One year of mepolizumab. Efficacy and safety in real-life in Italy

Diego Bagnasco, Marco Caminati, Francesco Menzella, Manlio Milanese, Giovanni Rolla, Carlo Lombardi, Caterina Bucca, Enrico Heffler, Giovanni Paoletti, Elisa Testino, Andrea Manfredi, Cristiano Caruso, Giuseppe Guida, Gianenrico Senna, Marco Bonavia, Anna Maria Riccio, Giorgio Walter Canonica, Giovanni Passalacqua

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number101836
JournalPulmonary Pharmacology and Therapeutics
Volume58
DOIs
Publication statusPublished - Oct 1 2019

Fingerprint

Italy
Safety
Asthma
Steroids
Prednisone
mepolizumab
Age of Onset
Eosinophils
Blood
Economics
Clinical Trials
Guidelines
Pharmaceutical Preparations

Keywords

  • Asthma
  • Biologics
  • Eosinophils
  • Exacerbations
  • IL-5
  • Mepolizumab
  • OCS
  • Quality of life
  • Real life
  • Safety
  • Severe asthma

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Biochemistry, medical
  • Pharmacology (medical)

Cite this

Bagnasco, D., Caminati, M., Menzella, F., Milanese, M., Rolla, G., Lombardi, C., ... Passalacqua, G. (2019). One year of mepolizumab. Efficacy and safety in real-life in Italy. Pulmonary Pharmacology and Therapeutics, 58, [101836]. https://doi.org/10.1016/j.pupt.2019.101836

One year of mepolizumab. Efficacy and safety in real-life in Italy. / Bagnasco, Diego; Caminati, Marco; Menzella, Francesco; Milanese, Manlio; Rolla, Giovanni; Lombardi, Carlo; Bucca, Caterina; Heffler, Enrico; Paoletti, Giovanni; Testino, Elisa; Manfredi, Andrea; Caruso, Cristiano; Guida, Giuseppe; Senna, Gianenrico; Bonavia, Marco; Riccio, Anna Maria; Canonica, Giorgio Walter; Passalacqua, Giovanni.

In: Pulmonary Pharmacology and Therapeutics, Vol. 58, 101836, 01.10.2019.

Research output: Contribution to journalArticle

Bagnasco, D, Caminati, M, Menzella, F, Milanese, M, Rolla, G, Lombardi, C, Bucca, C, Heffler, E, Paoletti, G, Testino, E, Manfredi, A, Caruso, C, Guida, G, Senna, G, Bonavia, M, Riccio, AM, Canonica, GW & Passalacqua, G 2019, 'One year of mepolizumab. Efficacy and safety in real-life in Italy', Pulmonary Pharmacology and Therapeutics, vol. 58, 101836. https://doi.org/10.1016/j.pupt.2019.101836
Bagnasco D, Caminati M, Menzella F, Milanese M, Rolla G, Lombardi C et al. One year of mepolizumab. Efficacy and safety in real-life in Italy. Pulmonary Pharmacology and Therapeutics. 2019 Oct 1;58. 101836. https://doi.org/10.1016/j.pupt.2019.101836
Bagnasco, Diego ; Caminati, Marco ; Menzella, Francesco ; Milanese, Manlio ; Rolla, Giovanni ; Lombardi, Carlo ; Bucca, Caterina ; Heffler, Enrico ; Paoletti, Giovanni ; Testino, Elisa ; Manfredi, Andrea ; Caruso, Cristiano ; Guida, Giuseppe ; Senna, Gianenrico ; Bonavia, Marco ; Riccio, Anna Maria ; Canonica, Giorgio Walter ; Passalacqua, Giovanni. / One year of mepolizumab. Efficacy and safety in real-life in Italy. In: Pulmonary Pharmacology and Therapeutics. 2019 ; Vol. 58.
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AU - Bagnasco, Diego

AU - Caminati, Marco

AU - Menzella, Francesco

AU - Milanese, Manlio

AU - Rolla, Giovanni

AU - Lombardi, Carlo

AU - Bucca, Caterina

AU - Heffler, Enrico

AU - Paoletti, Giovanni

AU - Testino, Elisa

AU - Manfredi, Andrea

AU - Caruso, Cristiano

AU - Guida, Giuseppe

AU - Senna, Gianenrico

AU - Bonavia, Marco

AU - Riccio, Anna Maria

AU - Canonica, Giorgio Walter

AU - Passalacqua, Giovanni

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N2 - 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.

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KW - Safety

KW - Severe asthma

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