World Allergy Organization Journal (Jan 2025)
Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI)
- 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
Affiliations
- Giorgio Walter Canonica, MD
- Dept 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.
- Francesco Blasi, PhD
- 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, Italy
- Pierluigi Paggiaro, MD
- Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy
- Enrico Heffler, PhD
- Dept 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
- Fulvio Braido, MD
- Respiratory Diseases and Allergy Department, IRCCS Polyclinic Hospital San Martino, Genoa, Italy; Department of Internal Medicine (DIMI), University of Genoa, Genoa, Italy
- Luisa Brussino, PhD
- S.C.D.U. Immunologia e Allergologia, A.O. Ordine Mauriziano Torino, Italy
- Giulia Scioscia, PhD
- Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy
- Cristina Cardini, MsC
- Fondazione per la Salute Respiratoria della Società Italiana di Pneumologia SIP-IRS, Milan, Italy
- Chiara Oriecuia, MsC
- Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy
- Isabella Sala, MsC
- Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy
- Vincenzo Bagnardi, PhD
- Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy
- Cecilia Calabrese, PhD
- Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy
- Gianna Camiciottoli, MD
- UNIT ASMA GRAVE - Ambulatorio Asma Grave Pneumologia e Fisiopatologia Toraco-Polmonare, Azienda Ospedaliera Universitaria Careggi (FI), Florence, Italy
- Giovanna Elisiana Carpagnano, PhD
- Department of Translational Biomedicine and Neuroscience“DiBraiN”, University of Bari Aldo Moro, Bari, Italy; Section of Respiratory Diseases, Policlinico Hospital of Bari, Italy
- Stefano Centanni, PhD
- Respiratory Unit, ASST Santi Paolo e Carlo, San Paolo Hospital, Department of Health Sciences, University of Milan, Milan, Italy
- Angelo Guido Corsico, PhD
- Division of Respiratory Diseases, IRCCS Policlinico San Matteo, Foundation and Department of Internal Medicine and Therapeutics, University of Pavia, Italy
- Maria Teresa Costantino, MD
- Allergy and Clinical Immunology Unit, Department of Medicine, ''Carlo Poma'' Hospital Mantova, Italy
- Claudia Crimi, PhD
- Respiratory Medicine Unit, Policlinico “G. Rodolico-San Marco” University Hospital, Catania, Italy
- Alice D'Adda, MD
- Broncopneumologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
- Simona D’Alò, MD
- UOC Allergologia - PO Civitanova Marche - AREA VASTA 3, Civitanova Marche, Italy
- Maria D'Amato, PhD
- Department of Respiratory Medicine, University “Federico II” of Naples, Italy
- Corrado D'Andria, MD
- Internal and Respiratory Medicine, SS Annunziata Hospital, Taranto, Italy
- Stefano Del Giacco, MD
- Unit of Allergy and Clinical Immunology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy
- Fabiano Di Marco, PhD
- Pulmonary Medicine Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy
- Nicola Cosimo Facciolongo, MD
- UOC di Pneumologia, Arcispedale S. Maria Nuova Azienda USL di Reggio Emilia, Italy
- Alessandro Farsi, MD
- SOSD Allergology and Clinical Immunology, Ospedale S. Stefano, USL Toscana Centro, Prato, Italy
- Manuela Latorre, PhD
- Pulmonary Unit, Nuovo Ospedale Apuano, Massa, Italy
- Manlio Milanese, PhD
- Pulmonology Unit, Santa Corona Hospital, Pietra Ligure (Savona), Italy
- Eustachio Nettis, MD
- Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, Italy
- Eleonora Nucera, MD
- Fondazione 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, Italy
- Giovanni Passalacqua, MD
- Respiratory Diseases and Allergy Department, IRCCS Polyclinic Hospital San Martino, Genoa, Italy
- Girolamo Pelaia, MD
- U.O. Malattie dell’Apparato Respiratorio, A.O.U. Mater Domini, Catanzaro, Italy
- Laura Pini, MD
- Department of Clinical and Experimental Sciences, University of Brescia - ASST Spedali Civili di Brescia, Italy
- Luisa Ricciardi, PhD
- Allergologia e Immunologia Clinica, AOU Policlinico G. Martino - Università di Messina, Messina Italy
- Fabio Luigi Massimo Ricciardolo, PhD
- Department of Clinical and Biological Sciences, University of Turin, San Luigi Gonzaga University Hospital, Orbassano, Turin, Italy
- Luca Richeldi, PhD
- Fondazione Policlinico Universitario A. Gemelli, IRCCS Catholic University of Rome, Italy
- Erminia Ridolo, PhD
- Department of Medicine and Surgery, University of Parma, Parma, Italy
- Pierachille Santus, PhD
- Department of Clinical and Biomedical Sciences, University of Milan, Respiratory Diseases, Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy
- Nicola Scichilone, PhD
- U.O.C. Pneumologia, Azienda Ospedaliera Universitaria Policlinico P. Giaccone di Palermo, Italy
- Gianenrico Senna, MD
- Department of Medicine, University of Verona, and Asthma Center and Allergy Unit, Verona University Hospital, Verona, Italy
- Giuseppe Spadaro, MD
- Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy
- Antonio Spanevello, MD
- Pneumologia Riabilitativa, ICS Maugeri IRCCS Tradate, Tradate, (VA), Italy
- Paolo Tarsia, MD
- Pneumology Unit, Grande Ospedale Metropolitano Niguarda, Milan, Italy
- Journal volume & issue
-
Vol. 18,
no. 1
p. 101016
Abstract
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).
