Bruno Sposato1, Gianna Camiciottoli2, Elena Bacci3, Marco Scalese4, Giovanna Elisiana Carpagnano5, Corrado Pelaia6, Pierachille Santus7, Mauro Maniscalco8, Simonetta Masieri9, Angelo Corsico10, Nicola Scichilone11, Stefano Baglioni12, Nicola Murgia13, Ilenia Folletti14, Giulio Bardi15, Amelia Grosso10, Paolo Cameli16, Manuela Latorre3, Antonino Musarra17, Elena Bargagli16, Alberto Ricci18, Girolamo Pelaia6, Pierluigi Paggiaro3, Paola Rogliani19. 1. Azienda USL Toscana Sud-Est Pneumology Department, "Misericordia" Hospital, Grosseto, Italy; Experimental Medicine and Systems, "PhD Program" Department of Systems Medicine University of Rome "Tor Vergata", Italy. Electronic address: bru.sposato@gmail.com. 2. Section of Respiratory Medicine, Department of Experimental and Clinical Medicine, Careggi University Hospital, University of Florence, Largo A Brambilla 3, 50134, Florence, Italy. 3. Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy. 4. Clinic Physiology Institute, National Research Centre, Pisa, Italy. 5. Institute of Respiratory Diseases, Department of Medical and Surgical Sciences, University of Foggia, Italy. 6. Department of Medical and Surgical Sciences, Section of Respiratory Diseases, University "Magna Græcia" of Catanzaro, Catanzaro, Italy. 7. Department of Biomedical and Clinical Sciences (DIBIC), Università Degli Studi di Milano, Division of Pulmonary Diseases, Ospedale L. Sacco, ASST Fatebenfratelli-Sacco, Milan, Italy. 8. Institute Clinic Scientific Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Telese, 82037, Telese Terme, BN, Italy. 9. Department of Sense Organs, Otorhinolaryngology Clinic, Policlinico Umberto I, "Sapienza" University, Rome, Italy. 10. Division of Respiratory Diseases, IRCCS "San Matteo" Hospital Foundation, University of Pavia, Italy. 11. Biomedical Department of Internal Medicine and Medical Specialties (DIBIMIS), University of Palermo, Palermo, Italy. 12. Pneumology Department, Perugia Hospital, Italy. 13. Section of Occupational Medicine, Respiratory Diseases and Toxicology, University of Perugia, Perugia, Italy. 14. Occupational Medicine, Terni Hospital, University of Perugia, Perugia, Italy. 15. Internal Medicine Department, Azienda USL 6 Livorno, Piombino Hospital, Italy. 16. Department of Medicine, Surgery and Neurosciences, Respiratory Diseases and Lung Transplant Unit, University of Siena, Siena, Italy. 17. Allergology Department, Casa della Salute di Scilla, Scilla, RC, Italy. 18. Division of Pneumology, Department of Clinical and Molecular Medicine, Sapienza University of Rome, AOU Sant 'Andrea, Rome, Italy. 19. Experimental Medicine and Systems, "PhD Program" Department of Systems Medicine University of Rome "Tor Vergata", Italy; Respiratory Unit, Department of Experimental Medicine, University of Rome "Tor Vergata" Rome, Italy.
Abstract
BACKGROUND: Mepolizumab (MEP) has been recently introduced to treat severe eosinophilic asthma. Trials have demonstrated a significant effectiveness in this asthma phenotype. We evaluated MEP efficacy on lung function, symptoms, asthma exacerbations, biologic markers, steroid dependence and controller treatment level in real-life. METHODS: We retrospectively analyzed 134 severe asthmatics (61 males; mean age 58.3 ± 11; mean FEV1%:72 ± 21), treated with MEP for at least 6 months (mean duration:10.9 ± 3.7 months). RESULTS: FEV1% improved significantly after MEP. Mean FEF25-75 also increased from 37.4 ± 25.4% to 47.2 ± 27.2% (p < 0.0001). Mean baseline blood eosinophil level was 712 ± 731/μL (8.4 ± 5.2%) decreasing to 151 ± 384/μL (1.6 ± 1.6%) (p < 0.0001), FENO levels decreased likewise. MEP treatment also led to a significant ACT improvement (mean pre:14.2 ± 4.4; mean post:20.5 ± 28) and exacerbations significantly fell from 3.8 ± 1.9 to 0.8 ± 1.1 (p < 0.0001). 74% of patients were steroid-dependent before MEP. 45.4% and 46.4% of them showed a suspension and dose reduction respectively (p < 0.0001). A significant number reduced also ICS doses. Only 67% of subjects used SABA as needed before MEP, falling to 20% after MEP. About 40% of patients highlighted a maintenance therapy step-down. Subjects showing an omalizumab treatment failure before MEP had a similar positive response when compared with omalizumab untreated patients. CONCLUSION: In real-life, MEP improved significantly all outcomes even small airway obstruction, suggesting its possible role also in distal lung region treatment. Furthermore, it demonstrated its high effectiveness in OC/ICS-sparing, in reducing SABA as needed and in stepping-down maintenance therapy. MEP is a valid alternative for patients with previous omalizumab treatment failure.
BACKGROUND: Mepolizumab (MEP) has been recently introduced to treat severe eosinophilic asthma. Trials have demonstrated a significant effectiveness in this asthma phenotype. We evaluated MEP efficacy on lung function, symptoms, asthma exacerbations, biologic markers, steroid dependence and controller treatment level in real-life. METHODS: We retrospectively analyzed 134 severe asthmatics (61 males; mean age 58.3 ± 11; mean FEV1%:72 ± 21), treated with MEP for at least 6 months (mean duration:10.9 ± 3.7 months). RESULTS: FEV1% improved significantly after MEP. Mean FEF25-75 also increased from 37.4 ± 25.4% to 47.2 ± 27.2% (p < 0.0001). Mean baseline blood eosinophil level was 712 ± 731/μL (8.4 ± 5.2%) decreasing to 151 ± 384/μL (1.6 ± 1.6%) (p < 0.0001), FENO levels decreased likewise. MEP treatment also led to a significant ACT improvement (mean pre:14.2 ± 4.4; mean post:20.5 ± 28) and exacerbations significantly fell from 3.8 ± 1.9 to 0.8 ± 1.1 (p < 0.0001). 74% of patients were steroid-dependent before MEP. 45.4% and 46.4% of them showed a suspension and dose reduction respectively (p < 0.0001). A significant number reduced also ICS doses. Only 67% of subjects used SABA as needed before MEP, falling to 20% after MEP. About 40% of patients highlighted a maintenance therapy step-down. Subjects showing an omalizumab treatment failure before MEP had a similar positive response when compared with omalizumab untreated patients. CONCLUSION: In real-life, MEP improved significantly all outcomes even small airway obstruction, suggesting its possible role also in distal lung region treatment. Furthermore, it demonstrated its high effectiveness in OC/ICS-sparing, in reducing SABA as needed and in stepping-down maintenance therapy. MEP is a valid alternative for patients with previous omalizumab treatment failure.
Authors: John Blakey; Li Ping Chung; Vanessa M McDonald; Laurence Ruane; John Gornall; Chris Barton; Sinthia Bosnic-Anticevich; John Harrington; Mark Hew; Anne E Holland; Trudy Hopkins; Lata Jayaram; Helen Reddel; John W Upham; Peter G Gibson; Philip Bardin Journal: Respirology Date: 2021-09-29 Impact factor: 6.175
Authors: Sumita B Khatri; Jonathan M Iaccarino; Amisha Barochia; Israa Soghier; Praveen Akuthota; Anna Brady; Ronina A Covar; Jason S Debley; Zuzana Diamant; Anne M Fitzpatrick; David A Kaminsky; Nicholas J Kenyon; Sandhya Khurana; Brian J Lipworth; Kevin McCarthy; Michael Peters; Loretta G Que; Kristie R Ross; Elena K Schneider-Futschik; Christine A Sorkness; Teal S Hallstrand Journal: Am J Respir Crit Care Med Date: 2021-11-15 Impact factor: 21.405