Diego Bagnasco1, Marco Caminati2, Francesco Menzella3, Manlio Milanese4, Giovanni Rolla5, Carlo Lombardi6, Caterina Bucca7, Enrico Heffler8, Giovanni Paoletti8, Elisa Testino1, Andrea Manfredi1, Cristiano Caruso9, Giuseppe Guida10, Gianenrico Senna2, Marco Bonavia11, Anna Maria Riccio1, Giorgio Walter Canonica8, Giovanni Passalacqua12. 1. Allergy and Respiratory Diseases, IRCCS Policlinico San Martino, University of Genoa, Italy. 2. Asthma Center and Allergy Unit, Verona University and General Hospital, Department of Medicine, University of Verona, Verona, Italy. 3. Azienda USL di Reggio Emilia-IRCSS, Santa Maria Nuova Hospital- Pneumology Unit, Reggio Emilia, Italy. 4. Division of Pneumology, S.Corona Hospital, Pietra Ligure, Italy. 5. Allergy and Immunology, AO Mauriziano Hospital, University of Turin, Italy. 6. Departmental Unit of Allergology & Respiratory Diseases, Fondazione Poliambulanza, Brescia, Italy. 7. Azienda Ospedale-Università Città della Salute e della Scienza, S.C. Pneumologia, Turin, Italy. 8. Personalized Medicine, Asthma and Allergy - Humanitas Clinical and Research Center - IRCCS, Rozzano (MI), Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy. 9. Allergy Unit, Fondazione Policlinico A. Gemelli, IRCSS, Rome, Italy. 10. Allergy and Pneumology Unit, A.O. S.Croce e Carle, Cuneo, Italy. 11. Pneumologia, Ospedale La Colletta, Arenzano, Italy. 12. Allergy and Respiratory Diseases, IRCCS Policlinico San Martino, University of Genoa, Italy. Electronic address: passalacqua@unige.it.
Abstract
BACKGROUND: Severe asthma is a disease with a heavy socio-economic burden and a relevant impact on the life of patients. Mepolizumab (MEP) was recently introduced in practice. The previous data were favourable as efficacy and safety are concerned. Nowadays, we can report the clinical data after more than one year of use of MEP in the real-life setting. OBJECTIVE: To evaluate the efficacy and safety of MEP in a real life framework, mainly concerning asthma exacerbations, steroid dependence, effects on respiratory function and adverse events. METHODS: This retrospective analysis was performed on 138 patients, treated with MEP for at least 12 months, and referred to eleven severe asthma clinics in Italy. All patients met the criteria for severe uncontrolled asthma according to ATS/ERS guidelines and prescribing MEP conditions according to the Italian Drug Agency (AIFA). RESULTS: We could observe 138 patients (78 female, age 58 ± 10 years). The average age of onset of asthma was 34 ± 16 years. The blood eosinophil count decreased from 822 ± 491/μL at baseline to 117 ± 96/μL (p < .0001) after 12 months of therapy. Exacerbations decreased from 3.8/year to 0.7/year (-81%; p < .0001). Steroid-dependent patients before MEP (80%) with a daily dose of 10.1 ± 9.4 mg prednisone decrease at 28% after 12 months with a mean of 2.0 ± 4.2 mg/day (p < .0001). The occurrence of adverse events was overall low. CONCLUSIONS & CLINICAL RELEVANCE: In this real-life setting, MEP confirmed its efficacy and safety profile, already shown in clinical trials. This was apparent concerning exacerbation rate, systemic steroids intake and safety.
BACKGROUND: Severe asthma is a disease with a heavy socio-economic burden and a relevant impact on the life of patients. Mepolizumab (MEP) was recently introduced in practice. The previous data were favourable as efficacy and safety are concerned. Nowadays, we can report the clinical data after more than one year of use of MEP in the real-life setting. OBJECTIVE: To evaluate the efficacy and safety of MEP in a real life framework, mainly concerning asthma exacerbations, steroid dependence, effects on respiratory function and adverse events. METHODS: This retrospective analysis was performed on 138 patients, treated with MEP for at least 12 months, and referred to eleven severe asthma clinics in Italy. All patients met the criteria for severe uncontrolled asthma according to ATS/ERS guidelines and prescribing MEP conditions according to the Italian Drug Agency (AIFA). RESULTS: We could observe 138 patients (78 female, age 58 ± 10 years). The average age of onset of asthma was 34 ± 16 years. The blood eosinophil count decreased from 822 ± 491/μL at baseline to 117 ± 96/μL (p < .0001) after 12 months of therapy. Exacerbations decreased from 3.8/year to 0.7/year (-81%; p < .0001). Steroid-dependent patients before MEP (80%) with a daily dose of 10.1 ± 9.4 mg prednisone decrease at 28% after 12 months with a mean of 2.0 ± 4.2 mg/day (p < .0001). The occurrence of adverse events was overall low. CONCLUSIONS & CLINICAL RELEVANCE: In this real-life setting, MEP confirmed its efficacy and safety profile, already shown in clinical trials. This was apparent concerning exacerbation rate, systemic steroids intake and safety.
Authors: Diego Bagnasco; Massimiliano Povero; Lorenzo Pradelli; Luisa Brussino; Giovanni Rolla; Marco Caminati; Francesco Menzella; Enrico Heffler; Giorgio Walter Canonica; Pierluigi Paggiaro; Gianenrico Senna; Manlio Milanese; Carlo Lombardi; Caterina Bucca; Andrea Manfredi; Rikki Frank Canevari; Giovanni Passalacqua Journal: World Allergy Organ J Date: 2021-01-27 Impact factor: 4.084
Authors: Diego Bagnasco; Elisa Testino; Stefania Nicola; Laura Melissari; Maria Russo; Rikki Frank Canevari; Luisa Brussino; Giovanni Passalacqua Journal: J Pers Med Date: 2022-04-07
Authors: Tim Harrison; Giorgio Walter Canonica; Geoffrey Chupp; Jason Lee; Florence Schleich; Tobias Welte; Antonio Valero; Kim Gemzoe; Aoife Maxwell; Sandra Joksaite; Shibing Yang; Peter Howarth; Melissa K Van Dyke Journal: Eur Respir J Date: 2020-10-15 Impact factor: 16.671