Biologics as well as inhaled anti-asthmatic therapy achieve clinical remission: Evidence from the Severe Asthma Network in Italy (SANI)
Year: 2024
Type: article
Study design: Observational Study
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).
Authors: Giorgio Walter Canonica, Francesco Blasi, Pierluigi Paggiaro, Enrico Heffler, Fulvio Braido, Luisa Brussino, Giulia Scioscia, Cristina Cardini, Chiara Oriecuia, Isabella Sala, Vincenzo Bagnardi, Cecilia Calabrese, Gianna Camiciottoli, Giovanna Elisiana Carpagnano, Stefano Centanni, Angelo Guido Corsico, Maria Teresa Costantino, Claudia Crimi, Alice D'Adda, Simona D’Alò, Maria D'Amato, Corrado D'Andria, Stefano Del Giacco, Fabiano Di Marco, Nicola Cosimo Facciolongo, Alessandro Farsi, Manuela Latorre, Manlio Milanese, Eustachio Nettis, Eleonora Nucera, Giovanni Passalacqua, Girolamo Pelaia, Laura Pini, Luisa Ricciardi, Fabio Luigi Massimo Ricciardolo, Luca Richeldi, Erminia Ridolo, Pierachille Santus, Nicola Scichilone, Gianenrico Senna, Giuseppe Spadaro, Antonio Spanevello, Paolo Tarsia
Institutions: Humanitas University, IRCCS Humanitas Research Hospital, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Pisa, Ospedale Policlinico San Martino, University of Genoa, A. O. Ordine Mauriziano di Torino, University of Foggia, University of Brescia, University of Milano-Bicocca, Azienda Ospedaliero-Universitaria Careggi, Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari, University of Bari Aldo Moro, Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo, University of Pavia, Policlinico San Matteo Fondazione, Azienda Ospedaliera Carlo Poma, Policlinico Universitario di Catania, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Federico II University Hospital, University of Naples Federico II, University of Cagliari, Ospedale Papa Giovanni XXIII, Azienda Sanitaria Unità Locale di Reggio Emilia, Santa Maria Nuova Hospital, Ospedale di Prato Santo Stefano, Azienda Usl Toscana Centro, Ospedale Santa Corona, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Azienda Ospedaliero-Universitaria "Renato Dulbecco", Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Messina, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Ospedale San Luigi Gonzaga, University of Turin, University of Parma, ASST Fatebenefratelli Sacco, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo, University of Verona, Azienda Ospedaliera Universitaria Integrata Verona, Istituti Clinici Scientifici Maugeri, Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,640
OpenAlex ID: W4405850788