Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI)
Background: This study aimed to evaluate the impact of severe asthma (SA) treatments after 12 months in achieving clinical remission (CR) within the context of the Severe Asthma Network in Italy (SANI) using the recent SANI definition of CR on treatment. Methods: CR has been defined by SANI as compl...
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2025-01-01
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| author | Giorgio Walter Canonica, MD Francesco Blasi, PhD Pierluigi Paggiaro, MD Enrico Heffler, PhD Fulvio Braido, MD Luisa Brussino, PhD Giulia Scioscia, PhD Cristina Cardini, MsC Chiara Oriecuia, MsC Isabella Sala, MsC Vincenzo Bagnardi, PhD Cecilia Calabrese, PhD Gianna Camiciottoli, MD Giovanna Elisiana Carpagnano, PhD Stefano Centanni, PhD Angelo Guido Corsico, PhD Maria Teresa Costantino, MD Claudia Crimi, PhD Alice D'Adda, MD Simona D’Alò, MD Maria D'Amato, PhD Corrado D'Andria, MD Stefano Del Giacco, MD Fabiano Di Marco, PhD Nicola Cosimo Facciolongo, MD Alessandro Farsi, MD Manuela Latorre, PhD Manlio Milanese, PhD Eustachio Nettis, MD Eleonora Nucera, MD Giovanni Passalacqua, MD Girolamo Pelaia, MD Laura Pini, MD Luisa Ricciardi, PhD Fabio Luigi Massimo Ricciardolo, PhD Luca Richeldi, PhD Erminia Ridolo, PhD Pierachille Santus, PhD Nicola Scichilone, PhD Gianenrico Senna, MD Giuseppe Spadaro, MD Antonio Spanevello, MD Paolo Tarsia, MD |
| author_facet | Giorgio Walter Canonica, MD Francesco Blasi, PhD Pierluigi Paggiaro, MD Enrico Heffler, PhD Fulvio Braido, MD Luisa Brussino, PhD Giulia Scioscia, PhD Cristina Cardini, MsC Chiara Oriecuia, MsC Isabella Sala, MsC Vincenzo Bagnardi, PhD Cecilia Calabrese, PhD Gianna Camiciottoli, MD Giovanna Elisiana Carpagnano, PhD Stefano Centanni, PhD Angelo Guido Corsico, PhD Maria Teresa Costantino, MD Claudia Crimi, PhD Alice D'Adda, MD Simona D’Alò, MD Maria D'Amato, PhD Corrado D'Andria, MD Stefano Del Giacco, MD Fabiano Di Marco, PhD Nicola Cosimo Facciolongo, MD Alessandro Farsi, MD Manuela Latorre, PhD Manlio Milanese, PhD Eustachio Nettis, MD Eleonora Nucera, MD Giovanni Passalacqua, MD Girolamo Pelaia, MD Laura Pini, MD Luisa Ricciardi, PhD Fabio Luigi Massimo Ricciardolo, PhD Luca Richeldi, PhD Erminia Ridolo, PhD Pierachille Santus, PhD Nicola Scichilone, PhD Gianenrico Senna, MD Giuseppe Spadaro, MD Antonio Spanevello, MD Paolo Tarsia, MD |
| author_sort | Giorgio Walter Canonica, MD |
| collection | DOAJ |
| description | Background: This study aimed to evaluate the impact of severe asthma (SA) treatments after 12 months in achieving clinical remission (CR) within the context of the Severe Asthma Network in Italy (SANI) using the recent SANI definition of CR on treatment. Methods: CR has been defined by SANI as complete, partial, and no CR. Complete CR is defined by the absence of oral corticosteroids (OCS), no symptoms, no exacerbations, and stable lung function, and partial CR requires the absence of OCS and the fulfillment of 2 out of the other 3 criteria. Patients who do not meet the previous criteria do not reach CR. Results: After 12 months of treatment, 283 patients were selected to evaluate the effectiveness of biologics (225 patients) and inhaled therapy (58 patients) in achieving CR. Among patients treated with biologic agents, 45.8% reached complete CR, 23.1% partial CR, and 31.1% no CR. Differences in CR achievement according to type of biologic agent administered were observed. Interesting results were found when assessing the inhaled therapy (ICS/LABA/LAMA and no biologics) effectiveness: 34.5% patients reached complete CR, 34.5% partial CR, and 31.0% did not reach CR. This finding is noteworthy since it further supports the efficacy of inhaled treatment in certain SA patients and highlights the relevance of using CR as a modern outcome of SA treatments. Chronic rhinosinusitis with nasal polyps (CRSwNP) comorbidity was associated, though not significantly, with CR achievement in patients treated with biologics. Asthma Control Test (ACT) and Asthma Control Questionnaire (ACQ) scores significantly impacted CR (p = 0.003 and p = 0.027, respectively), while biomarkers, namely IgE, blood eosinophils, or fractional exhaled nitric oxide (FeNO), were not associated with CR achievement. Conclusions: This study confirmed the effectiveness of biologics in reaching CR and demonstrated also inhaled therapies able to achieve CR. These innovative findings should encourage post hoc analysis of randomized clinical trials or even retrospective analysis of SA patient cohorts to evaluate CR with different inhaled treatments and further define the populations eligible for each treatment. Trial registration: ClinicalTrials.gov ID: NCT06625216; Central Ethics Committee: Comitato Etico Area Vasta Nord-Ovest Toscana (study number 1245/2016, protocol number:73714). |
| format | Article |
| id | doaj-art-11e9a995c14d47fba3fa50f3f3381b55 |
| institution | Kabale University |
| issn | 1939-4551 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | World Allergy Organization Journal |
| spelling | doaj-art-11e9a995c14d47fba3fa50f3f3381b552025-01-17T04:49:16ZengElsevierWorld Allergy Organization Journal1939-45512025-01-01181101016Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI)Giorgio Walter Canonica, MD0Francesco Blasi, PhD1Pierluigi Paggiaro, MD2Enrico Heffler, PhD3Fulvio Braido, MD4Luisa Brussino, PhD5Giulia Scioscia, PhD6Cristina Cardini, MsC7Chiara Oriecuia, MsC8Isabella Sala, MsC9Vincenzo Bagnardi, PhD10Cecilia Calabrese, PhD11Gianna Camiciottoli, MD12Giovanna Elisiana Carpagnano, PhD13Stefano Centanni, PhD14Angelo Guido Corsico, PhD15Maria Teresa Costantino, MD16Claudia Crimi, PhD17Alice D'Adda, MD18Simona D’Alò, MD19Maria D'Amato, PhD20Corrado D'Andria, MD21Stefano Del Giacco, MD22Fabiano Di Marco, PhD23Nicola Cosimo Facciolongo, MD24Alessandro Farsi, MD25Manuela Latorre, PhD26Manlio Milanese, PhD27Eustachio Nettis, MD28Eleonora Nucera, MD29Giovanni Passalacqua, MD30Girolamo Pelaia, MD31Laura Pini, MD32Luisa Ricciardi, PhD33Fabio Luigi Massimo Ricciardolo, PhD34Luca Richeldi, PhD35Erminia Ridolo, PhD36Pierachille Santus, PhD37Nicola Scichilone, PhD38Gianenrico Senna, MD39Giuseppe Spadaro, MD40Antonio Spanevello, MD41Paolo Tarsia, MD42Dept of Biomedical Sciences, Humanitas University, via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy; Asthma & Allergy Unit-IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy; Corresponding author. Department of Translational Biomedicine and Neuroscience“DiBraiN”, University of Bari Aldo Moro, Bari, Italy.Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, ItalyDepartment of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, ItalyDept of Biomedical Sciences, Humanitas University, via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy; Asthma & Allergy Unit-IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, ItalyRespiratory Diseases and Allergy Department, IRCCS Polyclinic Hospital San Martino, Genoa, Italy; Department of Internal Medicine (DIMI), University of Genoa, Genoa, ItalyS.C.D.U. Immunologia e Allergologia, A.O. Ordine Mauriziano Torino, ItalyDepartment of Medical and Surgical Sciences, University of Foggia, Foggia, ItalyFondazione per la Salute Respiratoria della Società Italiana di Pneumologia SIP-IRS, Milan, ItalyDepartment of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Department of Molecular and Translational Medicine, University of Brescia, Brescia, ItalyDepartment of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, ItalyDepartment of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, ItalyDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, ItalyUNIT ASMA GRAVE - Ambulatorio Asma Grave Pneumologia e Fisiopatologia Toraco-Polmonare, Azienda Ospedaliera Universitaria Careggi (FI), Florence, ItalyDepartment of Translational Biomedicine and Neuroscience“DiBraiN”, University of Bari Aldo Moro, Bari, Italy; Section of Respiratory Diseases, Policlinico Hospital of Bari, ItalyRespiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Department of Health Sciences, University of Milan, Milan, ItalyDivision of Respiratory Diseases, IRCCS Policlinico San Matteo, Foundation and Department of Internal Medicine and Therapeutics, University of Pavia, ItalyAllergy and Clinical Immunology Unit, Department of Medicine, ''Carlo Poma'' Hospital Mantova, ItalyRespiratory Medicine Unit, Policlinico “G. Rodolico-San Marco” University Hospital, Catania, ItalyBroncopneumologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, ItalyUOC Allergologia - PO Civitanova Marche - AREA VASTA 3, Civitanova Marche, ItalyDepartment of Respiratory Medicine, University “Federico II” of Naples, ItalyInternal and Respiratory Medicine, SS Annunziata Hospital, Taranto, ItalyUnit of Allergy and Clinical Immunology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, ItalyPulmonary Medicine Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, ItalyUOC di Pneumologia, Arcispedale S. Maria Nuova Azienda USL di Reggio Emilia, ItalySOSD Allergology and Clinical Immunology, Ospedale S. Stefano, USL Toscana Centro, Prato, ItalyPulmonary Unit, Nuovo Ospedale Apuano, Massa, ItalyPulmonology Unit, Santa Corona Hospital, Pietra Ligure (Savona), ItalyDepartment of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma, Italy; UOSD Allergologia e Immunologia Clinica, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma, ItalyRespiratory Diseases and Allergy Department, IRCCS Polyclinic Hospital San Martino, Genoa, ItalyU.O. Malattie dell’Apparato Respiratorio, A.O.U. Mater Domini, Catanzaro, ItalyDepartment of Clinical and Experimental Sciences, University of Brescia - ASST Spedali Civili di Brescia, ItalyAllergologia e Immunologia Clinica, AOU Policlinico G. Martino - Università di Messina, Messina ItalyDepartment of Clinical and Biological Sciences, University of Turin, San Luigi Gonzaga University Hospital, Orbassano, Turin, ItalyFondazione Policlinico Universitario A. Gemelli, IRCCS Catholic University of Rome, ItalyDepartment of Medicine and Surgery, University of Parma, Parma, ItalyDepartment of Clinical and Biomedical Sciences, University of Milan, Respiratory Diseases, Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, ItalyU.O.C. Pneumologia, Azienda Ospedaliera Universitaria Policlinico P. Giaccone di Palermo, ItalyDepartment of Medicine, University of Verona, and Asthma Center and Allergy Unit, Verona University Hospital, Verona, ItalyCenter for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, ItalyPneumologia Riabilitativa, ICS Maugeri IRCCS Tradate, Tradate, (VA), ItalyPneumology Unit, Grande Ospedale Metropolitano Niguarda, Milan, ItalyBackground: This study aimed to evaluate the impact of severe asthma (SA) treatments after 12 months in achieving clinical remission (CR) within the context of the Severe Asthma Network in Italy (SANI) using the recent SANI definition of CR on treatment. Methods: CR has been defined by SANI as complete, partial, and no CR. Complete CR is defined by the absence of oral corticosteroids (OCS), no symptoms, no exacerbations, and stable lung function, and partial CR requires the absence of OCS and the fulfillment of 2 out of the other 3 criteria. Patients who do not meet the previous criteria do not reach CR. Results: After 12 months of treatment, 283 patients were selected to evaluate the effectiveness of biologics (225 patients) and inhaled therapy (58 patients) in achieving CR. Among patients treated with biologic agents, 45.8% reached complete CR, 23.1% partial CR, and 31.1% no CR. Differences in CR achievement according to type of biologic agent administered were observed. Interesting results were found when assessing the inhaled therapy (ICS/LABA/LAMA and no biologics) effectiveness: 34.5% patients reached complete CR, 34.5% partial CR, and 31.0% did not reach CR. This finding is noteworthy since it further supports the efficacy of inhaled treatment in certain SA patients and highlights the relevance of using CR as a modern outcome of SA treatments. Chronic rhinosinusitis with nasal polyps (CRSwNP) comorbidity was associated, though not significantly, with CR achievement in patients treated with biologics. Asthma Control Test (ACT) and Asthma Control Questionnaire (ACQ) scores significantly impacted CR (p = 0.003 and p = 0.027, respectively), while biomarkers, namely IgE, blood eosinophils, or fractional exhaled nitric oxide (FeNO), were not associated with CR achievement. Conclusions: This study confirmed the effectiveness of biologics in reaching CR and demonstrated also inhaled therapies able to achieve CR. These innovative findings should encourage post hoc analysis of randomized clinical trials or even retrospective analysis of SA patient cohorts to evaluate CR with different inhaled treatments and further define the populations eligible for each treatment. Trial registration: ClinicalTrials.gov ID: NCT06625216; Central Ethics Committee: Comitato Etico Area Vasta Nord-Ovest Toscana (study number 1245/2016, protocol number:73714).http://www.sciencedirect.com/science/article/pii/S1939455124001480Severe asthmaClinical remissionInhaled therapyBiologicsRegistry |
| spellingShingle | Giorgio Walter Canonica, MD Francesco Blasi, PhD Pierluigi Paggiaro, MD Enrico Heffler, PhD Fulvio Braido, MD Luisa Brussino, PhD Giulia Scioscia, PhD Cristina Cardini, MsC Chiara Oriecuia, MsC Isabella Sala, MsC Vincenzo Bagnardi, PhD Cecilia Calabrese, PhD Gianna Camiciottoli, MD Giovanna Elisiana Carpagnano, PhD Stefano Centanni, PhD Angelo Guido Corsico, PhD Maria Teresa Costantino, MD Claudia Crimi, PhD Alice D'Adda, MD Simona D’Alò, MD Maria D'Amato, PhD Corrado D'Andria, MD Stefano Del Giacco, MD Fabiano Di Marco, PhD Nicola Cosimo Facciolongo, MD Alessandro Farsi, MD Manuela Latorre, PhD Manlio Milanese, PhD Eustachio Nettis, MD Eleonora Nucera, MD Giovanni Passalacqua, MD Girolamo Pelaia, MD Laura Pini, MD Luisa Ricciardi, PhD Fabio Luigi Massimo Ricciardolo, PhD Luca Richeldi, PhD Erminia Ridolo, PhD Pierachille Santus, PhD Nicola Scichilone, PhD Gianenrico Senna, MD Giuseppe Spadaro, MD Antonio Spanevello, MD Paolo Tarsia, MD Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) World Allergy Organization Journal Severe asthma Clinical remission Inhaled therapy Biologics Registry |
| title | Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) |
| title_full | Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) |
| title_fullStr | Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) |
| title_full_unstemmed | Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) |
| title_short | Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI) |
| title_sort | biologics as well as inhaled anti asthmatic therapy achieve clinical remission evidence from the severe asthma network in italy sani |
| topic | Severe asthma Clinical remission Inhaled therapy Biologics Registry |
| url | http://www.sciencedirect.com/science/article/pii/S1939455124001480 |
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