Santi Nolasco1, Claudia Crimi2, Corrado Pelaia3, Alida Benfante4, Maria Filomena Caiaffa5, Cecilia Calabrese6, Giovanna Elisiana Carpagnano7, Domenico Ciotta8, Maria D'Amato9, Luigi Macchia10, Girolamo Pelaia3, Simona Pellegrino8, Nicola Scichilone4, Giulia Scioscia5, Giuseppe Spadaro11, Raffaele Campisi12, Giuseppe Valenti13, Alessandro Vatrella8, Nunzio Crimi14. 1. Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy. 2. Respiratory Medicine Unit, A.O.U. Policlinico "G. Rodolico-San Marco", Catania, Italy. Electronic address: dott.claudiacrimi@gmail.com. 3. Department of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy. 4. PROMISE Department, University of Palermo, Palermo, Italy. 5. Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy. 6. Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy. 7. Respiratory Medicine Section, Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy. 8. Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Italy. 9. Respiratory Department, Division of Respiratory Diseases, "Federico II" University, Naples, Italy. 10. Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari Aldo Moro, Bari, Italy. 11. Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy. 12. Respiratory Medicine Unit, A.O.U. Policlinico "G. Rodolico-San Marco", Catania, Italy. 13. Allergology and Pulmonology Unit, Provincial Outpatient Center of Palermo, Palermo, Italy. 14. Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; Respiratory Medicine Unit, A.O.U. Policlinico "G. Rodolico-San Marco", Catania, Italy.
Abstract
BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) affects around 60% of patients with severe eosinophilic asthma (SEA). Benralizumab was recently approved for SEA add-on treatment. OBJECTIVE: To assess the real-world effectiveness of benralizumab in SEA with or without CRSwNP. METHODS: We conducted a multicenter observational study, including patients with SEA treated with benralizumab for 24 weeks in 12 Italian specialized facilities. Asthma exacerbations, Asthma Control Test (ACT), lung function, oral corticosteroid (OCS) dosage, and eosinophil and basophil count in peripheral blood were recorded at baseline and after 4, 12, and 24 weeks. The 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Mackay scores were assessed at baseline and after 24 weeks in SEA+CRSwNP. RESULTS: A total of 137 patients with late-onset SEA were included; 57.7% (79 of 137) showed the copresence of CRSwNP. Overall, severe asthma exacerbations decreased from 4 (3-6) to 0 (0-2) (P < .0001) after 24 weeks of treatment, and significant improvements were observed as early as 4 weeks in ACT score, OCS dosage, forced expiratory volume in the 1st second (FEV1)%, FEV1 (L), forced vital capacity (FVC)%, FEV1/FVC% (P < .0001), and forced expiratory flow between 25% and 75% of FVC (FEF25-75)% (P = .0022). Eosinophils and basophils in peripheral blood were rapidly depleted. In patients with SEA+CRSwNP, SNOT-22 decreased from 46 (39.5-64.5) to 32 (19-46) (P < .0001). Furthermore, in comparison with SEA, they showed enhanced responses with regard to ACT minimal clinically important difference (P = .0387), FEV1% (P = .017), FEV1 (L) (P = .02), and FEF25-75% (P = .0362). CONCLUSIONS: These real-world data suggest that benralizumab can represent a valid add-on therapeutic option for patients with SEA, especially with comorbid CRSwNP.
BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) affects around 60% of patients with severe eosinophilic asthma (SEA). Benralizumab was recently approved for SEA add-on treatment. OBJECTIVE: To assess the real-world effectiveness of benralizumab in SEA with or without CRSwNP. METHODS: We conducted a multicenter observational study, including patients with SEA treated with benralizumab for 24 weeks in 12 Italian specialized facilities. Asthma exacerbations, Asthma Control Test (ACT), lung function, oral corticosteroid (OCS) dosage, and eosinophil and basophil count in peripheral blood were recorded at baseline and after 4, 12, and 24 weeks. The 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Mackay scores were assessed at baseline and after 24 weeks in SEA+CRSwNP. RESULTS: A total of 137 patients with late-onset SEA were included; 57.7% (79 of 137) showed the copresence of CRSwNP. Overall, severe asthma exacerbations decreased from 4 (3-6) to 0 (0-2) (P < .0001) after 24 weeks of treatment, and significant improvements were observed as early as 4 weeks in ACT score, OCS dosage, forced expiratory volume in the 1st second (FEV1)%, FEV1 (L), forced vital capacity (FVC)%, FEV1/FVC% (P < .0001), and forced expiratory flow between 25% and 75% of FVC (FEF25-75)% (P = .0022). Eosinophils and basophils in peripheral blood were rapidly depleted. In patients with SEA+CRSwNP, SNOT-22 decreased from 46 (39.5-64.5) to 32 (19-46) (P < .0001). Furthermore, in comparison with SEA, they showed enhanced responses with regard to ACT minimal clinically important difference (P = .0387), FEV1% (P = .017), FEV1 (L) (P = .02), and FEF25-75% (P = .0362). CONCLUSIONS: These real-world data suggest that benralizumab can represent a valid add-on therapeutic option for patients with SEA, especially with comorbid CRSwNP.
Authors: Ismael García-Moguel; Ana Rosado; Aída Gómez-Cardeñosa; Mar Gandolfo-Cano; Teresa Robledo Echarren; Maria Del Mar Moro Moro; Mª Del Mar Reaño Martos; Rafael Pineda-Pineda; Marcela Valverde-Monge; Cristina Martin-Arriscado Arroba; Javier Domínguez-Ortega Journal: J Asthma Allergy Date: 2022-05-13
Authors: Cristiano Caruso; Paolo Cameli; Elena Altieri; Maria Aliani; Pietro Bracciale; Luisa Brussino; Maria Filomena Caiaffa; Giorgio Walter Canonica; Stefano Centanni; Maria D'Amato; Stefano Del Giacco; Fausto De Michele; Elide Anna Pastorello; Girolamo Pelaia; Paola Rogliani; Micaela Romagnoli; Pietro Schino; Marco Caminati; Alessandra Vultaggio; Alessandro Zullo; Sara Rizzoli; Silvia Boarino; Gianfranco Vitiello; Francesco Menzella; Fabiano Di Marco Journal: Front Med (Lausanne) Date: 2022-09-02
Authors: Maria D'Amato; Francesco Menzella; Elena Altieri; Elena Bargagli; Pietro Bracciale; Luisa Brussino; Maria Filomena Caiaffa; Giorgio Walter Canonica; Cristiano Caruso; Stefano Centanni; Fausto De Michele; Fabiano Di Marco; Elide Anna Pastorello; Girolamo Pelaia; Paola Rogliani; Micaela Romagnoli; Pietro Schino; Gianenrico Senna; Alessandra Vultaggio; Alessandra Ori; Lucia Simoni; Silvia Boarino; Gianfranco Vitiello; Maria Aliani; Stefano Del Giacco Journal: Front Allergy Date: 2022-05-18
Authors: Luis A Pérez de Llano; Borja G Cosío; Ignacio Lobato Astiárraga; Gregorio Soto Campos; Miguel Ángel Tejedor Alonso; Nuria Marina Malanda; Alicia Padilla Galo; Isabel Urrutia Landa; Francisco J Michel de la Rosa; Ismael García-Moguel Journal: J Asthma Allergy Date: 2022-01-14