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1. Severe asthma: One disease and multiple definitions

Author

Diego Bagnasco, MD, PhD, Pierluigi Paggiaro, MD, Manuela Latorre, MD, Chiara Folli, BS, Elisa Testino, MD, Arianna Bassi, MD, Manlio Milanese, MD, Enrico Heffler, MD, Andrea Manfredi, Anna Maria Riccio, BS, Laura De Ferrari, BS, Francesco Blasi, Rikki Frank Canevari, MD, Giorgio Walter Canonica, MD, Giovanni Passalacqua, MD, Gabriella Guarnieri, Vincenzo Patella, Foschino Barbaro Maria Pia, Giovanna Elisiana Carpagnano, Anna del Colle, Giulia Scioscia, Pelaia Gerolamo, Francesca Puggioni, Francesca Racca, Elisabetta Favero, Sandra Iannacone, Eleonora Savi, Marcello Montagni, Gianna Camiciottoli, Chiara Allegrini, Carlo Lombardi, Giuseppe Spadaro, Caterina Detoraki, Francesco Menzella, Carla Galeone, Patrizia Ruggiero, Monna Rita Yacoub, Alvise Berti, Nicola Scichilone, Carmen Durante, Maria Teresa Costantino, Chiara Roncallo, Mariachiara Braschi, Alice D’Adda, Erminia Ridolo, Massimo Triggiani, Roberta Parente, D’Amato Maria, Maria Vittoria Verrillo, Giovanni Rolla, Luisa Brussino, Agata Valentina Frazzetto, Zappa Maria Cristina, Marianna Lilli, Nunzio Crimi, Marco Bonavia, Angelo Guido Corsico, Amelia Grosso, Stefano Del Giacco, Margherita Deidda, Luisa Ricciardi, Stefania Isola, Francesca Cicero, Giuliana Amato, Federica Vita, Antonio Spanevello, Patrizia Pignatti, Francesca Cherubino, Dina Visca, Fabio Luigi Massimo Ricciardolo, Vitina Maria Anna Carriero, Francesca Bertolini, Pierachille Santus, Roberta Barlassina, Andrea Airoldi, Giuseppe Guida, Nucera Eleonora, Arianna Aruanno, Angela Rizzi, Cristiano Caruso, Stefania Colantuono, Gianenrico Senna, Marco Caminati, Alessandra Arcolaci, Andrea Vianello, Fulvia Chieco Bianchi, Maria Rita Marchi, Stefano Centanni, Simone Luraschi, Silvia Ruggeri, Rocco Rinaldo, Elena Parazzini, Cecilia Calabrese, Martina Flora, Lorenzo Cosmi, Linda Di Pietro, Enrico Maggi, Laura Pini, Luigi Macchia, Danilo Di Bona, Luca Richeldi, Carola Condoluci, Leonello Fuso, Matteo Bonini, Alessandro Farsi, Giulia Carli, Paolo Montuschi, Giuseppe Santini, Maria Elisabetta Conte, Elisa Turchet, Carlo Barbetta, Francesco Mazza, Simona D’Alo, Stefano Pucci, Maria Filomena Caiaffa, Elena Minenna, Luciana D'Elia, Carlo Pasculli, Vittorio Viviano, Paolo Tarsia, Joyce Rolo, Mariacarmela Di Proietto, and Salvatore Lo Cicero

Subjects
Severe asthma, Classification, Definition, Biological treatment, Immunologic diseases. Allergy, RC581-607
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
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2. Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life

Author

Diego Bagnasco, Massimiliano Povero, Lorenzo Pradelli, Luisa Brussino, Giovanni Rolla, Marco Caminati, Francesco Menzella, Enrico Heffler, Giorgio Walter Canonica, Pierluigi Paggiaro, Gianenrico Senna, Manlio Milanese, Carlo Lombardi, Caterina Bucca, Andrea Manfredi, Rikki Frank Canevari, Giovanni Passalacqua, Gabriella Guarnieri, Vincenzo Patella, Foschino Barbaro Maria Pia, Elisiana Carpagnano, Anna del Colle, Giulia Scioscia, Pelaia Gerolamo, Manuela Latorre, Francesca Puggioni, Francesca Racca, Elisabetta Favero, Sandra Iannacone, Eleonora Savi, Marcello Montagni, Gianna Camiciottoli, Chiara Allegrini, Giuseppe Spadaro, Caterina Detoraki, Carla Galeone, Patrizia Ruggiero, Monna Rita Yacoub, Alvise Berti, Gisella Colombo, Nicola Scichilone, Carmen Durante, Maria Teresa Costantino, Chiara Roncallo, Mariachiara Braschi, Francesco Blasi, Alice D'Adda, Erminia Ridolo, Massimo Triggiani, Roberta Parente, D'Amato Maria, Maria Vittoria Verrillo, Zappa Maria Cristina, Marianna Lilli, Nunzio Crimi, Marco Bonavia, Angelo Guido Corsico, Amelia Grosso, Stefano Del Giacco, Margherita Deidda, Luisa Ricciardi, Stefania Isola, Francesca Cicero, Giuliana Amato, Federica Vita, Antonio Spanevello, Patrizia Pignatti, Francesca Cherubino, Dina Visca, Eleonora Aletti, Fabio Luigi Massimo Ricciardolo, Vitina Maria Anna Carriero, Francesca Bertolini, Pierachille Santus, Roberta Barlassina, Andrea Airoldi, Giuseppe Guida, Nucera Eleonora, Arianna Aruanno, Angela Rizzi, Cristiano Caruso, Stefania Colantuono, Alessandra Arcolaci, Andrea Vianello, Fulvia Chieco Bianchi, Maria Rita Marchi, Stefano Centanni, Simone Luraschi, Silvia Ruggeri, Rocco Rinaldo, Elena Parazzini, Cecilia Calabrese, Martina Flora, Lorenzo Cosmi, Linda Di Pietro, Enrico Maggi, Laura Pini, Luigi Macchia, Danilo Di Bona, Luca Richeldi, Carola Condoluci, Leonello Fuso, Matteo Bonini, Alessandro Farsi, Giulia Carli, Paolo Montuschi, Giuseppe Santini, Maria Elisabetta Conte, Elisa Turchet, Carlo Barbetta, Francesco Mazza, Simona D'Alo, Stefano Pucci, Maria Filomena Caiaffa, Elena Minenna, Luciana D'Elia, Carlo Pasculli, Vittorio Viviano, Paolo Tarsia, Joyce Rolo, Mariacarmela Di Proietto, and Salvatore Lo Cicero

Subjects
Severe asthma, Mepolizumab, Anti IL-5, Pharmacoeconomics, OCS, Comorbidities, Immunologic diseases. Allergy, RC581-607
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
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3. Severe asthma: One disease and multiple definitions

Author

Maria Teresa Costantino, Luigi Macchia, Angelo Corsico, Andrea Airoldi, Carla Galeone, Zappa Maria Cristina, Paolo Tarsia, Foschino Barbaro Maria Pia, Silvia Ruggeri, Pierluigi Paggiaro, Lorenzo Cosmi, A. Farsi, Vitina Maria Anna Carriero, Arianna Bassi, Francesca Bertolini, Giovanni Passalacqua, Fulvia Chieco Bianchi, Carlo Lombardi, Salvatore Lo Cicero, Giovanni Rolla, Carmen Durante, Rocco Rinaldo, Elena Parazzini, Arianna Aruanno, Maria Rita Marchi, Chiara Folli, Alessandra Arcolaci, Carlo Pasculli, Fabio Luigi Massimo Ricciardolo, Vittorio Viviano, Alvise Berti, Stefano Del Giacco, Andrea Manfredi, Roberta Barlassina, Agata Valentina Frazzetto, Pierachille Santus, Luisa Brussino, Anna del Colle, Marco Bonavia, Dina Visca, Nicola Scichilone, Patrizia Pignatti, Enrico Heffler, Francesca Racca, Giuseppe Santini, Nucera Eleonora, Giovanna Elisiana Carpagnano, Linda Di Pietro, Stefano Centanni, Maria Elisabetta Conte, Vincenzo Patella, Monna Rita Yacoub, Diego Bagnasco, Nunzio Crimi, Anna Maria Riccio, Stefania Isola, Margherita Deidda, Gabriella Guarnieri, Giuseppe Guida, Elena Minenna, Manuela Latorre, Gianna Camiciottoli, Maria Vittoria Verrillo, Luca Richeldi, Marcello Montagni, Francesca Cicero, Maria Filomena Caiaffa, Antonio Spanevello, Cecilia Calabrese, Carlo Barbetta, Elisabetta Favero, Gianenrico Senna, Giuliana Amato, Amelia Grosso, Federica Vita, Francesco Blasi, Luisa Ricciardi, Carola Condoluci, Massimo Triggiani, Enrico Maggi, Mariacarmela Di Proietto, Giulia Carli, Roberta Parente, Eleonora Savi, Chiara Roncallo, Paolo Montuschi, Luciana D'Elia, Francesco Mazza, Simona D’Alo, Patrizia Ruggiero, Francesca Puggioni, Matteo Bonini, Simone Luraschi, Francesco Menzella, Leonello Fuso, Marco Caminati, Martina Flora, Mariachiara Braschi, Cristiano Caruso, Angela Rizzi, Sandra Iannacone, Rikki Frank Canevari, Andrea Vianello, D’Amato Maria, Manlio Milanese, Stefania Colantuono, Giorgio Walter Canonica, Giulia Scioscia, Laura Pini, Elisa Testino, Erminia Ridolo, Joyce Rolo, Elisa Turchet, Pelaia Gerolamo, Danilo Di Bona, Laura De Ferrari, Francesca Cherubino, Alice D’Adda, Marianna Lilli, Giuseppe Spadaro, Stefano Pucci, Caterina Detoraki, Chiara Allegrini, 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, C., Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, A., 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, F., Santus, P., Barlassina, R., Airoldi, A., Guida, G., Eleonora, N., Aruanno, A., Rizzi, A., Caruso, C., 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, C., Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, L., Condoluci, C., Fuso, L., Bonini, M., Farsi, A., Carli, G., Montuschi, P., 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, 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 C., Spadaro G., Detoraki C., Menzella F., Galeone C., Ruggiero P., Yacoub M.R., Berti A., 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 F., Santus P., Barlassina R., Airoldi A., Guida G., Eleonora N., Aruanno A., Rizzi A., Caruso C., 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 C., Flora M., Cosmi L., Di Pietro L., Maggi E., Pini L., Macchia L., Di Bona D., Richeldi L., Condoluci C., Fuso L., Bonini M., Farsi A., Carli G., Montuschi P., 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 S., Bagnasco, D, Paggiaro, P, Latorre, M, Folli, C, Testino, E, Bassi, A, Milanese, M, Heffler, E, Manfredi, A, Riccio, A, De Ferrari, L, Blasi, F, Frank Canevari, R, Canonica, G, Passalacqua, G, Guarnieri, G, Patella, V, Foschino Barbaro, M, Carpagnano, G, del Colle, A, Scioscia, G, Gerolamo, P, Puggioni, F, Racca, F, Favero, E, Iannacone, S, Savi, E, Montagni, M, Camiciottoli, G, Allegrini, C, Lombardi, C, Spadaro, G, Detoraki, C, Menzella, F, Galeone, C, Ruggiero, P, Yacoub, R, Verrillo, M, Rolla, G, and Lo Cicero, S

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Severe asthma, Immunology, Nice, Disease, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Article, Pulmonary function testing, Internal medicine, Biological treatment, Classification, Definition, medicine, Immunology and Allergy, Respiratory function, computer.programming_language, Biological therapies, business.industry, Settore MED/09 - MEDICINA INTERNA, RC581-607, Severe asthma, Classification, Definition, Biological treatment, Biological treatment, Classification, Definition, Severe asthma, Immunologic diseases. Allergy, business, computer
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

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