEASE 2019, CLINICAL CHARACTERISTICS, CANCER, RECIPIENTS, SEVERITY, OUTCOMES, IMPACT, RATES, Breast Feeding, Child, Preschool, Practice Guidelines as Topic, Female, 2019-nCoV Vaccine mRNA-1273, Human, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, BNT162 Vaccine, COVID-19, ChAdOx1 nCoV-19, Humans, Infant, SARS-CoV-2, Hypersensitivity, Immunocompromised Host, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Population, MEDLINE, CORONAVIRUS DISEASE 2019, medicine, RATES, education, Pharmacology, business.industry, medicine.disease, Vaccine efficacy, RECIPIENTS, SEVERITY, Family medicine, Pregnancy Complications, Infectiou, business
Abstract

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit–risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01131-6.

Published
2021

25. Higher blood eosinophil levels after omalizumab treatment may be associated with poorer asthma outcomes

Author

Sposato, B, Scalese, M, Milanese, M, Masieri, S, Cavaliere, C, Latorre, M, Scichilone, N, Ricci, A, Cresti, A, Santus, P, Olivieri, C, Perrella, A, Rogliani, P, Paggiaro, P, Migliorini, M. G, Di Tomassi, M, Camiciottoli, G, Maselli, R, Pelaia, G, Busceti, M. T, Sabato, E, Cagnazzo, M. G, Colombo, F, Palumbo, L, Ravazzi, A, Bucca, C, Caiaffa, M. F, Berra, A, Calabrese, C, Stanziola, A. A, Schino, P, Di Gioacchino, M, Cazzola, M, Segreti, A, Pastorello, E. A, Scibilia, G, Vianello, A, Marchi, M. R, Paladini, L, Baglioni, S, Abbritti, M, Almerigogna, F, Matucci, A, Vultaggio, A, Maggi, E, Maestrelli, P, Guarnieri, G, Steinhilber, G, Bonavia, M, Rottoli, P, Bargagli, E, Senna, G, Caminati, M, Macchia, L, Bellia, V, Novelli, F, Vergura, L, Rosati, Y, Folletti, I, Pio, R, Pio, A, Maccari, U, Maggiorelli, C, Scala, R, Vignale, L, Pulerà, N, Carpagnano, G. E, Foschino Barbaro, M. P, The Omalizumab Italian Study Group, Sposato, B, Scalese, M, Milanese, M, Masieri, S., Cavaliere, C, Latorre, M., Scichilone, N., Ricci, A., Cresti, A., Santus, P., Olivieri, C., Perrella, A., Rogliani, P., Paggiaro, P., Sposato, B., Migliorini, M. G., Di Tomassi, M., Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M. T., Sabato, E., Cagnazzo, M. G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Caiaffa, M. F., Berra, A., Calabrese, C., Stanziola, A. A., Schino, P., Di Gioacchino, M., Cazzola, M., Segreti, A., Pastorello, E. A., Scibilia, G., Vianello, A., Marchi, M. R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Novelli, F., Vergura, L., Scalese, M., Rosati, Y., Milanese, M., Folletti, I., Pio, R., Pio, A., Maccari, U., Maggiorelli, C., Scala, R., Vignale, L., Pulera, N., Carpagnano, G. E., Foschino Barbaro, M. P., Cavaliere, C., Sposato B., Scalese M., Milanese M., Masieri S., Cavaliere C., Latorre M., Scichilone N., Ricci A., Cresti A., Santus P., Olivieri C., Perrella A., Rogliani P., Paggiaro P., Migliorini M.G., Di Tomassi M., Camiciottoli G., Maselli R., Pelaia G., Busceti M.T., Sabato E., Cagnazzo M.G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Caiaffa M.F., Berra A., Calabrese C., Stanziola A.A., Schino P., Di Gioacchino M., Cazzola M., Segreti A., Pastorello E.A., Scibilia G., Vianello A., Marchi M.R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Matucci A., Vultaggio A., Maggi E., Maestrelli P., Guarnieri G., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Macchia L., Bellia V., Novelli F., Vergura L., Rosati Y., Folletti I., Pio R., Pio A., Maccari U., Maggiorelli C., Scala R., Vignale L., Pulera N., Carpagnano G.E., and Foschino Barbaro M.P.

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/09 - Medicina Interna, Treatment outcome, MEDLINE, Omalizumab, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Immunoglobulin E, eosinophil, Omalizumab, anti-IgE, asthma, Leukocyte Count, Text mining, Forced Expiratory Volume, Internal medicine, Eosinophilia, medicine, Humans, Immunology and Allergy, Anti-Asthmatic Agents, Blood eosinophil, Aged, Retrospective Studies, Asthma, biology, business.industry, Retrospective cohort study, Middle Aged, asthma, Prognosis, medicine.disease, Eosinophils, Treatment Outcome, inflammation, biology.protein, Female, business, medicine.drug
Published
2019

27. Processos de ocupação nas novas fronteiras da Amazônia: o interflúvio do Xingu/ Iriri

Author

Maria Isabel Sobral Escada, Ima Célia G. Vieira, Silvana A. Kampel, Roberto Araújo, Jonas Bastos da Veiga, Ana Paula Dutra Aguiar, Iran Veiga, Myriam Oliveira, Jorge Luís Gavina Pereira, Arnaldo Carneiro Filho, Philip Martin Fearnside, Adriano Venturieri, Felix Carriello, Marcelo Thales, Tiago Senna G. Carneiro, Antônio Miguel Vieira Monteiro, and Gilberto Câmara

Subjects
Uso da terra, apropriação fundiária, desmatamento, unidades de conservação, fronteiras, Land use, land appropriation, deforestation, conservation unities, frontiers, Social sciences (General), H1-99
Abstract

Este trabalho apresenta os primeiros resultados do esforço conjunto de várias instituições, organizadas em torno da rede Geoma (Rede Temática de Pesquisa em Modelagem Ambiental da Amazônia) para avançar a compreensão dos novos padrões e processos de estruturação do território nas novas frentes no sul do Pará, analisando padrões de desmatamento e os processos que dão origem a esses padrões. Busca-se, aqui, produzir os subsídios necessários para o desenho de políticas públicas responsáveis, que não privilegiem um único aspecto do problema, como a abertura de estradas, por exemplo. Aponta-se, então, a partir desses primeiros resultados, que apenas uma solução integrada que procure estruturar os principais agentes e processos na cadeia produtiva seria possível para minorar os efeitos do desmatamento e nortear o desenvolvimento integrado para a região, com benefícios para a floresta e para as populações que ali vivem.This work presents the first results achieved through an interdisciplinary and multi-institutional effort conduct by the Geoma Network, aiming to advance in the comprehension of the new frontiers in the South of the Pará State, in the Amazonian region, by examining the new patterns of deforestation and the underlying processes that are generating them. Our objective is to product information aiding to draw responsible public policies considering not only one dimension of the problem like roads infra-structure, as usual. Based on the analysis presented here we pointed out that only an integrated solution, that considers the main actors and the organization of economical processes in the productive chains over the region, would be capable to minimize the effects of deforestation and would drive an integrated development policy to the region bringing benefits to forest conservation and the local population.

Published
2005
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29. Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food—A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA²LEN position paper

Author

Zuberbier, T. Dörr, T. Aberer, W. Alvaro, M. Angier, E. Arasi, S. Arshad, H. Ballmer-Weber, B. Bartra, J. Beck, L. Bégin, P. Bindslev-Jensen, C. Bislimovska, J. Bousquet, J. Brockow, K. Bush, A. Cianferoni, A. Cork, M.J. Custovic, A. Darsow, U. de Jong, N. Deleanu, D. Del Giacco, S. Deschildre, A. Dunn Galvin, A. Ebisawa, M. Fernández-Rivas, M. Ferrer, M. Fiocchi, A. Gerth van Wijk, R. Gotua, M. Grimshaw, K. Grünhagen, J. Heffler, E. Hide, M. Hoffmann-Sommergruber, K. Incorvaia, C. Janson, C. Malte John, S. Jones, C. Jutel, M. Katoh, N. Kendziora, B. Kinaciyan, T. Knol, E. Kurbacheva, O. Lau, S. Loh, R. Lombardi, C. Mäkelä, M. Marchisotto, M.J. Makris, M. Maurer, M. Meyer, R. Mijakoski, D. Minov, J. Mullol, J. Nilsson, C. Nowak–Wegrzyn, A. Nwaru, B.I. Odemyr, M. Pajno, G.B. Paudel, S. Papadopoulos, N.G. Renz, H. Ricci, G. Ring, J. Rogala, B. Sampson, H. Senna, G. Sitkauskiene, B. Smith, P.K. Stevanovic, K. Stoleski, S. Szajewska, H. Tanaka, A. Todo-Bom, A. Topal, F.A. Valovirta, E. Van Ree, R. Venter, C. Wöhrl, S. Wong, G.W.K. Zhao, Z. Worm, M.

Subjects
digestive, oral, and skin physiology
Abstract

Background: Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as “may contain traces of” is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. Methods: MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. Results: In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion: Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement “this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product” for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged. © 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

Published
2021

30. IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper (vol 12, 100080, 2020)

Author

Ansotegui, IJ, Melioli, G, Canonica, GW, Caraballo, L, Villa, E, Ebisawa, M, Passalacqua, G, Savi, E, Ebo, D, Gomez, RM, Sanchez, OL, Oppenheimer, JJ, Jensen-Jarolim, E, Fischer, DA, Haahtela, T, Antila, M, Bousquet, JJ, Cardona, V, Chiang, WC, Demoly, PM, DuBuske, LM, Puga, MF, Wijk, RGV, Diaz, SNG, Gonzalez-Estrada, A, Jares, E, Kalpaklioglu, AF, Tanno, LK, Kowalski, ML, Ledford, DK, Ortega, OPM, Morais-Almeida, M, Pfaar, O, Poulsen, LK, Pawankar, R, Renz, HE, Romano, AG, Rosario Filho, NA, Rosenwasser, L, Borges, MAS, Scala, E, Senna, G-E, Sisul, JC, Tang, MLK, Thong, BY-H, Valenta, R, Wood, RA, Zuberbier, T, Ansotegui, IJ, Melioli, G, Canonica, GW, Caraballo, L, Villa, E, Ebisawa, M, Passalacqua, G, Savi, E, Ebo, D, Gomez, RM, Sanchez, OL, Oppenheimer, JJ, Jensen-Jarolim, E, Fischer, DA, Haahtela, T, Antila, M, Bousquet, JJ, Cardona, V, Chiang, WC, Demoly, PM, DuBuske, LM, Puga, MF, Wijk, RGV, Diaz, SNG, Gonzalez-Estrada, A, Jares, E, Kalpaklioglu, AF, Tanno, LK, Kowalski, ML, Ledford, DK, Ortega, OPM, Morais-Almeida, M, Pfaar, O, Poulsen, LK, Pawankar, R, Renz, HE, Romano, AG, Rosario Filho, NA, Rosenwasser, L, Borges, MAS, Scala, E, Senna, G-E, Sisul, JC, Tang, MLK, Thong, BY-H, Valenta, R, Wood, RA, and Zuberbier, T

Abstract

[This corrects the article DOI: 10.1016/j.waojou.2019.100080.].

Published
2021

31. Severe asthma: One disease and multiple definitions

Author

Bagnasco, D., Paggiaro, P., Latorre, M., Folli, C., Testino, E., Bassi, A., Milanese, M., Heffler, E., Manfredi, A., Riccio, A. M., De Ferrari, L., Blasi, F., Canevari, R. F., Canonica, G. W., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, G. E., Colle, A. D., Scioscia, G., Gerolamo, P., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Lombardi, Celestino Pio, Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Rolla, G., Brussino, L., Frazzetto, A. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, Cristiano, Colantuono, S., Senna, G., Caminati, M., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Lombardi C. (ORCID:0000-0001-8910-6693), Berti A., Bertolini F., Guida G., Eleonora Nucera. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Caruso C., Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Paggiaro, P., Latorre, M., Folli, C., Testino, E., Bassi, A., Milanese, M., Heffler, E., Manfredi, A., Riccio, A. M., De Ferrari, L., Blasi, F., Canevari, R. F., Canonica, G. W., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, G. E., Colle, A. D., Scioscia, G., Gerolamo, P., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Lombardi, Celestino Pio, Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Rolla, G., Brussino, L., Frazzetto, A. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, Cristiano, Colantuono, S., Senna, G., Caminati, M., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Lombardi C. (ORCID:0000-0001-8910-6693), Berti A., Bertolini F., Guida G., Eleonora Nucera. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Caruso C., Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.

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, NICE, WHO, ATS/ERS, GINA, ENFUMOSA, and TENOR. Results: 540 patients, were extracted from the SANI database. We observed that 462 (86%) met the ATS/ERS criteria as well as the GINA criteria, 259 (48%) the U-Biopred, 222 (41%) the NICE, 125 (23%) the WHO, 313 (58%) the Enfumosa, and 251 (46%) the TENOR criteria. The mean eosinophil value were similar in the ATS/ERS, U-Biopred, and Enfumosa (528, 532 and 516 cells/mcl), higher in WHO and Tenor (567 and 570 cells/mcl) and much higher in the NICE classification (624 cells/mcl). Lung function tests resulted similarly in all groups, with WHO (67%) and ATS/ERS-GINA (73%), respectively, showing the lower and upper mean FEV1 values. Conclusions: The present observations clearly evidence the heterogeneity in the distribution of patients when different definitions of severe asthma are used. However, the recent definition of severe asthma, provided by the GINA document, is similar to that indicated in 2014 by ATS/ERS, allowing mirror reclassification of the patients examined. This lack of homogeneity could complicate the access to biological therapies. The definition provided by the GINA document, which reflects what suggested by ATS/ERS, could partially overcome the problem.

Published
2021

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

Author

Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.

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 working days lost due to the disease. The primary objective was to compare the annual total cost per patient pre- and post-MEP. Secondary outcomes included rates of exacerbations and number of OCS-dependent patients. Results: 106 patients were enrolled in the study: 46 male, median age 58 years. Mean annual cost pre- and post-MEP (cost of biologic excluded) was €3996 and €1,527, respectively. Total savings due to MEP resulted in €2469 (95%CI 1945–2993), 62% due to exacerbations reduction and 33% due to productivity increase. Such savings could fund about 22% of the total cost of MEP for one year. The introduction of MEP induced a clinical benefit by reducing both OCS-dependent patients (OR = 0.12, 95%CI 0.06–0.23) and exacerbation rate (RR = 0.19, 95%CI 0.15–0.24). Conclusions: Patients with severe eosinophilic asthma experienced a clinical benefit in asthma control adding MEP to standard therapy. Biologic therapy can be, partially, funded by the savings produced by patients’ improvement.

Published
2021

34. Frequency of tiotropium bromide use and clinical features of patients with severe asthma in a real-life setting: Data from the severe asthma network in Italy (sani) registry

Author

Puggioni, F., Brussino, L., Canonica, G. W., Blasi, F., Paggiaro, P., Caminati, M., Latorre, M., Heffler, E., Senna, G., Sani, Group, Bonavia, M., Caiaffa, Mf., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, Me., Corsico, Ag., Cosmi, L., Costantino, Mt., Crimi, N., D’Alo, S., D’Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino, Bmp., Guarnieri, G., Guida, G., Yacoub, Mr., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montuschi, P., Nucera, E., Paoletti, G., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardi, L., Ricciardolo, Flm., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Zappa, Mc., Concetta, Sirena., Daniela, Morrone, and Silvia, Rabotti

Subjects
lcsh:Immunologic diseases. Allergy, Pulmonary and Respiratory Medicine, severe asthma, registry, long-acting muscarinic antagonists, real-ligfe, medicine.medical_specialty, Registry, Severe asthma, Respimat, real-life, Exacerbation, Long-acting muscarinic antagonists, Real-life, Umeclidinium bromide, Internal medicine, Journal of Asthma and Allergy, Immunology and Allergy, Medicine, Glycopyrronium bromide, Original Research, Asthma, Bronchiectasis, biology, business.industry, Tiotropium bromide, Lama, medicine.disease, biology.organism_classification, respiratory tract diseases, real-ligfe, lcsh:RC581-607, business, medicine.drug
Abstract

Francesca Puggioni,1,2 Luisa Brussino,3 Giorgio Walter Canonica,1,2 Francesco Blasi,4,5 Pierluigi Paggiaro,6 Marco Caminati,7,8 Manuela Latorre,6 Enrico Heffler,1,2 Gianenrico Senna7,8 On behalf of the Severe Asthma Network in Italy (SANI) group1Personalized Medicine, Asthma and Allergy – Humanitas Clinical and Research Center, IRCCS – Rozzano (MI), Milan, Italy; 2Department of Biomedical Sciences, Humanitas University – Pieve Emanuele (MI), Milan, Italy; 3Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I – Torino, Torino, Italy; 4Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; 5Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy; 6Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy; 7Department of Medicine, University of Verona, Verona, Italy; 8Allergy Unit and Asthma Center, Verona University Hospital, Verona, Verona, ItalyCorrespondence: Enrico HefflerPersonalized Medicine, Asthma and Allergy, Istituto Clinico Humanitas, Milan, ItalyTel +39 0288247013Fax + 39 0282246484Email enrico.heffler@hunimed.euPurpose: Patients with uncontrolled asthma despite high doses of inhaled corticosteroid therapy plus another controller are defined as severe asthmatics. Tiotropium bromide respimat (TBR) is the only long-acting muscarinic antagonists (LAMA) approved for severe asthma. The aim of this study was to explore the frequency of severe asthmatics treated with TBR and characterize their clinical features in a real-life, registry-based setting.Materials and Methods: Baseline data from the Severe Asthma Network in Italy (SANI) registry have been analyzed to determine the use of TBR and other LAMA, and to compare clinical, functional and inflammatory features associated with the use of LAMA.Results: Among a total of 698 enrolled patients, 35.9% were treated with LAMA (23.3% TBR, 4.5% tiotropium bromide handihaler, 4.5% aclidinium, 3.4% glycopyrronium bromide 0.3% umeclidinium bromide). Age of asthma onset was higher in patients taking LAMA, whom, compared to others were more frequently former smokers. They also had a higher annual exacerbation rate, experienced worst asthma control, worst disease-related quality of life and poorer lung function. Bronchiectasis was more frequently found in LAMA users (25.9% vs 13.1%).Conclusion: TBR is still underused in severe asthma in a real-life setting, while a relevant proportion of patients are treated with other LAMA that are not approved for severe asthma treatment. Patients taking LAMA have features characteristic of even more severe asthma.Keywords: severe asthma, registry, long-acting muscarinic antagonists, real-ligfe

Published
2020

35. A WAO - ARIA - GA2LEN consensus document on molecular-based allergy diagnosis (PAMD@): Update 2020

Author

Ansotegui, IJ, Melioli, G, Canonica, GW, Maximiliano Gomez, R, Jensen-Jarolim, E, Ebisawa, M, Luengo, O, Caraballo, L, Passalacqua, G, Poulsen, LK, Savi, E, Zuberbier, T, Villa, E, Oppenheimer, J, Asero, R, Bernstein, J, Bousquet, J, Cardona, V, Cox, L, Demoly, P, Ferreira, F, Bianchi, PG, Gonzalez Diaz, S, Jakob, T, Tanno, LK, Kleine-Tebbe, J, Levin, M, Martin, B, Matricardi, PM, Monge Ortega, OP, Almeida, MM, Nunes, C, Ortega Martell, JA, Renz, H, Rosario Filho, N, Rouadi, P, Ruiba, A, Sampson, H, Sanchez Borges, M, Scala, E, Schmid-Grendelmeier, P, Senna, G-E, Carlos Sisul, J, Tang, MLK, Valenta, R, van Hage, M, Wong, GWK, Yanez, A, Ansotegui, IJ, Melioli, G, Canonica, GW, Maximiliano Gomez, R, Jensen-Jarolim, E, Ebisawa, M, Luengo, O, Caraballo, L, Passalacqua, G, Poulsen, LK, Savi, E, Zuberbier, T, Villa, E, Oppenheimer, J, Asero, R, Bernstein, J, Bousquet, J, Cardona, V, Cox, L, Demoly, P, Ferreira, F, Bianchi, PG, Gonzalez Diaz, S, Jakob, T, Tanno, LK, Kleine-Tebbe, J, Levin, M, Martin, B, Matricardi, PM, Monge Ortega, OP, Almeida, MM, Nunes, C, Ortega Martell, JA, Renz, H, Rosario Filho, N, Rouadi, P, Ruiba, A, Sampson, H, Sanchez Borges, M, Scala, E, Schmid-Grendelmeier, P, Senna, G-E, Carlos Sisul, J, Tang, MLK, Valenta, R, van Hage, M, Wong, GWK, and Yanez, A

Abstract

Precision allergy molecular diagnostic applications (PAMD@) is increasingly entering routine care. Currently, more than 130 allergenic molecules from more than 50 allergy sources are commercially available for in vitro specific immunoglobulin E (sIgE) testing. Since the last publication of this consensus document, a great deal of new information has become available regarding this topic, with over 100 publications in the last year alone. It thus seems quite reasonable to publish an update. It is imperative that clinicians and immunologists specifically trained in allergology keep abreast of the new and rapidly evolving evidence available for PAMD@. PAMD@ may initially appear complex to interpret; however, with increasing experience, the information gained provides relevant information for the allergist. This is especially true for food allergy, Hymenoptera allergy, and for the selection of allergen immunotherapy. Nevertheless, all sIgE tests, including PAMD@, should be evaluated within the framework of a patient's clinical history, because allergen sensitization does not necessarily imply clinical relevant allergies.

Published
2020

36. IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper

Author

Ansotegui, IJ, Melioli, G, Canonica, GW, Caraballo, L, Villa, E, Ebisawa, M, Passalacqua, G, Savi, E, Ebo, D, Maximiliano Gomez, R, Luengo Sanchez, O, Oppenheimer, JJ, Jensen-Jarolim, E, Fischer, DA, Haahtela, T, Antila, M, Bousquet, JJ, Cardona, V, Chiang, WC, Demoly, PM, DuBuske, LM, Ferrer Puga, M, van Wijk, RG, Gonzalez Diaz, SN, Gonzalez-Estrada, A, Jares, E, Kalpaklioglu, AF, Tanno, LK, Kowalski, ML, Ledford, DK, Monge Ortega, OP, Almeida, MM, Pfaar, O, Poulsen, LK, Pawankar, R, Renz, HE, Romano, AG, Rosario Filho, NA, Rosenwasser, L, Sanchez Borges, MA, Scala, E, Senna, G-E, Carlos Sisul, J, Tang, MLK, Thong, BY-H, Valenta, R, Wood, RA, Zuberbier, T, Ansotegui, IJ, Melioli, G, Canonica, GW, Caraballo, L, Villa, E, Ebisawa, M, Passalacqua, G, Savi, E, Ebo, D, Maximiliano Gomez, R, Luengo Sanchez, O, Oppenheimer, JJ, Jensen-Jarolim, E, Fischer, DA, Haahtela, T, Antila, M, Bousquet, JJ, Cardona, V, Chiang, WC, Demoly, PM, DuBuske, LM, Ferrer Puga, M, van Wijk, RG, Gonzalez Diaz, SN, Gonzalez-Estrada, A, Jares, E, Kalpaklioglu, AF, Tanno, LK, Kowalski, ML, Ledford, DK, Monge Ortega, OP, Almeida, MM, Pfaar, O, Poulsen, LK, Pawankar, R, Renz, HE, Romano, AG, Rosario Filho, NA, Rosenwasser, L, Sanchez Borges, MA, Scala, E, Senna, G-E, Carlos Sisul, J, Tang, MLK, Thong, BY-H, Valenta, R, Wood, RA, and Zuberbier, T

Abstract

Currently, testing for immunoglobulin E (IgE) sensitization is the cornerstone of diagnostic evaluation in suspected allergic conditions. This review provides a thorough and updated critical appraisal of the most frequently used diagnostic tests, both in vivo and in vitro. It discusses skin tests, challenges, and serological and cellular in vitro tests, and provides an overview of indications, advantages and disadvantages of each in conditions such as respiratory, food, venom, drug, and occupational allergy. Skin prick testing remains the first line approach in most instances; the added value of serum specific IgE to whole allergen extracts or components, as well as the role of basophil activation tests, is evaluated. Unproven, non-validated, diagnostic tests are also discussed. Throughout the review, the reader must bear in mind the relevance of differentiating between sensitization and allergy; the latter entails not only allergic sensitization, but also clinically relevant symptoms triggered by the culprit allergen.

Published
2020

37. Characteristics and treatment regimens across ERS SHARP severe asthma registries

Author

van Bragt, JJMH, Adcock, IM, Bel, EHD, Braunstahl, G-J, ten Brinke, A, Busby, J, Canonica, GW, Cao, H, Chung, KF, Csoma, Z, Dahlen, B, Davin, E, Hansen, S, Heffler, E, Horvath, I, Korn, S, Kots, M, Kuna, P, Kwon, N, Louis, R, Plaza, V, Porsbjerg, C, Ramos-Barbon, D, Richards, LB, Skrgat, S, Sont, JK, Vijverberg, SJH, Weersink, EJM, Yasinska, V, Wagers, SS, Djukanovic, R, Maitland-van der Zee, AH, Abenhardt, B, Adler, J, Alfonso, R, Ali, R, Alkameh, S, Almonacid Sanchez, C, Alvares, L, Anderson, G, Assing, K, Ayre, S, Becker, J, Bergmann, K, Bieksiene, K, Bjerring, N, Blasi, F, Bloemen, P, Blum, H, Boeing, S, Bonavia, M, Bossios, A, Bourdin, A, Brons, A, Brusselle, G, Buis, J, Caiaffa, M, Calabrese, C, Camiciottoli, G, Caruso, C, Castilla Martinez, M, Centanni, S, Cisneros Serrano, C, Corsico, A, Cosmi, L, Costantino, M, Costello, R, Crimi, N, Dahlen, S, D'Amato, M, Davies, D, Garcia-Cosio Piqueras, FDB, Decarlo, G, Deimling, A, Del Giacco, S, Diaz Campos, R, Djandji, M, Doberer, D, Dupont, L, Dyett, K, Edelbaher, N, Edelmann, M, Ehmann, R, Ekberg-Jansson, A, Farsi, A, Favero, E, Feimer, J, Fletcher, M, Foschino, B, Frankemolle, B, Gaga, M, Gappa, M, Garcia de Pedro, J, Garcia Rivero, J, Gasplmayr, M, Gebhardt, R, Geldmacher, H, Geltner, C, Gerstlauer, M, Gibson, T, Giuseppe, G, Gogoll, C, Grimm-Sachs, V, Grisle, I, Gruen, B, Gruenewaldt, A, Guarnieri, G, Gullon Blanco, J, Hamelmann, E, Hamerlijnck, D, Hammers-Reinhard, A, Hanon, S, Harzheim, D, Heaney, L, Hellmich, S, Herden, M, Hering, T, Herth, F, Hilberg, O, Howarth, P, Hubatsch, M, Humbert, M, Husemann, K, Idzko, M, Jackson, D, Jandl, M, Jaumont, X, Joos, G, Joest, M, Juech, M, Kabesch, M, Kaiser-Labusch, P, Kardos, P, Kaessner, F, Keeley, T, Kerr, W, Kirschner, J, Klimek, L, Koca, M, Koczulla, R, Koerner-Rettberg, C, Kopac, P, Kronsbein, J, Lipinska, IK, Langer, M, Langeveld, B, Lantz, A, Lazarinis, N, Lazic, Z, Lehtimaki, L, Leuppi, J, Lombardi, C, Lommatzsch, M, Lopez-Vina, A, Luca, R, Ludviksdottir, D, Luettecke-Hecht, C, Macchia, L, Magni, T, Martinez Rivera, C, Mastoridis, P, Mazza, F, Menzella, F, Menzies-Gow, A, Michils, A, Mihaltan, F, Milanese, M, Milger-Kneidinger, K, Molinska, J, Montagna, I, Montuschi, P, Muelleneisen, N, Munoz Esquerre, M, Nanzer-Kelly, A, Nenasheva, N, Neurohr, C, Nucera, E, Otker, J, Oud, K, Paggiaro, P, Parente, R, Parkinson, J, Passalacqua, G, Patberg, N, Patella, V, Patino, O, Paulsson, T, Peche, R, Pelaia, G, Peress, E, Perez de Llano, L, Pfeffer, P, Pfister, P, Pilette, C, Pinedo Sierra, C, Pini, L, Powitz, F, Ranger, T, Rasmussen, L, Rasmussen, K, Rezelj, M, Ricciardi, L, Ricciardolo, F, Ridolo, E, Rijssenbeek-Nouwens, L, Rolla, G, Romero Ribate, D, Ruediger, S, Safioti, G, Sandstrom, T, Santus, P, Sauer, R, Schauerte, G, Schipmann, R, Schleich, F, Schmid, J, Schmidt, F, Schmidt, O, Schmitz, M, Schrag, T, Schroeer, S, Schultz, K, Schulz, C, Scichilone, N, Sedlak, V, Selb, J, Senna, G, Sergejeva, S, Serrano Pariente, J, Sichau, M, Simona, D, Singer, A, Skowasch, D, Smeenk, F, Smith, S, Solidoro, P, Spadaro, G, Spanevello, A, Stefansdottir, M, Steinmetz, K, Steiss, J, Stephan, M, Stieglitz, S, Suhling, H, Taube, C, Yavuz, ST, Tudoric, N, Ulrik, C, van de Ven, M, van den Elshout, F, Van Dyke, M, Van Nederveen-Bendien, S, van Veen, I, Vandenplas, O, Velthove, K, Vianello, A, Vogelberg, C, Wallen-Nielsen, E, Weersink, EJ, Wisskirchen, T, Yacoub, M, Yancey, S, Zappa, M, Zielen, S, Zimmermann, C, Zimmermann, R, van Bragt, JJMH, Adcock, IM, Bel, EHD, Braunstahl, G-J, ten Brinke, A, Busby, J, Canonica, GW, Cao, H, Chung, KF, Csoma, Z, Dahlen, B, Davin, E, Hansen, S, Heffler, E, Horvath, I, Korn, S, Kots, M, Kuna, P, Kwon, N, Louis, R, Plaza, V, Porsbjerg, C, Ramos-Barbon, D, Richards, LB, Skrgat, S, Sont, JK, Vijverberg, SJH, Weersink, EJM, Yasinska, V, Wagers, SS, Djukanovic, R, Maitland-van der Zee, AH, Abenhardt, B, Adler, J, Alfonso, R, Ali, R, Alkameh, S, Almonacid Sanchez, C, Alvares, L, Anderson, G, Assing, K, Ayre, S, Becker, J, Bergmann, K, Bieksiene, K, Bjerring, N, Blasi, F, Bloemen, P, Blum, H, Boeing, S, Bonavia, M, Bossios, A, Bourdin, A, Brons, A, Brusselle, G, Buis, J, Caiaffa, M, Calabrese, C, Camiciottoli, G, Caruso, C, Castilla Martinez, M, Centanni, S, Cisneros Serrano, C, Corsico, A, Cosmi, L, Costantino, M, Costello, R, Crimi, N, Dahlen, S, D'Amato, M, Davies, D, Garcia-Cosio Piqueras, FDB, Decarlo, G, Deimling, A, Del Giacco, S, Diaz Campos, R, Djandji, M, Doberer, D, Dupont, L, Dyett, K, Edelbaher, N, Edelmann, M, Ehmann, R, Ekberg-Jansson, A, Farsi, A, Favero, E, Feimer, J, Fletcher, M, Foschino, B, Frankemolle, B, Gaga, M, Gappa, M, Garcia de Pedro, J, Garcia Rivero, J, Gasplmayr, M, Gebhardt, R, Geldmacher, H, Geltner, C, Gerstlauer, M, Gibson, T, Giuseppe, G, Gogoll, C, Grimm-Sachs, V, Grisle, I, Gruen, B, Gruenewaldt, A, Guarnieri, G, Gullon Blanco, J, Hamelmann, E, Hamerlijnck, D, Hammers-Reinhard, A, Hanon, S, Harzheim, D, Heaney, L, Hellmich, S, Herden, M, Hering, T, Herth, F, Hilberg, O, Howarth, P, Hubatsch, M, Humbert, M, Husemann, K, Idzko, M, Jackson, D, Jandl, M, Jaumont, X, Joos, G, Joest, M, Juech, M, Kabesch, M, Kaiser-Labusch, P, Kardos, P, Kaessner, F, Keeley, T, Kerr, W, Kirschner, J, Klimek, L, Koca, M, Koczulla, R, Koerner-Rettberg, C, Kopac, P, Kronsbein, J, Lipinska, IK, Langer, M, Langeveld, B, Lantz, A, Lazarinis, N, Lazic, Z, Lehtimaki, L, Leuppi, J, Lombardi, C, Lommatzsch, M, Lopez-Vina, A, Luca, R, Ludviksdottir, D, Luettecke-Hecht, C, Macchia, L, Magni, T, Martinez Rivera, C, Mastoridis, P, Mazza, F, Menzella, F, Menzies-Gow, A, Michils, A, Mihaltan, F, Milanese, M, Milger-Kneidinger, K, Molinska, J, Montagna, I, Montuschi, P, Muelleneisen, N, Munoz Esquerre, M, Nanzer-Kelly, A, Nenasheva, N, Neurohr, C, Nucera, E, Otker, J, Oud, K, Paggiaro, P, Parente, R, Parkinson, J, Passalacqua, G, Patberg, N, Patella, V, Patino, O, Paulsson, T, Peche, R, Pelaia, G, Peress, E, Perez de Llano, L, Pfeffer, P, Pfister, P, Pilette, C, Pinedo Sierra, C, Pini, L, Powitz, F, Ranger, T, Rasmussen, L, Rasmussen, K, Rezelj, M, Ricciardi, L, Ricciardolo, F, Ridolo, E, Rijssenbeek-Nouwens, L, Rolla, G, Romero Ribate, D, Ruediger, S, Safioti, G, Sandstrom, T, Santus, P, Sauer, R, Schauerte, G, Schipmann, R, Schleich, F, Schmid, J, Schmidt, F, Schmidt, O, Schmitz, M, Schrag, T, Schroeer, S, Schultz, K, Schulz, C, Scichilone, N, Sedlak, V, Selb, J, Senna, G, Sergejeva, S, Serrano Pariente, J, Sichau, M, Simona, D, Singer, A, Skowasch, D, Smeenk, F, Smith, S, Solidoro, P, Spadaro, G, Spanevello, A, Stefansdottir, M, Steinmetz, K, Steiss, J, Stephan, M, Stieglitz, S, Suhling, H, Taube, C, Yavuz, ST, Tudoric, N, Ulrik, C, van de Ven, M, van den Elshout, F, Van Dyke, M, Van Nederveen-Bendien, S, van Veen, I, Vandenplas, O, Velthove, K, Vianello, A, Vogelberg, C, Wallen-Nielsen, E, Weersink, EJ, Wisskirchen, T, Yacoub, M, Yancey, S, Zappa, M, Zielen, S, Zimmermann, C, and Zimmermann, R

Abstract

Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day-1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.

Published
2020

38. Minimal clinically important difference for asthma endpoints: An expert consensus report

Author

Bonini, Matteo, Di Paolo, M., Bagnasco, D., Baiardini, I., Braido, F., Caminati, M., Carpagnano, E., Contoli, M., Corsico, A., Giacco, S. D., Heffler, E., Lombardi, C., Menichini, Isabella, Milanese, M., Scichilone, N., Senna, G., Canonica, G. W., Bonini M. (ORCID:0000-0002-3042-0765), Menichini I., Bonini, Matteo, Di Paolo, M., Bagnasco, D., Baiardini, I., Braido, F., Caminati, M., Carpagnano, E., Contoli, M., Corsico, A., Giacco, S. D., Heffler, E., Lombardi, C., Menichini, Isabella, Milanese, M., Scichilone, N., Senna, G., Canonica, G. W., Bonini M. (ORCID:0000-0002-3042-0765), and Menichini I.

Abstract

Minimal clinically important difference (MCID) can be defined as the smallest change or difference in an outcome measure that is perceived as beneficial and would lead to a change in the patient’s medical management. The aim of the current expert consensus report is to provide a “state-of-the-art” review of the currently available literature evidence about MCID for end-points to monitor asthma control, in order to facilitate optimal disease management and identify unmet needs in the field to guide future research. A series of MCID cut-offs are currently available in literature and validated among populations of asthmatic patients, with most of the evidence focusing on outcomes as patient reported outcomes, lung function and exercise tolerance. On the contrary, only scant and partial data are available for inflammatory biomarkers. These clearly represent the most interesting target for future development in diagnosis and clinical management of asthma, particularly in view of the several biologic drugs in the pipeline, for which regulatory agencies will soon require personalised proof of efficacy and treatment response predictors.

Published
2020

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

Author

Canonica, G. W., Blasi, F., Paggiaro, P., Senna, G., Passalacqua, G., Spanevello, A., Aliberti, S., Bagnasco, D., Bonavia, M., Bonini, Matteo, Brussino, L., Bucca, C., Caiaffa, M. F., Calabrese, Anna Chiara, Camiciottoli, G., Caminati, M., Carpagnano, G. E., Caruso, Corrado Maria Roberto, Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alo, S., D'Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino Barbaro, M. P., Guarnieri, G., Guida, Maria Grazia, Latorre, M., Lo Cicero, Stefano, Lombardi, Celestino Pio, Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montagni, M., Montuschi, Paolo, Nucera, Eleonora, Parente, R., Patella, V., Pelaia, G., Pini, L., Puggioni, F., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, Luca, Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Spadaro, G., Vianello, A., Viviano, V., Yacoub, M. R., Zappa, M. C., Heffler, E., Bonini M. (ORCID:0000-0002-3042-0765), Calabrese C., Caruso C., Guida G., Lo Cicero S., Lombardi C. (ORCID:0000-0001-8910-6693), Montuschi P. (ORCID:0000-0001-5589-1750), Nucera E. (ORCID:0000-0002-0565-7680), Richeldi L. (ORCID:0000-0001-8594-1448), Canonica, G. W., Blasi, F., Paggiaro, P., Senna, G., Passalacqua, G., Spanevello, A., Aliberti, S., Bagnasco, D., Bonavia, M., Bonini, Matteo, Brussino, L., Bucca, C., Caiaffa, M. F., Calabrese, Anna Chiara, Camiciottoli, G., Caminati, M., Carpagnano, G. E., Caruso, Corrado Maria Roberto, Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alo, S., D'Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino Barbaro, M. P., Guarnieri, G., Guida, Maria Grazia, Latorre, M., Lo Cicero, Stefano, Lombardi, Celestino Pio, Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montagni, M., Montuschi, Paolo, Nucera, Eleonora, Parente, R., Patella, V., Pelaia, G., Pini, L., Puggioni, F., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, Luca, Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Spadaro, G., Vianello, A., Viviano, V., Yacoub, M. R., Zappa, M. C., Heffler, E., Bonini M. (ORCID:0000-0002-3042-0765), Calabrese C., Caruso C., Guida G., Lo Cicero S., Lombardi C. (ORCID:0000-0001-8910-6693), Montuschi P. (ORCID:0000-0001-5589-1750), Nucera E. (ORCID:0000-0002-0565-7680), and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

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 all alternatives currently available for a large part of severe asthmatics.

Published
2020

40. Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: Evidences from the Severe Asthma Network Italy (SANI) registry

Author

Canonica, G. W., Malvezzi, L., Blasi, F., Paggiaro, P., Mantero, M., Senna, G., Heffler, E., Bonavia, M., Caiaffa, P., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alonzo, Silvia, D'Amato, M., Del Giacco, S., Favero, E., Farsi, A., Foschino, B. P. M., Guarnieri, G., Guida, G., Latorre, M., Lombardi, C., Macchia, Gabriella, Menzella, F., Milanese, M., Montuschi, Paolo, Nucera, Eleonora, Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardolo, F. L. M., Ricciardi, L., Richeldi, Luca, Ridolo, E., Marolla, Giovanna, Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Yacoub, M. R., Zappa, M. C., D'Alo S., Macchia L., Montuschi P. (ORCID:0000-0001-5589-1750), Nucera E. (ORCID:0000-0002-0565-7680), Richeldi L. (ORCID:0000-0001-8594-1448), Rolla G., Canonica, G. W., Malvezzi, L., Blasi, F., Paggiaro, P., Mantero, M., Senna, G., Heffler, E., Bonavia, M., Caiaffa, P., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alonzo, Silvia, D'Amato, M., Del Giacco, S., Favero, E., Farsi, A., Foschino, B. P. M., Guarnieri, G., Guida, G., Latorre, M., Lombardi, C., Macchia, Gabriella, Menzella, F., Milanese, M., Montuschi, Paolo, Nucera, Eleonora, Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardolo, F. L. M., Ricciardi, L., Richeldi, Luca, Ridolo, E., Marolla, Giovanna, Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Yacoub, M. R., Zappa, M. C., D'Alo S., Macchia L., Montuschi P. (ORCID:0000-0001-5589-1750), Nucera E. (ORCID:0000-0002-0565-7680), Richeldi L. (ORCID:0000-0001-8594-1448), and Rolla G.

Abstract

Background: The clinical and laboratory features of patients enrolled in the Severe Asthma Network in Italy (SANI) registry, a web-based observatory collecting demographic, clinical, functional and inflammatory data of patients with severe asthma were evaluated, with a special emphasis to chronic rhinosinusitis with nasal polyposis (CRSwNP). Methods: For each eligible patients the following information has been collected: demographic data, clinical features, asthma control in the previous month according to the GINA (Global INitiative for Asthma) Guidelines and standardized questionnaires, concomitant regular and on demand treatments and inflammatory markers. Results: 695 patients with severe asthma enrolled in 66 SANI centers were analyzed. The prevalence of chronic rhinosinusitis with nasal polyposis was 40.6%. Atopic dermatitis and bronchiectasis was significantly more frequent in patients with CRSwNP than in subjects without nasal polyposis; similarly, FeNO values are significantly higher in subject with CRSwNP than in patients without nasal polyposis. Finally, patients with CRSwNP had a significantly higher number of asthma exacerbations per year, more days on oral corticosteroids and were more likely to be OCS long term users. Conclusion: OCS sparing is needed in patients with severe asthma, mainly in subjects with CRSwNP, adopting adequate strategies such as a better adherence to the treatment with inhaled therapy according to the GINA recommendations, the use of biologic agents and a multidisciplinary approach of the patient.

Published
2020

45. Higher blood eosinophil levels after omalizumab treatment may be associated with poorer asthma outcomes

Author

Sposato, B., Migliorini, M.G., Di Tomassi, M., Olivieri, C., Perrella, A., Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M.T., Sabato, E., Cagnazzo, M.G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Caiaffa, M.F., Berra, A., Calabrese, C., Stanziola, A.A., Schino, P., Di Gioacchino, M., Rogliani, P., Cazzola, M., Segreti, A., Pastorello, E.A., Scibilia, G., Vianello, A., Marchi, M.R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Scichilone, N., Paggiaro, P., Novelli, F., Latorre, M., Vergura, L., Masieri, S., Scalese, M., Rosati, Y., Milanese, M., Folletti, I., Pio, R., Pio, A., Maccari, U., Maggiorelli, C., Scala, R., Vignale, L., Pulerà, N., Carpagnano, G.E., Foschino Barbaro, M.P., Sposato, Bruno, Scalese, Marco, Milanese, Manlio, Masieri, Simonetta, Cavaliere, Carlo, Latorre, Manuela, Scichilone, Nicola, Ricci, Alberto, Cresti, Alberto, Santus, Pierachille, Olivieri, Carmela, Perrella, Antonio, Rogliani, Paola, and Paggiaro, Pierluigi

Published
2019
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46. Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA2LEN taskforce position paper

Author

Baiardini, I., Braido, F., Bindslev-Jensen, C., Bousquet, P. J., Brzoza, Z., Canonica, G. W., Compalati, E., Fiocchi, A., Fokkens, W., van Wijk, Gerth R., Giménez-Arnau, A., Godse, K., Grattan, C., Grob, J. J., La Grutta, S., Kalogeromitros, D., Kocatürk, E., Lombardi, C., Mota-Pinto, A., Ridolo, E., Saini, S. S., Sanchez-Borges, M., Senna, G. E., Terreehorst, I., Bom, Todo A., Toubi, E., Bousquet, J., Zuberbier, T., and Maurer, M.

Published
2011
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49. Characteristics and treatment regimens across ERS SHARP severe asthma registries

Author

van Bragt, JJMH, Adcock, IM, Bel, EHD, Braunstahl, GJ, ten Brinke, A, Busby, J, Canonica, GW, Cao, H, Chung, KF, Csoma, Z, Dahlen, B, Davin, E, Hansen, S, Heffler, E, Horvath, I, Korn, S, Kots, M, Kuna, P, Kwon, N, Louis, R, Plaza, V, Porsbjerg, C, Ramos-Barbon, D, Richards, LB, Skrgat, S, Sont, JK, Vijverberg, SJH, Weersink, EJM, Yasinska, V, Wagers, SS, Djukanovic, R, Maitland-van der Zee, AH, Abenhardt, B, Adler, J, Alfonso, R, Ali, R, Alkameh, S, Sanchez, CA, Alvares, L, Anderson, G, Assing, K, Ayre, S, Becker, J, Bergmann, K, Bieksiene, K, Bjerring, N, Blasi, F, Bloemen, P, Blum, H, Boing, S, Bonavia, M, Bossios, A, Bourdin, A, Brons, A, Brusselle, G, Buis, J, Caiaffa, M, Calabrese, C, Camiciottoli, G, Caruso, C, Martinez, MC, Centanni, S, Serrano, CC, Corsico, A, Cosmi, L, Costantino, M, Costello, R, Crimi, N, Dahlen, S, D'Amato, M, Davies, D, Piqueras, FDGC, Decarlo, G, Deimling, A, Del Giacco, S, Campos, RD, Djandji, M, Doberer, D, Dupont, L, Dyett, K, Edelbaher, N, Edelmann, M, Ehmann, R, Ekberg-Jansson, A, Farsi, A, Favero, E, Feimer, J, Fletcher, M, Foschino, B, Frankemolle, B, Gaga, M, Gappa, M, de Pedro, JG, Rivero, JG, Gasplmayr, M, Gebhardt, R, Geldmacher, H, Geltner, C, Gerstlauer, M, Gibson, T, Giuseppe, G, Gogoll, C, Grimm-Sachs, V, Grisle, I, Grun, B, Grunewaldt, A, Guarnieri, G, Blanco, JG, Hamelmann, E, Hamerlijnck, D, Hammers-Reinhard, A, Hanon, S, Harzheim, D, Heaney, L, Hellmich, S, Herden, M, Hering, T, Herth, F, Hilberg, O, Howarth, P, Hubatsch, M, Humbert, M, Husemann, K, Idzko, M, Jackson, D, Jandl, M, Jaumont, X, Joos, G, Jost, M, Juch, M, Kabesch, M, Kaiser-Labusch, P, Kardos, P, Kassner, F, Keeley, T, Kerr, W, Kirschner, J, Klimek, L, Koca, M, Koczulla, R, Koerner-Rettberg, C, Kopac, P, Kronsbein, J, Lipinska, IK, Langer, M, Langeveld, B, Lantz, A, Lazarinis, N, Lazic, Z, Lehtimaki, L, Leuppi, J, Lombardi, C, Lommatzsch, M, Lopez-Vina, A, Luca, R, Ludviksdottir, D, Luttecke-Hecht, C, Macchia, L, Magni, T, Rivera, CM, Mastoridis, P, Mazza, F, Menzella, F, Menzies-Gow, A, Michils, A, Mihaltan, F, Milanese, M, Milger-Kneidinger, K, Molinska, J, Montagna, I, Montuschi, P, Mulleneisen, N, Esquerre, MM, Nanzer-Kelly, A, Nenasheva, N, Neurohr, C, Nucera, E, Otker, J, Oud, K, Paggiaro, P, Parente, R, Parkinson, J, Passalacqua, G, Patberg, N, Patella, V, Patino, O, Paulsson, T, Peche, R, Pelaia, G, Peress, E, de Llano, LP, Pfeffer, P, Pfister, P, Pilette, C, Sierra, CP, Pini, L, Powitz, F, Ranger, T, Rasmussen, L, Rasmussen, K, Rezelj, M, Ricciardi, L, Ricciardolo, F, Ridolo, E, Rijssenbeek-Nouwens, L, Rolla, G, Ribate, DR, Rudiger, S, Safioti, G, Sandstrom, T, Santus, P, Sauer, R, Schauerte, G, Schipmann, R, Schleich, F, Schmid, J, Schmidt, F, Schmidt, O, Schmitz, M, Schrag, T, Schroer, S, Schultz, K, Schulz, C, Scichilone, N, Sedlak, V, Selb, J, Senna, G, Sergejeva, S, Pariente, JS, Sichau, M, Simona, D, Singer, A, Skowasch, D, Smeenk, F, Smith, S, Solidoro, P, Spadaro, G, Spanevello, A, Stefansdottir, M, Steinmetz, K, Steiss, J, Stephan, M, Stieglitz, S, Suhling, H, Taube, C, Yavuz, ST, Tudoric, N, Ulrik, C, van de Ven, M, van den Elshout, F, Van Dyke, M, Van Nederveen-Bendien, S, van Veen, I, Vandenplas, O, Velthove, K, Vianello, A, Vogelberg, C, Wallen-Nielsen, E, Weersink, EJ, Wisskirchen, T, Yacoub, M, Yancey, S, Zappa, M, Zielen, S, Zimmermann, C, Zimmermann, R, Graduate School, AII - Inflammatory diseases, APH - Personalized Medicine, Pulmonology, Paediatric Pulmonology, van Bragt, J. J. M. H., Adcock, I. M., Bel, E. H. D., Braunstahl, G. -J., ten Brinke, A., Busby, J., Canonica, G. W., Cao, H., Chung, K. F., Csoma, Z., Dahlen, B., Davin, E., Hansen, S., Heffler, E., Horvath, I., Korn, S., Kots, M., Kuna, P., Kwon, N., Louis, R., Plaza, V., Porsbjerg, C., Ramos-Barbon, D., Richards, L. B., Skrgat, S., Sont, J. K., Vijverberg, S. J. H., Weersink, E. J. M., Yasinska, V., Wagers, S. S., Djukanovic, R., Maitland-Van der Zee, A. H., Abenhardt, B., Adler, J., Alfonso, R., Ali, R., Alkameh, S., Almonacid Sanchez, C., Alvares, L., Anderson, G., Assing, K., Ayre, S., Becker, J., Bergmann, K., Bieksiene, K., Bjerring, N., Blasi, F., Bloemen, P., Blum, H., Boing, S., Bonavia, M., Bossios, A., Bourdin, A., Brons, A., Brusselle, G., Buis, J., Caiaffa, M., Calabrese, C., Camiciottoli, G., Caruso, C., Castilla Martinez, M., Centanni, S., Cisneros Serrano, C., Corsico, A., Cosmi, L., Costantino, M., Costello, R., Crimi, N., Dahlen, S., D'Amato, M., Davies, D., de Borja Garcia-Cosio Piqueras, F., Decarlo, G., Deimling, A., Del Giacco, S., Diaz Campos, R., Djandji, M., Doberer, D., Dupont, L., Dyett, K., Edelbaher, N., Edelmann, M., Ehmann, R., Ekberg-Jansson, A., Farsi, A., Favero, E., Feimer, J., Fletcher, M., Foschino, B., Frankemolle, B., Gaga, M., Gappa, M., Garcia de Pedro, J., Garcia Rivero, J., Gasplmayr, M., Gebhardt, R., Geldmacher, H., Geltner, C., Gerstlauer, M., Gibson, T., Giuseppe, G., Gogoll, C., Grimm-Sachs, V., Grisle, I., Grun, B., Grunewaldt, A., Guarnieri, G., Gullon Blanco, J., Hamelmann, E., Hamerlijnck, D., Hammers-Reinhard, A., Hanon, S., Harzheim, D., Heaney, L., Hellmich, S., Herden, M., Hering, T., Herth, F., Hilberg, O., Howarth, P., Hubatsch, M., Humbert, M., Husemann, K., Idzko, M., Jackson, D., Jandl, M., Jaumont, X., Joos, G., Jost, M., Juch, M., Kabesch, M., Kaiser-Labusch, P., Kardos, P., Kassner, F., Keeley, T., Kerr, W., Kirschner, J., Klimek, L., Koca, M., Koczulla, R., Koerner-Rettberg, C., Kopac, P., Kronsbein, J., Kuprys Lipinska, I., Langer, M., Langeveld, B., Lantz, A., Lazarinis, N., Lazic, Z., Lehtimaki, L., Leuppi, J., Lombardi, C., Lommatzsch, M., Lopez-Vina, A., Luca, R., Ludviksdottir, D., Luttecke-Hecht, C., Macchia, L., Magni, T., Martinez Rivera, C., Mastoridis, P., Mazza, F., Menzella, F., Menzies-Gow, A., Michils, A., Mihalthan, F., Milanese, M., Milger-Kneidinger, K., Molinska, J., Montagna, I., Montuschi, P., Mulleneisen, N., Munoz Esquerre, M., Nanzer-Kelly, A., Nenasheva, N., Neurohr, C., Nucera, E., Otker, J., Oud, K., Paggiaro, P., Parente, R., Parkinson, J., Passalacqua, G., Patberg, N., Patella, V., Patino, O., Paulsson, T., Peche, R., Pelaia, G., Peress, E., Perez de Llano, L., Pfeffer, P., Pfister, P., Pilette, C., Pinedo Sierra, C., Pini, L., Powitz, F., Ranger, T., Rasmussen, L., Rasmussen, K., Rezelj, M., Ricciardi, L., Ricciardolo, F., Ridolo, E., Rijssenbeek-Nouwens, L., Rolla, G., Romero Ribate, D., Rudiger, S., Safioti, G., Sandstrom, T., Santus, P., Sauer, R., Schauerte, G., Schipmann, R., Schleich, F., Schmid, J., Schmidt, F., Schmidt, O., Schmitz, M., Schrag, T., Schroer, S., Schultz, K., Schulz, C., Scichilone, N., Sedlak, V., Selb, J., Senna, G., Sergejeva, S., Serrano Pariente, J., Sichau, M., Simona, D., Singer, A., Skowasch, D., Smeenk, F., Smith, S., Solidoro, P., Spadaro, G., Spanevello, A., Stefansdottir, M., Steinmetz, K., Steiss, J., Stephan, M., Stieglitz, S., Suhling, H., Taube, C., Tolga Yavuz, S., Tudoric, N., Ulrik, C., van de Ven, M., van den Elshout, F., van Dyke, M., van Nederveen-Bendien, S., van Veen, I., Vandenplas, O., Velthove, K., Vianello, A., Vogelberg, C., Wallen-Nielsen, E., Wisskirchen, T., Yacoub, M., Yancey, S., Zappa, M., Zielen, S., Zimmermann, C., Zimmermann, R., UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (MGD) Service de pneumologie, van Bragt J.J.M.H., Adcock I.M., Bel E.H.D., Braunstahl G.-J., ten Brinke A., Busby J., Canonica G.W., Cao H., Chung K.F., Csoma Z., Dahlen B., Davin E., Hansen S., Heffler E., Horvath I., Korn S., Kots M., Kuna P., Kwon N., Louis R., Plaza V., Porsbjerg C., Ramos-Barbon D., Richards L.B., Skrgat S., Sont J.K., Vijverberg S.J.H., Weersink E.J.M., Yasinska V., Wagers S.S., Djukanovic R., Maitland-Van der Zee A.H., Abenhardt B., Adler J., Alfonso R., Ali R., Alkameh S., Almonacid Sanchez C., Alvares L., Anderson G., Assing K., Ayre S., Becker J., Bergmann K., Bieksiene K., Bjerring N., Blasi F., Bloemen P., Blum H., Boing S., Bonavia M., Bossios A., Bourdin A., Brons A., Brusselle G., Buis J., Caiaffa M., Calabrese C., Camiciottoli G., Caruso C., Castilla Martinez M., Centanni S., Cisneros Serrano C., Corsico A., Cosmi L., Costantino M., Costello R., Crimi N., Dahlen S., D'Amato M., Davies D., de Borja Garcia-Cosio Piqueras F., Decarlo G., Deimling A., Del Giacco S., Diaz Campos R., Djandji M., Doberer D., Dupont L., Dyett K., Edelbaher N., Edelmann M., Ehmann R., Ekberg-Jansson A., Farsi A., Favero E., Feimer J., Fletcher M., Foschino B., Frankemolle B., Gaga M., Gappa M., Garcia de Pedro J., Garcia Rivero J., Gasplmayr M., Gebhardt R., Geldmacher H., Geltner C., Gerstlauer M., Gibson T., Giuseppe G., Gogoll C., Grimm-Sachs V., Grisle I., Grun B., Grunewaldt A., Guarnieri G., Gullon Blanco J., Hamelmann E., Hamerlijnck D., Hammers-Reinhard A., Hanon S., Harzheim D., Heaney L., Hellmich S., Herden M., Hering T., Herth F., Hilberg O., Howarth P., Hubatsch M., Humbert M., Husemann K., Idzko M., Jackson D., Jandl M., Jaumont X., Joos G., Jost M., Juch M., Kabesch M., Kaiser-Labusch P., Kardos P., Kassner F., Keeley T., Kerr W., Kirschner J., Klimek L., Koca M., Koczulla R., Koerner-Rettberg C., Kopac P., Kronsbein J., Kuprys Lipinska I., Langer M., Langeveld B., Lantz A., Lazarinis N., Lazic Z., Lehtimaki L., Leuppi J., Lombardi C., Lommatzsch M., Lopez-Vina A., Luca R., Ludviksdottir D., Luttecke-Hecht C., Macchia L., Magni T., Martinez Rivera C., Mastoridis P., Mazza F., Menzella F., Menzies-Gow A., Michils A., Mihalthan F., Milanese M., Milger-Kneidinger K., Molinska J., Montagna I., Montuschi P., Mulleneisen N., Munoz Esquerre M., Nanzer-Kelly A., Nenasheva N., Neurohr C., Nucera E., Otker J., Oud K., Paggiaro P., Parente R., Parkinson J., Passalacqua G., Patberg N., Patella V., Patino O., Paulsson T., Peche R., Pelaia G., Peress E., Perez de Llano L., Pfeffer P., Pfister P., Pilette C., Pinedo Sierra C., Pini L., Powitz F., Ranger T., Rasmussen L., Rasmussen K., Rezelj M., Ricciardi L., Ricciardolo F., Ridolo E., Rijssenbeek-Nouwens L., Rolla G., Romero Ribate D., Rudiger S., Safioti G., Sandstrom T., Santus P., Sauer R., Schauerte G., Schipmann R., Schleich F., Schmid J., Schmidt F., Schmidt O., Schmitz M., Schrag T., Schroer S., Schultz K., Schulz C., Scichilone N., Sedlak V., Selb J., Senna G., Sergejeva S., Serrano Pariente J., Sichau M., Simona D., Singer A., Skowasch D., Smeenk F., Smith S., Solidoro P., Spadaro G., Spanevello A., Stefansdottir M., Steinmetz K., Steiss J., Stephan M., Stieglitz S., Suhling H., Taube C., Tolga Yavuz S., Tudoric N., Ulrik C., van de Ven M., van den Elshout F., van Dyke M., van Nederveen-Bendien S., van Veen I., Vandenplas O., Velthove K., Vianello A., Vogelberg C., Wallen-Nielsen E., Wisskirchen T., Yacoub M., Yancey S., Zappa M., Zielen S., Zimmermann C., Zimmermann R., Amsterdam UMC, National Heart and Lung Institute [London] (NHLI), Imperial College London-Royal Brompton and Harefield NHS Foundation Trust, Department of Medical Microbiology and Infection Control, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands., Medical Centre Leeuwarden, Queen's University [Belfast] (QUB), Humanitas University [Milan] (Hunimed), Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, Korányi National Institute of Pulmonology (OKPI), Karolinska University Hospital [Stockholm], The European Lung Foundation (ELF), Bispebjerg and Frederiksberg Hospitals, Humanitas Clinical and Research Center [Rozzano, Milan, Italy], University Medical Center of the Johannes Gutenberg-University Mainz, Chiesi Farmaceutici, Medical University of Łódź (MUL), GlaxoSmithKline, Brentford, Middlesex, Centre Hospitalier Universitaire de Liège (CHU-Liège), Hospital de la Santa Creu i Sant Pau, Copenhagen University Hospital, Respiratory and Allergic Diseases [Golnik, Slovenia], University Clinic of Respiratory and Allergic Diseases Golnik, Leiden University Medical Center (LUMC), Biosci Consulting, University Hospital Southampton NHS Foundation Trust, SHARP Clinical Research, Hôpital Arnaud de Villeneuve [CHRU Montpellier], and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)

Subjects
Severe asthma, Pediatrics, MESH: Registries, MESH: Asthma, Cross-sectional study, Respiratory System, Medizin, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, 0302 clinical medicine, MESH: Belgium, Belgium, Medicine research, Anti-Asthmatic Agents, Registries, 030212 general & internal medicine, [SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology, 10. No inequality, 11 Medical and Health Sciences, Netherlands, 2. Zero hunger, education.field_of_study, SHARP CRC, MESH: Administration, Inhalation, MESH: Anti-Asthmatic Agents, 3. Good health, Europe, Italy, MESH: Poland, MESH: Sweden, medicine.drug, Pulmonary and Respiratory Medicine, medicine.medical_specialty, MESH: Hungary, Population, Investigació mèdica, Settore MED/10 - Malattie Dell'Apparato Respiratorio, 03 medical and health sciences, MESH: Cross-Sectional Studies, Administration, Inhalation, MESH: Spain, medicine, Humans, education, Asma, Retrospective Studies, Asthma, Sweden, Hungary, MESH: Humans, business.industry, Settore MED/09 - MEDICINA INTERNA, MESH: Italy, MESH: Retrospective Studies, Retrospective cohort study, Original Articles, asthma, medicine.disease, Clinical trial, Cross-Sectional Studies, Clinical research, 030228 respiratory system, Spain, MESH: Netherlands, MESH: Europe, Poland, business, Body mass index, Mepolizumab
Abstract

Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m−2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day−1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day−1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.

Published
2019

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